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RegisterBCS III Classification [Dissolution / BCS / IVIVC]
Dear All,
I have a question concerning the criterion for classification of a pharmaceutical product as Class III. Some text would say there are two criteria namely: High Solubility and Low Permeability. However some other text would add a third criterion: Very Rapid Dissolution.
Which is correct? If the later is correct, then where do we classify a product with High Solubility, Low Permeability and Rapid Dissolution (ie 85% of the API does not go into solution within 15 minutes but will within 30 minutes or even beyond)?
Similarly, for BCS class I, must all products under this class be Rapidly Dissolving? If so, then how do we classify a product that's Highly Soluble, Highly Permeable and Moderately Dissolving (85% of API dissolves beyond 30 minutes across all physiologic pH.
Regards
I have a question concerning the criterion for classification of a pharmaceutical product as Class III. Some text would say there are two criteria namely: High Solubility and Low Permeability. However some other text would add a third criterion: Very Rapid Dissolution.
Which is correct? If the later is correct, then where do we classify a product with High Solubility, Low Permeability and Rapid Dissolution (ie 85% of the API does not go into solution within 15 minutes but will within 30 minutes or even beyond)?
Similarly, for BCS class I, must all products under this class be Rapidly Dissolving? If so, then how do we classify a product that's Highly Soluble, Highly Permeable and Moderately Dissolving (85% of API dissolves beyond 30 minutes across all physiologic pH.
Regards
—
Scopy
Scopy
Complete thread:
- BCS III ClassificationObinoscopy 2018-04-20 08:09 [Dissolution / BCS / IVIVC]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BCS-based biowaivers for Class III Helmut 2018-04-20 12:15
- BCS-based biowaivers for Class III Obinoscopy 2018-04-20 16:06
- BCS-based biowaivers for Class III The Outlaw Torn 2018-06-21 09:48
- BCS-based biowaivers for Class III nobody 2018-06-21 10:33
- BCS-based biowaivers for Class III The Outlaw Torn 2018-06-21 12:11
- BCS-based biowaivers for Class III: Syrups Helmut 2018-06-21 12:21
- BCS-based biowaivers for Class III: Syrups The Outlaw Torn 2018-06-21 12:47
- BE of solutions Helmut 2018-06-21 13:33
- BE of solutions The Outlaw Torn 2018-06-21 13:39
- BE of solutions The Outlaw Torn 2018-06-27 15:22
- Solutions (T) vs Tablets (R) or Vice Versa= Invivo BE Study Obinoscopy 2018-07-01 02:06
- Solutions (T) vs Tablets (R) or Vice Versa= Invivo BE Study The Outlaw Torn 2018-07-03 15:02
- Reversed procedure? Helmut 2018-07-03 15:33
- