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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