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Storage Temperature on Label – Freeze Cold Cool Dry Label Storage Temperature

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Storage Temperature on Label - Freeze Cold Cool Dry Label Storage Temperature

Hello buddies. Pharmawiki.in here with another amazing and most important article “Storage Temperature on Label – Freeze Cold Cool Dry Label Storage Temperature” for all the pharma students pharmacists and any one who is into pharmaceutical field. This article not only helps pharma people but also the general public as we see these terms daily on all the pharmaceutical products we use. Specifically today we are talking about storage temperature on the label. These temperatures and definitions will also help you in many competitive and entrance examinations like GPAT Pharmacist exam, Drug Inspector examination. Then why delay just jump into the points straight away. 

Storage Temperature and Humidity

Specific directions are stated in some monographs with respect to the temperatures and humidity at which official articles shall be stored and distributed (including the shipment of articles to the consumer) when stability data indicate that storage and distribution at a lower or a higher temperature and a higher humidity produce undesirable results. Such directions apply except where the label on an article states a different storage temperature on the basis of stability studies of that particular formulation. Where no specific storage directions or limitations are provided in the individual monograph, but the label of an article states a storage temperature that is based on stability studies of that particular formulation, such labeled storage directions apply. ) The conditions are defined by the following terms.

Freezer

“Freezer” indicates a place in which the temperature is maintained thermostatically between −25° and −10° (−13° and 14°F).

Cold

Any temperature not exceeding 8° (46°F) is “cold.” A “refrigerator” is a cold place in which the temperature is maintained thermostatically between 2° and 8° (36° and 46°F).

Cool

Any temperature between 8° and 15° (46° and 59°F) is “cool.” An article for which storage in a cool place is directed may, alternatively, be stored and distributed in a refrigerator, unless otherwise specified by
the individual monograph.

 Controlled Cold Temperature

Storage Temperature on Label - Freeze Cold Cool Dry Label Storage Temperature

“Controlled cold temperature” is defined as temperature maintained thermostatically between 2° and 8° (36° and 46°F), that allows for excursions in temperature between 0° and 15° (32° and 59°F) that may be experienced during storage, shipping, and distribution such that the allowable calculated mean kinetic temperature is not more than 8° (46°F). Transient spikes up to 25° (77°F) may be permitted if the manufacturer so instructs and provided that such spikes do not exceed 24 hours unless supported by stability data or the manufacturer instructs otherwise.

Room Temperature

“Room temperature” indicates the temperature prevailing in a working area.

Controlled Room Temperature

“Controlled room temperature” indicates a temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25° (68° to 77°F); that results in a mean kinetic temperature calculated to be not more than 25°; and that allows for excursions between 15° and 30° (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses. Provided the mean kinetic temperature remains in the allowed range, transient spikes up to 40° are permitted as long as they do not exceed 24 hours. Spikes above 40° may be permitted if the manufacturer so instructs. Articles may be labeled for storage at “controlled room temperature” or at “up to 25°”, or USP Pharmacists’ Pharmacopeia

General Notices other wording based on the same mean kinetic temperature. The mean kinetic temperature is a calculated value that may be used as an isothermal storage temperature that simulates the nonisothermal effects of storage temperature variations.  An article for which storage at controlled room temperature is directed may, alternatively, be stored and distributed in a cool place, unless otherwise specified in the individual monograph or on the label.

Warm

Any temperature between 30° and 40° (86° and 104°F) is “warm.”

 Excessive Heat

“Excessive heat” means any temperature above 40° (104°F).

Protection From Freezing

Where, in addition to the risk of breakage of the container, freezing subjects an article to loss of strength or potency, or to destructive alteration of its characteristics, the container label bears an appropriate instruction to protect the article from freezing.

Dry Place

The term “dry place” denotes a place that does not exceed 40% average relative humidity at Controlled Room Temperature or the equivalent water vapor pressure at other temperatures. The determination may be made by direct measurement at the place or may be based on reported climatic conditions. Determination is based on not less than 12 equally spaced measurements that encompass either a season, a year, or, where recorded data demonstrate, the storage period of the article. There may be values of up to 45% relative humidity provided that the average value is 40% relative humidity. Storage in a container validated to protect the article from moisture vapor, including storage in bulk, is considered storage in a dry place.

I hope this Storage Temperature on Label – Freeze Cold Cool Dry Label Storage Temperature article helped you. You need to know the definitions of these exactly to know where to store your medicines.

ROUTES OF DRUG ADMINISTRATION PPT PDF 10 Routes of Drug Administration

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Which drug administration route is fastest?,

ROUTES OF DRUG ADMINISTRATION: The possible routes for drug entry into the body. Most drugs can be administered by a variety of routes. The choice of appropriate route in a given situation depends both on drug as well as patient related factors. Mostly common sense considerations, feasibility and convenience dictate the route to be used. Generally routes of drug administration refer to the right path or the required route through which a drug has to be administered into the body to obtain maximum benefit. Here is the list of  5, 10+ outes of drug administration.

  1. oral
  2. sublingual
  3. rectal
  4. nasal
  5. ocular
  6. otic
  7. inhalation
  8. nebulization
  9. transdermal
  10. Subcutaneous (under the skin)
  11. Intramuscular (in a muscle)
  12. Intravenous (in a vein)
  13. Intrathecal (around the spinal cord

Factors governing choice of route

  1. Physical and chemical properties of the drug (solid/ liquid/gas; solubility, stability, pH, irritancy).
  2. Site of desired action—localized and approachable or generalized and not approachable.
  3. Rate and extent of absorption of the drug from different routes.
  4. Effect of digestive juices and first pass metabolism on the drug.
  5. Rapidity with which the response is desired (routine treatment or emergency).
  6. Accuracy of dosage required (i.v. and inhalational can provide fine tuning).
  7. Condition of the patient (unconscious, vomiting).

Routes of Administration can be broadly divided into those for

(a) Local action and (b) Systemic action.

LOCAL ROUTES

These routes can only be used for localized lesions at accessible sites and for drugs whose systemic absorption from these sites is minimal or absent. Thus, high concentrations are attained at the desired site without exposing the rest of the body. Systemic side effects or toxicity are consequently absent or minimal. For drugs (in suitable dosage forms) that are absorbed from these sites/routes, the same can serve as systemic route of administration, e.g. glyceryl trinitrate (GTN) applied on the skin as ointment or transdermal patch. The local routes are:

  1. Topical

This refers to external application of the drug to the surface for localized action. It is often more convenient as well as encouraging to the patient. Drugs can be efficiently delivered to the localized lesions on skin, oropharyngeal/ nasal mucosa, eyes, ear canal, anal canal or vagina in the form of lotion, ointment, cream, powder, rinse, paints, drops, spray, lozengens, suppositories or pesseries. Nonabsorbable drugs given orally for action on g.i. mucosa (sucralfate, vancomycin), inhalation of drugs for action on bronchi (salbutamol, cromolyn sodium) and irrigating solutions/jellys (povidone iodine, lidocaine) applied to urethra are other forms of topical medication.

  1. Deeper tissues

Certain deep areas can be approached by using a syringe and needle, but the drug should be in such a form that systemic absorption is slow, e.g. intra-articular injection (hydrocortisone acetate in knee joint), infiltration around a nerve or intrathecal injection (lidocaine), retrobulbar injection (hydrocortisone acetate behind the eyeball).

  1. Arterial supply

Close intra-arterial injection is used for contrast media in angiography; anticancer drugs can be infused in femoral or brachial artery to localise the effect for limb malignancies.

SYSTEMIC ROUTES

The drug administered through systemic routes is intended to be absorbed into the blood streamand distributed all over, including the site of action, through circulation

  1. Oral

Oral ingestion is the oldest and commonest mode of drug administration. It is safer, more convenient, does not need assistance, noninvasive, often painless, the medicament need not be sterile and so is cheaper. Both solid dosage forms (powders, tablets, capsules, spansules, dragees, moulded tablets, gastrointestinal therapeutic systems— GITs) and liquid dosage forms (elixirs, syrups, emulsions, mixtures) can be given orally.

