A pill is one of the most common oral solid dosage forms of pharmaceutical products for oral administration, containing compact powders comprising active ingredients (APIs) and excipients. Excipients are used in the 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 release properties.
Compared to other types of dosage forms, tablets are most popular among doctors, patients and manufacturers because they offer a wide range of applications and benefits, as well as good physical and chemical stability and ease of ingestion. However, if a tiny error occurs during the manufacturing process, the entire batch may be discarded, which is a great inconvenience in its formation. Therefore, the evaluation of the tablets is extremely important to avoid errors during the production of the tablets. The different types of tablets such as multiple sustained release, chewable, sublingual, buccal, sweet, enteric film and gelatin tablets etc. are formulated as needed.
Quality control is the process by which a manufacturer measures actual quality performance, compares it to Pharmacopoeia (USP/IP/BP) standards, and determines the causes of deviations from the standard in order to produce a product of consistent quality.
What is a weight variation test?
Weight variation testing, also known as weight uniformity, is the official quality control test performed to ensure that each tablet dosage form contains the precise amount of drug. Weight consistency is a process test parameter that ensures consistency of dosage units as indicated on their label. The test is performed by weighing 20 tablets individually on an analytical balance, calculating the average weight and comparing the weights of the individual tablets to the average.
How is a weight variation test performed?
If the statistical distribution of tablet weights is considered normal, all tablets should fall within the prescribed range of established tablet weights. Throughout the manufacturing process, the average weight and variation in weight of the individual tablet from the average is calculated and monitored to ensure that the tablets contain the desired amount of drug and that there is no more than acceptable variation between tablets. lots of pills.
Test procedure for weight variation:
- The necessary devices and materials are tablets/caplets/capsules, electronic or analytical balance and weighing boat, etc.
- According to the USP, individually weigh the 20 randomly selected pills and calculate the average weight.
- If no more than two tablets exceed the percentage limit and no tablet exceeds more than twice the percentage limit, the tablet passes the USP test.
How to calculate the weight change test for tablets?
The weight transfer test is calculated using the formula, weight transfer = (IW - AW)/AW X 100% On, IW is the individual weight and AW is the average weight.
These standards are exempt for coated tablets, but must pass the content uniformity test.
What factors affect weight change?
The weight variation of tablets is mainly influenced by factors such as machine speed, head pressure, compression machine, particle size distribution and powder flow properties and degree of segregation, these are the common cause of weight change during compression.
The most frequently asked questions about tablet reviews are as follows.
What is the benefit of the weight change test?
The main advantage is that it is an official ongoing test that ensures that each dose contains the correct amount of medicine.
What are the quality control tests for dosage forms?
The various 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 tests for the pills that are used according to the official regulation/no. official standards.
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