If excipients do not have pharmacodynamic activity, how do excipients affect the performance of the drug product?
Answer the following questions:
1. If excipients do not have pharmacodynamic activity, how do excipients affect the performance of the drug product?
2. What is meant by the rate-limiting step in drug bioavailability from a solid oral drug product?
3. What is the usual rate-limiting step for a poorly soluble and highly permeable drug (BCS 2)?
4. How could the manufacturing process affect drug product performance?
5. Drug absorption involves at least three distinct steps: dissolution, permeation, and disposition during transit in GI (an additional step of drug disposition in the body is involved as well for bioavailability). How are these processes validated in vitro when the in vivo requirement for drug bioavailability is waived?
6. What is meant by “sink” conditions?
7. What physical or chemical properties of a drug substance are important in designing a drug for (a) oral administration or (b) parenteral administration?
8. For a lipid-soluble drug that has very poor aqueous solubility, what strategies could be used to make this drug more bioavailable after oral administration?
9. For a weak ester drug that is unstable in highly acidic or alkaline solutions, what strategies could be used to make this drug more bioavailable after oral administration?
10. Why can two generic drug products have different dissolution profiles in vitro and still be bioequivalent in vivo?
This under Bipharmaceurics and Pharmacokinetics subject
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