Limitations of oral route of administration

  • Action of drugs is slower and thus not suitable for emergencies.
  • Unpalatable drugs (chloramphenicol) are difficult to administer; drug may be filled in capsules to circumvent this.
  • May cause nausea and vomiting (emetine).
  • Cannot be used for uncooperative/unconscious/ vomiting patient.
  • Absorption of drugs may be variable and erratic; certain drugs are not absorbed (streptomycin).
  • Others are destroyed by digestive juices (penicillin G, insulin) or in liver (GTN, testosterone, lidocaine).

  1. Sublingual (s.l.) or buccal

The tablet or pellet containing the drug is placed under the tongue or crushed in the mouth and spread over the buccal mucosa. Only lipid soluble and non-irritating drugs can be so administered. Absorption is relatively rapid—action can be produced in minutes. Though it is somewhat inconvenient, one can spit the drug after the desired effect has been obtained. The chief advantage is that liver is bypassed and drugs with high first pass metabolism can be absorbed directly into systemic circulation. Drugs given sublingually are—GTN, buprenorphine, desamino-oxytocin.

  1. Rectal

Certain irritant and unpleasant drugs can be put into rectum as suppositories or retention enema for systemic effect. This route can also be used when the patient is having recurrent vomiting or is unconscious. However, it is rather inconvenient and embarrassing; absorption is slower, irregular and often unpredictable, though diazepam solution and paracetamol suppository are rapidly and dependably absorbed from the rectum in children. Drug absorbed into external haemorrhoidal veins (about 50%) bypasses liver, but not that absorbed into internal haemorrhoidal veins. Rectal inflammation can result from irritant drugs. Diazepam, indomethacin, paracetamol, ergotamine and few other drugs are some times given rectally.

  1. Cutaneous

Highly lipid soluble drugs can be applied over the skin for slow and prolonged absorption. The liver is also bypassed. The drug can be incorporated in an ointment and applied over specified area of skin. Absorption of the drug can be enhanced by rubbing the preparation, by using an oily base and by an occlusive dressing.

 

Transdermal therapeutic systems (TTS)

 

These are devices in the form of adhesive patches of various shapes and sizes (5–20 cm2) which deliver the contained drug at a constant rate into systemic circulation via the stratum corneum (Fig. 1.2). The drug (in solution or bound to a polymer) is held in a reservoir between an occlusive backing film and a rate controlling micropore membrane, the under surface of which is smeared with an adhesive impregnated with priming dose of the drug. The adhesive layer is protected by another film that is to be peeled off just before application. The drug is delivered at the skin surface by diffusion for percutaneous absorption into circulation. The micropore membrane is such that rate of drug delivery to skin surface is less than the slowest rate of absorption from the skin. This offsets any variation in the rate of absorption according to the properties of different sites. As such, the drug is delivered at a constant and predictable rate irrespective of site of application. Usually chest, abdomen, upper arm, lower back, buttock or mastoid region are utilized. Transdermal patches of GTN, fentanyl, nicotine and estradiol are available in India, while those of isosorbide dinitrate, hyoscine, and clonidine are marketed elsewhere. For different drugs, TTS have been designed to last for 1–3 days. Though more expensive, they provide smooth plasma concentrations of the drug without fluctuations; minimize interindividual variations (drug is subjected to little first pass metabolism) and side effects. They are also more convenient— many patients prefer transdermal patches to oral tablets of the same drug; patient compliance is better. Local irritation and erythema occurs in some, but is generally mild; can be minimized by changing the site of application each time by rotation. Discontinuation has been necessary in 2–7% cases.

 

  1. Inhalation

Volatile liquids and gases are given by inhalation for systemic action, e.g. general anaesthetics. Absorption takes place from the vast surface of alveoli—action is very rapid. When administration is discontinued the drug diffuses back and is rapidly eliminated in expired air. Thus, controlled administration is possible with moment to moment adjustment. Irritant vapours (ether) cause inflammation of respiratory tract and increase secretion.

  1. Nasal

The mucous membrane of the nose can readily absorb many drugs; digestive juices and liver are bypassed. However, only certain drugs like GnRH agonists and desmopressin applied as a spray or nebulized solution have been used by this route. This route is being tried for some other peptide drugs like insulin, as well as to bypass the bloodbrain barrier.

  1. Parenteral

Conventionally, parenteral refers to administration by injection which takes the drug directly into the tissue fluid or blood without having to cross the enteral mucosa. The limitations of oral administration are circumvented. Drug action is faster and surer (valuable in emergencies). Gastric irritation and vomiting are not provoked. Parenteral routes can be employed even in unconscious, uncooperative or vomiting patient. There are no chances of interference by food or digestive juices. Liver is bypassed. Disadvantages of parenteral routes are—the preparation has to be sterilized and is costlier, the technique is invasive and painful, assistance of another person is mostly needed (though self injection is possible, e.g. insulin by diabetics), there are chances of local tissue injury and, in general, parenteral route is more risky than oral.

The important parenteral routes are:

(i) Subcutaneous (s.c.)

The drug is deposited in the loose subcutaneous tissue which is richly supplied by nerves (irritant drugs cannot be injected) but is less vascular (absorption is slower than intramuscular). Only small volumes can be injected s.c. Self-injection is possible because deep penetration is not needed. This route should be avoided in shock patients who are vasoconstricted— absorption will be delayed. Repository (depot) preparations that are aqueous suspensions can be injected for prolonged action. Some special forms of this route are:

 (a) Dermojet

In this method needle is not used; a high velocity jet of drug solution is projected from a microfine orifice using a gun like implement. The solution passes through the superficial layers and gets deposited in the subcutaneous tissue. It is essentially painless and suited for mass inoculations.

(b) Pellet implantation

The drug in the form of a solid pellet is introduced with a trochar and cannula. This provides sustained release of the drug over weeks and months, e.g. DOCA, testosterone.

(c) Sialistic (nonbiodegradable) and biodegradable implants

Crystalline drug is packed in tubes or capsules made of suitable materials and implanted under the skin. Slow and uniform leaching of the drug occurs over months providing constant blood levels. The nonbiodegradable implant has to be removed later on but not the biodegradable one. This has been tried for hormones and contraceptives (e.g. NORPLANT).

 (ii) Intramuscular (i.m.)

The drug is injected in one of the large skeletal muscles—deltoid, triceps, gluteus maximus, rectus femoris, etc. Muscle is less richly supplied with sensory nerves (mild irritants can be injected) and is more vascular (absorption of drugs in aqueous solution is faster). It is less painful, but self injection is often impracticable because deep penetration is needed. Depot preparations (oily solutions, aqueous suspensions) can be injected by this route. Intramuscular injections should be avoided in anticoagulant treated patients, because it can produce local haematoma.

(iii) Intravenous (i.v

.) The drug is injected as a bolus (Greek: bolos–lump) or infused slowly over hours in one of the superficial veins. The drug reaches directly into the blood stream and effects are produced immediately (great value in emergency). The intima of veins is insensitive and drug gets diluted with blood, therefore, even highly irritant drugs can be injected i.v., but hazards are—thrombophlebitis of the injected vein and necrosis of adjoining tissues if extravasation occurs. These complications can be minimized by diluting the drug or injecting it into a running i.v. line. Only aqueous solutions (not suspensions, because drug particles can cause embolism) are to be injected i.v. and there are no depot preparations for this route. Chances of causing air embolism is another risk. The dose of the drug required is smallest (bioavailability is 100%) and even large volumes can be infused. One big advantage with this route is—in case response is accurately measurable (e.g. BP) and the drug short acting (e.g. sodium nitroprusside), titration of the dose with the response is possible. However, this is the most risky route—vital organs like heart, brain, etc. get exposed to high concentrations of the drug.

ROUTES OF DRUG ADMINISTRATION 10 Fastest routes

ROUTES OF DRUG ADMINISTRATION 10 Fastest routes PDF

routes of administration PPT

(iv) Intradermal injection

The drug is injected into the skin raising a bleb (e.g. BCG vaccine, sensitivity testing) or scarring/multiple puncture of the epidermis through a drop of the drug is done. This route is employed for specific purposes only.

Search Terms

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What is DRX RPH Meaning Definition RX Full Form ?

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What is DRX RPH Meaning Definition RX Full Form ?

