M pharm Pharmaceutics Notes: EVALUATION OF COLON-SPECIFIC DRUG DELIVERY PDF

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EVALUATION OF COLON-SPECIFIC DRUG DELIVEY SYSTEMS

Various in vitro and in vivo evaluation techniques have been developed and proposed to test the performance and stability of colon-specific drug delivery systems.

 

  1. In vitro dissolution testing

Dissolution testing has been an integral component in pharmaceutical research and development of solid dosage forms. It provides decisive information on formulation selection, the critical processing variables, in vitro/in vivo correlation and quality assurance during clinical manufacturing. In order to provide this information, dissolution testing should be conducted in physiochemically and hydrodynamically defined conditions to simulate the environment that the dosage form encounters in the GI tract. Currently, four dissolution apparatus are recommended in the USP to accommodate different actives and dosage forms: basket method, paddle method, Bio-Dis method and flow-through cell method. However, certain constraints associated with USP dissolution methods were recognized, especially in the dissolution evaluation of complex controlled release drug delivery systems for oral application, and modification of USP dissolution methods to evaluate such delivery systems was deemed necessary (Pillay and Fassihi, 1999). For in vitro evaluation of colon-specific drug delivery systems, the ideal dissolution testing should closely mimic the in vivo conditions with regard to pH, bacteria, types of enzymes, enzymatic activity, fluid volume and mixing intensity.

 

  1. Conventional dissolution testing

Dissolution testing of colon delivery systems with the conventional basket method has usually been conducted in different buffers for different periods of time to simulate the GI tract pH and transit time that the colon-specific delivery system might encounter in vivo (Rudolph et al., 2001). For example, Takeuchi et al., (2000) assessed the dissolution of spray-dried lactose composite particles containing alginate-chitosan complex as a compression coating in pH 1.2 and 6.8 buffers. Results indicated that such dry-coating showed excellent acid-resistance and prolonged induction periods for drug release.

M pharma pharmaceutics notes - evaluation of colon specific drug delivery systems

USP Dissolution Apparatus III (reciprocating cylinder) was employed to assess in vitro performance of guar-based colonic formulations. Because of the unique setup of dissolution apparatus III (i.e. the dissolution tubes can be programmed to move along successive rows of vessels), drug release can be evaluated in different medium successively. Wong et al., (1997) evaluated several guar-based colonic formulations using apparatus III in simulated gastric fluid (pH 1.2), simulated intestinal fluid (pH 7.5) and simulated colonic fluids containing galactomannanase. As expected, when compared with drug release in simulated gastric and intestinal fluids, results showed that drug release was accelerated in the colonic fluid due to the presence of the galactomannanase that could hydrolyze the guar gum.

Despite the simplicity and convenience, conventional dissolution testing primarily provides essential information on the processing specifications of a colon-specific delivery system rather than on the validity of the system design. For those delivery systems triggered by bacteria in the colon, the conventional dissolution testing appears unlikely to be predictive of in vivo performance. Additional factors that make conventional dissolution testing of colon-specific drug delivery systems less predictive of its in vivo performance are scarcity of fluid and reduced motility in the colon. One function of colon is to absorb water (Debongnie and Phillips, 1978) and thus condense the luminal contents into semisolids. This would influence the drug release from the system and diffusion within luminal contents.

 

  1. Alternative method for evaluation of colon-specific delivery system in vitro

To overcome the limitation of conventional dissolution testing for evaluating the performance of colon-specific delivery systems triggered by colon-specific bacteria, animal caecal contents including rats (Rubinstein et al., 1993), rabbits (Larsen et al., 1989), and pigs (Larsen et al., 1989) have been utilized as alternative dissolution medium. Because of the similarity of human and rodent colonic microflora, predominantly comprising Bifidobacterium, Bacteroides and Lactobacillus, rat caecal contents were more commonly used in the dissolution studies. Rat caecal contents were usually prepared immediately prior to the initiation of drug release study due to the

anaerobic nature of the cecum. Rats were anaesthetized and the cecum was exteriorized for collection of the contents. The caecal contents were diluted with phosphate-buffered saline (PBS, pH 7) to obtain an appropriate concentration for release study. This step was conducted under CO2 or nitrogen to maintain an anaerobic environment. The drug release studies were generally carried out in sealed glass vials at 37 0C for a defined period of time. Samples were withdrawn at different intervals for analysis (Rubinstein et al., 1992, 1993; Yang et al., 2001).

 

In the present in vitro study, the volume of dissolution fluid, containing rat caecal contents, was only 100 ml in order to simulate the fluid volume of the colon. Apparatus 2 is not suitable since the wider paddle blade (diameter 75 mm) can not be dipped in the dissolution fluid contained in the beaker (diameter 55 mm).

USP apparatus 3 was used for the evaluation of guar gum formulations meant for colonic drug delivery (Wong et al., 1997). In this study the authors used water soluble enzyme, galactomannase, at a concentration of 0.01 mg/ml. The level of polysaccharidases in 4 g of rat caecal contents used in the present study, though not estimated, may be far less than what was used by Wong et al., (1997). Hence, it is necessary that the guar gum formulations be continuously in contact with the dissolution fluid for better access to the caecal enzymes. This could be achieved by the use of USP apparatus 1. Moreover, the use of USP apparatus 3 also results in settling of the rat caecal contents in the bottom of the vessel. The maintenance of an anaerobic environment in USP apparatus 3 may also be problematic. Because of these reasons, USP apparatus 1 with slight modifications was used in the present study to evaluate guar gum as a carrier in the form of compression coat for colon-specific drug delivery. Further, earlier workers (Ashford et al., 1993b, Krishnaiah et al., 1998) also used apparatus 1 for the evaluation of colonic delivery systems.

 

  1. In vivo evaluation of colon-specific drug delivery systems

As in other controlled release delivery systems, the successful development of a colon-specific drug delivery system is ultimately determined by its ability to achieve colon-specific drug release and thus exert the intended therapeutic effect. When the system design is conceived and prototype formulation with acceptable in vitro characteristics is obtained, in vivo studies are usually conducted to evaluate the site specificity of drug release and to obtain relevant pharmacokinetics information of the delivery system. Although animal models have obvious advantages in assessing colon-specific drug delivery systems, human subjects are increasingly utilized for evaluation of this type of delivery systems with visualization techniques such as γ-scintigraphy imaging.

  1. Animal studies

Different animals have been used to evaluate the performance of colon-specific drug delivery systems, such as rats (Van den Mooter et al., 1995; Tozaki et al., 2001), pigs (Friend et al., 1991; Gardner et al., 1996), and dogs (Yang et al., 2001). To closely simulate the human physiological environment of the colon, the selection of an appropriate animal model for evaluating a colon-specific delivery system depends on its triggering mechanism and system design. For instance, guinea pigs have comparable glycosidase and glucuronidase activities in the colon and similar digestive anatomy and physiology to that of human (Hawksworth et al., 1971), so they are more suitable in evaluating glucoside and glucuronate conjugated prodrugs intended for colon delivery.

Friend et al., (1991) evaluated the therapeutic efficacy of dexamethasone-β-D-glucoside with dexamethasone in guinea pigs with experimentally induced IBD (Friend et al., 1991). Even though guinea pig is the preferred animal model to investigate the in vivo performance of certain colon specific delivery systems, it is difficult to administer the delivery system orally.

Rats were also used to evaluate colon-specific drug delivery systems based on azo-polymers or prodrugs containing azo bonds because the distribution of azoreductase activity in GI tract is similar between rats and human subjects (Renwick., 1982).

Another animal commonly used to evaluate oral controlled release delivery systems is the dog (Renwick, 1982). The in vivo performance of CODES™ was evaluated in beagle dogs using acetaminophen as a model drug and lactulose as the matrix-forming excipient in the core tablet (Yang et al., 2001).

It is well recognized that significant differences exist between human subjects and commonly used laboratory animals in GI tract anatomy and physiology, including GI transit time, pH, distribution of enzyme activity, population of bacteria, etc. Therefore, the data obtained from animal models should be interpreted with caution.

 

  1. Gamma-Scintigraphy

In most cases, conventional pharmacokinetic evaluation may not generate sufficient information to elucidate the intended rationale of system design. γ-Scintigraphy is an imaging modality, which enables the in vivo performance of drug delivery systems to be visualized under normal physiological conditions in a non-invasive manner. Through γ-scintigraphy imaging, the following information regarding the performance of a colon-specific delivery system within human GI tract can be obtained: the location as a function of time, the time and location of both initial and complete system disintegration, the extent of dispersion, the colon arrival time, stomach residence and small intestine transit times.

