Bioequivalence and Bioavailability Forum

Ken Peh ★ Malaysia, 2014-04-22 12:48 (3650 d 21:37 ago) Posting: # 12871 Views: 5,539	Drug degrades in pH4.5 and HCl [Dissolution / BCS / IVIVC] Post reply
	Dear All, If a drug degrades in pH4.5 and pH1.2 (0.1 HCl), is comparative dissolution profile necessary to be run at these two pH values ? In cases like this, pH 6.8 is sufficient ? Is there any guideline addressing this ? Appreciate your input. Thank you. Regards, Ken Please don’t write “RE: ” in the subject line; removed. [Helmut]

Dr_Dan ★★ Germany, 2014-04-22 14:42 (3650 d 19:43 ago) @ Ken Peh Posting: # 12873 Views: 4,589	Drug degrades in pH4.5 and HCl Post reply
	Dear Ken Even if the drug degrades in pH4.5 and pH1.2 (0.1 HCl) the comparative dissolution profiles obtained in these media will give you some information on your formulation in comparison to the reference. Degradation is substance specific whereas disintegration and solubility of your API in your product are formulation specific. Kind regards Dr_Dan — Kind regards and have a nice day Dr_Dan

Ken Peh ★ Malaysia, 2014-04-27 22:43 (3645 d 11:42 ago) @ Dr_Dan Posting: # 12897 Views: 4,464	Drug degrades in pH4.5 and HCl Post reply
	Dear Dr Dan, Thank you very much for your input. Regards, Ken

Helmut
★★★

Vienna, Austria,
2014-05-26 21:18
(3616 d 13:07 ago)

@ Ken Peh
Posting: # 13008
Views: 4,217

Drug degrades…

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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