RX DRX-and-RPH: There are thousand of short abbreviations that are being used on a regular basis when we speak about pharmaceutical applications and in relation to taking drugs.  The medical dictionary has thousands of medical abbreviations that basically denote something in a shorter form which the physicians or those in relation to this trade are aware of but which most of us, the common masses or those who are not related to this field are aware of.  Each one of them has a specific meaning and denotes a specific action when speaking about the pharmaceutical products and is in accordance with treatment.  While the physicians prescribe drugs, generally they provide these short abbreviations in the prescriptions for us to know how and when to take them.  Today we are going to look at the meaning of DRx and RPh, its full form and use in brief here and consider its application and go through what they really means.

What is DRX RPH Meaning Definition RX Full Form ?

The meaning Rx and RPh

Rx and RPh are two of the most common abbreviations that are being used.  Firstly the “Rx” has derived from a Latin word which means “recipe”.  It basically means the action of taking something or receiving something or the fact of it being received.  This symbol basically has originated in the medieval manuscripts and denotes abbreviation of the late Latin verb “recipere”.  Here it denotes that the way how the things (which here is medicine) needs to be taken by the patient.  It basically denotes the direction by which the prescribed medicine needs to be taken by the patient in plain and simple words.  This is a symbol that is commonly found at the head of the prescription provided by the physician to us when means “take, thou”.

Thus accordingly when a pharmacist get the prescription and sees “Rx” written over it they get a clear idea about what the drugs have been prescribed to the patient and thus provides them in accordance to the order they are being prescribed.

What is “RPh”

Now speaking about “RPh” another most common term that is being used in the medical terminology and found common in the prescription, we get to know that it indicates the individual is registered under the State Board of Pharmacy (acknowledged by the Medical Board) and is eligible to prescribe drugs when in need.  He or she has been certified by the Government to prescribe medicines and drugs to patients.  The term “Rph” stands for “Registered Pharmacist”.  Now someone who is willing to complete and get registration must need to complete a tertiary degree in Pharmacy like that of a Bachelor or Master of Pharmacy.  Once the individual is graduated, he or she needs to go through a registration procedure with affiliated board of that particular country and complete internship which takes approximately a year or two (according to the rules laid by the medical bord of that particular country) and finally obtain a registered pharmacist degree.

Now in order to avoid any discrepancies the physicians use these types of short form which not only indicates how to take it but also denotes when to take.  It often helps them to write in short and to fully express what they intend to mean in the way of taking each and every drug as per the requirement.  Though these types of short abbreviations are quite impossible to understand for the common mass who have less knowledge about them, the druggist or the pharmacist who regularly handle medical cases are very much aware of the terms and understands the meaning perfectly.  This helps them to provide drugs to the patient in accordance.

Pharmacodynamics Basic Notes – PDF PPT – ATROPINE FUROSIMIDE HEPARIN BASTI VAMANA

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Pharmacodynamics Basic Notes - PDF PPT - ATROPINE FUROSIMIDE HEPARIN BASTI VAMANA

Pharmacodynamics Definition:

Pharmacodynamics the branch of pharmacology concerned with the effects of drugs and the mechanism of their action.

“Pharmacodynamics involves how the drugs act on target cells to alter cellular function.”

A. Receptor and non-receptor mechanisms: Most of the drugs act by interacting with a cellular component called receptor. Some drugs act through simple physical or chemical reactions without interacting with any receptor.

• Receptors are protein molecules present either on the cell surface or with in the cell e.g. adrenergic receptors, cholinoceptors, insulin receptors, etc.
• The endogenous neurotransmitters, hormones, autacoids and most of the drugs produce their effects by binding with their specific receptors.
• Aluminium hydroxide and magnesium trisilicate, which are used in the treatment of peptic ulcer disease act by non-receptor mechanism by neutralizing the gastric acid.

Pharmacodynamics Basics:

Many drugs are similar to or have similar chemical groups to the naturally occurring chemical and have the ability to bind onto a receptor where one of two things can happen- either the receptor will respond or it will be blocked.
A drug, which is able to fit onto a receptor, is said to have affinity for that receptor. Efficacy is the ability of a drug to produce an effect at a receptor. An agonist has both an affinity and efficacy whereas antagonist has affinity but not efficacy or intrinsic activity.
When a drug is able to stimulate a receptor, it is known as an agonist and therefore mimics the endogenous transmitter.
When the drug blocks a receptor, it is known as antagonist and therefore blocks the action of the endogenous transmitter (i.e. it will prevent the natural chemical from acting on the receptor).
However, as most drug binding is reversible, there will be competition between the drug and the natural stimulus to the receptor.

Pharmacodynamics Basic Notes – PDF PPT – ATROPINE FUROSIMIDE HEPARIN BASTI VAMANA
The forces that attract the drug to its receptor are termed chemical bonds and they are

(a)hydrogen bond

(b) ionic bond

(c) covalent bond

(d) Vander waals force.

Covalent bond is the strongest bond and the drug-receptor complex is usually irreversible.
K1 K3
DR Biological effect
D+R K2
Where D = Drug, R= receptor DR= Drug receptor complex (affinity)
K1 = association constant
K2 = dissociation constant
K3 = intrinsic activity
When first messengers like neurotransmitters, hormones, autacoids and most of drugs bind with their specific receptors, the drug receptor complex is formed which subsequently causes the synthesis and release of another intracellular regulatory molecule termed as second messengers e.g. cyclic AMP, calcium, cyclic GMP, inositol triphosphate (IP3), diacylglycerol and calmodulin which in turn produce subcellular or molecular mechanism of drug action.

B. Site of drug action:

– A drug may act:
(i) Extracellularly e.g: osmotic diuretics, plasma expanders.
(ii) On the cell surface e.g.: digitalis, penicillin, catecholamines
(iii) Inside the cell e.g.: anti-cancer drugs, steroid hormones.
C. Dose Response relationship
The exact relationship between the dose and the response depends on the biological object under observation and the drug employed.
When a logarithm of dose as abscissa and responses as ordinate are constructed graphically, the “S” shaped or sigmoid type curve is obtained.
The lowest concentration of a drug that elicits a response is minimal dose, and the largest concentration after which further increase in concentration will not change the response is the maximal dose.
1. Graded dose effect: As the dose administered to a single subject or tissue increases, the pharmacological response also increases in graded fashion up to ceiling effect.
– It is used for characterization of the action of drugs. The concentration that is required to produce 50 % of the maximum effect is termed as EC50 or ED50.50

2. Quantal dose effect: It is all or none response, the sensitive objects give response to small doses of a drug while some will be resistant and need very large doses. The quantal dose effect curve is often characterized by stating the median effective dose and the median lethal dose.
Median lethal dose or LD50: This is the dose (mg/kg), which would be expected to kill one half of a population of the same species and strain.
Median effective dose or ED50: This is the dose (mg/kg), which produces a desired response in 50 per cent of test population.
Therapeutic index: It is an approximate assessment of the safety of the drug. It is the ratio of the median lethal dose and the median effective dose. Also called as therapeutic window or safety.

The larger the therapeutic index, the safer is the drug. Penicillin has a very high therapeutic index, while it is much smaller for the digitalis preparation.

D. Structural activity relationship

The activity of a drug is intimately related to its chemical structure. Knowledge about the chemical structure of a drug is useful for:
(i) Synthesis of new compounds with more specific actions and fewer adverse reactions
(ii) Synthesis of competitive antagonist and
(iii) Understanding the mechanism of drug action.
Slight modification of structure of the compound can change the effect completely.

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Pharmacodynamics Examples:

Pharmacodynamics Basic Notes - PDF PPT - ATROPINE FUROSIMIDE HEPARIN BASTI VAMANA

Pharmacodynamics of atropine:

Atropine, a naturally occurring belladonna alkaloid, is a racemic mixture of equal parts of d- and l-hyoscyamine, whose activity is due almost entirely to the levo isomer of the drug. Atropine is commonly classified as an anticholinergic or antiparasympathetic (parasympatholytic) drug. More precisely, however, it is termed an antimuscarinic agent since it antagonizes the muscarine-like actions of acetylcholine and other choline esters. Adequate doses of atropine abolish various types of reflex vagal cardiac slowing or asystole. The drug also prevents or abolishes bradycardia or asystole produced by injection of choline esters, anticholinesterase agents or other parasympathomimetic drugs, and cardiac arrest produced by stimulation of the vagus. Atropine may also lessen the degree of partial heart block when vagal activity is an etiologic factor. Atropine in clinical doses counteracts the peripheral dilatation and abrupt decrease in blood pressure produced by choline esters. However, when given by itself, atropine does not exert a striking or uniform effect on blood vessels or blood pressure.