The in vivo performance of the colonic delivery system based on pectin and galactomannan coating was also evaluated in healthy human subjects with γ-scintigraphy together with conventional pharmacokinetic analysis using nifedipine as a model drug (Pai et al., 2000). Overall, γ-scintigraphic results demonstrated that it took 5.44 h for the tablets to reach the ascending colon in 92% of 12 subjects. Upon arrival in the ascending colon, approximately additional 1 h was required to initiate the tablet disintegration. The mean plasma concentration of nifedipine was negligible for more than 5 h post-dose, and then increased rapidly. The pharmacokinetic profile exhibited a good correlation with the scintigraphic results. In essence, γ-scintigraphic evaluation of a colon-specific drug delivery system provides ‘proof of concept’, i.e. visualization of system disintegration event and ascertainment of disintegration location in the GI tract.

 M pharma pharmaceutics notes – evaluation of colon specific drug delivery systems PDF doc M pharm Pharmaceutics Notes EVALUATION OF COLON-SPECIFIC DRUG DELIVEY SYSTEMS

  1. Roentgenography

The inclusion of a radio-opaque material into a solid dosage form enables it to be visualized by the use of X-rays. By incorporating barium sulphate into a pharmaceutical dosage form, it is possible to follow the movement, location and the integrity of the dosage form after oral administration by placing the subject under fluoroscope and taking series of X-rays at various time points. This technique was used by Dew et al., (1982) to evaluate a capsule dosage form coated with Eudragit S to deliver orally ingested drugs to the colon using barium sulphate as a radio- opaque material.

Table 4. Marketed colon specific drug delivery systems

 

Drug Trade Name Coating Polymers
Mesalazine claversa®

Asacolitin

Mesazal

Asacol

 Eudragit® L100

Eudragit® S

Eudragit® L100

Eudragit® S
Budesonide Entrocort®

Budenofalk®

Targit®

 Eudragit® L100-55

Eudragit® S

Coated Starch Capsule
Sulfasalazine Azulfidine

 

Colo-Pleon

 Cellulose acetate phthalate

 

Eudragit® L100-55

 

Colon – ANOTOMY & PHYSIOLOGY OF COLON Functions Pharmacology Notes

B Pharmacy M pharmacy Study Material Pharmacology Notes PDF DRUGS SUITABLE FOR COLONIC DRUG DELIVERY

 

 

 

Pharmaceutics M Pharmacy Project Title – Example Summary Aim – B pharm Projects

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Pharmaceutics M Pharmacy Project Title – Example Summary Aim – B pharm Projects

BIOAVAILABILITY STUDY AND COLONIC RESIDENCE TIME EVALUATION BY X-RAY OF ORNIDAZOLE FROM COATED TABLETS IN HEALTHY HUMAN VOLUNTEERS

Pharmaceutics M Pharmacy Project Title – Example Summary Aim – B pharm Projects

 

BIOAVAILABILITY STUDY AND COLONIC RESIDENCE TIME EVALUATION BY X-RAY OF ORNIDAZOLE FROM COATED TABLETS USING APPROVED PHARMACEUTICAL EXCIPIENTS IN HEALTHY HUMAN VOLUNTEERS

 

Summary

Aim                             :           1) To carry bioavailability study of Ornidazole from coated tablets by using pharmaceutical excipients and compare with marketed product.

2) To carry colonic residence time  evaluation by X-ray study of Ornidazole from coated tablets.

Drugs used                 :           Ornidazole 400 mg.

Subjects                      :           Eight healthy human male volunteers

Study design              :           Crossover design

Institution                   :

Principal Investigator:

Study Procedure:

Eight human healthy male subjects in the age group of 25-30 will be enrolled in the study after physical examination by a physician and standard laboratory tests.

Inclusion Criteria:

  1. Non-allergic to drug
  2. Healthy as per the physical examination and laboratory tests
  • Non-participation in any study/blood donation during preceding three months
  1. Written informed consent

Study design: Simple randomized crossover design

The subject will be treated with single oral dose of Ornidazole after overnight fasting.  In the crossover study, subjects will be given coated tablets of Ornidazole.  Blood samples will be collected at 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 and 30 hours.

The subject will be treated with single oral dose of placebo tablets after overnight fasting.  In the crossover study, subjects will be given placebo tablets of Ornidazole.  X-Rays will be taken at 2, 5, 8,12 and 24 hours.

Pharmaceutics M Pharmacy Project Title – Example Summary Aim – B pharm Projects PDF

Pharmaceutics M Pharmacy Project Title – Example Summary Aim – B pharm Projects Pharmaceutics M Pharmacy Project Title – Example Summary Aim – B pharm Projects

Treatments: Eight male volunteers shall be distributed in to two groups. A 2×2 cross over design shall be used in the study. Each volunteer in the two groups will receive the floating matrix tablets and commercial dosage form as                           .

The study consists of two treatments (Ornidazole coated, commercial).     Ornidazole 400 mg will be given by oral route in the form of coated tablets and blood samples will be collected at 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 and 30 hours.

A drug free interval of at least two weeks will be kept between the two treatments.  A standard breakfast will be served 2 hours after drug administration followed by standard lunch after 4 hours.

ORNIDAZOLE

Ornidazole is an anti infective / antibacterial and antiprotozaol drug available as 400mg, 500 mg and 1000 mg tablets for oral administration. Its chemical name is 1-(3-chloro-2-hydroxypropyl)-2-methyl-5-nitroimidazole.

The half-life of the drug is approximately 7.4 hours in plasma. Ornidazole is metabolised in liver through biotranformation reactions while excretion is mainly by  Urine.

ContraIndications:

Hypersensitivity to ornidazole or to other nitroimidazole derivatives

Adverse Reactions:

Somnolence, headache, nausea, vomiting, dizziness, tremor, rigidity, poor coordination, seizures, tiredness, vertigo, temporary loss of consciousness and signs of sensory or mixed peripheral neuropathy, taste disturbances, abnormal LFTs, skin reaction.

 


Physical properties:

Solubility                    :           It is slightly soluble in water, and soluble in chloroform.

Pka                             :           2.4 ± 0.1

Category                    :           It is a anti-infective and anti-protozoal agent

 

Pharmacokinetics

Bioavailability            :           >90 % by oral route

Absorption                 :           Absorbed from entire GIT.

Protein Binding         :           <15 %

Half life                      :           14.67 + 1.0 hrs

Dosage                       :          400 to 1000 mg daily.

 

 


APPROVAL OF THE ETHICAL COMMITTEE

 

The study entitled “Bioavailability study and colonic residence time evaluation by x-ray of Ornidazole from coated tablets in healthy human volunteers” has been approved / not approved for conducting in the healthy human volunteers.

 

Pharmacology Study Notes: Colon : COLON SPECIFIC DRUG DELIVERY SYSTEM PDF

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Pharmacology Study Notes Colon COLON SPECIFIC DRUG DELIVERY SYSTEM

Pharmacology Study Notes: Colon : COLON SPECIFIC DRUG DELIVERY SYSTEM

 

FACTORS TO BE CONSIDERED IN THE DESIGN OF COLON SPECIFIC DRUG DELIVERY SYSTEM

To reach the colon and to be able to specifically deliver and absorb the drug there, the dosage forms must be formulated taking into account the obstacles of the gastrointestinal tract. The various strategies developed to achieve this goal have used the specific characteristics of this organ, i.e. transit time, pH, microflora, enzymes, disease and the colonic environment. Nevertheless, these parameters can vary from one individual to the next and also according to the pathological condition and diet.

 

Physiological Factors

Gastrointestinal transit

Gastrointestinal transit time is important for nearly all orally targeting delivery systems. The drug delivery systems first enter in to stomach and small intestine via mouth and then reach colon. In fasted state, the motility proceeds through four phases occurring in stomach and small intestine that span over a period of 2-3 h. Phase I is a quiescent period of 40-60 min, Phase II consists of intermittent contractions for a period of 40-60 min. Phase III is a period of intense contractions sweeping material out of the stomach and down the small intestine followed by Phase IV with contractions dissipating. The feeding state affects the normal pattern by irregular contractile activity.  

It has been well documented that gastric emptying varies with different types of dosage forms. Examples of gastric residence times of single-unit tablets are given in Table 1 (Abrahamsson, 1993). It has been generally accepted that liquid emptying follows a monoexponential process and digestible solids empty in a linear fashion with time.

