Wednesday, June 30, 2021

Friability test for tablets

Friability is an evaluation test for tablets used to determine the physical strength of compressed or uncoated tablets when exposed to mechanical shock and attrition.

Dosage forms are the means by which drug molecules are delivered to sites of action within the body. They can be solid, semisolid, liquid, and gaseous forms and can be taken orally, parenterally, sublingually, topically, rectally, and topically, etc. There are many types of dosage forms used to treat such as tablets, capsules, powders, caplets, granules, transdermal patch, plasters, paste, creams, gels, suppository, pessaries, solutions, drops, syrups, linctus, and lotions, etc. however tablets are one of the most commonly used since they offer several advantages.

Tablets are solid unit dosage forms of pharmaceuticals that contain both active pharmaceutical ingredients (API) and excipients and are designed for oral administration. It is normally in powder form and is pressed using a compression machine into a solid dosage. Depending on the amount of therapeutic substance and the desired manner of administration, they are formulated in different sizes, shapes, appearances, tastes, odors, weights, thickness, hardness, disintegration, and dissolution. Depending on the rate of release in the stomach or intestines, several types of tablets can be formulated such as compressed, multiple-compressed, sugar-coated, film-coated, enteric-coated, chewable tablets, etc.

To evaluate tablets there are different quality control test is performed to ensure the quality of the product which is mentioned in pharmacopeias (USP, BP, and IP) such as hardness test, weight variation test, friability test, content uniformity test, disintegration test, and dissolution test, etc. some are the official and some are the non-official.

What is the friability test in tablets?

Friability test is a quality control test for tablet dosage forms as per official standards which are described in the pharmacopeia such as USP which also mentions their standard ranges. Friability testing is a technique for determining the physical strength of uncoated or compressed tablets when they are subjected to mechanical shock and attrition. In other words, friability testing determines how much mechanical stress the tablets can bear during the entire manufacture, delivery, and client handling.

Friability testing has become a widely recognized technique in the pharmaceutical industries and research, and the equipment used to perform this procedure is known as a friability tester or friabilator. It involves repeatedly dropping a tablet sample over a set time, using a drum that rotates with a spin. 10 whole tablets are weighed and placed in the drum of the friabilator where it is rotated. The broken tablets are checked, as well as the percentage of tablet mass lost due to chipping.

Why friability test is performed?

The friability test is performed to determine how much % weight is lost due to mechanical shock during entire manufacturing, transportation, and delivery. Or, it is performed to check the durability of tablets and mass loss of tablet powder through chipping.

How many tablets are used for the friability test?

10 tablets are used to perform the friability test. Take tablets weighing equal to or less than 6.5 grams if the unit weight is equal to or less than 650 milligrams. If a unit weight of tablets exceeds 650 mg, collect 10 tablets as a whole sample.

What types of tablets are used for friability tests?

Friability testing is usually performed using uncoated and compressed tablets.

How do you calculate friability? 

The friability value is expressed in %, which is calculated using the below formula.
Friability = W1–W2/W1 X 100, where W1=Weight of the tablet before the test, and W2=Weight of the tablet after the test.

Typically, the test is run only once, however in case of difficulty in the interpretation of the result, or if the final weight loss exceeds the target value, the test may be repeated twice, and the result may be returned as the mean of the three trials. Except for cracked, broken, chipped tablets, the test is not acceptable if the rolled tablet weighs more than 1%.

What is the limit for friability of tablets?

According to the USP, the acceptance criteria after friability testing for 4 minutes or 100 rounds in the apparatus should not exceed 1% of the tablet's weight.

Factors affecting friability of tablets:

The several factors that can affect the friability test such as tablet design, hardness, punches that are in poor condition, binder being used, and moisture content of tablet granules.

Friability test procedure:

  • Requirement: Tablet dosage form and friability test apparatus.
  • Weigh the number of tablets accurately and complete the procedure as in the individual monograph, if any.
  • Ensure the cleaning and power connection of the instrument.
  • Before starting operation, check the calibration status of the apparatus.
  • Note the weight and transfer the required amount of tablets into the drum.
  • Set all test parameters such as revolution count (100 rounds/ 4 min) and time and start testing.
  • Remove the sample from the drum, and out dust or powder, and re-weigh them.
  • Subtract the weight from the starting weight to calculate the loss.
  • Now calculate the friability by applying the formula.
  • If the result is outside the acceptable limits, repeat the test three times and determine the mean.
  • Clean the device thoroughly and turn it off.
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Tuesday, June 29, 2021

Content uniformity test

The content uniformity testing is a critical evaluation of oral solid dosage forms according to pharmacopoeia standards such as USP, BP, and, IP, and is used in research and development as a regulatory perspective.

