6. Dr. Liu\'s bonus question for fun: You are working as a Regulatory Affairs sp
ID: 983395 • Letter: 6
Question
6. Dr. Liu's bonus question for fun: You are working as a Regulatory Affairs specialist at Bayer. The Director of Product Development comes to CH H3C you seeking your advice about pursuing a FDA biowaiver (background info for biowaiver provided below) for their Nifedipine products. Nifedipine (shown in the figure) is a dihydro idine calcium COCH. channel blocker used to treat hypertension. Bayer has H3COG both a 10 mg immediate-release capsule (Nifedipine Immediate) taken three times a day, and a 30 mg NO2 sustained-release version (Nifedipine Sustained Release) taken once daily. The aqueous solubility of Nifedipine is 0.006 mg/mL at pH 7 and it has an octanol/water partition coefficient of 10, 000. The absolute bioavailability is 45-75 for Nifedipine Immediate and 84-89% for Nifedipine Sustained-Release. What is your advice to the director, and why? (Please limit your answer to 300 words) (1 extra point) Hint: For some drug products, human in-vivo bioavailability and/or bioequivalence studies may be waived from the list of regulatory requirements for approval by the FDA. Instead, in-vitro dissolution studies may be used to demonstrate "equivalence". Biowaivers are best suited for BCS class I drugs that are intended to be immediate release dosage forms.Explanation / Answer
Nifedipine, is widely used for the treatment of hypertension. Available in the form Sustained- and immediate -release nifedipine, alone or in combination with other agents. Literature reveals told that Sustained- or extended-release formulations were used in 85% of study arms and 91% of treatment exposures, and immediate-release formulations were used in 15% of study arms and 9% of treatment exposures.
Literature results told that the sustained or extended-release nifedipine in the treatment of mild or moderate hypertension when it is used in combination with other drugs instead giving immediate Nifedipine. Tablet with high dosage is not permissible one or the patient it will cause side effect and the patient undergo some other disease.
The dosage of tablet with low concentration and higher number intake will be preferred one so Nifedipine sustained release is preferred for the patient when compared to immediate release.
Related Questions
drjack9650@gmail.com
Navigate
Integrity-first tutoring: explanations and feedback only — we do not complete graded work. Learn more.