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Dear All
Right now we are in process of developing dissolution method for Fulvestrant.
We have tried several buffers from pH 1 to 7 but failed to get full release
mainly because of precipitation issue At present we could get 50 % dissolution
profile using 1 % SLS as dissolution media.
It would be nice. if someone can help me with or suggest me any reference
available pertaining to dissolution medium/technique for fulvestrant.
Warm Regards
*****************
Bhupesh
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The following message was posted to: PharmPK
HI Bhupesh,
You can try following dissolution media
1. Increase the SLS concentration up to 2% it is acceptable to regulatory
agencies and increase the RPM and maintain the sink condition
2. Add some amount of bile salts
3. Biorelevant media like FaSSIF and FeSSIF as per USP
Regards
Ashok Meena
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hi,
I think why not try the form of ultrafine powder?
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hi,
I think why not try the form of ultrafine powder?
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The following message was posted to: PharmPK
HI Bhupesh,
You can try following dissolution media
1. Increase the SLS concentration up to 2% it is acceptable to regulatory
agencies and increase the RPM and maintain the sink condition
2. Add some amount of bile salts
3. Biorelevant media like FaSSIF and FeSSIF as per USP
Regards
Ashok Meena
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