Bioequivalence and Bioavailability Forum • F1 and F2 values and dissolution profile

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

posted by govardhanpillari – India, 2009-03-06 07:04 (6320 d 23:11 ago) – Posting: # 3328
Views: 31,819

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

Complete thread:

F1 and F2 values and dissolution profile govardhanpillari 2009-03-04 12:30
- F1 and F2 values and dissolution profile drcampos 2009-03-04 13:51
- F1 and F2 values and dissolution profile Aceto81 2009-03-05 12:30
  - F1 and F2 values and dissolution profile Helmut 2009-03-05 14:01
  - F1 and F2 values and dissolution profilegovardhanpillari 2009-03-06 06:04
    - F1 and F2 values and dissolution profile drcampos 2009-03-06 14:31
      - F1 and F2 values and dissolution profile govardhanpillari 2009-03-07 05:47
- US RLD / European reference Helmut 2009-03-05 14:15
  - European reference Ohlbe 2009-03-05 19:09
- F1 and F2 values and dissolution profile jayeshd 2010-04-17 08:58
  - EU + US Ohlbe 2010-04-17 20:19
  - F1 and F2 values and dissolution profile Dr_Dan 2010-04-19 14:51