Explain the importance of solubility in drug product formulation. 2.
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1. Explain the importance of solubility in drug product formulation.
2.
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- 2. Discuss the difference between first-generation and second-generation antihistamines. 3. When dispensing antihistamine drugs, what auxiliary label must be attached to the product? Explain its importance.1. Relationship of Drug solubility & dissolution rate on Physico-Chemical Properties 2. Relationship of Particle size & effective surface area on Physico-Chemical Properties1. 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…
- 2.The prescriber ordered Amevive (alefacept) 15 mg IM once per week for 12 weeks. The instructions on the 15 mg vial states "reconstitute with 0.4 mL of the supplied diluent to yield 15 mg/0.5 mL." How many milliliters of this biologic response modifier would you administer?15. (Drug Development) What is the major difference in regulatory requirements between the approval of a new API dosage form (NDA) and a generic dosage form (ANDA)?7. For those drugs that need to be applied with dissolution sustained system, what are their original properties? A. Low aqueous solubility and slow dissolution rate B. High aqueous solubility and slow dissolution rate C. Low aqueous solubility and fast dissolution rate D. High aqueous solubility and fast dissolution rate E. Gaseous state in room temperature with low aqueous solubility 8. Which of the following drug injection methods does involve perpendicularly inserting needle to the patient's body? A. Intramuscular injection B. Intravenous injection C. Subcutaneous injection D. Intradermal injection E. None of the above 9. Which of the following proteins is NOT commonly bound with drug in the bloodstream? A. Albumins B. Globulins C. Fibrinogens D. Antibodies E. None of the above 10. Which of the following events cannot increase the bioavailability of a drug? A. Patients suffer from cirrhosis B. Patients suffer from diarrhea C. Switch to intravenous injection from oral administration…