Mauricio Sampaio
★    

Brazil,
2019-07-19 22:29

Posting: # 20407
Views: 681
 

 BSC approach at each strength? [Dissolution / BCS / IVIVC]

Dear all, happy to write here again!

According ICH guideline M9 on biopharmaceutics classification system based biowaivers, is said: "For products with more than one strength the BCS approach should be applied for each strength, i.e., it is expected that test and reference product dissolution profiles are compared at each strength."

My question is: If a biowaiver test (vitro) according BCS replaces a bioequivalence test (in vivo), why not performing just one BCS approach for high strengh (test and reference) and after to do a compare by dissolution test of Tested product (high strengh) versus Test product (low strengh) in an only dissolution medium?

What is the technical reason to performing the BSC approach at each strength?

I really appreciate your opinion!

Best regards
jag009
★★★

NJ,
2019-07-22 19:56

@ Mauricio Sampaio
Posting: # 20428
Views: 547
 

 BSC approach at each strength?

Hi,
» What is the technical reason to performing the BSC approach at each strength?

You mean what is the tech reason to perform disso testing (T vs R) at each strength?

J
Mauricio Sampaio
★    

Brazil,
2019-07-22 21:43

@ jag009
Posting: # 20429
Views: 535
 

 BSC approach at each strength?

Hi,

» You mean what is the tech reason to perform disso testing (T vs R) at each strength?»

Yes! For example: three strenght of 80 mg, 40 mg and 20 mg and the drug is class 1. I understand that BCS in three pHs (1,2; 4,5 and 6,8) is requeried to strenght 80 mg (Test 80 mg vs Reference 80 mg)

But, I do not understand why is necessary to perform a BSC approach to others strength (Test 40 mg vs Reference 40 mg and Test 20 mg vs Reference 20 mg).

If, there is a biowaiver for strenght of 80 mg, I could make compare Test 80 mg vs Test 40 mg and Test 80 mg vs Test 20 mg, in an only pH condiction (for example: 4,5)?

BR
Ohlbe
★★★

France,
2019-07-22 23:58

@ Mauricio Sampaio
Posting: # 20431
Views: 532
 

 BSC approach at each strength?

Dear Mauricio,

» For example: three strength of 80 mg, 40 mg and 20 mg and the drug is class 1.

I'm absolutely not a specialist of dissolution testing and BCS... But my understanding is that you need to demonstrate the BCS classification not only for the active substance, but also for the formulation. If your 3 strengths have a different composition, you could theoretically have a slower or lower dissolution for a lower strength and not meet the criteria for class 1 at 20 mg even if the 80 mg formulation is class 1.

Regards
Ohlbe
Mauricio Sampaio
★    

Brazil,
2019-07-23 04:48

@ Ohlbe
Posting: # 20432
Views: 521
 

 BSC approach at each strength?

» If your 3 strengths have a different composition, »

Thank you dear Ohlbe.
But I'm assuming proportionally the same qualitative composition for each strength.
Mauricio Sampaio
★    

Brazil,
2019-07-26 15:32

@ Mauricio Sampaio
Posting: # 20444
Views: 428
 

 BCS approach at each strength?

Another question....

Is it possible establish a relation between linear pharmacokinetics and BCS test to choose the strength?

I know that questions are strange, but brazilian people are much more creative to create procedures. I received many questions about that and I would like to know your opnion.

I really appreciate any opinion
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