Pharmaceutical Lab Instruments & Equipment

Pharmaceutical Laboratory Equipment

Most of us have been aware of what Pharmaceutical Laboratory equipment’s are and what their utilization is. In general, we get to know them more in our early days of college.  Most of us who deal in science and come from a science background do have a little bit of knowledge about what Pharmaceutical Laboratory looks like and what type of experiments do take place there.  Today I take the opportunity to discuss the Pharmaceutical Laboratory equipment’s in brief and I will take this perfect opportunity to throw a light at some of the uses of few of the well known equipment’s that are being used on a regular basis.

Pharmaceutical Laboratory equipment’s are of different size, shape, style and moreover uses.  There is the Bunsen burner, one of the well known apparatus which allow us to heat up the mixture when in need to a required amount of degree for performing the experiment.  Then there is the analytical balance, which works in all close proximity and allows us to take perfect weight of elements before we start the reaction in the lab.  It provides an accurate reading to us as no air is allowed to enter the close chamber for a more detailed reading.  Other than this, there are different apparatus or equipments like Vortex mixture, Oscilloscope, dasymeter, Gooch crucible, comparison microscope.  We have the other form of safety equipments that are being used for safety purposes, like gloves, goggles to protect our body parts from any hazards or accident caused by vigorous chemical reaction and getting directly in contact with the skin.  This in turn can really cause severe irritation, bleeding and other forms of trauma to our skin.  Spatulas and scoopulas are the most important equipment’s too.  They are used to dissect or check with the condition of the chemical reaction in the Pharmaceutical Laboratory when in process.  Droppers, Pipettes, Burets, tongs and forceps, balances are some of the other common forms of equipments that are generally been found in a Pharmaceutical Laboratory for experiment purposes.

These Pharmaceutical Laboratory equipment’s play a major part in the Pharmaceutical Laboratory research as these are the tools by which complex and simple chemical formulations are being directed and providing result to final outcome.  These equipment’s are found in different sizes and shapes, but whatever may be the size or shape of these equipments each one of them are as important as the other.  The more the intricacy and complex nature of the chemical formulation and process is the more the important is the right choice of these equipments means.  Some of these apparatus do cost pretty high and are very much brittle in origin.  In terms of safety, these equipments are tender and brittle in origin as mentioned and needs proper attention and care when handling them.  Overheating or extreme coldness to these apparatus that is beyond the resistance capability can create a lot of issues.  These apparatus would tend to crack and burst which can be fatal while experimenting.  Thus one must know the proper handling and the nature of the activities of these Pharmaceutical Laboratory equipment’s in order to avoid any kind of accidents or mishaps.

Pharmaceutical Lab Instruments & Equipment

Drawing a conclusion to this short brief to this topic, it is always important and mandatory to check with all these equipments prior to use.  It takes years of practice and expertise to be able to use and handle these Pharmaceutical Laboratory equipment’s perfectly and safely.  Thus it is always recommended that one must use safety devices such as gloves, goggles, protective eye-care and others in order to perform all the Pharmaceutical Laboratory activities safely.  Be always comfortable and safe while using these.

Top Pharmaceutical Machinery Manufacturers in India – Pharma Machinery Suppliers

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Pharmaceutical Machinery Manufacturers in India

Pharmaceutical Machinery Manufacturers in India: In today’s world when most of the countries are on the verge of extending their capabilities in each and every spheres of life and implementing new ideas and innovations to satisfy life on a larger scale, India is also on the same track as well.  When pharmaceutical machinery manufacturing in India is concerned, today India is considered to be one of the best in the world and is simply reaching new heights of success on a whole.  Hereby we try to figure out some of the prime manufactures in India who are a leading brand in manufacturing pharmaceutical machinery and about their activities in short.

Pharmaceutical Machinery Manufacturers in India

  • Pharma Tech International

Pharma Tech International is considered to be one of the finest Pharmaceutical machinery manufacturers from India.  The company came into existence in the year 2007 with a current annual turnover of Rs 50 lacks to 1 Crore according to stats obtained from sources.  This company boots itself in producing high profile machines like automatic capping machine, capsule section machinery, ointment section machinery, tablet section machinery, crushing machines, globule making machines and the list goes on.  The products are really durable in nature with capabilities of performing accurately and mostly are fully automatic in nature and require less amount of human interference.

  • Prism Pharma Machinery

Prism Pharma Machinery from the land of Gujarat came into existence in the year 2003.  They provide some of the best durable and highly sophisticated pharmaceutical machinery.  With a reputed base and trust of serving this industry from a long time they boost their capabilities in providing machines like high shear mixer granulation, RMG, Tray dryer, oscillating granulator, bin blender, Tumbler bender, Drum mixer blender, mass mixers and others.  They are best in making Roll compactor, Vibro shifter, basket extruder, movable hoist, automatic tablet coater, colloid mill, capsule polishing machine, sealing machine and the list is endless.