 

Small intestinal transit

Normally, transit times through the small intestine generally found to be 3-4 h. Liquids, small solids (beads, small tablets), and larger capsule-sized units moved essentially at the same rates and the transit is unaffected by food status (Davis, 1986). In a more recent study concerning dosing in relation to the timing of food intake, found that although SIT is relatively independent of food and dosage form, it was actually shortened significantly if the dose is given 30 min before food intake. This can have adverse impact on the in vivo performance of the dosage forms.

 

Colonic Transit

In the stomach and small intestine, food residue and endogenous secretions are exposed to an essentially sterile environment through which their transit can be measured by hours. On entering the large intestine, dosage forms encounter a rich bacterial flora and transit through the large intestine can be as long as several days. It was reported that overall mean transit time is 36 h with a range of 1 to 72 h and that the transit of liquids and small solids is equal (Phillips., 1993). Thus, absorption from colon may be incomplete and erratic depending on the dose and physicochemical properties of a particular drug. In general, absorption of an insoluble drug with high dose or a drug with limited permeability is unfavorable in this region because of the limited volume of fluid available for dissolution and the significantly reduced surface area.

 Pharmacology Study Notes Colon COLON SPECIFIC DRUG DELIVERY SYSTEM pdf Pharmacology Study Notes Colon COLON SPECIFIC DRUG DELIVERY SYSTEM Pharmacology Study Notes Colon COLON SPECIFIC DRUG DELIVERY SYSTEM

Table 1. Gastrointestinal transit times for felodipine CR hydrophilic matrix

section Gastric emptying (h) Small intestine transit (h) Colon arrival (h)
Fasting Fed Fasting Fed Fasting Fed
Mean 0.6 3.2 4.7 5.1 5.3 8.3
Range 0.1-1.1 1.9-4.8 3.9-5.9 2.2-7.7 4.0-7.0 6.0-11.0
P <0.001 >0.05 >0.01

 

 

 

pH in the Colon

The pH gradient in the GIT is not in an increased order and is subjected to both inter- and intra-subject variations. In stomach the pH is 1.5 – 2.0 and 2 – 6 in fasted and fed conditions, respectively. The acidic pH is responsible for the degradation of various pH sensitive drugs and enteric coating may prevent it. In small intestine, the pH increases slightly from 6.6 – 7.5. On entry into the colon, the pH dropped to 6.4 in right colon. The pH of mid colon was found to be 6.6 and in the left colon, 7.0 (Evans et al., 1988).

Colonic pH has been shown reduced in disease state. The mean pH in a group of 7 patients with untreated ulcerative colitis was 4.7 whereas in 5 patients receiving treatment it was 5.5 (Raimundo et al., 1992).

Colonic microflora

The human colon is a dynamic and ecologically diverse environment, containing over 400 distinct species of bacteria with a population of 1011 to 1012 CFU/mL (Cummings et al., 1991), with Bacteroides, Bifidobacterium, Eubacterium, Lactobacillus, etc greatly outnumbering other species. For example, it was reported that Bacteroides, Bifidobacterium and Eubacterium could constitute as much as over 60% of the total cultivable flora (Salyers, 1984). These bacteria produce a wide spectrum of enzymes that, being reductive and hydrolytic in nature, are actively involved in many processes in the colon, such as carbohydrate and protein fermentation, bile acid and steroid transformation, metabolism of xenobiotic substances, as well as the activation and destruction of potential mutagenic metabolites. Nitroreductase, azoreductase, N-oxide and sulfoxide reductase are the most extensively investigated reductive enzymes, while glucosidase and glucuronidase are the most extensively studied hydrolytic enzymes. The primary source of nutrition for these anaerobic bacteria is carbohydrates such as non-starch polysaccharides (i.e., dietary fibers) from the intestinal chime. It is well established that non-starch polysaccharides are fermented during transit through the colon and the breakdown in the stomach and small intestine is negligible. Enzymes responsible for the degradation of polysaccharides include α-L-arabinofuranosidase, β-D-fucosidase,  β-D-

galactosidase, β-Dglucosidase, β-xylosidase, with the last three enzymes being the most active (Englyst et al., 1987). Additionally, the composition of colonic bacteria and corresponding enzymes can be influenced by many factors, including age, diet, diseases, medication such as antibiotics, and geographic regions (Mueller et al., 2006). A unique feature of colon microflora is that the growth and activity of certain specific species, most notably bifidobacteria and lactobacilli, can be selectively stimulated by nondigestible oligosaccharides which are known as prebiotics. Similar bacteriological data were observed in the rats fed with indigestible oligosaccharides where the caecal bifidobacteria population was higher than in the controls (Campbell et al., 1997).

Volume of the ascending colon

Up to 1,500 g of liquids and undigested materials (dietary fibers, resistant starch, partially degraded polysaccharides proteins, mucins, exfoliated epithelial cells, etc.) enters colon per day, which act as the substrates for microflora fermentation. Water together with the products of the fermentation and other nutrients was efficiently absorbed in the colon, condensing the contents into feces through the transit in the colon for eventual defecation. Therefore, it is very likely that the ascending colon contains the largest quantity of liquid. It would be expected that the low water–high gas environment of the transverse colon limits dissolution of materials.  The moisture content of caecal contents is believed to be about 86% (Cummings and Macfarlane, 1991). The volume of the ascending colon was measured in healthy subjects using a single photon emission computed tomography (SPECT) by acquiring the imaging of the ascending colon filled with 99Tcm-labelled Amberlite pellets, and was found to be 170±40 ml (Badley., 1993). If the moisture content in the ascending colon is approximately comparable to that of caecal contents, the quantity of fluid in the ascending colon should be 146±34 ml.

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Disease and the Colonic Environment

General intestinal diseases such as inflammatory bowel disease, Crohn’s disease, constipation and diarrhea may affect the release and absorption of colon specific drug delivery systems. All the specific approaches so far mentioned rely on the concept that enzymes produced by colonic microflora provide the trigger for specific delivery of fermentable coatings, anti-inflammatory azobond drugs, and other prodrugs to the cecum. Carrette and co-workers (1995) demonstrated that in patients with active Crohn’s disease, the metabolic activity of digestive flora (assessed on the activity of fecal glycosidases) was decreased. Azoreductase activity in feces of 14 patients with active Crohn’s disease was 20% of that of healthy subjects and similarly, beta-D-glucosidase and beta-D-glucuronidase activities in fecal homogenates incubated under anaerobic conditions were also decreased in patients. These data probably reflect large-bowel hypermotility and the associated diarrhea, leading to lower bacterial mass in the colon and might contribute to the therapeutic failure of targeting mechanisms in active ileocolic and colic Crohn’s disease.

 

[DOC Pdf PPT] Colon – ANOTOMY & PHYSIOLOGY OF COLON Functions Pharmacology Notes

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Here is best notes for our readers to understand the concept of anatomy of Colon to study in depth of its physiology. Colon – ANOTOMY & PHYSIOLOGY OF COLON Functions Pharmacology Notes

The GI tract is divided into stomach, small intestine and large intestine. The large intestine extending from the ileocaecal junction to the anus is divided into three main parts. These are the colon, the rectum and the anal canal. The location of the parts of the colon is either in the abdominal cavity or behind it in the retroperitoneum. The colon itself is made up of the caecum, the ascending colon, the hepatic flexure, the transverse colon, the splenic flexure, the descending colon and the sigmoid colon (Figure 1). It is about 1.5 m long, the transverse colon being the longest and most mobile part (Meschan, 1975), and has a average diameter of about 6.5 cm. The colon from the cecum to the splenic flexure (the junction between the transverse and descending colon) is also known as the right colon. The remainder is known as the left colon.

      Arterial supply to the colon of humans comes from branches of the superior and inferior mesenteric arteries. Venous drainage usually mirrors colonic arterial supply, with the inferior mesenteric vein draining into the splenic vein, and the superior mesenteric vein joining the splenic vein to form the portal vein, which then enters the liver.

       Lymphatic drainage from the entire colon and proximal two-thirds of the rectum is to the paraortic nodes, which then drain into the cisterna chyli. The lymph from the remaining rectum and anus can either follow the same route, or drain to the internal illiac and superficial inguinal nodes. The dentate line only roughly marks this transition.  