Dosage forms are the means by which an active pharmaceutical ingredient (API) is delivered to specific sites of action within the body. They are classified according to physical forms and routes of drug administration. The physical forms include solid, semisolid, liquid, and gaseous, while the routes of drug administration include oral, parenteral (injection), buccal, topical, inhalation, ophthalmic, otic, and rectal, etc. They are available in several types such as tablets, caplets, capsules, granules, powders, suspensions, emulsions, liniments, lotions, syrups, solutions, elixirs, liquids, drops, linctus, creams, paste, gels, transdermal patch, plasters, collodion, suppository, pessaries, and aerosols, etc. 

Pharmaceuticals dosage forms must be in the form of safe, therapeutically effective formulations that are administered consistently and predictably. Since the dosage form is a method of entering or delivering drugs in biological systems, they need to be evaluated by quality control tests that are listed in pharmacopeias (USP/BP/IP) along with their standard limits. The evaluation test consists of hardness, weight variation, friability, content uniformity, dissolution, and disintegration test. To meet quality standards (official or non-official), these tests must be performed throughout the manufacturing process and validated once each batch is completed.

What is a content uniformity test?

The content uniformity test is a quality control test as per the official standards which are described in the pharmacopeias (USP/BP/IP) which also mentions their standard limits. Individual dosages of finished pharmaceuticals are tested using the content uniformity testing method for batch release to confirm that the product meets quality criteria.

Content uniformity testing is to ensure that each dosage form includes the equivalent amount of active pharmaceutical ingredient or drug substance. This method applies to tablets that have less than 10% w / w or 10 mg of the active pharmaceutical ingredient or drug substance. Use the method given in the monograph to determine the content of the drug in every of the 10 coated tablets that are taken randomly. 

Content uniformity is different than the weight variation test. This test applies to those tablets where less than 10 mg or less than 10% of the API is w / w. It does not apply to multivitamins and trace elements. The pooled sample of the test tablet is done only after the content of the active ingredients, which is shown within the allowed range of the specified content. 

As per the USP procedure of content uniformity, randomly 10 tables are taken according to the method described in the individual monograph. Their content of API is determined in each of the 10 tables and the mean value is calculated. Samples pass if the average value of more than one of the individual values is none out of the range of 85 to 115% and 75 to 125% of the average value is not out of range. The test is repeated by 20 another tablets if two or three separate tablets are out of 85 to 115% of the average value and no limit is beyond the limit of 75 to 125%. The tablets fulfill with the test if the total sample of 30 tablets is > 3 of the separate value of 85 to 125% are out of range and 75 to 125% of the average value is not out of range.

It has many advantages and is widely used in pharmaceutical industries where solid dosage forms such as tablets and capsules are manufactured.

Why do we perform a content uniformity test?

Content uniformity test is performed to ensure whether the strength of the drug(S) remains within particular acceptance limits.

How many tablets are used for content uniformity tests?

For the test of content uniformity, 10 tablets are randomly selected from a sample to evaluate and calculate the amount of active medicinal components present.

Factors affecting content uniformity of tablets:

Inconsistent distribution of the drug in the granules or powder, tablet weight variation, and segregation of the powder or granulation throughout the processes of the formulation are the major factors are responsible for the variable content uniformity in tablets.

Application of content uniformity:

The content uniformity and weight variation test is used for several dosage forms such as tablets, capsules, solids in single-unit containers, and solutions in single-unit containers, etc. The content uniformity test of preparation of a single dosage is based on the assay of the individual contents of several single-dose units to find out whether the individual contents are inside the limit set in the official with reference to the average content of the sample.


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Sunday, June 27, 2021

Difference between content uniformity and assay

The major difference between content uniformity and assay is that content uniformity is a quality control test in which the individual evaluation units are performed, while assay is a test in which numerous units are performed at the same time. Moreover, the evaluation process of uniformity of content tests is the same for all units.

Dosage forms are pharmaceutical products that deliver active pharmaceutical ingredients (API) to a particular part of the body in order to cure diseases. The physical forms of the dosage forms include solid, semisolid, liquid, and gaseous, while the routes of drug administration include oral, parenteral (injection), inhalation, sublingual, buccal, topical, and among others. Examples of dosage forms include tablets, capsules, caplets, granules, powders, pastes, aerosols, creams, linctus, gels, colloids, elixirs, suspensions, liniments, drops, emulsions, lotions, syrups, liquids, and solutions.

