Bioequivalence and Bioavailability Forum • comparative dissolution profile between various strengths

Falisa_Mustafa
☆

Malaysia,
2010-08-09 06:34
(5783 d 14:59 ago)

Posting: # 5743
Views: 8,266

comparative dissolution profile between various strengths [Dissolution / BCS / IVIVC]

Good day everyone.

I have few queries regarding CDP, in support of a BE study as follows:

If the dissolution medium for QC test contains surfactant, and CDP need to be conducted in other medium such as in pH 1.2, 4.5 and 6.8 (to compare dissolution of other strengths), can surfactant be included in that medium or the dissolution run need to be done without surfactant?
Is it possible/acceptable if the CDP between various strengths failed to show f2 value within 50-100, but dissolution is >80% in 15 minutes? How should we proceed with the results presented?
Can we use different batch from the batch used to perform BE study to conduct CDP?

Hope someone can help me to clarify on these matter as i'm still very 'green' in this BABE field.

TQ & kind regards,
Falisa

Dr_Dan
★★

Germany,
2010-08-09 11:42
(5783 d 09:50 ago)

@ Falisa_Mustafa
Posting: # 5744
Views: 7,132

comparative dissolution profile between various strengths

Post reply

Dear Falisa
Without knowing the details I can only give a general statement: Surfactants should be avoided whenever possible.
If dissolution is >80% in 15 minutes you do not have to calculate and present f2 values. The formulations are regarded similar without further mathematical proof.
The batch used to perform the BE study is the base for your CDP. If you use a different batch you have to give evidence that the other batch shows the same results as the BE batch and you have to give a reasonable rationale to do so.
I hope this helps.
Kind regards
Dan

—
Kind regards and have a nice day
Dr_Dan

Falisa_Mustafa
☆

Malaysia,
2010-08-20 12:31
(5772 d 09:02 ago)

@ Dr_Dan
Posting: # 5816
Views: 7,201

comparative dissolution profile between various strengths

Post reply

Dear Dr. Dan,

thank you so much for your reply.
sorry i forgot to include example in my previous post.

ok, let me give you a situation that relates to my previous question: e.g Losartan potassium only dissolves in pH around 6.8 (according to the manufacturer) and fails to show similar dissolution profile in more acidic pH. so they can only prove dissolution similarity in one medium. is this acceptable? or do we need to advice the manufacturer to add surfactant in their dissolution medium?

i also have another question. for Simvastatin, according to USFDA both parent compound and active metabolite should be analyze and reported but bioequivalence determination is based on the result of parent compound. we received a lot of report whereby parent failed to show BE but they use results of active metabolite to prove that the product is bioequivalent. is that acceptable? in your opinion, what is the justification of this condition?

hope to hear from you soon.

TQ!!