ANOTOMY & PHYSIOLOGY OF COLON

 Figure 1.  Main features of the colon

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Functions of Colon

The colon serves four major functions. They are

  1. Creation of suitable environment for the growth of colonic microorganisms
  2. Storage reservoir of faecal contents
  3. Expulsion of the contents of the colon at an appropriate time and
  4. Absorption of potassium and bicarbonate.

 

B Pharmacy M pharmacy Study Material Pharmacology Notes PDF DRUGS SUITABLE FOR COLONIC DRUG DELIVERY

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B Pharmacy M pharmacy Study Material Pharmacology Notes DRUGS SUITABLE FOR COLONIC DRUG DELIVERY

B Pharmacy M pharmacy Study Material Pharmacology Notes is an article with detailed notes on DRUGS SUITABLE FOR COLONIC DRUG DELIVERY. 

 B Pharmacy M pharmacy Study Material Pharmacology Notes DRUGS SUITABLE FOR COLONIC DRUG DELIVERY

DRUGS SUITABLE FOR COLONIC DRUG DELIVERY

Drug delivery selectively to the colon through the oral route is becoming increasingly popular for the treatment of large intestinal diseases and for systemic absorption of protein and peptide drugs. There has been an increasing interest in utilizing the colon as a site for systemic absorption of these drugs in view of the less hostile environment prevailing in the colon. A variety of protein and peptide drugs like calcitonin, interferon, interleukins, erythropoietin and even insulin are being investigated for their absorption using colon specific drug delivery (Mackay and Tomlinson., 1993).

Inflammatory bowel disease (IBD) such as ulcerative colitis and Crohn’s disease require selective local delivery of drugs to the colon. Sulfasalazine is the most commonly prescribed drug for such diseases. Selective delivery of the drug to the colon is required for therapeutic efficacy with less or no side effects. The other drugs used in IBD are steroids, such as dexamethasone, prednisolone, and hydrocortisone.  In colonic cancer, anticancer drugs like 5-flurouracil, doxorubicin, and nimustine are to be delivered specifically to the colon. The site specific delivery of drugs like, metronidazole, mebendazole, albendazole is used in the treatment of infectious diseases, such as amoebiasis and helmenthiasis (Krishnaiah et al., 2002b; Krishnaiah et al., 2001; Jain et al., 2004).

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Besides peptide and protein drugs, the colon is also a good site for the absorption of drugs that are not stable in the acidic environment of the stomach, cause gastric irritation (e.g. aspirin, iron supplements) or those degraded by small intestinal enzymes. A number of drugs available as sustained release or delayed release or timed release tablets or capsules for oral administration are anti-inflammatory drugs, anti-hypertensive drugs, etc. Unless these drugs have good absorption characteristics in the colon, their intended use in the management of respective disorders through sustained release or timed release formulations will be in question.  The drugs that are having good absorption properties from the colon include theophylline, glibenclamide (Brockmeier et al., 1985), and oxprenolol (Devis et al., 1988). Diclofenac, ibuprofen, nitrendipine, isosorbide, metoprolol, nifedipine etc. and hence can be investigated for better bioavailability through colon specific drug delivery (Fara, 1989).

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

[Doc PDF PPT ] Adenosine: Pharmacology notes B pharm M pharmacy Study Material

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Adenosine Pharmacology notes for B M Pharmacy students

Pharmacology noted for B pharmacy and M Pharmacy students is readily available in our site www.pharmawiki.in/ [Doc PDF PPT ] Adenosine: Pharmacology notes B pharm M pharmacy Study Material is here below. Have a look at it and study it.

Adenosine is a purine nucleoside that regulates many physiological functions which includes respiratory regulation, neural function ,platelet aggregation, hormonal action , lymphocyte differentiation, vascular tone, negative chronotropic  and dromotropic effect on heart , also mediates inhibition of neurotransmitter release and lipolysis . These physiological function have been largely revised.(1),(2)

These functions are mediated through different adenosine receptor. There are four subtypes of AR-A1,A2A-AR,A2B-AR,A3-AR  each of these receptors has distinct tissue distribution and effector coupling. They belong to super family of G-protein coupled receptors (3).among these  receptors A1,A3AR1 are closely related  based on their sequence similarity while A2A,A2B AR also similarly related. A1 and A3 are primarly couple to G(subi) –family of G-protein.A2A and A2B are mostly coupled to GS  like G- protein. Each of these receptors plays an essential role in responding to adenosine in central nervous system(4) ,regulating pain (5) . cerebral blood flow(6). Basal gangalia function (7) respiration (8) and sleep (9.) thus these receptors can be therapeutic  targets for several diseases. Development of more selective agonists and antagonists  for adenosine receptor subtype provide aclass of therapeutics for treatment of numerous human diseases such as apain (10).  parkinsons disease (11)  asthma(12)   huntingtons disease(13).A search for new leads acting on specific adenosine acting on specific adenosine receptors may provide a key for novel therapeutics

Adenosine Pharmacology notes for B M Pharmacy students

Structure of A2A AR

        A2A-AR subtype is linked to  and G(S) and G(OLF) protein and up on activation the intracellular levels of Camp  are increased . the  expression  A2A AR expression is higest in brain, .spleen,thymus,leucocyte and blood platelets and intermediate in heart lungs and blood vessel.(14)(15)..Crystal structure of A2A AR was determined in 2008,physiological functions  A2A AR are regulation of sensori motors integration in basal ganglia., inhibition of platelet aggregation and polymorpho nuclear leucocytes, vasodilation protection  against ischemic damage, stimuation of sensory nerve activity . (17)  these wide range of functions implies their significant role in the body and use of chemical moieties to alter these function in disease state (may be agonists or antagonists).

A2A AR Adenosine antagonists:

A2A AR antagonist have their role in parkinsons disease, (18) keep regulations (19) controlling alcohol abuse (20) invivo receptor imaging (21)  there can also be used an anti depressant drug. (22) A2 AR agonists can be a treatment for ischemic renal injure (23) paraoxysmal supro ventricular tachycardia. They can be used as vasodilators (24) antithrombic agent (25)  antinflamatory (26) . they can also be used in treatment of asthma( 27), arthritis(28) sepsis (29) inflamatory bowel disease (30) and reduced skin pressure  ulcer formation (26) and accelerator  wound healing,(31)

In view of the role of A2A AR in these diseases afurther study in to the subject may reveal beneficial (facts) information for the treatment of such dieases. These receptors became agood targeting strategy  to bring out novel therapeutics for effective treatment of dieases.

Click here to download Pharmacology notes for B pharmacy M pharmacy StudentsADENOSINE

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Pharmacology study material ADENOSINE Article REFRENCES:

(1) K. A. Jacoboson, Z.G.Gao, Adenosine receptors as therapeutic targets Nal.Rev., Drug Discovery 5(2006) 247-264

(2)M.P.Abbracchio, G.BUrnstock, A.verkhasatsky, H. Zimmermann, purinergic signalling in nervous system an over view ,Trends Neurosci. 32 (2009) 19-29

(3)B.B. Fredholm, G.Arsian, L.Halldner, B.kull, G.Schutte, W.Wasserman, structure and function of adenosine receptors and their genes , Naunyn – Schmiedebergs Arch.pnaarmacol.362 (2006) 19-29

(4)(a) . T.V Dunwiddie, S.A .Masina Annu . Rev.Neurosci 24,31(2001)

(b). K.A.Jacobson, Z.G.Gao , Nat .Rev Drug Discover.5,247 (2006)

(5) J.sawynok,x.J.Liv,Drog Neurobio . 69,313 (2003)
(6) Y.Shietal, J.Cereb Blood Flow Method . 28,111 (2008)

(7) M.A.Schwarzchild , L.Agnati, K. Fure, J. Fichsn, M.M orelli , Trends Neurobiol 29. 647 (2006)

(8) S.Lahiri, CH.Nitchell.D.Reigade , A.Roy , N.s.chemiack , Respir. Physiol. Nenrobiol. 157 ,123 (2007)

(9) R.Basheer,R.E.Strecker,MM.Thatkar,R.W.M.Carley Prog. Neurobiol.73,379 (2009)

(10)J,Sawynok,X.J.Liu. Prpg.Neurobio.69,313

(11)A.H.Schapira.et.al, Nat.Rev.Drug.Discor.5,845 (2006)
(12)A. Brow, D.Spina, C.p.page, Br.J.Pharmacol.153,(suppli),5446(2008)

(13)D.Blum, R.Hourez, M.C.Galar, P.Popoli,S.N.Schiftmann, Lancet Neurol.2,366(2003)

(14)F.Meng, G.X.Xic, D.Chalmeri, C.Margan,S.J.Watson,Jr.,H.Akil,Cloning and expression of the A2a  receptors from guinea pig brain Neuro chem 66(1996) 613-621

(15)R.A.Deter freud,M.Maccollin,J.Gusella,J.S.Flink Characterization and expression of the human A2a adenosine receptors gene, Neuro chem. 66(1996)362-368.