Today they stand as one of the finest in the business and provide some of the best products for pharmaceutical use.

Pharmaceutical Machinery Manufacturers in India

  • Harrison’s Pharma Machinery Pvt. Ltd

This ISO certified company from Delhi since its inception days in the year 1983 have always been in the limelight with the quality of machines they manufacture and have the repute also of providing wide range of products as well.  The list is long and some of the wide variety of products they manufacture includes ointment plant, lami tube filling & sealing machine, stainless steel storage tank, Mini Pulverizer, Cyclone Type Pulverizer, Powder mixer and rotary bottle washing machinery as well.  They also produce some of the finest quality machines in relation to laboratory use, syrup manufacturing, multipurpose equipments and many more.

Top Pharmaceutical Machinery Manufacturers in India – Pharma Machinery Suppliers

  • Lohashilpi

This is another innovative manufacturer from the state of Kerala which is considered to be one of the finest pharmaceutical machinery manufactures in India.  They have a huge number of productivity which includes Liquid filling machines, Semi automatic blister sealing machines, Hydro pneumatic blister trimming machines.  They are capable of providing some of the best quality products available in the market today with capabilities of producing high range products for use.  They also deal in automatic rubber machinery, packaging solutions and manufacturing machines yielding rubber accessories as well.

Given above are some of the finest pharmaceutical machinery manufacturers from India who really have done a great job and helped largely improving the quality of pharmaceutical products on a whole.  There are different other companies as well which do have the similar potentials and produce a great variety and quality machines that not only improve the quality but also improves the volume of manufacturing.

Pharmaceutical Machinery Manufacturers in Mumbai – Pharma Navi Bombay

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pharma machinery manufacturers in navi mumbai

Pharmaceutical Machinery Manufacturers in Mumbai: Today we will be concentrating on some of the best pharmaceutical machine manufacturers from Mumbai, India who have who have constantly given enough effort and hard work to make world class product and compete in the market on a global scenario.  Most of them have years of expertise in this specific field and have managed to earn goodwill in the market by their effort.  Here are few of the most trusted brands from Mumbai who develop and manufacture pharmaceutical machinery.

Pharma machinery manufacturers in navi mumbai

  • Jay Pharma Machinery Equipments

This is one of the most trusted companies that are situated in the heart of Mumbai city, India.  Over the last six years the company has grown from strength to strength increasing the numbers of their clients with good service and maintenance of quality product.  This company has the perfect expertise in manufacturing pharmaceutical machinery like wet mixtures, milling machines, washing system, blender, filter press, Ointment Manufacturing Plant, Inline Homogenizer, pallets, cooting system and the list goes on and on.  Today Jay Pharma Machinery Equipments stands high among its rival companies serving the best out of the best.

  • Bright Pharma Machinery

Situated in Andheri, East Mumbai, Bright Pharma Machinery this company is one of the leading manufacturers of Pharmaceutical machinery along with production of cosmetic, bio product machinery as well.  From 20 years this company has been working in the market with infusing and implementing new ideas for the betterment of the business.  It has expertise in designing and manufacturing machines in relation to ointment/cream manufacturing plant, transfer pump, metering pump, filtration unit, cream manufacturing plant, fluid bed dryer, coating pan, spray coating machine, Vibro shifter, rapid mixer granulator and the list is a long one indeed.  This company over the years has a good repute of producing the best when it comes to business on a whole.

  • Prince Pharma Machinery Bombay

Incorporated in the year 2007 at Mumbai, Prince Pharma Machinery has the perfect expertise in providing impeccable quality of pharmaceutical machinery that are of world class standards.  Since its establishment, the company has paved itself to the top with a team of members who have a vision to think big and innovative in the field of pharmaceuticals.  Today they have an arsenal of some of the best machinery which includes manufacturing of fluid bed dryer, Vibro shifter, Mutlil mill, coating machine, starch paste kettle, Zero hold up filter press, tray dryer, Octagonal blender and much more.  This manufacturing unit is considered to be one of the finest in the business today.

pharma machinery manufacturers in navi mumbai

  • Mec Well Pharma Machinery Company – Mumbai

From Thane, Maharashtra Mec Well Pharma Machinery has the perfect capabilities and adequate infrastructure to design and develop some of the most needed pharmaceutical machinery that are of high quality and capable of producing volume productivity.  The company boost itself with manufacture of highly efficient machinery like blending machine, fluid bed dryers, Vibro shifter, blending vessel, liquid manufacturing plant, ointment plant, Ointment Manufacturing Plant, Pharmaceuticals Processing Plant, oral liquid manufacturing plant, pharmaceutical ovens, fermentation tank and the list is endless.  This company today stands as one of the finest manufacturing company and have been serving clients globally with trust and quality.  They have successfully marketed themselves with hard and dedication as one of the best in the business

There are other companies too like Chamunda Pharma Machinery Pvt. Ltd, Harish Pharma Engineeringm Pharma Fab Industries, S K Pharma Machinery Private Limited, Champion Pharma Machines and etc. from Mumbai who are considered to be equally capable, well trusted and rewound when it comes to manufacturing of Pharmaceutical machinery in Mumbai, Maharashtra.