Pharmacodynamics of Furosemide

Furosemide, a sulfonamide-type loop diuretic structurally related to bumetanide, is used to manage hypertension and edema associated with congestive heart failure, cirrhosis, and renal disease, including the nephrotic syndrome.

Furosemide, a loop diuretic, inhibits water reabsorption in the nephron by blocking the sodium-potassium-chloride cotransporter (NKCC2) in the thick ascending limb of the loop of Henle. This is achieved through competitive inhibition at the chloride binding site on the cotransporter, thus preventing the transport of sodium from the lumen of the loop of Henle into the basolateral interstitium. Consequently, the lumen becomes more hypertonic while the interstitium becomes less hypertonic, which in turn diminishes the osmotic gradient for water reabsorption throughout the nephron. Because the thick ascending limb is responsible for 25% of sodium reabsorption in the nephron, furosemide is a very potent diuretic.

Pharmacodynamics of Heparin

Unfractionated heparin is a highly acidic mucopolysaccharide formed of equal parts of sulfated D-glucosamine and D-glucuronic acid with sulfaminic bridges. The molecular weight ranges from 3000 to 30,000 daltons. Heparin is obtained from liver, lung, mast cells, and other cells of vertebrates. Heparin is a well-known and commonly used anticoagulant which has antithrombotic properties. Heparin inhibits reactions that lead to the clotting of blood and the formation of fibrin clots both in vitro and in vivo. Small amounts of heparin in combination with antithrombin III, a heparin cofactor,) can inhibit thrombosis by inactivating Factor Xa and thrombin. Once active thrombosis has developed, larger amounts of heparin can inhibit further coagulation by inactivating thrombin and preventing the conversion of fibrinogen to fibrin. Heparin also prevents the formation of a stable fibrin clot by inhibiting the activation of the fibrin stabilizing factor. Heparin prolongs several coagulation tests. Of all the coagulation tests, activated partial prothrombin time (aPTT) is the most clinically important value.

Mechanism of action

Under normal circumstances, antithrombin III (ATIII) inactivates thrombin (factor IIa) and factor Xa. This process occurs at a slow rate. Administered heparin binds reversibly to ATIII and leads to almost instantaneous inactivation of factors IIa and Xa The heparin-ATIII complex can also inactivate factors IX, XI, XII and plasmin. The mechanism of action of heparin is ATIII-dependent. It acts mainly by accelerating the rate of the neutralization of certain activated coagulation factors by antithrombin, but other mechanisms may also be involved. The antithrombotic effect of heparin is well correlated to the inhibition of factor Xa. Heparin is not a thrombolytic or fibrinolytic. It prevents progression of existing clots by inhibiting further clotting. The lysis of existing clots relies on endogenous thrombolytics.

Pharmacodynamics of paracetamol
Pharmacodynamics of Acetaminophen

Acetaminophen (USAN) or Paracetamol (INN) is a widely used analgesic and antipyretic drug that is used for the relief of fever, headaches, and other minor aches and pains. It is a major ingredient in numerous cold and flu medications and many prescription analgesics. It is extremely safe in standard doses, but because of its wide availability, deliberate or accidental overdoses are not uncommon. Acetaminophen, unlike other common analgesics such as aspirin and ibuprofen, has no anti-inflammatory properties or effects on platelet function, and it is not a member of the class of drugs known as non-steroidal anti-inflammatory drugs or NSAIDs. At therapeutic doses acetaminophen does not irritate the lining of the stomach nor affect blood coagulation, kidney function, or the fetal ductus arteriosus (as NSAIDs can). Like NSAIDs and unlike opioid analgesics, acetaminophen does not cause euphoria or alter mood in any way. Acetaminophen and NSAIDs have the benefit of being completely free of problems with addiction, dependence, tolerance and withdrawal. Acetaminophen is used on its own or in combination with pseudoephedrine, dextromethorphan, chlorpheniramine, diphenhydramine, doxylamine, codeine, hydrocodone, or oxycodone.

Mechanism of action:

Acetaminophen is thought to act primarily in the CNS, increasing the pain threshold by inhibiting both isoforms of cyclooxygenase, COX-1, COX-2, and COX-3 enzymes involved in prostaglandin (PG) synthesis. Unlike NSAIDs, acetaminophen does not inhibit cyclooxygenase in peripheral tissues and, thus, has no peripheral anti-inflammatory affects. While aspirin acts as an irreversible inhibitor of COX and directly blocks the enzyme’s active site, studies have found that acetaminophen indirectly blocks COX, and that this blockade is ineffective in the presence of peroxides. This might explain why acetaminophen is effective in the central nervous system and in endothelial cells but not in platelets and immune cells which have high levels of peroxides. Studies also report data suggesting that acetaminophen selectively blocks a variant of the COX enzyme that is different from the known variants COX-1 and COX-2. This enzyme is now referred to as COX-3. Its exact mechanism of action is still poorly understood, but future research may provide further insight into how it works. The antipyretic properties of acetaminophen are likely due to direct effects on the heat-regulating centres of the hypothalamus resulting in peripheral vasodilation, sweating and hence heat dissipation.

Pharmacodynamics of salbutamol

Salbutamol (INN) or albuterol (USAN), a moderately selective beta(2)-receptor agonist similar in structure to terbutaline, is widely used as a bronchodilator to manage asthma and other chronic obstructive airway diseases. The R-isomer, levalbuterol, is responsible for bronchodilation while the S-isomer increases bronchial reactivity. The R-enantiomer is sold in its pure form as Levalbuterol. The manufacturer of levalbuterol, Sepracor, has implied (although not directly claimed) that the presence of only the R-enantiomer produces fewer side-effects.

Mechanism of action:

Salbutamol is a beta(2)-adrenergic agonist and thus it stimulates beta(2)-adrenergic receptors. Binding of albuterol to beta(2)-receptors in the lungs results in relaxation of bronchial smooth muscles. It is believed that salbutamol increases cAMP production by activating adenylate cyclase, and the actions of salbutamol are mediated by cAMP. Increased intracellular cyclic AMP increases the activity of cAMP-dependent protein kinase A, which inhibits the phosphorylation of myosin and lowers intracellular calcium concentrations. A lowered intracellular calcium concentration leads to a smooth muscle relaxation and bronchodilation. In addition to bronchodilation, salbutamol inhibits the release of bronchoconstricting agents from mast cells, inhibits microvascular leakage, and enhances mucociliary clearance.

Pharmacodynamics of vamana

The overall Pharmacodynamic of Vamanopaga dasemāni drugs is based on guna concept. Most of the drugs (90%) are having property of Laghu and Ruksa guna. These are based on Vāyu, Agni and Ākasa mahābhaūtik (one of the five elements of the universe) composition. Ācarya Caraka has mentioned only the role of gunas in the  Pharmacodynamic of Vamana karma (Bhadanta Nāgārjunā, Rasavaisesika, 2010). In fact guna is the thing
which represents a drug. So, the selection of a drug should be on the basis of gunas for Vamana karma. 
Ācarya has mentioned predominance of Vāyu and Agni mahābhūta drugs for Vamana karma. Rasas (taste) of vamana dravyas are chiefly katu and kasāya rasa which are composition of the same mahābhūtas. Most of
drugs are katu Vipāka having similar bhaūtic constitution. Other drugs are supportive to the therapy or to avoid complications during Vamana karma. As an example; honey which is mentioned in Vamanopaga dasemāni is added
to Vamana kalpa (prepared medicine) for increasing the palatability and giving soothing effect. Āyurveda says it is a good kapha chedaka (expectorant), helps in better expulsion of malarūpī kapha by vamana karma. Likewise Saindhava (salt) should be added to Vamana kalpa for Vilāyana (Agnivesa, Caraka Samhita, 2001) (liquefying)
of sticky Kaphadosa in channels. Effect of both the drugs is to help in a comfortable and irritation less procedure. added to Vamana kalpa for Vilāyana (Agnivesa, Caraka Samhita, 2001) (liquefying) of sticky Kaphadosa in channels. Effect of both the drugs is to help in a comfortable and irritation less procedure.

Pharmacodynamics of basti

Basti is chief Panchakama procedure used in Ayurveda. The pharmacodynamics of systemic effect of Basti may be understood through absorption mechanism, concept of system biology, neural stimulation mechanism, and excretory mechanism. As Basti is homogenous emulsion mixture of Honey, Saindhava,Sneha Dravya, Kalka, and decoction of crude drugs and Prakshepa Dravya, which is given through rectum, is absorbed, hence Basti is used as route of drug administration. Through rectal route large quantity of drugs can be delivered for systemic circulation and act accordingly. Concept of system biology opines that a change at cellular level of a system can bring changes in tissue, organ and system and in another system consequently & finally in whole body. As per recent advancement intestine not only is highly vascular but also highly innervated organ which forms ‘Enteric Nervous System’ (ENS).ENS may works in synergism with Central Nervous System of body. The cleansing action of Basti is related with the facilitation of excretion of morbid substances responsible for the disease process into the colon, from where it is evacuated.

Basti being the most widely used and highly effective treatment modality in the Ayurveda, it is the prime subject of interest for modern scientific community. With this background the basic question which comes forward regarding Basti is, “do active principles of drugs used in Basti get absorbed in systemic circulation. Triphaladi decoction Basti containing biomarker gallic acid and after Basti they traced it in the circulation. The rectum has rich blood and lymph supply and drugs can cross the rectal mucosa like other lipid membrane. Thus unionised and lipid soluble
substances are readily absorbed from the rectal mucosa. Small quantity of short chain fatty acid fatty acids, such as those from butterfat are absorbed directly into portal blood rather than being converted into triglycerides. This is because short chain fatty acids are more water soluble and allow direct diffusion from the epithelial cells into
capillary blood of villi. However decoction Basti gets a very little time maximum 48 minutes  to absorb from colon and rectum how so ever these areas have very large surface area and highly vascular needed for absorption. Retention time for Anuvashana Basti is relatively more so probability of absorption also increases. Anuvasana Basti
after reaching in the rectum and colon causes secretion of bile from gall bladder which leads to the formation of conjugate micelles which is absorbed through passive diffusion. Especially short chain fatty acid present in Sneha of
Anuvasana Basti may absorb from colon and large intestine part of gastrointestinal tract and break the pathology of disease. In Basti Karma, a homogenous emulsion

2) By System Biology Concept of Honey, Saindhava, Sneha Dravya, Kalka, and decoction mixed in remarkable combination after proper churning (break the large and middle chain fatty acid into small chain fatty acids) is given which facilitates absorption better then a single drug per rectum. In Ayurveda classics, various Basti Dravya are
mentioned in diverse proportion in different diseases, it again confirms pharmacodynamics of Basti through absorption mechanism

Pharmacodynamics of phenytoin

Phenytoin is an antiepileptic drug which can be useful in the treatment of epilepsy. The primary site of action appears to be the motor cortex where spread of seizure activity is inhibited. Phenytoin reduces the maximal activity of brain stem centers responsible for the tonic phase of tonic-clonic (grand mal) seizures. Phenytoin acts to dampen the unwanted, runaway brain activity seen in seizure by reducing electrical conductance among brain cells. It lacks the sedation effects associated with phenobarbital. There are some indications that phenytoin has other effects, including anxiety control and mood stabilization, although it has never been approved for those purposes by the FDA. Phenytoin is primarily metabolized by CYP2C9.

Mechanism of action

Phenytoin acts on sodium channels on the neuronal cell membrane, limiting the spread of seizure activity and reducing seizure propagation. By promoting sodium efflux from neurons, phenytoin tends to stabilize the threshold against hyperexcitability caused by excessive stimulation or environmental changes capable of reducing membrane sodium gradient. This includes the reduction of post-tetanic potentiation at synapses. Loss of post-tetanic potentiation prevents cortical seizure foci from detonating adjacent cortical areas.

Pharmacodynamics of Aspirin

Acetylsalicylic acid is an analgesic, antipyretic, antirheumatic, and anti-inflammatory agent. Acetylsalicylic acid’s mode of action as an antiinflammatory and antirheumatic agent may be due to inhibition of synthesis and release of prostaglandins. Acetylsalicylic acid appears to produce analgesia by virtue of both a peripheral and CNS effect. Peripherally, acetylsalicylic acid acts by inhibiting the synthesis and release of prostaglandins. Acting centrally, it would appear to produce analgesia at a hypothalamic site in the brain, although the mode of action is not known. Acetylsalicylic acid also acts on the hypothalamus to produce antipyresis; heat dissipation is increased as a result of vasodilation and increased peripheral blood flow. Acetylsalicylic acid’s antipyretic activity may also be related to inhibition of synthesis and release of prostaglandins.

Mechanism of action:

The analgesic, antipyretic, and anti-inflammatory effects of acetylsalicylic acid are due to actions by both the acetyl and the salicylate portions of the intact molecule as well as by the active salicylate metabolite. Acetylsalicylic acid directly and irreversibly inhibits the activity of both types of cyclooxygenase (COX-1 and COX-2) to decrease the formation of precursors of prostaglandins and thromboxanes from arachidonic acid. This makes acetylsalicylic acid different from other NSAIDS (such as diclofenac and ibuprofen) which are reversible inhibitors. Salicylate may competitively inhibit prostaglandin formation. Acetylsalicylic acid’s antirheumatic (nonsteroidal anti-inflammatory) actions are a result of its analgesic and anti-inflammatory mechanisms; the therapeutic effects are not due to pituitary-adrenal stimulation. The platelet aggregation-inhibiting effect of acetylsalicylic acid specifically involves the compound’s ability to act as an acetyl donor to cyclooxygenase; the nonacetylated salicylates have no clinically significant effect on platelet aggregation. Irreversible acetylation renders cyclooxygenase inactive, thereby preventing the formation of the aggregating agent thromboxane A2 in platelets. Since platelets lack the ability to synthesize new proteins, the effects persist for the life of the exposed platelets (7-10 days). Acetylsalicylic acid may also inhibit production of the platelet aggregation inhibitor, prostacyclin (prostaglandin I2), by blood vessel endothelial cells; however, inhibition prostacyclin production is not permanent as endothelial cells can produce more cyclooxygenase to replace the non-functional enzyme.

Pharmacodynamics of pantaprazole

Pantoprazole is a substituted benzimidazole indicated for the short-term treatment (up to 16 weeks) in the healing and symptomatic relief of erosive esophagitis. Pantoprazole is a proton pump inhibitor (PPI) that suppresses the final step in gastric acid production.

Mechanism of action:

Pantoprazole is a proton pump inhibitor (PPI) that suppresses the final step in gastric acid production by forming a covalent bond to two sites of the (H+,K+ )- ATPase enzyme system at the secretory surface of the gastric parietal cell. This effect is dose- related and leads to inhibition of both basal and stimulated gastric acid secretion irrespective of the stimulus.

Define TRIPS? Relationship b/w TRIPS & IPR #Regulatory Affairs M Pharmacy Notes PDF PPT

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Define TRIPS? Relationship b/w TRIPS & IPR #Regulatory Affairs M Pharmacy Notes PDF PPT

Define trips? highlight the relationship between trips and ipr?

Trips TRADE-RELATED ASPECTS OF INTELLECTUAL PROPERTY RIGHTS

The Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) is an international agreement administered by the World Trade Organization (WTO) that sets down minimum standards for many forms of intellectual property (IP) regulation as applied to nationals of other WTO Members. [1] It was negotiated at the end of the Uruguay Round of the General Agreement on Tariffs and Trade (GATT) in 1994.

 Specifically, TRIPS contains requirements that nations’ laws must meet for: copyright rights, including the rights of performers, producers of sound recordings and broadcasting organizations; geographical indications, including appellations of origin; industrial designs; integrated circuit layout-designs; patents; monopolies for the developers of new plant varieties; trademarks; trade dress; and undisclosed or confidential information. TRIPS also specifies enforcement procedures, remedies, and dispute resolution procedures.

Protection and enforcement of all intellectual property rights shall meet the objectives to contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations. The

TRIPS agreement introduced intellectual property law into the international trading system for the first time and remains the most comprehensive international agreement on intellectual property to date. In 2001, developing countries, concerned that developed countries were insisting on an overly narrow reading of TRIPS, initiated a round of talks that resulted in the Doha Declaration. The Doha declaration is a WTO statement that clarifies the scope of TRIPS, stating for example that TRIPS can and should be interpreted in light of the goal “to promote access to medicines for all.”

TRIPS has been criticized by the alter-globalization movement. Members of the movement object, for example, to its consequences with regards to the AIDS pandemic in Africa.

TRIPS was negotiated at the end of the Uruguay Round of the General Agreement on Tariffs and Trade (GATT) in 1994. Its inclusion was the culmination of a program of intense lobbying by the United States, supported by the European Union, Japan and other developed nations.

Campaigns of unilateral economic encouragement under the Generalized System of Preferences and coercion under Section 301 of the Trade Act played an important role in defeating competing policy positions that were favored by developing countries, most notably Korea and Brazil, but also including Thailand, India and Caribbean Basin states.

In turn, the United States strategy of linking trade policy to intellectual property standards can be traced back to the entrepreneurship of senior management at Pfizer in the early 1980s, who mobilized corporations in the United States and made maximizing intellectual property privileges the number one priority of trade policy in the United States.

 

After the Uruguay round, the GATT became the basis for the establishment of the World Trade Organization. Because ratification of TRIPS is a compulsory requirement of World Trade Organization membership, any country seeking to obtain easy access to the numerous international markets opened by the World Trade Organization must enact the strict intellectual property laws mandated by TRIPS. For this reason, TRIPS is the most important multilateral instrument for the globalization of intellectual property laws.

States like Russia and China that were very unlikely to join the Berne Convention have found the prospect of WTO membership a powerful enticement. Furthermore, unlike other agreements on intellectual property, TRIPS has a powerful enforcement mechanism. States can be disciplined through the WTO’s dispute settlement mechanism.

Objectives of TRIPS

The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations.

Principles:

1. Members may, in formulating or amending their laws and regulations, adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socio-economic and technological development, provided that such measures are consistent with the provisions of this Agreement.

2. Appropriate measures, provided that they are consistent with the provisions of this Agreement, may be needed to prevent the abuse of intellectual property rights by right holders or the resort to practices which unreasonably restrain trade or adversely affect the international transfer of technology.

Discuss the provisions of TRIPS

Nature and Scope of Obligations  TRIPS:

1. Members shall give effect to the provisions of this Agreement. Members may, but shall not be obliged to, implement in their law more extensive protection than is required by this Agreement, provided that such protection does not contravene the provisions of this Agreement. Members shall be free to determine the appropriate method of implementing the provisions of this Agreement within their own legal system and practice.

2. For the purposes of this Agreement, the term “intellectual property” refers to all categories of intellectual property that are the subject of Sections 1 through 7 of Part II.

3. Members shall accord the treatment provided for in this Agreement to the nationals of other Members.

(1) In respect of the relevant intellectual property right, the nationals of other Members shall be understood as those natural or legal persons that would meet the criteria for eligibility for protection provided for in the Paris Convention (1967), the Berne Convention (1971), the Rome Convention and the Treaty on Intellectual Property in Respect of Integrated Circuits, were all Members of the WTO members of those conventions.

(2) Any Member availing itself of the possibilities provided in paragraph 3 of Article 5 or paragraph 2 of Article 6 of the Rome Convention shall make a notification as foreseen in those provisions to the Council for Trade-Related Aspects of Intellectual Property Rights (the “Council for TRIPS”).

Define TRIPS? Relationship b/w TRIPS & IPR #Regulatory Affairs M Pharmacy Notes PDF PPT
Define TRIPS? Relationship b/w TRIPS & IPR #Regulatory Affairs M Pharmacy Notes PDF PPT

Define TRIPS? Relationship b/w TRIPS & IPR #Regulatory Affairs M Pharmacy Notes PDF PPT

Provision requirements of TRIPS:

TRIPS requires member states to provide strong protection for intellectual property rights. For example, under TRIPS:

• Copyright terms must extend to 50 years after the death of the author, although films and photographs are only required to have fixed 50 and to be at least 25 year terms, respectively.(Art. 7(2),(4))

• Copyright must be granted automatically, and not based upon any “formality”, such as registrations or systems of renewal.

• Computer programs must be regarded as “literary works” under copyright law and receive the same terms of protection.

• National exceptions to copyright (such as “fair use” in the United States) are constrained by the Berne three-step test

• Patents must be granted in all “fields of technology,” although exceptions for certain public interests are allowed (Art. 27.2 and 27.3)[2] and must be enforceable for at least 20 years (Art 33).

• Exceptions to the exclusive rights must be limited, provided that a normal exploitation of the work (Art. 13) and normal exploitation of the patent (Art 30) is not in conflict.
• No unreasonable prejudice to the legitimate interests of the right holders of computer programs and patents is allowed.

• Legitimate interests of third parties have to be taken into account by patent rights (Art 30).

• In each state, intellectual property laws may not offer any benefits to local citizens which are not available to citizens of other TRIPs signatories by the principles of national treatment (with certain limited exceptions, Art. 3 and 5)[3]. TRIPS also has a most favored nation clause.
Many of the TRIPS provisions on copyright were imported from the Berne Convention for the Protection of Literary and Artistic Works and many of its trademark and patent provisions were imported from the Paris Convention for the Protection of Industrial Property.

Access to essential medicines:

The most visible conflict has been over AIDS drugs in Africa. Despite the role which patents have played in maintaining higher drug costs for public health programs across Africa, this controversy has not led to a revision of TRIPs. Instead, an interpretive statement, the Doha Declaration, was issued in November 2001, which indicated that trips should not prevent states from dealing with public health crises.

A 2003 agreement loosened the domestic market requirement, and allows developing countries to export to other countries where there is a national health problem as long as drugs exported are not part of a commercial or industrial policy.[4] Drugs exported under such a regime may be packaged or colored differently to prevent them from prejudicing markets in the developed world.
In 2003, the Bush administration also changed its position, concluding that generic treatments might in fact be a component of an effective strategy to combat HIV. Bush created the PEPFAR program, which received $15 billion from 2003-2007, and was reauthorized in 2007 for $30 billion over the next five years. Despite wavering on the issue of compulsory licensing, PEPFAR began to distribute generic drugs in 2004-5.

Implementation in developing countries:

The obligations under TRIPS apply equally to all member states, however developing countries were allowed extra time to implement the applicable changes to their national laws, in two tiers of transition according to their level of development. The transition period for developing countries expired in 2005. The transition period for least developed countries was extended to 2016, and could be extended beyond that.

Developed countries are massive net-exporters of copyright-, patent- and trademark-related royalties. It has therefore been argued that the TRIPS standard of requiring all countries to create strict intellectual property systems will be detrimental to poorer countries’ development.[5] Many argue[who?] that it is, prima facie, in the strategic interest of most if not all underdeveloped nations to use any flexibility available in TRIPS to write the weakest IP laws possible. This has not happened in most cases. A 2005 report by the WHO found that many developing countries have not incorporated TRIPS flexibilities (compulsory licensing, parallel importation, limits on data protection, use of broad research and other exceptions to patentability, etc.) into their legislation to the extent authorized under Doha.

Trips TRADE-RELATED ASPECTS OF INTELLECTUAL PROPERTY RIGHTS PDF PPT

This is likely caused by the lack of legal and technical expertise needed to draft legislation that implements flexibility, which has often led to developing countries directly copying developed country IP legislation,[7] or relying on technical assistance from the World Intellectual Property Organization (WIPO), which, according to critics such as Cory Doctorow, encourages them to implement stronger intellectual property monopolies.

Expected search queries: trips agreement summary, trips agreement pdf, trips agreement ppt, salient features of trips agreement, trims agreement, objectives of trips agreement, trips agreement india, trips agreement in hindi.

HPLC Detectors – Types Comparison Principles {PDF PPT}*

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HPLC Detectors - Types Comparison Principles {PDF PPT}*

Here in this article we provide HPLC Detectors – Types Comparison Principles {PDF PPT}*.Different types of HPLC Detectors are given here for you for educational purpose. The HPLC detectors are used to detect the solute present in the eluent comes from the HPLC column. Different HPLC detectors are used in analysis of different types of samples to detect solute having different chemical nature.