(16)Veli-Pekka Jaakola, Mark.T.Grifftin,Micheal, A.Hanson, Vadim cherezov , ellen y.t chien, J.Robert lane ,Adlioan, P.L.Jzerman, Raymond c.sterenes, the 2.6 Angstroun Crystal structure of a human A2a Adenosine  receptor Bound to an Antagonist

(17)B.B.Fredholm, Adenosine, an endogenous distress signal, modulates tissue damage and repair not cell death and differentiation (2007) 14, 1315-1323

(18)Michael A .Schwarzschild, Luigi Agnati, Kjell Fuxe ,Jiang – fanchen and micaela morelli, Targetting Adenosine A2a receptors in parkinsons disease Trends in neurosciences Vol.29 No.11

(19) Satoh, S., Matsumura, H. & Hayaishi, O. Involvement of adenosine A2A receptor in sleep promotion. Eur. J. Pharmacol. 351, 155–162 (1998

(20) Yao, L. et al. dimers mediate synergy of dopamine D2 and adenosine A2 receptor-stimulated PKA signalling and regulate ethanol consumption. Cell 109, 733–743 (2002).

(21) Moresco, R. M. et al. In vivo imaging of adenosine A2A receptors in rat and primate brain using [11C]SCH442416. Eur. J. Nucl. Med. Mol. Imaging 32,405–413 (2005).

(22) El Yacoubi, M. et al. Absence of the adenosine A2A receptor or its chronic blockade decrease ethanol withdrawal-induced seizures in mice. Neuropharmacology 40, 424–432 (2001).

(23) Okusa, M. D. et al. A2A adenosine receptor-mediated inhibition of renal injury and neutrophil adhesion. Am.J. Physiol. Renal Physiol. 279, F809–F818 (2000).

(24) Fredholm, B. B., IJzerman, A. P., Jacobson, K. A., Klotz, K. N. & Linden, J. International Union of Pharmacology. XXV. Nomenclature and classification of adenosine receptors. Pharmacol. Rev. 53,527–552 (2001).

(25) Varani, K. et al. Dose and time effects of caffeine intake on human platelet adenosine A2A receptors:functional and biochemical aspects. Circulation 102,285–289 (2000)

(26) Peirce, S. M., Skalak, T. C., Rieger, J. M.,Macdonald, T. L. & Linden, J. Selective A2A adenosine receptor activation reduces skin pressure ulcer formation and inflammation. Am. J. Physiol. Heart Circ. Physiol. 281, H67–H74 (2001).

(27) Fozard, J. R., Ellis, K. M., Villela Dantas, M. F., Tigani, B. & Mazzoni, L. Effects of CGS 21680, a selective adenosine A2A receptor agonist, on allergic airways inflammation in the rat. Eur. J. Pharmacol. 438, 183–188 (2002).

(28) Montesinos, M. C. et al. Adenosine A2A or A3 receptors are required for inhibition of inflammation by methotrexate and its analog MX-68. Arthritis Rheum. 48, 240–247 (2003

(29) Sullivan, G. W., Fang, G., Linden, J. & Scheld, W. M. A2A adenosine receptor activation improves survival in mouse models of endotoxemia and sepsis. J. Infect. Dis. 189, 1897–1904 (2004).

(30) Odashima, M. et al. Activation of A2A adenosine receptor attenuates intestinal inflammation in animal models of inflammatory bowel disease. Gastroenterology 129, 26–33 (2005).

(31) Montesinos, M. C. et al. Wound healing is accelerated by agonists of adenosine A2 (Gs-linked) receptors. J. Exp. Med. 186, 1615–1620 (1997).

Top Pharmacy Colleges Andhra Pradesh & Telangana 10 A.P Best Universities B Pharmacy M Pharm

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Top Pharmacy Colleges In Andhra Pradesh & Telangana 10 Best

Top Pharmacy Colleges In Andhra Pradesh & Telangana

There are zillions of Pharmacy colleges in Andhra Pradesh & Telangana that are offering are performing excellence in providing B. Pharmacy courses to the pharmacy seeking students.  Students are showing more interest in studying pharmacy, which is why the number of Pharmacy colleges is also increasing time by time.  There are many named Pharmacy colleges and Universities in the state of Andhra Pradesh & Telangana that offer best quality education in Pharmacy to the students.  All the pharmacy colleges and universities are offering various pharmacy courses from under graduation level to post graduation level.

For the students who are searching for best Pharmacy colleges and Universities in the state of Andhra Pradesh & Telangana to join Pharmacy, this article can help you a great deal.  We have gathered up some information about the best and top Pharmacy colleges in Andhra Pradesh & Telangana.  Students who took entrance examination to enter the field of Pharmacy can check our top 10 list to know the near and best colleges to study Pharmacy.  All the colleges and Universities we are going to enlist will provide both under graduation and post graduation courses.

The courses offered by these Universities and Colleges in Andhra Pradesh & Telangana include M. Pharmacy Diploma in Pharmacy (D. Pharmacy), which is a two year course, Bachelor of Pharmacy (B. Pharmacy), which is a four year course, and Pharm.D, which is a six year course.  The Pharmacy Council of India (PCI) is a statutory body that governs the Pharmacy education in the country.  There are many pharmacy qualifications that are regulated by the Pharmacy Act 1948.

Top Pharmacy Colleges In Andhra Pradesh & Telangana 10 Best

Top 10 Pharmacy Colleges in Andhra Pradesh & Telangana

  1. NIPER,Hyderabad {Best Pharmacy Colleges In Andhra Pradesh & Telangana}

National Institute of Pharmaceutical Education and Research (NIPER), Hyderabad is an institute of National importance.  It is the top one institute in Andhra Pradesh & Telangana.  It is headquartered in Mohali and later six branches of NIPER were established all over the country.  It offers two year M.S. (Pharm), M.B.A (Pharm), M.Tech (Pharm) courses and Ph.D programmes.

  1. Pulla Reddy College of Pharmacy, Hyderabad {Top 2 Pharmacy Colleges In Andhra Pradesh & Telangana}
  2. Pulla Reddy College of Pharmacy is established in the year 1994. It is located in Mehdipatnam, Hyderabad. It works with a vision to envisage becoming the center of excellence for research in Pharmacy.  It aims to contribute significantly to drug development and drug discovery.

  3. Deccan School of Pharmacy, Hyderabad {Good Pharmacy Colleges In Andhra Pradesh & Telangana}

Deccan School of Pharmacy has spectra of institutions in Hyderabad.  It offers various programs like Pharmacy, Medical, Engineering, Nursing, Management, Physiotherapy and so on.  It works towards imparting quality education to the needy in various disciplines.

  1. Vaagdevi College of Pharmacy, Warangal {4th in List of Pharmacy Colleges In Andhra Pradesh & Telangana}

Vaagdevi College of Pharmacy was established in 1997 with a motive to develop a premier educational institution to meet the requirements of pharmaceutical industry and health care profession.  It is affiliated to Kakatiya University, Warangal.  It offers highest standards of education to the students studying under it.

  1. Yalamarty B. Pharmacy College, Visakhapatnam {Pharmacy Council of India approved colleges in Andhra Pradesh}

Yalamarty B. Pharmacy College, Visakhapatnam was established in 2004 by Yalamarty.  It is approved by All India Council of Technical Education (AICTE), New Delhi and Pharmacy Council of India (PCI).  Its main objective is to provide quality education and training to the students.

  1. Vignan’s Institute of Pharmaceutical Sciences, Nalgonda {Top Pharmacy Colleges in Telangana}

Vignan Institute of Pharmaceutical Sciences was established in 1999.  It is affiliated to JNTUH.  It philosophy of the college is to provide high quality pharmaceutical sciences education.  It aims to be on forefront in imparting the quality pharmacy education in graduate level.