Pharmaceutical Packaging Machinery – Medicines Packing Equipment Types

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Pharmaceutical Packaging Machinery - Medicines Packing Equipment Types

Pharmaceutical Packaging Machinery: In today’s date Pharmaceutical packing machinery hold a very important position when it comes to doing business with the same.  As we all known good packaging not only increased the overall quality appearance of the product but also helps it to do a good branding and provide successful business also.  Today there are different companies who are specialized in this field of work.  They solely work on packing and distributing pharmaceutical packaging.  There are different types of machinery which are uses in this case.  The list is pretty long and most of them are complex in nature whereas there are also simple machinery as well.  Today we are going to discuss about few of the most important Pharmaceutical packaging machinery in short and their use.

Pharmaceutical Packaging Machinery – Medicines Packing Equipment Types

One of the most well known Pharmaceutical packaging machines used very often is Blister Packing Machine.  It is available both for large and small batches of drug processing expediting marketability of Pharma products via blister packing.  Next there is the Pharmaceutical Automatic Capping Machine.  It is used for capping of the pharmaceutical products and is considered to be one of the final steps of ensuring the quality of the product as well.  Next is the Pharmaceutical Filling Machine which simply expedites the current process of packaging.  This filling machine perfectly works for large scale filling used to measure sterility and dispensing of correct volume when in use.  One of the most well-known and widely used machines is Pharmaceutical Ampoule Filling Machine.  This machine is a very complex one and works on a very sophisticated or delicate procedure.  These types of machinery are basically used for pharmaceutical ampoule filling equipment.  The process is a fully automated one and works on a constant basis to provide the required result.  It provides the option of weight checking of product and as well as laser sealing as well.  Another one of the important packaging machinery used for pharmaceutical products is Pharmaceutical Liquid Filling Machine.  It is used for manufacturing of liquid drug suspensions.  This packaging machine is used in variety of forms and use.  It comes in both small and large size.  The operation involves filling of liquid.

Medicines Packing Equipment Types

Now pharmaceutical packaging machinery comes in different price range and in different shapes and sizes.  There are different companies who are best at making these types of machinery.  Some of them are small and some are big production houses.  These production houses basically deal in making pharmaceutical packaging machinery that are all in compliance with FDA standards and maintain a strict protocol as per general guidelines.  Some are semi automatic in nature, some are fully automatic.  When we speak about these type of Pharmaceutical packaging machinery there are different vendor who have earned a good name in the market over the years and have provided world class quality products on a regular basis.  Some of them are Marchesini Group with its headquarters at Italy.  Then there is Mg2 as well from Italy along with Multivac Sepp Haggenmuller.  Bosch and Romaco are two of the most important names that we can add to this list as well and both are from Germany who have the repute of consistently providing quality machinery in this field as well.

Pharmaceutical Packaging Machinery - Medicines Packing Equipment Types

Coming to the concluding part of this discussion, it has been found that these packaging machinery are a very important part of the production of the pharmaceutical products worldwide and provides safety to the finish products as well.  Proper packaging not only ensures the safety of the product but also maintains a proper hygiene to the pharmaceutical products as well which is essential.

Tray Dryer Working Principle

Pharmaceutical Mixing Equipment – Pharmaceutical Blending & Mixing pdf

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Pharmaceutical Mixing Equipment - Pharmaceutical Blending & Mixing pdf

Pharmaceutical Mixing Equipment: Mixing has always been a very integral part of manufacturing pharmaceutical equipment.  In order to form a right pharmaceutical product with proper compositing and content mixing plays a very important and integrated part.  Today we will be looking at some of the well known and primary pharmaceutical mixing equipment that are widely used in the production units for manufacturing of pharmaceutical products.  We try to look at few of them in a very short and precise way.

Pharmaceutical Mixing Equipment – Pharmaceutical Blending & Mixing pdf

Depending on type of mixing we can categorize the procedures accordingly which are as follows:

  • Liquid-liquid mixing

There are different types of mixtures used for mixing liquid with liquid in the pharmaceutical production units.  This process is quite complex and requires additional monitoring.  There are different types of mixers used for this purpose namely, Shaker mixers, Propeller mixers, Paddle mixers, Turbine mixers, sonic and ultrasound devices such as Rapisonic homogenizer.  These equipment are uses for manufacturing antacid suspensions, different emulsions, anti-diarrhoeal mixtures and other such pharmaceutical products.

  • Solid-solid mixing

For solid to solid mixing of pharmaceutical products there are different types of equipments in use on a general basis.  This includes Agitator mixers, Tumbling mixers, Double cone mixers, and V-blenders and others.  These equipments are generally used for mixing of dry (solid base) powders.  These are mainly used for making tablets of various types and sizes.