HPLC Detectors – Types:

  1. 1. Ultraviolet/visible spectroscopic detectors{UV Detector/ VIS Detector}

    – Fixed Wavelength Detector
    – Variable Wavelength Detector
    – Diode array Detector
    PDA Detector

  2. 2. Refractive-Index Detector

    -Deflection Detector
    -Refractive Detector (Fresnel refractometer)

  3. 3. Evaporative Light Scattering Detector

  4. 4. Multi-Angle Light Scattering Detector

  5. 5. Mass Spectrometer

  6. 6. Conductivity Detector

  7. 7. Fluorescence Detector

  8. 8. Chemiluminescence Detector

  9. 9. Optical Rotation Detector

  10. 10. Electro Chemical Detector

HPLC Detectors Comparision – Best Detectors properties:

Regardless of the principle of operation, an ideal LC detector should have the following properties:
Low drift and noise level (particularly crucial in trace analysis).
High sensitivity.
Fast response.
Wide linear dynamic range (this simplifies quantitation).
Low dead volume (minimal peak broadening).
Cell design which eliminates remixing of the separated bands.
Insensitivity to changes in type of solvent, flow rate, and temperature.
Operational simplicity and reliability.
It should be tuneable so that detection can be optimized for different compounds.
It should be non-destructive.

HPLC Detectors Uses:

Most common Detectors of HPLC:

Refractive index
UV/Vis
Fixed wavelength (no longer used)
Variable wavelength
Diode array
Fluorescence

Less common, but important Detectors:

Conductivity
Mass-spectrometric (LC/MS)
Evaporative light scattering

HPLC Detectors - Types Comparison Principles {PDF PPT}*

HPLC Detectors – Types Comparison Principles {PDF PPT}*:

Variable-wavelength UV detectors:

Detectors which allow the selection of the operating wavelength called variable wavelength detectors and they are are particularly useful in three cases:
offer best sensitivity for any absorptive component by selecting an appropriate wavelength;
individual sample components have high absorptivity at different wavelengths and thus, operation at a single wavelength would reduce the system’s sensitivity;

Depending on the sophistication of the detector, wavelength change is done manually or programmed on a time basis into the memory of the system.

Any chemical compound could interact with the electromagnetic field. Beam of the electromagnetic radiation passed through the detector flow-cell will experience some change in its intensity due to this interaction. Measurement of this changes is the basis of the most optical HPLC detectors.
Radiation absorbance depends on the radiation wavelength and the functional groups of the chemical compound. Electromagnetic field depending on its energy (frequency) can interact with electrons causing their excitation and transfer onto the higher energetical level, or it can excite molecular bonds causing their vibration or rotation of the functional group. The intensity of the beam which energy corresponds to the possible transitions will decrease while it is passing through the flow-cell. According to the Lambert-Bear law absorbance of the radiation is proportional to the compound concentration in the cell and the length of the cell.

HPLC Detectors – Types Comparison Principles Power point {PDF PPT}

Multi-Angle Light Scattering Detector:

For the SEC analysis, MW of analyte is estimated from the calibration curve drown using a set of known standards. However, by using a MALS, MW can be determined directly without the need of calibration curve. Also MALS can provide an absolute MW of the analyte with very low detection limit.

Refractive index detectors:

These bulk property detectors are based on the change of refractive index of the eluant from the column with respect to pure mobile phase. Although they are widely used, the refractive index detectors suffer from several disadvantages – lack of high sensitivity, lack of suitability for gradient elution, and the need for strict temperature control (±0.001 °C) to operate at their highest sensitivity. A pulseless pump, or a reciprocating pump equipped with a pulse dampener, must also be employed. The effect of these limitations may to some extent be overcome by the use of differential systems in which the column eluant is compared with a reference flow of pure mobile phase. The two chief types of RI detector are as follows.

Deflection refractometer:

The deflection refractometer, which measures the deflection of a beam of monochromatic light by a double prism in which the reference and sample cells are separated by a diagonal glass divide. When both cells contain solvent of the same composition, no deflection of the light beam occurs; if, however, the composition of the column mobile phase is changed because of the presence of a solute, then the altered refractive index causes the beam to be deflected. The magnitude of this deflection is dependent on the concentration of the solute in the mobile phase.

Fresnel refractometer:

The Fresnel refractometer which measures the change in the fractions of reflected and transmitted light at a glass-liquid interface as the refractive index of the liquid changes. In this detector both the column mobile phase and a reference flow of solvent are passed through small cells on the back surface of a prism. When the two liquids are identical there is no difference between the two beams reaching the photocell, but when the mobile phase containing solute passes through the cell there is a change in the amount of light transmitted to the photocell, and a signal is produced. The smaller cell volume (about 3 ilL) in this detector makes it more suitable for high-efficiency columns but, for sensitive operation, the cell windows must be kept scrupulously clean.

HPLC Detectors – Types Comparison Principles PDF word document {PDF PPT}

Mass Spectrometer:

The analytes are detected based on their MW. The obtained information is especially useful for compound structure identification. However, its use is not limited to structure identification and can be used to quantify very low detection limit of elemental and molecular components.

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Friabilator Operation Cleaning {Friability Test Apparatus Procedure of Tablets}

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Friabilator Operation Cleaning

Friabilator – Operation & Cleaning:

Friabilator Operation Cleaning {Friability Test Apparatus Procedure of Tablets}

 

Friabilator Operation

Start

↓
Connect power cord to an
appropriate electrical outlet

↓
Unscrew locking nut to release drum

↓
Brush any loose dust from tablets

↓
Accurately weigh tablets

↓
Load tablets into drum

↓
Place plastic cover over drum

↓
Hold cover firmly in place and

↓
slide drum onto the shaft

↓
Place locking nut onto the end of the shaft

↓
Tighten locking nut into position

↓
Turn timer to the desired

↓
number of rotations

↓
Wait until drum returns
to stationary position

↓
Remove locking nut

↓
Carefully remove drum from shaft

↓
Remove tablets and brush away
any loose powder

↓

Any cracked, cleaved
or broken tablets

↓
Tablets sample has failed the friability test

↓
Reweigh tablets

↓
Calculate the percentage weight loss using
the following formula:

↓
% Weight Loss = (Initial weight – Final
weight) /

This Standard Operating Procedure (SOP) applies to the staff and students using the Friability Tester in the laboratories of the Pharmacy Department

Standard Operating Procedure SOP FOR OPERATION AND CLEANING

Friabilator Operation Cleaning

1.0 PURPOSE:
To provide a written procedure for operation and cleaning of the Automated Friabilator EF-2 (USP) .

2.0 SCOPE:
Applicable to determine Friability of tablets in Manufacturing.

3.0 RESPONSIBILITY:
Executive Manufacturing,Executive QA and Assistant Manager QA.

4.0 ACCOUNTABILITY:
Manager Quality Assurance

5.0 DEFINITIONS:
Tablet friability can be used to measure efficiency of tabletting equipment or as an indicator of formulation suitability as well as routine QC functions. It can also be thought of as measuring “dusting”. Tablets are rotated in a plastic drum for a specified period of time.  A gravimetric determination is then made to quantitate the amount of surface material that has worn off.

6.0 PROCEDURE:

Friabilator

6.1 OPERATION:

6.1.1

Check cleanliness of the equipment.

6.1.2 Switch ON the instrument, drum will initialize itself to the loading position, the display will now show START.

6.1.3 Weigh and record the weight of the tablets.

A. For the tablets having individual weight up to 0.650 g take 20 tablets.
B. For the tablets having individual weight above 0.650 g take 10 tablets.

6.1.4 Adjust the counts to 100 by pressing the COUNT key followed by ‘1’, ‘0’, ‘0’ keys. (Count range 1 to 99999).

6.1.5 Press ENTER to confirm the reading.

6.1.6 To see and confirm the number of counts press COUNT key.

6.1.7 On confirming the number of counts press RUN/HALT key to start, the display shows the elapsed count.

6.1.8 NOTE: Test can be performed by adjusting ‘TIME’ similarly as ‘COUNT’.

6.1.9 When test is over drum rotates in reverse direction discharging the tablets in the tray.

6.1.10 The test over is indicated by an audible beep and display shows END

6.1.11 The drum initializes itself to loading position and display shows START indicating the instrument is ready for the next run.