  1. Rao’s College of Pharmacy, Nellore {Top Pharmacy Colleges In AP}

Rao’s College of Pharmacy was started in the year 2004 under the management of Sanjeevani Arts and Science College Committee.  Its vision is to enlighten the institute in the Galaxy of Business Schools by producing dynamic Kautilyas to control and direct our National Resources in a most efficient manner.  To meet the criteria of innovation, novelty, relevance and application of teaching practice.

  1. RIPER, Anantapur {Government approved Pharmacy Colleges In Andhra Pradesh}

Rghavendra Institute of Pharmaceutical Education and Research (RIPER) is a premier educational institute in Andhra Pradesh & Telangana.  It is one of the top institutes that offer Pharmacy education to the students in Diploma and Doctoral degree.  This institute is affiliated to Jawaharlal Nehru Technological University Ananthapur, Andhra Pradesh & Telangana.

  1. V.S.R Siddartha College of Pharmaceutical Sciences, Vijayawada {PCI approved Pharmacy Colleges In Andhra Pradesh}

KVSR Siddartha College of Pharmaceutical Sciences was established in 1994.  It is affiliated to Acharya Nagarjuna University and from 2010 is affiliated to Krishna University.  It offers under graduation, post graduation and six year Pharm D degree programmes.

  1. Bapatla College of Pharmacy {Top Doctor of pharmacy colleges in Andhra Pradesh}

The Bapatla College of Pharmacy is one of the first private pharmacy colleges established in the year 1995 with Diploma and Degree in Pharmacy.  It is affiliated to JNTUK.  It offers various courses of Pharmacy for the students and is very much named college.

 

Indian Pharmaceutical Industry Overview Analysis 2018 {PDF PPT}

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Indian Pharmaceutical Industry Overview Analysis 2018 {PDF PPT}

Indian pharmaceutical industry Overview and Analysis 2018 PDF PPT is now here ready for you to have a glance. The Indian pharmaceuticals market is the next biggest concerning quantity and thirteenth largest concerning value, according to a report by Equity Master. India is the biggest provider of generic medications internationally using all the Indian generics accounting for 20 percent of global exports concerning volume. Naturally, consolidation is now a significant feature of the Indian pharmaceutical marketplace as the business is extremely fragmented.
India enjoys a significant position in the worldwide pharmaceuticals sector. The nation also has a huge pool of engineers and scientists having the capability to steer the business forward to a much greater degree. Currently over 80 percent of these antiretroviral drugs used worldwide to fight AIDS (Acquired Immuno Deficiency Syndrome) are provided by Indian pharmaceutical companies.

Important Points:

  • The pharmaceutical industry in India ranks 3rd in the world terms of volume and 14th in terms of value.India’s cost of production is nearly 33 per cent lower than that of the US
  • Labour costs are 50–55 per cent cheaper than in Western countries. The cost of setting up a production plant in India is 40 per cent lower than in Western countries
  • Cost-efficiency continues to create opportunities for Indian companies in emerging markets & Africa
  • India has a skilled workforce as well as high managerial & technical competence in comparison to its peers in Asia
  • India has the 2nd largest number of USFDA-approved manufacturing plants outside the US
  • India has 2,633 FDA-approved drug products. India has over 546 USFDA-approved company sites, the highest number outside the US

Growing per capita sales of pharmaceuticals in India offers ample opportunities for players in this market
Per capita sales of pharmaceuticals expanded at a CAGR of 17.6 per cent to US$ 33 in 2016
Economic prosperity would improve affordability for generic drugs in the market & improve per capita sales of pharmaceuticals in India

The UN-backed Medicines Patent Pool has signed six sub-licences with Aurobindo, Cipla, Desano, Emcure, Hetero Labs and Laurus Labs, allowing them to make generic anti-AIDS medicine TenofovirAlafenamide (TAF) for 112 developing countries.

Indian Pharmaceutical Industry Overview Analysis 2018 {PDF PPT}

Present Indian Pharma Industry Scenario

The Indian pharma industry, which is expected to grow over 15 per cent per annum between 2015 and 2020, will outperform the global pharma industry, which is set to grow at an annual rate of 5 per cent between the same period!. The market is expected to grow to US$ 55 billion by 2020, thereby emerging as the sixth largest pharmaceutical market globally by absolute size, as stated by Mr Arun Singh, Indian Ambassador to the US. Branded generics dominate the pharmaceuticals market, constituting nearly 80 per cent of the market share (in terms of revenues). The sector is expected to generate 58,000 additional job opportunities by the year 2025. *
India’s pharmaceutical exports stood at US$ 16.4 billion in 2016-17 and are expected to grow by 30 per cent over the next three years to reach US$ 20 billion by 2020, according to the Pharmaceuticals Export Promotion Council of India (PHARMEXCIL).

Indian companies & Approvals:

Indian companies received 55 Abbreviated New Drug Application (ANDA) approvals and 16 tentative approvals from the US Food and Drug Administration (USFDA) in Q1 of 2017. The USFDA approvals are expected to cross 700 ANDA in 2017, thereby recording a year-on-year growth of 17 per cent. The country accounts for around 30 per cent (by volume) and about 10 per cent (value) in the US$ 70-80 billion US generics market.

India’s biotechnology industry comprising bio-pharmaceuticals, bio-services, bio-agriculture, bio-industry and bioinformatics is expected grow at an average growth rate of around 30 per cent a year and reach US$ 100 billion by 2025. Biopharma, comprising vaccines, therapeutics and diagnostics, is the largest sub-sector contributing nearly 62 per cent of the total revenues at Rs 12,600 crore (US$ 1.89 billion).

Indian Pharma Industry Investments:

The Union Cabinet has given its nod for the amendment of the existing Foreign Direct Investment (FDI) policy in the pharmaceutical sector in order to allow FDI up to 100 per cent under the automatic route for manufacturing of medical devices subject to certain conditions.

The drugs and pharmaceuticals sector attracted cumulative FDI inflows worth US$ 14.71 billion between April 2000 and March 2017, according to data released by the Department of Industrial Policy and Promotion (DIPP).

Major investments in Indian pharmaceutical Sector:

Indian pharmaceutical firm, Eric Lifesciences Pvt Ltd, has launched its initial public offering (IPO) worth Rs 2,000 crore (US$ 311 million) in June 2017.

Indian pharmaceutical company, Cadila Healthcare Ltd, is planning to raise Rs 1,000 crore (US$ 155 million) via a qualified institutional placement (QIP) of shares shortly.

Capital International Group, a private equity fund, has acquired a three per cent stake in Intas Pharmaceuticals Ltd from ChrysCapital Llc for a consideration of US$ 107 million, thereby valuing Intas Pharma at approximatively US$ 3.5 billion.

Aurobindo Pharma Ltd, has acquired four biosimilar products from Swiss firm TL Biopharmaceutical AG, which will require TL Biopharmaceutical to supply all the developmental data for four molecules, which will be developed, commercialised and marketed by Aurobindo Pharma

Piramal Enterprises Ltd acquired a portfolio of spasticity and pain management drugs from UK-based specialty biopharmaceutical company Mallinckrodt Pharmaceuticals, in an all-cash deal for Rs1,160 crore (US$ 171 million).
Aurobindo Pharma has bought Portugal based Generis Farmaceutica SA, a generic drug company, for EUR 135 million (US$ 144 million).

Sun Pharmaceutical Industries Ltd, India’s largest drug maker, has entered into an agreement with Switzerland-based Novartis AG, to acquire the latter’s branded cancer drug Odomzo for around US$ 175 million.
Kedaara Capital Advisors LLP, a private equity (PE) firm, plans to invest Rs 430 crore (US$ 64.5 million) to acquire a minority stake in Hyderabad-based diagnostics chain Vijaya Diagnostic Centre Pvt Ltd.
Sun Pharmaceuticals Industries Limited plans to acquire 85.1 per cent stake in Russian company Biosintez for US$ 24 million for increasing its presence in Russia through local manufacturing capability.
Abbott Laboratories, a global drug maker based in US, plans to set up an innovation and development center (I&D) in Mumbai, which will help in developing new drug formulations, new indications, dosing, packaging and other differentiated offerings for Abott’s global branded generics business.

Indian Government in Indian Pharma Sector:

The Indian government has taken many steps to reduce costs and bring down healthcare expenses. Speedy introduction of generic drugs into the market has remained in focus and is expected to benefit the Indian pharmaceutical companies. In addition, the thrust on rural health programme, lifesaving drugs and preventive vaccines also augurs well for the pharmaceutical companies.
The implementation of the Goods and Services Tax (GST) is expected to be a game-changer for the Indian Pharmaceuticals industry. It will lead to tax-neutral inter-state transactions between two dealers, thereby reducing the dependency on multiple states and increasing the focus on regional hubs. It is expected to result in an efficient supply chain management, which is expected to reduce its cost considerably. The cost of technology and investment is expected to reduce on account of tax credit which can be availed now on the duties levied on import of costly machinery and equipment.