Pharmaceuticals should be in the form of safe, clinically effective formulations that are administered consistently and predictably. Therefore they should be evaluated by quality control tests which are mentioned in the pharmacopeias (USP/BP/IP) which also mentions their standard limits. The evaluation test consists of appearance, organoleptic properties, weight variation, hardness, content uniformity, friability, disintegration, and dissolution test. These tests must be done throughout the manufacturing and validated after each batch is completed in order for the product to meet quality standards (official or unofficial).

The content uniformity test and the assay are both are the quality control test used to determine whether a dosage form (tablet/capsule) batch is acceptable. These two tests are not independent, and their acceptance criteria are inconsistent.

Content uniformity test:

It is used to verify that the drug substance is evenly distributed in a production batch. This is done by determining the amount of the active ingredient in each of the dosage units. It gives criteria for the individual active ingredients measured, with no requirements for average and standard deviation. In which the number of dose units taken at random (10), and uniformity were accepted if individual values were found to be in the range of 85–115% of the calculated average.

Assay:

The purpose of the assay test is to verify that the average active content of a sample batch is close to its label claim. The assay limits for medicines are defined in the pharmacopeia monographs. The maximum allowable deviation from the label claim upon release should not exceed ± 5%.

Difference between content uniformity and assay:

  • Uniformity of content is used to ensures that each dosage form contains the same amount of drug or medication, whereas assay is used as an analytical process to qualitatively assess or quantitatively determine the presence, quantity, or functional activity of a sample. This is another major difference between assay and content uniformity.
  • Content uniformity is a type of qualitative test, whereas an assay can be both qualitative and quantitative.
  • In a content uniformity test, each unit is evaluated individually, whereas, in the assay, testing is done by combining the content of numerous units (tablets/capsules).
  • A content uniformity test is used to assess the uniformity of active ingredients, whereas an assay is used to characterize the main functional component of a sample.
  • In content uniformity, the pharmaceutical drugs are used as a sample, whereas in assay the pharmaceutical drugs, protein, DNA, RNA, antibodies, carbohydrates, and metal ions, etc. are used as a sample.

Similarities between assay and content uniformity:

Assay and content uniformity is the quality control test (analytical tests) which is used to determine the quality of a pharmaceutical product. They both are used the same procedure and their samples are the same (drug).

Why do we perform a content uniformity test?

Content uniformity test is performing to ensure that whether the strength of the therapeutic product remains within specified acceptance limits.


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Saturday, June 26, 2021

Difference between weight variation and content uniformity

Weight variation and content uniformity are used for the same purpose but in different ways. They both are the official quality control tests for the dosage forms, one of two methods can be used to demonstrate uniformity of dosage units.

The dosage forms are pharmaceutical products meant to be delivering the active pharmaceutical ingredients (API) at the particular site within the body to treat the diseases. The dosage forms have different types such as solid, liquid, and gaseous based on the physical form, and based on the route of drug administration they are topical, oral, parenteral (injection), inhalation, sublingual and buccal, etc.

Quality of pharmaceutical products such as tablet, capsules, caplets, powders, granules, liquid, solution, syrup, suspension, emulsion, colloid, drop, liniment, lotion, elixir, linctus, gel, cream, and paste, etc. is very important because pharmaceuticals must be marketed as safe and therapeutically active formulations with consistent and predictable performance. 

Hence they need to be evaluated by quality control tests mentioned in pharmacopeias (USP/BP/IP) such as appearance, organoleptic properties, weight variation, hardness, friability, content uniformity, disintegration, and dissolution test. In order for the product to meet quality standards (official or unofficial), these tests must be performed throughout production and verified after each batch is produced.

Difference between weight variation and content uniformity:

The major difference between weight variation and content uniformity is that the weight variation testing is to ensure that the weight of the active ingredient per weight of dosage unit is uniform, whereas the content uniformity testing is performed to ensure that each dosage form contains the same amount of the active pharmaceutical ingredient (API) or drug.

Weight variation test:

  • The purpose of the uniformity of weight test is to ensure that each batch is uniform around the label claim in the product, which indicates the uniformity of the drug throughout all formulation batches.
  • It is performed by weighing and determining the individual weights of 20 tablets randomly selected from a tablets/capsules batch and calculates the average weight.
  • The sample passes the test, If not more than two tablets are outside the % limit and no tablet differs by more than two times the percentage restriction.

Content uniformity test:

  • The purpose of the content uniformity test is to ensure the content consistency of the drug within a narrow range.
  • Several tablets/capsules are chosen at random, and the individual content of the active ingredient in each dosage is determined using a suitable analytical method is applied to the assay.
  • The sample passes the test, if not more than one individual ingredient is outside the range of 85 to 115% of the average content and no one is out of the range of 75 to 125% of the average content.
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Friday, June 25, 2021

Weight Variation Test for Tablets

Weight variation or uniformity of weight is a quality control test for dosage forms that are performed to ensure that each dosage contains the appropriate amount of drug.

