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Questions and Answers
What is the most important method of administering drugs for systemic effects?
The oral route of drug administration
What percentage of active ingredient do tablets like asprin usually contain?
90% or more
What is the purpose of measuring the weight of a tablet?
To ensure that a tablet contains the proper amount of drug
What test is used to determine the drug content uniformity in the process of production and finish product?
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What is the limit for permissible variations in the weights of individual tablets?
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What is the condition under which the weight variation test is a satisfactory method of determining the drug content uniformity?
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Why is the weight variation test not sufficient to assure uniform potency of tablets of moderate- or low-dose drugs?
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What is the aspect of weight variation stated in USP 21-NF 16?
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Study Notes
Weight and Its Application in Testing
- The oral route of drug administration is the most common method for systemic effects, with solid oral dosage forms being the preferred type of product.
Tablets and Capsules
- Tablets and capsules are unit dosage forms, where one usual dose of the drug is accurately placed.
- The weight of a tablet is measured to ensure it contains the proper amount of drug.
Weight Variation Test
- The weight variation test is used to determine drug content uniformity during production and in finish products.
- USP 20-NF 15 sets limits for permissible weight variations in individual tablets, expressed as a percentage of the average weight of the sample.
Limitations of Weight Variation Test
- The test is only reliable for tablets with high active ingredient content (90-95%) or perfect drug distribution in the granulation or powder form.
- For moderate- or low-dose drugs, the test is insufficient to assure uniform potency, as excipients make up the bulk of the tablet weight.
Uniformity of Dosage Units
- USP 21-NF 16 states that the difference aspect of weight variation falls under the Uniformity of Dosage Units.
- The permissible variation is the limit of the drug content as a percentage of the label amount in individual tablets.
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Description
The quiz covers the importance of uniformity in pharmaceutical dosage forms, specifically in tablets and capsules, and the role of weight in ensuring accurate drug dosing.