Click below to view:

Indian Pharmaceutical Industry Overview Analysis 2018 {PDF PPT}

Pharma Vision 2020:

Some of the initiatives taken by the government to promote the pharmaceutical sector in India are as follows:
The Government of India unveiled ‘Pharma Vision 2020’ aimed at making India a global leader in end-to-end drug manufacture. Approval time for new facilities has been reduced to boost investments.
The government introduced mechanisms such as the Drug Price Control Order and the National Pharmaceutical Pricing Authority to deal with the issue of affordability and availability of medicines.
Mr Ananth Kumar, Union Minister of Chemicals and Petrochemicals, has announced setting up of chemical hubs across the country, early environment clearances in existing clusters, adequate infrastructure, and establishment of a Central Institute of Chemical Engineering and Technology.
Road Ahead

Future Indian pharmaceutical market:

The Indian pharmaceutical market size is expected to grow to US$ 100 billion by 2025, driven by increasing consumer spending, rapid urbanisation, and raising healthcare insurance among others.
Going forward, better growth in domestic sales would also depend on the ability of companies to align their product portfolio towards chronic therapies for diseases such as such as cardiovascular, anti-diabetes, anti-depressants and anti-cancers that are on the rise.

Exchange Rate Used: INR 1 = US$ 0.0155 as on June 20, 2017.

Indian Pharmaceutical Industry Overview Analysis 2018 PPT}

References:

Consolidated FDI Policy, Department of Industrial Policy & Promotion (DIPP), Press Information Bureau (PIB), Media Reports, Pharmaceuticals Export Promotion Council
Note: ! – According to a study by UBM India, the Indian arm of London-based media and events company; * – According to IIHMR University, Jaipur.

Source :www.ibef.org

 

B. Pharmacy First Year Books List – Subject Notes Books PDF

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B. Pharmacy First Year Books List - Subject Notes Books PDF

B. Pharmacy First Year Books List

Here we are providing the list of books that are needed for the Pharmacy students and the links for downloading the books. Are you just tired in search of finding the First year Pharmacy books then you are up to the right place. We will provide you the cent percent correct information here and you can know all the information that you want here. In the first year course of the Pharmacy students, there are two semesters. A semester is a 6 months course and the year is divided into two semesters. Students will have the books and syllabus to be followed for a particular semester in the year.

Do you know What are the subjects of B.Pharma first semester? B.pharmacy first semester subjects are Pharamaceutics, Pharamaceutical inorganic chemistry,physics.computer programming mathematics and graphics,mathematics and statistics then your having four lab

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B. Pharmacy First Year Books List - Subject Notes Books PDF

Pharmacy First Semester Books for First Year Students:

          In the first semester of the Pharmacy, you will have 9 subjects of which 5 are theory oriented and the remaining 4 are for labs. Following table shows the first semester books for the students:

S.No Subject T P Credits
1 English 3 + 1 – 3
2 Remedial Mathematics/Remedial Biology 3/2 + 1 – 3/2
3 Human Anatomy & Physiology – I 3 + 1 – 3
4 Dispensing Pharmacy & Ethics 3 + 1 – 3
5 Pharmaceutical Organic Chemistry-I 3 + 1 – 3
6 English Communications Skills Lab – 3 2
7 Remedial Biology Lab – 2 0/1
8 Dispensing Pharmacy Lab – 3 2
9 Pharmaceutical Organic Chemistry-I Lab – 3 2
Total Credits 21

These are the first semester subjects for the students and the books for these subjects to be followed by the students. The prescribed textbooks are:

English:

‘Trail Blazers’ by Orient Black Swan Pvt. Ltd. Publishers

Remedial Mathematics/Remedial Biology:

  1. Intermediate first Year mathematics
  2. Intermediate Second year mathematics, printed and published by Telugu Academy, Himayatnagar, Hyderabad
  3. Pharmaceutical Arithmetic’s by Mohd. Ali CBS publishers and distributor, New Delhi.
  4. Higher Engineering Mathematics by Grewal.

Human Anatomy & Physiology – I:

  1. Tortora, G.J and Anagnodokas, Principles of Anatomy and Physiology, N.P Harper & Row Publishers N.Y
  2. C.C.Chatterjee, Human Physiology.
  3. Ross & Wilson, Anatomy-Physiology in health and illness.
  4. Donald.C Rizzo, Fundamental of Anatomy and Physiology.

DISPENSING PHARMACY & ETHICS:

  1. Cooper & Gunns Dispensing Pharmacy, CBS, Publ. and Distributors New Delhi.
  2. R.M Metha, Dispensing Pharmacy.
  3. NK Jain and GD Guptha, Modern Dispensing Pharmacy, Pharma Med Press.
  4. Sanmathi BS and Anshu Guptha, Dispensing Pharmacy – A Practical Manual, Pharma Med Press.

PHARMACEUTICAL ORGANIC CHEMISTRY-I:

  1. T.R. Morrison and R.N. Boyd, Organic chemistry, pentice hall of India private limited, New Delhi.
  2. Arun Bahl & Bahl, Advanced Pharmaceutical Organic Chemistry.

Pharmacy Second Semester Books for First Year Students:

          In the second semester of the Pharmacy, you will be having 8 subjects. Of them 5 subjects are theory oriented and the remaining 3 are labs. Here the following table shows the subjects by specifying their credits too:

S.No Subject T P Credits
1 Human Anatomy & Physiology – II 3 + 1 – 3
2 Pharmacy Inorganic Chemistry 3 + 1 – 3
3 Pharmacy Organic Chemistry – II 3 + 1 – 3
4 Physical Pharmacy – I 3 + 1 – 3
5 Computer Applications & Biostatistics 3 + 1 – 3
6 Human Anatomy & Physiology Lab – 3 2
7 Physical Pharmacy – I Lab – 3 2
8 Computer Applications Lab – 3 2
Total Credits 21

These are the subjects that are present in the second semester of the first year Pharmacy. The prescribed textbooks for these subjects are provided given below:

HUMAN ANATOMY & PHYSIOLOGY – II:

  1. Tortora, G.J and Anagnodokas, Principles of Anatomy and Physiology, N.P Harper & Row Publishers N.Y
  2. Ross & Wilson – Anatomy & Physiology in health and illness – Anne Waugh, Allison Grant.
  3. T.S. Ranganathan, A Text book of Human Anatomy.
  4. Human Anatomy and Physiology. C.C Chatterjee.

PHARMACEUTICAL INORGANIC CHEMISTRY:

  1. A.H.Beckett and J.B.Stenlake, Practical pharmaceutical chemistry, Part-I. The Athtone press, University of London, London.
  2. Advanced Inorganic Chemistry by Satya prakash, G.D.Tuli B.PHARMACY 39
  3. Wal Ankita, Wal, Pranay, Rai, Awani Kumar, Inorganic Pharmaceutical Chemistry, New Age International Publishers.

PHARMACEUTICAL ORGANIC CHEMISTRY-II:

  1. T.R.Morrison and R.N.Boyd, Organic chemistry, pentice hall of India private limited, New Delhi.
  2. Arun Bahl & Bahl, Advanced Pharmaceutical Organic Chemistry.

PHYSICAL PHARMACY – I:

  1. Patrick J. Sinko, Martin’s Physical Pharmacy and Pharmaceutical Sciences Fifth Edition.
  2. C.V.S.Subramanyam, Essentials of Physical Pharmacy, Vallabh Prakashan.
  3. E. Shotton and K. Ridgaway, Physical Pharmaceutics, Oxford University Press, London.
  4. S. J Carter, Cooper and Gunn’s Tutorial pharmacy.
  5. B. Pharmacy First Year Books List pdf

COMPUTER APPLICATIONS AND BIOSTATISTICS:

  1. Computer Fundamentals, Anita Goel, Pearson.
  2. Information Technology Workshop, 3e, G Praveen Babu, M V Narayana BS Publications.
  3. Khan & Khan, “Fundamentals of Biostatistics”.
  4. Pranab Kumar Banerjee, “Introduction to Biostatistics”.
  5. Incoming searches: b pharmacy subjects list first year, subjects in b pharmacy 1st year, pharmacy books for 1st year, b pharmacy 1st year materials, subjects in b pharmacy 2nd year, b pharmacy books pdf free download, b pharmacy 1st year notes, b pharmacy syllabus for 1st year jntu.

