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F1 and F2 values and dissolution profile [Dissolution / BCS / IVIVC]

posted by govardhanpillari - India, 2009-03-06 06:04  - Posting: # 3328
Views: 16,960

Dear Ace, HS, Daniel and ohlbe,

Thank you very much for your information.

My product is Hydroxychloroquine sulfate 200 mg tablets.. The dissolution data of US and EU are as follows,
Type : USP Type - II (paddle)
RPM   50, Temp: 37C
Medium : Purified water
Volume :  900 ml, 

S.No     time (min)    US RLD      EU RLD 
1            5           13          21
2           10           40          64
3           15           62          86
4           20           78          94
5           30           94          95
6           45           98          96
7           60           99          95

F1 value is 16.3
f2 value is 41.7


This drug may comes under BCS class III drug. Usally Invitro -Invivo correlation is only possible for BCS II and slightly for BCS IV drugs...

My question is, Does the invivo activity of these RLDs depend on dissolution? (it is highly soluble drug)...

Thanks & Regards,

Govardhan


Edit: Full quote removed. Please see this post, and here for instructions to construct simple tables in the forum. [Helmut]

Govardhan.P

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