Bioequivalence and Bioavailability Forum • Drug degrades…

Drug degrades… [Dissolution / BCS / IVIVC]

posted by Helmut – Vienna, Austria, 2014-05-26 21:18 (4408 d 04:56 ago) – Posting: # 13008
Views: 5,889

Hi Ken,

just saw a similar topic:*

Q When we do the acid stage in the dissolution test for pantoprazole sodium delayed-release tablets, we observe that pantoprazole degrades in the 0.1 N hydrochloric acid medium, and we can’t quantify the amount released in the acid stage. What could be done to solve this issue?
A Pantoprazole, omeprazole, lansoprazole, and all the other members of this family of compounds are unstable in acid medium. This is the reason they are formulated as delayed-release capsules or tablets. Instead of measuring the amount of drug substance released into the acid-stage medium of the dissolution test for a dosage form containing this type of compound, you can measure the amount of drug substance that still remains in the dosage form. You can do this determination using the assay method or the content uniformity procedure.

Marques M and W Brown (United States Pharmacopeia, Rockville, MD)
Question & Answer Section
Dissolution Technologies 21(1), 50–4 (2014)

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Helmut Schütz

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Science Quotes

Drug degrades in pH4.5 and HCl Ken Peh 2014-04-22 10:48
- Drug degrades in pH4.5 and HCl Dr_Dan 2014-04-22 12:42
  - Drug degrades in pH4.5 and HCl Ken Peh 2014-04-27 20:43
- Drug degrades…Helmut 2014-05-26 19:18