First impression is the best impression as said by elders. You need to score good marks in the first year to lead a happy and peaceful life along with success in your whole college life. Don’t hesitate to write to write us regarding any doubts we are happy to help you. Tell your friends about our website to help them grow in the carriers. there will be more distractions in the first year of your college but still you need to concentrate on your studies. Life will not be a bed of roses on the first here itself but as you to remove the thorns one by one you will see the fruitful year ahead. We wish you all the very best on on your first typing stone of success.

donot leave your concentration for anything. Hope this article about b pharmacy subjects list first year and the syllabus for the first year of B Pharma has helped you. Share your thoughts here on our Pharmawiki website.

[PDF PPT DOC] Pharmaceutical FILTER VALIDATION – Sterile Protocol FDA Guide

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Pharmaceutical FILTER VALIDATION PDF DOC PPT- Sterile Protocol FDA Guide

FILTER VALIDATION

Do you know Pharmaceutical Filter validation importance? Pharmaceutical processes are validated processes to assure a reproducible product  within set specifications. Equally important is the validation of the filters used within the process, especially the sterilizing grade filters, which, often enough, are used before filling or the final processing of the drug product. In its Guideline on General Principles of Process Validation, 1985, and Guideline on Sterile Drug Products Produced by Aseptic Processing, 1987, the FDA makes plain that the validation of sterile processes is required by the manufacturers of sterile products. Sterilizing grade filters are determined by the bacteria challenge test. This test is performed under strict parameters and a defined solution (ASTM F 838-83).

In any case, the FDA nowadays also requires evidence that the sterilizing grade filter will create a sterile filtration, no matter the process, fluid or bioburden, found. This means that bacteria challenge tests have to be performed with the actual drug product, bioburden, if different or known to be smaller than B. diminuta and the process parameters. The reason for the requirement of a product bacteria challenge test is threefold. First, the influence of the product and process parameters to the microorganism has to be tested. There may be cases of either shrinkage of organisms due to a higher osmolarity of the product or prolonged processing times. Second, the filter’s compatibility with the product and the parameters has to be tested. The filter should not show any sign of degradation due to the product filtered. Additionally, rest assurance is required that the filter used will withstand the process parameters; e.g., pressure pulses, if happening, should not influence the filter’s performance.

Third, there are two separation mechanisms involved in liquid filtration: sieve retention and retention by adsorptive sequestration. In sieve retention, the smallest particle or organism size is retained by the biggest pore within the membrane structure. The contaminant will be retained, no matter the process parameters. This is the ideal. Retention

by adsorptive sequestration depends on the filtration conditions. Contaminants smaller than the actual pore size penetrate such and may be captured by adsorptive attachment to the pore wall. This effect is enhanced using highly adsorptive filter materials, for example,

Glassfibre as a prefilter or Polyamide as a membrane. Nevertheless, certain liquid properties can minimize the adsorptive effect, which could mean penetration of organisms. Whether the fluid has such properties and will lower the effect of adsorptive sequestration and may eventually cause penetration has to be evaluated in specific product bacteria challenge tests.

[PDF PPT DOC] FILTER VALIDATION - Sterile Protocol FDA Guide

Before performing a product bacteria challenge test, it has to be assured that the liquid product does not have any detrimental, bactericidal or bacteriostatic, effects on the challenge organisms. This is done utilizing viability tests. The organism is inoculated into the product

to be filtered at a certain bioburden level. At specified times, the log value of this bioburden is tested. If the bioburden is reduced due to the fluid properties, a different bacteria challenge test mode becomes applicable. If the reduction is a slow process, the challenge test will

be performed with a higher bioburden, bearing in mind that the challenge level has to reach 107 per square centimeter at the end of the processing time. If the mortality rate is too high, the toxic substance is either removed or product properties are changed. This challenge fluid is called a placebo. Another methodology would circulate the fluid product through the filter at the specific process parameters as long as the actual processing time would be. Afterwards, the filter is flushed extensively with water and the challenge test, as described in ASTM F838-38, performed. Nevertheless, such a challenge test procedure would be more or less a filter compatibility test.

Besides the product bacteria challenge test, tests of extractable substances or  articulate releases have to be performed. Extractable measurements and the resulting data are available from filter manufacturers for the individual filters. Nevertheless, depending

on the process conditions and the solvents used, explicit extractable tests have to be  performed. These tests are commonly done only with the solvent used with the drug product but not with the drug ingredients themselves, because the drug product usually

covers any extractables during measurement. Such tests are conducted by the validation services of the filter manufacturers using sophisticated separation and detection methodologies, as GC-MS, FTIR, and RP-HPLC. These methodologies are required, due to the fact that the individual components possibly released from the filter have to be identified and quantified. Elaborate studies, performed by filter manufacturers, showed that there is neither a release of high quantities of extractables (the range is ppb to max ppm per 10-inch element) nor have toxic substances been found. Particulates are critical in sterile filtration, specifically of injectables. The USP 24 (United States Pharmacopoeia) and BP (British Pharmacopoeia) quote specific limits of particulate level contaminations for defined particle sizes. These limits have to be kept and, therefore, the particulate release of sterilizing

grade filters has to meet these requirements. Filters are routinely tested by evaluating the filtrate with laser particle counters. Such tests are also performed with the actual product under process conditions to prove that the product, but especially process conditions, do

not result in an increased level of particulates within the filtrate.

Additionally, with certain products, loss of yield or product ingredients due to adsorption shall be determined. For example, preservatives, like  benzalkoniumchloride or chlorhexadine, can be adsorbed by specific filter membranes. Such membranes need to be saturated by the preservative to avoid preservative loss within the actual product. This preservative loss e.g., in contact lens solutions, can be detrimental, due

to long-term use of such solutions. Similarly, problematic would be the adsorption of required proteins within a biological solution. To optimize the yield of such proteins within an application, adsorption trials have to be performed to find the optimal membrane

material and filter construction.

Cases that use the actual product as a wetting agent to perform integrity tests require the evaluation of product integrity test limits. The product can have an influence on the measured integrity test values due to surface tension, or solubility. A lower surface tension,

for example, would shift the bubble point value to a lower pressure and could result in a false negative test. The solubility of gas into the product could be reduced, which could result in false positive diffusive flow tests. Therefore, a correlation of the product as a wetting agent to the, water wet values has to be done, according to standards set by the manufacturer of the filter. This correlation is carried out by using a minimum of three filters of three filter lots. Depending on the  product and its variability, one or three product lots are used to perform the correlation. The accuracy of such a correlation is enhanced by automatic integrity test

machines. These test machines measure with highest accuracy and sensitivity and do not rely on human judgement, as with a manual test. Multipoint diffusion testing offers the ability to test the filter’s performance and, especially, to plot the entire diffusive flow graph through the bubble point. The individual graphs for a water-wet integrity test can now be compared to the product wet test and a possible shift evaluated. Furthermore, the multipoint diffusion test enables the establishment of an improved statistical base to determine the product wet versus water-wet limits.

Look out here Pharmaceutical FILTER INTEGRITY TESTING – FDA Guideline on Sterile Drug Products

Pharmaceutical Filter Validation References:

  1. Cooper and Gunn’s. Tutorial Pharmacy by S.J.Carter.
  2. Pharmaceutical engineering; K. Sambamurthy
  3. Pharmaceutical engineering; principles and practices, C.V.S. Subrahmanyam
  4. Encyclopedia of pharmaceutical technology, vol 3, edited by James Swarbrick.
  5. Pikal, M.J.; Lukes, A.L.; Lang, J.E. Thermal decomposition of amorphous beta-lactam antibacterials. J. Pharm. Sci. 1977, 66, 1312–1316.
  6. Pikal, M.J.; Lukes, A.L.; Lang, J.E.; Gaines, K. Quantitative crystallinity determinations of beta-lactam antibiotics by solution calorimetry: correlations with stability. J. Pharm. Sci. 1978, 67, 767–773.
  7. Pikal, M.J.; Dellerman, K.M. Stability testing of pharmaceuticals by high-sensitivity isothermal calorimetry at 25_C: cephalosporins in the solid and aqueous solution states. Int. J. Pharm. 1989, 50, 233–252.
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