A tablet is one of the most common oral solid dosage forms of pharmaceuticals for oral administration, containing powder compacts that include both active ingredients (API) and excipients. Excipients are used in formulation to achieve a specific fill weight in a dosage form, improve drug release behavior, protect, support, or enhance stability, patient acceptability, or bioavailability. Depending on the number of medicinal substances and the intended route of drug administration, they vary in weight, shape, size, thickness, hardness, dissolution, solubility, and other releasing properties.

When compared to other types of dosage forms, tablets are the most popular among physicians, patients, and manufacturers because they offer a wide range of applications and, advantages as well as good physical and chemical stability and ease of swallowing. However, if a minute error arises throughout the manufacturing process, the entire batch may be discarded, which is a major disadvantage in its formation. Thus, evaluation of tablets is extremely significant to avoid any errors throughout the production of tablets. The different types of tablets such as compressed, multiple-compressed sustained action, chewable, sublingual, buccal, sugarcoated, film-coated enteric-coated and gelatin-coated tablet, etc. are formulated as per the requirement.

Quality control is the process by which a manufacturer measures actual quality performance, compares it to pharmacopeia standards (USP/IP/BP), and determines the causes of deviation from the standard in order to produce a consistently high-quality product.

What is a weight variation test?

Weight variation test is also known as uniformity of weight, it is the official quality control test which is performed to ensure that each tablet dosage form has the accurate amount of drug. The consistency of weight is a process test parameter that ensures uniformity of dose units as per the label claim. The test is conducted by weighing 20 tablets individually on an analytical balance, computing the average weight, and comparing the individual weights of the tablet to the average.

How do you perform a weight variation test?

If the statistical distribution of the weight of the tablet is considered normal then all tablets should fall within the prescribed range of established tablet weights. Throughout the manufacturing process, the average weight and variation of individual tablet weight from the average are calculated and controlled to ensure that the tablets contain the desired amount of drug and that there is no more than acceptable variation among tablets within a batch.

The test procedure for weight variation:
  • Required apparatus and materials are tablets/caplets/capsules, electronic or analytical balance, and weighing boat, etc. 
  • As per the USP, weigh the randomly selected 20 tablets individually and calculate the average weight.
  • If no more than two tablets exceed the % limit and no tablets differ by more than twice the percentage limit, the tablet passes the USP test.

How to calculate weight variation test for tablets?

The weight variation test is calculated using the formula, weight variation = (IW - AW)/AW X 100% Where, IW is individual weight, and AW is average weight.

The following table lists the USP, BP, and IP limits for tablet weight variation.
Weight variation test for tablets
These standards are exempted for coated tablets, but they must pass the content uniformity test. 

What are the factors that affect weight variation?

The weight variation of the tablet is mostly influenced factors by the machine speed, head pressure, compression machine, particle size distribution, and the flow properties of the powder, and degree of segregation, these are the common cause of weight variation throughout compression.


Commonly asked questions on the evaluation of tablets are as follows.

What is the advantage of the weight variation test?
The major advantage is that it is an official in-process test that ensures that each dose contains the proper amount of drug.

What are the tests quality control tests for dosage forms?
The different evaluation tests are uses such as appearance, size and shape, organoleptic properties, unique identification marking, hardness, weight variation, friability, content uniformity, disintegration, and dissolution these are the test for tablets are used as per the official/non-official standards.


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Tuesday, June 22, 2021

Evaluation tests for tablet dosage form

The quality control test for tablets involves different evaluation tests that are used to determine whether product quality standards (official or unofficial) are met, these tests should be carried out during production and verified after each batch is produced.

The dosage forms are pharmaceutical products are meant to deliver the drug/medication to the diagnosis, prevention, and treatment of disease at the specific site of the body. They are formulated in different types based on the physical form and route of the drug administration. Based on the physical form they are solid, semisolid, liquid, and gaseous, and based on the route they are oral, parenteral (injection), ocular, topical, nasal, inhalation, sublingual, and buccal, etc. Some examples of dosage forms are tablets, capsules, caplets, granules, powders, cream, gel, liniment, moisturizer, paste, colloid, lotion, suspension, emulsion, elixir, linctus, drop, tonic, and syrup, etc.