  • Semi-solid mixing

Then there is semi to solid mixing equipment perfectly designed for this specific purpose also.  For this purpose there are different types of Agitator mixers that are in use like sigma mixers and planetary mixers.  Other than this there is Shear mixer like triple roller mills and colloidal mills as well.  These are basically used for wet granulation procedure while manufacturing tablets and also in the production of ointments as well.  Sigma mixture can also be used in case of solid to solid mixing as well.

Other than the above mixing equipment there are different types of mixtures that are also in use while making up of Pharmaceutical products.  These include tumbling mixer.  These are close vessel mixer rotating about its axis.  They are basically found in double cone, V-mixer and rotating cube as well.  Here the quality of mixing is limited and works on diffusive mixing mechanism.

Then comes Convective mixers which is accompanied with some diffusive and shear mixing.  This machine works typically less than 60 rpm.  Here ribbon blenders are used on a horizontal axis in a static cylinder set on a circular pattern within in a static shell.  Paddles or rotating blades are used in this machine.

Other important pharmaceutical mixing equipments include Conical screw mixer, Muller mixer, Pug mill, Pan mixer, Change can mixer, Banbury mixer and the list is endless.

Pharmaceutical Mixing Equipment - Pharmaceutical Blending & Mixing pdf

On a whole it can be easily said that these different types of mixing equipment are used in order to serve different purposes and to obtain a specific result in the pharmaceutical product manufacturing.  Most of these mixers work on a very complex process and generally have an automatic procedure to work on.  This really is a complex process and needs lot of understand and one must go through years of experience in order to progress and handle these types of machine with care and in a right way.  Without prior knowledge about these type of machine, handling can really be difficult and would produce inverse reaction to the pharmaceutical process.  Most of these equipment are built in a specific way according to their way of action and mostly are brittle in nature and use of pharmaceutical mixing equipments can really be challenging.

Read about Tray Dryer Working Principle

Pharmaceutical Machinery Manufacturers in Ahmedabad -Pharma Machinery

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Pharmaceutical Machinery Manufacturers in Ahmedabad

Ahmedabad has always been a happening place since Independence.  In western India, it is the largest city in the state of Gujarat.  In terms of providing business there is no other state that can ever compete with Ahmedabad and has always been in the limelight for good reasons.  Today we look at some of the best Pharmaceutical machinery manufacturers in Ahmedabad and throw a light about their product and production unit as well.

Pharmaceutical Machinery Manufacturers in Ahmedabad

  • Prism Pharma Machinery

Prism is one of the most trusted brands in Ahmedabad when we speak about manufactures and exporters of pharmaceutical machinery.  Founded in the year 2003, this company with the advent of time has managed to excel its work activities and have successfully gained good reputation.  They provide a wide range of products that includes High Shear Mixer Granulator- RMG, Mass Mixer, Roto Cone Vacuum Dryer, Tablet Press – PTCMD4, Movable Hoist, Fluid Bed Dryer, Spraying System, Lab Scale Mini Tablet Press, Automatic Liquid Syrup Manufacturing, Inline Homogenizer, Preparation vessel, reactor & Storage and the list is endless.  Today Prism Pharma Machinery stands for its quality and goodwill.

  • Ambica Pharma Machines Private Limited

Ambica Pharma Machines Private Limited is considered to be among the best in manufacturing Pharmaceutical machinery from Ahmedabad.  They have a production unit which is well established in manufacturing wide variety of machinery.  The company boosts its capability in producing different types of machinery that includes vial washing machine, automatic high speed 8 head linear Vial liquid filling, 4 head Linear Vial liquid filling, Automatic high speed 2 head injectable liquid filling, powder and liquid filling combo, dry syrup filling machine, injectable powder filling machine, different types of cap sealing machines for pharmaceuticals, screw cap sealing machine, vial aluminum cap sealing machine and the list is endless.  Since its inception the company till date is growing and today stands as a trusted brand in the business.

  • Spark Tech India – pharmaceutical machinery

Spark technologies have always been in the limelight for providing supreme quality of pharmaceutical machinery that are of world-class quality.  Since its inception in the year 1999, this company has got many acclamation from its clients worldwide and today boots its capabilities of solidifying platform of excellence in business.  They provide quality product which includes different types of liquid filling machinery, heavy automatic high-speed syrup filling machinery, washing machines of different kind which are mostly automatic in nature, different types of cap sealing machines for pharmaceuticals and different other machinery that can really improve the quality of pharmaceutical products and its productivity as well.

Pharmaceutical Machinery Manufacturers in Ahmedabad

  • N K Industries

N K Industries situated in Ahmadabad, Gujarat is a pioneer in the field of pharmaceutical machinery production from a long time and hold a good repute for over 35 years which has simply help them to establish a trust between the client and themselves on the global platform.  Their products are of high quality and impeccable productivity.  Some of their products include tablet pill capsule counting filling machine, Auger powder filling machine, capping machine, Ropp capping machine, washing machine, Injectable dry powder filling machine, screw capping machine and many more which rightly have high demands in today’s market.

