baxivishal
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2009-07-06 17:49
(6201 d 00:09 ago)

Posting: # 3930
Views: 4,455
 

 leflunomide extended release [Bioanalytics]

Dear all

Since we are in process of conducting leflunomide study i would like to know whether leflunomide tablets are available in extended release.

Regards
Vishal baxi
Helmut
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Vienna, Austria,
2009-07-06 18:35
(6200 d 23:22 ago)

@ baxivishal
Posting: # 3931
Views: 3,606
 

 leflunomide extended release

Dear Vishal!

❝ [...] whether leflunomide tablets are available in extended release.


I don't think so.
Note: if you want to submit to the FDA, only the metabolite A77 1726 should be measured.

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drcampos
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Brazil,
2009-07-06 20:41
(6200 d 21:16 ago)

@ baxivishal
Posting: # 3933
Views: 3,882
 

 leflunomide extended release

Dear Vishal,

Leflunomide presents a half life of 11 days. Due to this long half life a modified release formulation is not necessary.

regards,

Daniel Rossi de Campos
Brazil
Helmut
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Vienna, Austria,
2009-07-06 20:51
(6200 d 21:06 ago)

@ drcampos
Posting: # 3934
Views: 3,594
 

 Reasonability of MR formulations

Dear Daniel!

❝ [...] Due this long half life a modified release formulation is not necessary.


Exactly. But not everything in the world of big pharma is driven by science. :angry: I once came across a drug, where the innovator got his first market authorization with a modified release formulation despite a half-live of two days. Obviously this was just done to make the life of generic companies miserable (it’s much more difficult to demonstrate BE of an MR formulation).

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drcampos
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Brazil,
2009-07-07 21:45
(6199 d 20:12 ago)

@ Helmut
Posting: # 3943
Views: 3,556
 

 Reasonability of MR formulations

Dear Helmut,

I really appreciate your comments. Thank you! :ok:

regards,

Daniel Rossi de Campos
Brazil
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