Tablets are solid unit dosage forms of pharmaceuticals intended for oral administration that contains active ingredients (API) as well as excipients. It is usually in powder form and is pressed or compressed into a solid dosage using a compression machine. They vary in size, shape, weight, hardness, thickness, dissolution, dissolution, and other release characteristics depending on the amount of medicinal substance and the intended method of administration. Tablets can be made in different types depending on the rate of release in the stomach or intestines, for example, compressed tablets, multiple-compressed tablets, sustained action tablets, gelatin-coated tablets, film-coated tablets, sugar-coated tablets, chewable tablets, and enteric-coated tablets, etc.

Tablets are the most popular dosage forms among physicians, patients, and manufacturers when compared to other types of dosage forms, as it has a broad range of advantages and applications, good physical and chemical stability, and ease of swallowing. However, a significant disadvantage in its formulation is that if a minor defect occurs during production, the entire batch of the unit may be discarded. Therefore, the evaluation of tablets is very important to avoid any errors during the production process, and before the final batch is dispatched or delivered.

Evaluation test for tablets:

Tablet evaluation includes assessment of the physical, chemical, and biological aspects of the tablet. To ensure the quality of tablets, capsules, and different types of dosage forms, almost all pharmacopeias (USP, BP, and IP) incorporate suitable standards and tests. These tests are divided into two categories: pharmacopoeial (official) tests and non-pharmacopoeial (unofficial) testing. Pharmacopoeial or official tests are standardized testing procedures that clearly state the limits within which tablets can be accepted.

Evaluation test for tablets

Appearance test for tablets:

Consumer acceptance, managing lot-to-lot consistency, and tablet-to-tablet uniformity all depend on the overall design, identity, and elegance. The general appearance of the tablet can be controlled by assessing several characteristics such as size, color, shape, readability of any identification marks, presence or absence of taste, and odor, etc.

Size and shape test for tablets:

The thickness of a tablet determines its size and shape and it can be described and controlled dimensionally. The size and shape of the tablet dosage form have a significant impact on patient compliance. As tablet size increases, administration (swallow) becomes more difficult, particularly for child and elderly patients. To determine the thickness of a tablet a micrometer apparatus is used. The thickness of the tablet should be controlled within a ± 5% variation of the standard value.

Unique identification marking test for tablets:

For rapid identification of their product, in addition to providing color, the pharmaceutical manufacturers use printing, embossing, or engraving as a type of distinctive marking. These markings include the name of the manufacturer, the name, and code of the product, the strength of the drug, etc.

Organoleptic properties test for tablets:

As an important means of quick identification and consumer acceptance several pharmaceutical tablets use color, and the color of the product should be uniform within one tablet. Mottling is the term for non-uniformity, resulting in poor product quality. For comparison, the color of the tablet should be compared with the standard color. Organoleptic compounds such as coloring additives, flavoring agents, and sweeteners may be found in some tablets. A reflectance spectrophotometer is used to be evaluated the color uniformity of the tablet.

Hardness test for tablets:

Tablet hardness refers to the amount of force required to completely crush a tablet. To withstand the mechanical shocks of handling in production, packaging, and shipping, tablets require a particular amount of hardness or strength and resistance. Hardness is performed by tablet hardness tester they can be Monsanto hardness tester or Pfizer hardness tester, nowadays automated testers are also used. It is a significant quality control test since it can impact tablet disintegration, dissolution, and friability. It is also used adjustment pressure on the tablet compression machine and adjusts the disintegration of the tablet.

Weight variation test for tablets:

If the statistical distribution of tablet weight is considered normal then all tablets must fall within the specified range of predefined tablet weights. Many tablets are weighed separately, and the average weight and variation of individual tablet weight from the average are calculated and controlled throughout the manufacturing process to confirm that the tablets contain the preferred quantity of active ingredients and that there is no more than acceptable variation among tablets within a batch.

As per the USP, the weight variation test is performed by individually weighing 20 tablets, calculating the average weight, and comparing the individual tablet weight to the average. Tablet passes the USP test if not more than 2 tablets do not exceed the percentage limit and if no tablets differ by more than 2 times the percentage limit.

The formula of weight Variation = (IW - AW)/AW X 100% Where, IW is individual weight, and AW is average weight.

Friability test for tablets:

The friability test is official in USP but not in BP and IP. It is designed to measure how much weight loss occurs during transportation and handling, as well as the physical strength of tablets when exposed to mechanical shock and attrition.

The friability of a tablet can be determined in a laboratory using friability test apparatus. It consists of a plastic chamber that rotates at 25 rpm, 10 tablets are weighed and placed in the chamber of the friabilator, dropping the tablets into the friabilator over a 6-inch distance, and then operating for 100 revolutions. As per the USP, IP, and BP, it should be no more than 1.0%.