On conclusion it can be easily said that these are some of the well trusted brands from Ahmedabad that have gained much popularity through their quality productivity.  There are other names too which are equally best whose activities and productivity are as vibrant as that of the above.  All in all, Ahmedabad truly stands as one of the best pharmaceutical machinery manufacturing production hub.

{PDF} Tablet Evaluation – Pharmaceutics Pharmaceutical Apparatus Material PPT

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PDF Tablet Evaluation - Pharmaceutics Pharmaceutical Apparatus Material.JPG

Topic: {PDF} Tablet Evaluation – Pharmaceutics Pharmaceutical Apparatus Material: Tablets are defined as solid unit dosage form of medicaments intended for oral use. They became most popular as they were easy in preparation compared to any other type of dosage forms. But the major drawback exists in its manufacturing. If any minor problem occurs during their manufacturing then the whole batch of the unit should be discarded. It is necessary to avoid any sort of errors during its manufacturing and as a result evaluation of tablets is very important before dispatching of a batch. In the present study, we discussed about the evaluation tests for tablets.

Tablet Evaluation:

Before a tablet is released out into the market it has to pass a few quality checks, which is mandatory. Evaluation of tablet includes the assessment of tablets physical, chemical and biological properties. To studies them the following test are formulated

  •    Appearance,
  • • Size and Shape,
  • • Organoleptic properties,
  • • Uniformity of thickness,
  • • Hardness,
  • • Friability,
  • • Drug Content Uniformity,
  • • Weight Variation Test,
  • • Wetting time,
  • • Water Absorption Ratio,
  • • In vitro Dispersion Time,
  • • In vitro Disintegration Test,
  • • In vitro Dissolution Studies,
  • • Two set of apparatus,

Description:

Appearance:

Appearance is the first most required quality for the acceptance of tablet. General elegance and its identity play a major role for the consumer acceptance. Acceptance of the appearance of batches of the tablet has been done based on the measurement of the following factors like size, color, shape, presence or absence of odor, taste etc. [26-50]. Size and shape

General appearance is the physical appearance of the tablet it has two aspects to address

First one is the patient compliance, if the tablet is appearance is legible and good, it improves the patient compliance.

The second one Is for the manufacturer, it helps him in trouble free manufacturing if there is tablet to tablet, batch to batch and lot to lto uniformity of tablet.

General appearance would include a number of aspects like, size, shape, odor, taste, texture, legibility, identifying marks.

For rapid identification of the tablet and consumer acceptance the tablet are given a specific colour, the colour of the tablet will enable the manufacturer form differentiating the tablet lot.

The uniformity of the colour is important parameter here, the tablet should be free form mottling.

The colour uniformity and gloss of the tablet is evaluated by using reflectance spectrophotometer, tristimulus colorimetric measurement, microreflectance photometer.

Size and shape

Size and shape of a tablet has been determined by its thickness. Size and shape of a tables plays an important role in its patient compliance as the size of the tablet increases it is not much easier for its administration. Micrometer is the devise which is used to determine the thickness of a tablet. It can be acceptable if the batch falls within the ±5% of standard deviation.

Organoleptic properties:

Color should be distributed uniformly without appearance of any signs of mottling. Colour of the tablet should be compared with the standard colour for comparison.

Uniformity of thickness:

To determine the uniformity of thickness random selection of tablets has to be done from each and every batch and need to measure its thickness independently. If the thickness of any single tablet varies then the batch containing that batch will not be dispatched into market

 WEIGHT VARIATION TEST

The weight variation test would be a satisfactory method for determining drug content uniformity of drug distribution. In practice this test is performed by taking 20 tablets, from a batch. 20 tablets are weighed at a time and the average weight is taken. Then the tablet is weighed individually.

 

Average Weight Percentage Difference
130 mg or less 10
More than 130 mg through
324 mg		 7.5
More than 324 mg 5

2) THICKNESS AND DIAMETER (SIZE AND SHAPE)

The thickness of individual tablets is measured with a micrometer, which gives us information about the variation between tablets. Tablet thickness should be within a ±5% variation of a standard value. Any variation in thickness within a particular lot of tablets or between manufacturer’s lots should not be clear to the unaided eye for consumer acceptance of the product. In addition, thickness should be controlled to smooth the progress of packaging.

PDF Tablet Evaluation - Pharmaceutics Pharmaceutical Apparatus Material.JPG

Different shapes and sizes of tablet are available in the market they are manufactured in order to differentiate them based on their purpose of use and quantity of active ingredient, and the age group of the patient who is going to be administered with the drug.

Heart shape tablet signify that they are for the cardiac problems, small toy shape, tablet are manufactured in order to attract children etc.

The shape and size of a tablet would vary based on tooling used in the tablet manufacturing.

The prime consideration here would be the crown size, because if the concavity is very high it many lead to capping, or chipping problem.