6.1.12 Remove the tablets from the tray.

6.1.13 De- dust and weigh the tablets and note down the weight of the tablets.

Calculate the percentage loss in the weight by using the formula

Percentage Loss =Initial Wt – Final Wt/Initial Wt X 100

Notes :
• Do not hold the drums while rotating.
• After testing destroy the tablets.

6.2 CLEANING: Friabilator

6.2.1 Remove the knob on the shaft by pressing the button.

6.2.2 Pull the outside drum out from the shaft carefully. Similarly remove the inside drum by pulling it outside.

6.2.3 Remove the detachable disc from the drum by pulling it outside of both the drums.

6.2.4 Clean both the drums with clean cloth.

6.2.5 Remove both the trays.

6.2.6 Clean the trays with clean cloth.

6.2.7 After cleaning, put the drums and trays back on its position.

7.0 REFERENCES:

References

British Pharmacopoeia 2009 Vol 4. London: The Stationary Office; 2009. P. A438-A439.

Chourasia A, Mishra BJ, Mishra R, Kannojia P. Comparative in vitro Evaluation of Government Hospital Supplied and Commercial Brands of Paracetamol Tablets. The Pharmacist 2007; 2 (2): 37-39.

Huynh-Ba K, editor. Handbook of Stability Testing in Pharmaceutical Development. New York: Springer; 2009. p. 215-216.

Salman AD, Ghadiri M, Hounslow MJ editors. Volume 12 Particle Breakage. The Netherlands: Elsevier; 2007. p. 960-962.

Varian. Friability Tester Operator’s Manual. North Carolina: Varian Inc;
2006.

Handling of friabilator appratus
8.0 6. Precautions

6.1. Do not open the electical compartment due to the risk of shock and allow only trained personnel to do so.

6.2. When tightening the locking nut, ensure that it is not overtightened since this can cause damage to the drum.

6.3. Do not use cleaning compounds containing ammonia or abrasive cleaners to clean the plastic drum since such compounds may damage plastic, causing it to crack and fracture.

6.4. For tablets with a unit mass equal to or less than 650mg, a sample of tablets corresponding as near as possible to 6.5g is to be used whilst for tablets with a unit mass greater than 650mg, a sample of 10 whole tablets is to be used.

6.5. According to the British Pharmacopoeia, 100 rotations are considered to be the standard number of rotations to be used for each test.

6.6. According to the British Pharmacopoeia, a maximum loss of mass not greater than 1.0 per cent is considered acceptable for most types of tablets.
9.0 ABBREVIATION:

9.1 Wt: Weight.
Tablet friability can be used to measure efficiency of tabletting equipment or as an indicator of formulation suitability as well as routine QC functions. It can also be thought of as measuring “dusting”. Tablets are rotated in a plastic drum for a specified period of time. A gravimetric determination is then made to quantitate the amount of surface material that has worn off.

Friabilator Operation Cleaning {Friability Test Apparatus Procedure of Tablets}

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Primary standards – Criteria, Properties and Examples

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primary standard

What is a Primary Standard?

Primary standard is a compound of  sufficient purity from which standard solutions of known normalities can be prepared by direct weighing of it and diluting to a defined volume of solution.

Examples

Sodium carbonate Na2CO3
Sodium borate Na2B4O7
Potassium hydrogen iodate KH(IO3)2
Pure metals and their salts like Zn, Mg, Cu, Mn, Ag, AgNO3 , NaCl, KCl, KBr   – used in Acid base titrations
K2Cr2O7, KBrO3, KIO3, KI(IO3)2, NaC2O4, As2O3, pure iron – used in redox titrations

Eligibility criteria for a primary standard

A primary standard should satisfy the following conditions

primary standard
primary standard
  1. should be very pure
  2. should neither be deliquescent (absorbing moisture) nor efflorescent (losing water)
  3. should have high molecular weight so that weighing errors can be minimised
  4. should be chemically stable
  5. shall be readily soluble under given conditions
  6. it should react stoichiometrically

For more information one can read Benteley and Driver’s Textbook of Qualitative chemical analysis

Primary drinking water standards:

Primary standards and treatment techniques protect public health by limiting the levels of contaminants in drinking water.
Microorganisms
Disinfectants
Disinfection Byproducts
Inorganic Chemicals
Organic Chemicals
Radionuclides

Maximum Contaminant Level Goal (MCLG) – The level of a contaminant in drinking water below which there is no known or expected risk to health. MCLGs allow for a margin of safety and are non-enforceable public health goals.
Maximum Contaminant Level (MCL) – The highest level of a contaminant that is allowed in drinking water. MCLs are set as close to MCLGs as feasible using the best available treatment technology and taking cost into consideration. MCLs are enforceable standards.
Maximum Residual Disinfectant Level Goal (MRDLG) – The level of a drinking water disinfectant below which there is no known or expected risk to health. MRDLGs do not reflect the benefits of the use of disinfectants to control microbial contaminants.
Treatment Technique (TT) – A required process intended to reduce the level of a contaminant in drinking water.
Maximum Residual Disinfectant Level (MRDL) – The highest level of a disinfectant allowed in drinking water. There is convincing evidence that addition of a disinfectant is necessary for control of microbial contaminants.

epa primary drinking water standards

The National Primary Drinking Water Regulations (NPDWR) are here:

Contaminant MCLG1 (mg/L)2 MCL or TT1 (mg/L)2 Potential Health Effects from Long-Term Exposure Above the MCL (unless specified as short-term) Sources of Contaminant in Drinking Water
Cryptosporidium zero TT3
Gastrointestinal illness (such as diarrhea, vomiting, and cramps)
Human and animal fecal waste
Giardia lamblia zero TT3
Gastrointestinal illness (such as diarrhea, vomiting, and cramps)
Human and animal fecal waste
Heterotrophic plate count (HPC) n/a TT3
HPC has no health effects; it is an analytic method used to measure the variety of bacteria that are common in water. The lower the concentration of bacteria in drinking water, the better maintained the water system is.
HPC measures a range of bacteria that are naturally present in the environment
Legionella zero TT3
Legionnaire’s Disease, a type of pneumonia
Found naturally in water; multiplies in heating systems
Total Coliforms (including fecal coliform and E. Coli)
Quick reference guide
zero 5.0%4
Not a health threat in itself; it is used to indicate whether other potentially harmful bacteria may be present5
Coliforms are naturally present in the environment; as well as feces; fecal coliforms and E. coli only come from human and animal fecal waste.

Click here down for primary drinking water standards PDF

primary drinking water standards PDF

 

Types of Patents

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patent

Three types of Patents

Utility Patents

Utility patents may be granted to anyone who invents or discovers any new and useful process, machine, article of manufacture or composition of matter or any new and useful improvement thereof

Design Patents

Design Patents may be granted to anyone who invents a new, original and ornamental design for an article of manufacture.

Plant Patent

Plant Patent May be granted to anyone who invents or discovers and asexually reproduces any distinct and new varieties of Plants

Types of Patents filed with Patent Offices

Divisional Application

During examination procedure, patent application can be divided in two or more divisional applications if it has consisted of more than one invention or if does not fulfill the condition of unity of invention. Each new application retains the same priority date as the original patent application. Divisional Application can be filed before sealing of Patent.

Continuation Patent Application

Continuation Patent Application can be used eg. for correcting formal errors within the priority year. It is a later application filed after an earlier patent application for the same invention was disallowed. The continuation application retains the same priority date as the original patent application. A continuation application must be filed before the first application becomes abandoned. Continuation application can be filed between notice of allowance and publication.

Continuation-in-Part (CIP) Patent Application

In the US, the applicant can file a continuation in part application in order to introduce new improvements, not covered in the original parent application. This can be done anytime while the patent is pending. A CIP application always have several priority dates. The original part of invention already covered in the parent application retains the old priority while the new matter gets the filing date of the CIP application as their priority date. The CIP applications are very common in the US.  Elsewhere it is not possible to add new material to the pending patent application otherwise than by filing a new application before the previous application has become public.

Patent of Addition

Patent of Addition May be applied for improvement in or modification of an invention for which a patent has already been applied for or granted.