The % friability is calculated using the below formula.
Friability = W1–W2/W1x100, where W1=Weight of the tablet before the test, and W2=Weight of the tablet after the test.

Content uniformity test for tablets:

Content uniformity test is to ensure that each dosage form contains an equal amount of the active pharmaceutical ingredient or pharmaceutical substance. In which randomly 10 tables are taken, if 9 out of 10 tablets should not contain less than 85% and more than 115% of the labeled drug content and the 10th tablet may not contain less than 75% and more than 125% of the labeled drug content, the tablet passes the test. It is usually tested using analytical methods such as high-performance liquid chromatography (HPLC), or UV-spectrophotometer for drug potency in several individual tablets.

Disintegration test for tablets:

This test is used to observe whether tablets disintegrate in the specified amount of time when placed in a liquid medium under the specified conditions. It is evaluated to make sure that the tablet dissolves or breaks up into granules or smaller particles upon contact with water under agitation. This allows it to be dissolved from its primary particles, fully available for dissolution and absorption from the gastrointestinal tract (GI).

Tablet disintegration test is perfumed using the USP disintegration test apparatus. This consists of 6 glass tubes that are 3” long that open at the top and 10 mesh screens at the bottom end. For testing disintegration time, a tablet sample is placed in each tube and the basket rack is placed in a beaker (1liter) of water or simulated gastric or intestinal fluid at 370C

, these tablets are 2.5 below the surface of liquid on their upward movement and no closer than 2.5 cm from the bottom of the beaker. The basket is moving that containing the tablet up and down at a frequency of 28 to 32 cycles per minute from a distance of 5-6 cm. The disintegration time of uncoated tablets is about 5-30 minutes, about 1-2 hours for the coated tablet, and usually not more than 15 min for immediate release (IR) tablets.

Dissolution test for tablets:

Dissolution is the process in which a substance forms a solution. The dissolution test measures the extent and rate of formation of a solution from dosage form (solid/semisolid). It is utilized as a quality control method to assure tablet-to-tablet and batch-to-batch uniformity in drug-release characteristics of tablets, as well as an in vitro–in vivo correlation tool for drug release (in vitro) and drug absorption (in vivo) (in vivo).

Dissolution includes seven USP standardized apparatus, of which baskets and paddles (Apparatus-1 and 2 ) are more commonly used. It consists of a specially coated paddle or basket, the rotating shaft is attached vertically at the end. The vessels are usually either partially immersed in a water bath solution. A motor to rotate a shaft immersed in the vessel, and a temperature controller that maintains the bath at 370C.


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Saturday, June 19, 2021

Difference between hardness and friability of tablet

The major difference between hardness and friability of tablet is that the tablet hardness testing determines its breaking point and structural integrity, as well as find out how it changes throughout packing, handling shipping, and storage before use, whereas the friability testing is a laboratory technique used by the pharmaceutical industry to test the durability of tablets during transit.

The pharmaceutical dosage forms are meant to deliver the active pharmaceutical ingredients (API) to the specific site of the body for diagnosis, prevention, and treatment of disease. As per the physical form dosage forms are solid, semisolid, liquid, and gaseous, and as per the route of drug administration dosage forms are oral, parenteral (injection), topical, inhalation, ocular, otic, nasal, sublingual, and buccal, etc. Tablets, caplets, capsules, powders, granules, syrup, suspension, tonic, drop, elixir, linctus, emulsion, suspension, liniment, lotion, paste, gel, cream, moisturizer, and colloid are some of the examples of dosage forms.

Pharmaceutical tablets:

The pharmaceutical tablets kind of oral solid dosage form is one of the most popular among patients, physicians, and manufacturers since it has a wide range of advantages, applications, good physical and chemical stability, and may contribute to patient compliance given their ease of swallow.

It consists of a mixture of drugs and excipients, usually in powder form, pressed or compacted from a powder to a solid dosage. Based on the amount of medicinal compounds, intended use, and preparation technique, they can vary in shape, weight, size, thickness, hardness, disintegration and dissolution characteristics, and other release characteristics.

Tablets can be formulated in different types according to the rate of release in the stomach or intestines such as compressed tablets, multiple-compressed tablets, sugar-coated tablets, film-coated tablets, gelatine-coated tablets, chewable tablets, sustained action tablets, enteric-coated tablets, and uncoated tablets.