The crown size is measured by using micrometer, and sliding caliper scale is used to measure the size of 5 to 10 tablets at a time.

We use Micrometer for tablet thickness

3) UNIQUE IDENTIFICATION MARK:

Pharmaceutical manufacturers in order to differentiate their product from the other manufacturers emboss a special marking g on the tablet. The marking can be an embossing, engraving or printing.

Apart from the company marking there can be imprints which include product code, product name, product potenct,

But care must be taken that the letters that are embossed on the tablet are properly printed without double impression.

5) HARDNESS AND FRIABILITY:

The hardness of the tablet is important for drug products that have bioavailability problem or that are sensitive to altered dissolution release profiles as a function of the compressive force employed. Tablet hardness is the force necessary to break the tablet diametrically. The tablets must be hard enough to withstand mechanical stress during packaging, shipment, and handling by the consumer.

Section <1216> of the USP 24/NF19 outlines a standard tablet friability test applicable to manufactured tablets. Most compounding pharmacy would not have the apparatus specified in Section <1216>. However, there are several hand operated tablet hardness testers that might be useful. Examples of devices are the Strong Cobb, Pfizer, and Stokes hardness testers. The principle of measurement involves subjecting the tablet to an increasing load until the tablet breaks or fractures. The load is applied along the radial axis of the tablet. Oral tablets normally have a hardness of 4 to 8 or 10 kg; however, hypodermic and chewable tablets are much softer (3 kg) and some sustained release tablets are much harder (10-20 kg).

Tablet hardness and strength are the essential to see that the tablet can with the shock and stress during manufacturing packing and transportation, and while handled by the patient.

To test the hardness of the tablet Monsanto tester, Strong-cobb tester, the Pfizer tester, the Erweka tester, the Schleuniger tester are used.

Hardness is sometimes termed the tablet crushing strength. To perform this test the tablets are located between two anvils and force is applied to the anvils, and the strength required to break the tablet is noted. If the tablet is too hard, the disintegration time is long and cannot meet up the dissolution specification, if its too soft, it cannot withstand handling when dealing with processes such as coating or packaging and shipping operations. The force with which the tablet is broken is expressed in kilograms and a hardness of 4Kg is usually well thought-out to be the minimum for satisfactory tablets. Oral tablets have a hardness of 4 to 10kg ; but, hypodermic and chewable tablets  have a hardness of 3 kg  and sustained release tablets have about 10-20 kg.

Pfzier hardness tester was used for measuring the hardness of the formulated Paracetamol tablets. From each batch 3 tablets were taken at random and subjected to test. The mean of these 3 tablets were calculated.

Friability is the tested for a tablet to see weather the tablet is stable to abrasion or not, it is tested by using Roche friabilator. This is made up of a plastic drum fixed with a machine which rotated at 25 rpm for 100 revolutions. And then the twenty tablets which were weighed prior to the test are taken out of the drum and cleaned with a cloth and weighed once again, the weight variation must not be less than 0.5 to 1.0% for an conventional tablet.

6) WEIGHT VARIATION:

Weight variation test is performed to check that the manufactured tablets have an uniform weight.

As per USP twenty tablets are weighed individually and an compendia weight is taken, the average weight is obtained by dividing the compendia weight by 20, now the average weight is compared to the individual weight of the tablet,

For a tablet to pass the test not more than 2 tablets should lie out of the specified percentage and if no tablet differs by more than two times the percentage limit.

Average weight

Maximum percentage difference allowed

WETTING TIME (Gohel et al., 2004)

A circular tissue paper of 10cm diameter were placed in a Petri dish having an internal diameter of 10 cm. 10 ml of water containing methylene blue (10% w/w) was added to the Petri dish. The tablet was carefully placed in the centre of the Petri dish and the time taken for the water to reach the upper surface of the tablets was known as wetting time.

7) DISINTEGRATION:

Disintegration is the first physical change observed for a drug when it enters into the body, thus to see simulate the disintegration of the tablet in the body the disintegration test is performed.

As per USP the disintegration apparatus consist of 6 glass tubes with a 10 number mesh at the bottom, each tube is 3 inch long.

This arrangement of 6 tubes is placed in a medium simulated to the disintegration environment. Which is maintained at 37oc +/- 2oc, in 1 liter vessel.

This system is made to move up and down through a distance of 5 to 6 cm at a frequency of 28 to 32 cycles per minute.

The disintegration time of the tablet is compared with the values in the monograph.

DRUG CONTENT (IP, 2007)

20 tablets were weighed and powdered. A quantity of powder containing 0.15 g of Paracetamol was added to 0.1 M NaOH, diluted with 100 ml of water. It was shaken for 15 minutes and sufficient water was added to produce 200 ml. 10 ml of the filtrate was diluted to 100 ml with water. Then 10 ml of the resulting solution was added to 10 ml of 0.1 M NaOH, finally diluted to 100 ml with water. The absorbance was measured at maximum of 257 nm. Calculate the content of C5H9N02 taking 715 as the value of A (1%, 1cm) at maximum at 257 nm.

