Question

Statement I: The problem of declining potency in an unstable preparation can be ameliorated by the addition of an excess or overage of the active ingredient.
Statement II: Overages, are added to pharmaceutical formulations to keep the content of the active ingredient well above the limit, compatible with therapeutic requirements, for a predetermined period of time

• A. Both Statement I and Statement II are correct
• B. Both Statement I and Statement II are incorrect
• C. Statement I is correct but Statement II is incorrect
• D. Statement I is incorrect but Statement II is correct

Answer 1

The Correct Option is C

Let's evaluate the statements presented in the question separately and determine their correctness based on pharmaceutical practices.

Statement I: "The problem of declining potency in an unstable preparation can be ameliorated by the addition of an excess or overage of the active ingredient."

This statement is correct. In pharmaceutical formulations, particularly those which are unstable and tend to lose potency over time, additional quantities of the active ingredient, known as overages, are sometimes added. This practice ensures that even as the active ingredient degrades, there remains enough of it to achieve the desired therapeutic effect until the end of the product's shelf life.

Statement II: "Overages are added to pharmaceutical formulations to keep the content of the active ingredient well above the limit, compatible with therapeutic requirements, for a predetermined period of time."

This statement is incorrect. While overages are indeed used to account for the loss of potency, they are not meant to keep the active ingredient content "well above" the therapeutic requirements. The purpose is to ensure that the content remains within the therapeutic window, not above it. Thus, the statement's suggestion of maintaining content "well above the limit" is misleading because doing so might lead to excessive dosages which can be harmful.

Conclusion: Thus, the correct answer is "Statement I is correct but Statement II is incorrect".