Overview:

Hardness and friability both are quality control tests for tablet dosage forms. The quality control test is the process by which a manufacturer determines actual quality performance, compares it to official pharmacopeia standards such as USP, IP, or BP, and determines the causes of deviation from the standard to ensure a high-quality product. Types of quality control tests are thickness and diameter, hardness test, weight variation test, friability test, drug content, disintegration time test, and in-vitro dissolution test, etc.

Tablet hardness test:

Tablet hardness testing is a quality control test used to check breaking point and structural integrity of tablet dosage form, as well as to determine how it changes "during storage, transit, packing, and handling conditions before use." The units of measurement for tablet hardness are largely based on materials testing standards.
  • It is used to determine the need for pressure adjustment on the tablet compression machine.
  • It is used in manufacturing, packaging, and shipping to withstand mechanical shocks.
  • It is used to ensure consumer acceptance.
  • It is used to adjust the disintegration of the tablet since hardness can affect the disintegration.
  • Monsanto and Pfizer hardness tester is commonly used to determine tablet hardness however nowadays digital hardness tester is also used.
  • This measures the degree of force Kilogram (kg), Newton (N), Kilopond (KP), and Strong-Cobb (SC), etc. needed to fracture a tablet.
  • This involves placing the tablet directly into the sample compartment and pressure can be applied manually or automatically.

Tablet friability test:

Friability is the percentage of weight loss of powder from the surface of the tablets caused by mechanical action, and the test is used to determine how much weight loss occurs during transportation and handling or determine the physical strength of uncoated tablets upon exposure to mechanical shock and attrition.
  • It is used to determine the ability of tablets to withstand breakage during manufacturing, distribution transportation, and handling.
  • This is a supplementary test for uncoated/compressed tablets other than hardness.
  • Friability tester is commonly used to determine to evaluate the ability of the tablet which is operated automatically by the control panel.
  • The friability tester determines friability by allowing the tablet to roll and fall up to 6 inches within the rotating tumbling equipment.
  • Friability strictly adheres to coated tablets and is indicated by chipping, breaking, (or) capping.
  • To operate, the tablets (previously weighed) must be placed in a drum that is rotated.

Commonly asked questions on hardness and friability are as follows.

What are the factors that affect the friability of tablets?
moisture content, the addition of a large amount of fine powder to the formula, hardness variations, amount and type of binder and lubricants used in formulation, etc.

What are the factors that affect the Hardness of tablets?
Amount of binder, compression of the tablet and compressive force, Method of granulation, types of binders used, the nature, press speed, granulation flow, and composition of the active pharmaceutical ingredients, etc.

What is the limit for friability of tablets?
A maximum mean weight loss USP limit is 0.5% to 1.0% is considered acceptable for most products.
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Thursday, June 17, 2021

Difference between Dissolution and Disintegration

The major difference between dissolution and disintegration is that dissolution is the process of dissolving solutes in a solvent that measures the drug being solubilizes in the liquid/media, while disintegration is a process of breaking solid substances into small granules that measure the breakdown of a solid dosage form.

Disintegration and dissolution are the two basic processes that are used for qualification purposes to improve the bioavailability and solubility of the dosage form and to be used in the chemical and pharmaceutical field, which are meant to break the force that grabs substances together. Both methods can be used on the same substance. However, dissolution can be applied to solids, liquids, and gases, and disintegration is applied to large solid substances.

Disintegration time is a process that is required to break down the dosage form in the specified size or into particles, this process is called disintegration. Whereas dissolution is a kinetic process in which the solids dissolve in the solution or dissolution medium, it is controlled by the affinity of solvent and solid substance. In other words, disintegration is measuring the breakdown time of a dosage form, and dissolution is used to measuring the rate of solute or oral dosage form dissolving in a medium or solution.

Dissolution testing:

The dissolution testing is used to determine the drug in pharmaceuticals such as tablets, caplets, or capsules to prepare any solid oral dosage forms according to the pharmacopeias such as USP, BP, or IP criteria. It determines adequate bioavailability and provides data for the formulation of solid dosage forms.

It is an important analytical procedure generally provide release rate of active pharmaceutical ingredient (API) and also used for check for the stability, quality control, and evaluation of the batch-to-batch consistency in the pharmaceutical industry. The different types of dissolution apparatus used to perform the dissolution process such as rotating basket, paddle type, reciprocating cylinder, flow-through cell, and paddle over the disk, rotating cylinder, and reciprocating disk apparatus, etc.

Disintegration testing:

Disintegration testing determines the ability of a tablet to break down into smaller particles or granules so that the active drug can be absorbed into the body. It is used to measure how rapidly a tablet breaks down into tiny particles, allowing for more surface area and drug availability when the patient consumes it. This test is performed using disintegration test apparatus and may also be available in different forms as per USP/IP/BP.