8) DISSOLUTION:

Tablet dissolution: Disintegration time determination is a useful tool for production control, but disintegration of a tablet does not imply that the drug has dissolved. A tablet can have a rapid disintegration time yet be biologically unavailable. The dissolution rate of the drug from the primary particles of the tablet is the important factor in drug absorption and for many formulations is the rate-limiting step. Therefore, a dissolution time is more indicative of the availability of a drug from a tablet than the disintegration test. Even though this is an important parameter to measure, most pharmacies do not have the equipment needed to conduct these kinds of tests.

The rate and extent of drug release form the tablet is estimated by dissolution test

Different types of apparatus are used to study the dissolution test of the tablet. As per IP apparatus I (paddle) and apparatus II(basket) are used. called basket dissolution apparatus and paddle dissolution apparatus

But as per USP dissolution apparatus used are

USP 30 classification

i. Rotating Basket (Ph.Eur./BP/JP)

ii. Paddle (Ph.Eur./BP/JP)

iii. Reciprocating Cylinder (Ph.Eur.)

iv. Flow Through Cell (Ph.Eur./BP/JP)

v. Paddle Over Disk (Ph.Eur.)

vi. Rotating Cylinder (Ph.Eur.)

vii. Reciprocating Holder

  1. DISSOLUTION KINETICS (Higuchi WI, 1962)

Method used to compare dissolution data is:

  • Model Dependent Methods (zero order, first order, Higuchi and Korsmeyer’s- Peppas).

Drug release kinetics

Drug release kinetics was studied from the datas obtained from in-vitro drug release studies which were plotted in various kinetics models: Zero order (equation 1) as Cumulative percentage of drug released against Time, First order (equation 2) as Log cumulative percentage of drug unreleased against Time, and Higuchi model (equation 3) as Cumulative percentage of drug released against Square root of time.

C = K0 t                                    (equation 1)

where       K0 indicates zero order rate constant expressed as                            concentration per time and t indicates the time in                                   hours.

A graph of concentration against time gives a straight line with a slope equal to K0 and intercept the origin of the axis.

log C = log C0 – K t/2.303                              (equation 2)

where         C0 be the initial concentration of drug,

K be the first order constant, and t is the time.

Q = K t1/2                                                                        (equation 3)

where        K indicates the constant of the system, t indicates the   time in hours.

Drug release were plotted in Korsmeyer equation (equation 4) as Log cumulative percentage of drug released against Log time, and the exponent was calculated from  the slope of the straight line.

Mt / Mα =  K tn                                                             (equation 4)

where          Mt / Mα is the fraction of solute release, t is the release time,  K is the kinetic constant

The dissolution time and rate is compared to the values mentioned in the monograph.

In vitro disintegration test

Disintegration is defined as the process of breakdown of tablet into small particles. Disintegration time of a tablet is determined by using disintegration test apparatus as per IP specifications. Place each tablet in each 6 tubes of the disintegration apparatus a then add a disc to each tube containing 6.8 pH phosphate buffer. The temperature of the buffer should maintain at 37 ± 2°C and run the apparatus raised and lowered for 30 cycles per minute. Note down the time taken for the complete disintegration of the tablet without any remitants .

References
1. J. S. Swarbrick, Encyclopedia of Pharmaceutical Technology, Third dition – 6 Volume Set,
Taylor & Francis, 2006.

Lachman et al., 1990

 

Dissolution Apparatus: Types of Dissolution Apparatus – Buy @ Best Price | PDF PPT II

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types of dissolution apparatus pdf,

The rate at which the drug is released is called the dissolution rate.When it comes to measuring the release rates of drugs in a manufacturing environment then the technique of Tablet Dissolution testing is employed.
Tablet Dissolution is a standardized method for measuring the rate of drug release from a dosage form and the key word here is “standardization” because for any results to be meaningful, it is essential that all the apparatus used for the testing, produces the same sets of results given all other parameters are equal.

Dissolution Apparatus: Types

Why do you need of Dissolution testing devices?

Reasons:
As solid drugs absorbed only from the solution .
In vitro test – estimate amount of drug released per unit time.
In vitro disintegration test not sufficient so we need Dissoluton.
In vitro dissolution test most reliable predictors of in vivo performance.
Dissolution is very crucial as it is the rate limiting factor.

Types of dissolution apparatus pdf:

Type 1 Basket apparatus 50-120rpm Conventional tablets, chewable tablets, CR
Type 2 Paddle apparatus 25-50rpm orally Disintegrating tablets, chewable tablets, CR, suspensions
Type 3 Reciprocating cylinder 6-35rpm CR, chewable tablets
Type 4 Flow through cell apparatus N/A ER , poorly soluble API, powder, granules, microparticles, implants
Type 5 Paddle over disk 25-50rpm Transdermal
Type 6 cylinder N/A Transdermal
Type 7 Reciprocating holder 30rpm CR(non disintegrating oral and Transdermal ) 6 USP APPARATUS

Apparatus 1 – The Rotating Basket Dissolution Apparatus

Rotating Basket USP1 is adopted in 1970 the rotating basket method of dissolution testing was the first official method.

The apparatus consists of a metallic drive shaft connected to the cylindrical basket. The basket is positioned inside a vessel made of glass or other inert, transparent material. The temperature of the media inside the vessel is kept constant by a water bath or heating jacket. The solution in the vessel is stirred smoothly by the rotating stirring element.

The diagram  shows a simple graphic of the rotating basket set-up. This is very tightly specified however and the official drawing according to the USP is shown below.

types of dissolution apparatus pdf,

The drawing shows a basket manufactured from mesh, connected to a basket hub of with a vent hole by the use of clips. The Basket hub is connected to a rotating shaft. Every parameter of those individual parts is specified.

The shafts and baskets must rotate freely and within specified limits, and importantly, they must be accurately centered in the vessel and be free from wobble. The validation of these parameters will be covered in a later chapter.

The standard basket consists of a stainless steel 40 mesh construction, but there are many variations depending on the monograph and application. For example, suppository baskets are manufactured from PTFE with vertical slits to facilitate dissolution.

Mesh size refers to the number of openings per linear inch and the diameter of the wire used to create the mesh is specified.

If the basket is reactive with the dosage form then it can be coated with PTFE or an inert substance such as gold or titanium.

The diagram shows that the basket is connected to the rotating shaft by use of clips onto a basket hub. The basket hub also has a specific dimension and importantly, a small vent hole at the top to allow air to escape from the basket should it become trapped. It is important that this hole does not become clogged over time.

Some baskets are supplied for use without clips, and use a push-on O-ring instead. While these are excellent for many applications, it is important to show that the results from this design are the same as the results obtained with clips – a process known as equivalence. It is by no means guaranteed that the results will be the same in every case.

It is also important to note that different dissolution tester manufacturers will manufacture their baskets and hubs to slightly different specifications but all within the USP guidelines. Even though they look similar, baskets are not interchangeable between different tester manufacturers. 

Note: Apparatus 1- Basket apparatus The assembly consists of the following : • A covered vessel • Transparent material • A motor • A metallic drive shaft, • A cylindrical basket, • The water bath permits the holding of temp inside vessel at 37±0.5 ̊C • The vessel is a cylindrical with hemispherical bottom .

Apparatus 2 Paddle Dissolution Apparatus

Type 2 Paddle apparatus

The Rotating Paddle, although Method 2, is actually the most widely used method in dissolution testing.

Rotating Paddle, is originally developed by Poole (1969) and was refined by scientists at the FDA for Drug Analysis in St Louis. The specifications for Apparatus 2 are identical with those for Apparatus 1 except that the paddle is substituted for the rotating basket.

The paddle apparatus (Apparatus II) consists of a special, coated paddle that minimizes turbulence due to stirring. The paddle is attached vertically to a variable-speed motor that rotates at a controlled 40 speed.

The tablet or capsule is placed into the round-bottom dissolution flask, which minimizes turbulence of the dissolution medium. The apparatus is housed in a constant-temperature water hall maintained at 370C, similar to the rotating-basket method.

Dissolution Apparatus: Types of Dissolution Apparatus - Buy @ Best Price | PDF PPT II

The position and alignment of the paddle are specified in the USP. The paddle method is very sensitive to tilting. Improper alignment may drastically affect the dissolution results with some drug products.

The same set of dissolution calibration standards is used to check the equipment before tests are run. The most common operating speed for Apparatus II are 50 rpm for solid oral dosage forms and 25 rpm for suspensions.

Apparatus II is generally preferred for tablets. A sinker, such as a few turns of platinum wire. may be used to prevent a capsule or tablet from floating.

A sinker may also be used for film coated tablets that stick to the vessel walls or help position the tablet or capsule under the paddle (Gray et al, 2001). The sinker should not alter the dissolution characteristics of the dosage form.

The dimensions of the paddle are closely controlled. Any variations can easily have a detrimental effect on reproducibility from vessel to vessel. For this reason, paddles should be treated as a precision piece of equipment, stored correctly, and inspected regularly for scratches, dents or other imperfections.

The dissolution test relies on uniform flow patterns and any imperfections can lead to turbulent flow. For that same reason, wobble and other deviations must be tightly controlled with specifications similar to the basket test.

Dissolution apparatus for more detailed info please go through these References

U.S. Pharmacopia,2008 31
Banakar V. U. and et. al. , pharmaceutical dissolution testing,
Remington, the science and practice of pharmacy, mack pub. Co. , 19th edition pg 594,601,602
Brahmankar D.M. , Jaiswal S. ,
biopharmaceutics and pharmacokinetics a treatise, vallab prakashan, 2nd edition, pg 29-34 4.
markcel deken, pg 4

 

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