Difference between dissolution and disintegration:

  • Dissolution is the process in which a substance forms a solution, while disintegration is a process of breaking down substances into small particles or their constituent elements.
  • The dissolution process can be carried out only after the particles of low solubility are broken down, while the disintegration process can be carried out for a sample regardless of whether it has a low or high solubility level.
  • The sample to be analyzed in dissolution can be solid, liquid, or gaseous, while the sample to be analyzed in disintegration can be solid substances only.
  • The pharmaceutical dissolution test performs with the help of the dissolution apparatus, while the disintegration study performs on the disintegration tester.

Difference between disintegration time and dissolution rate:

The time it takes for a dosage form to break down into granules of a specific size under precisely controlled conditions is known as disintegration time, while the dissolution rate is the transfer rate of individ0075al drug molecules from solid particles to solution in the form of individual free drug molecules.


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Wednesday, June 16, 2021

Difference between HPLC and UPLC

The major difference between HPLC and UPLC is that due to particle size HPLC works at lower pressures, while UPLC works at higher pressures, which allows UPLC a reduced run time, lower solvent consumption, and better analysis separation and detection by the detector.

Chromatography is a technique used to separate chemical compounds based on differences in their relative affinity for the mobile phase (gas/liquid) and stationary phase (solid/liquid). The different types of chromatography are paper chromatography, thin-layer chromatography (TLC), column chromatography, partition chromatography, high-performance liquid chromatography, and gas chromatography are commonly used for qualitative as well as quantitative determination of molecules.


Both high-performance liquid chromatography and ultra-performance liquid chromatography are the separation techniques used for separate different components found in the complex mixture. UPLC works on high pressures and particle size of columns is less, Whereas, HPLC works under low pressure, hence UPLC offers better detection and separation, shorter run times, and consumption of less solvent.

What is UPLC?

UPLC stands for ultra-performance liquid chromatography, it becomes the modern standard HPLC platform. Because it offers increased efficiency, sampling throughput, sensitivity, and reduced run time making it more powerful and time and cost-effective.

HPLC vs UPLC
Difference between HPLC and UPLC

What is HPLC?

HPLC stands for high-performance liquid chromatography, it is an analytical technique used to separate, identify, and quantify components in a sample mixture. It is the most common chromatography technique used in most laboratories across the world. HPLC system can withstand pressure up to 6000 PSI. The most commonly used form of HPLC is reversed-phase (RP-HPLC).

Difference between UPLC and HPLC:

  • UPLC works on about max 15000 psi pressure, while HPLC works on max up to 6000 psi pressure.
  • UPLC the particle size of the column stationary phase is less than 2 µm, whereas the particle size of the column stationary phase in HPLC is 3 to 5 µm.
  • The one more difference between HPLC and UPLC is they can analyze the sample of UPLC very quickly, which is about 3-10 minutes which can reduce the cost of operation; while HPLC can take about 10-20 minutes to separate the analytes.
  • UPLC analysis required less solvent and increases sample throughput than HPLC, while high-performance liquid chromatography analysis required more solvent or mobile phase and less sample throughput.
  • UPLC is more selective and sensitive than HPLC, while HPLC is less selective and sensitive than UPLC.
  • UPLC has high resolving power compared to HPLC, while HPLC has less resolving power compared to UPLC.
  • Because the packing material particles are less than 2 μm, UPLC columns are often non-regenerable and have a narrow use, whereas HPLC columns have more use.
  • Sample injection necessitates high precision in UPLC, while HPLC has lower comparative to UPLC.
  • A small injection volume is required for UPLC (generally 2 microlitres), while a large injection volume is required for HPLC (generally 5 to 20 microlitres).
  • UPLC system works with higher pressures and requires more efficient pumps than HPLC systems.
  • UPLC achieves a higher theoretical plate count than HPLC, while HPLC achieves a lower plate count.
  • Higher back pressure shortens column life in UPLC, while lower back pressure increases column life in conventional HPLC.

Commonly asked questions on liquid chromatography are as follows.

Which one is more popular between UPLC and HPLC?
In the analytical field, UPLC is more popular between UPLC and HPLC, especially for complex sample analysis, because of its advantages of higher resolution, faster processing speed, and better potential sensitivity.

What is the advantage of UHPLC?
Improved resolution, faster analysis (up to 10 times), eluent saving, enhanced sensitivity, and excellent peak shape is the major advantage of UHPLC.

Why UPLC is higher efficiency than HPLC?
Because of particles less than 2m in diameter ultra-performance liquid chromatography (UPLC) provides superior resolution and higher efficiency than HPLC.


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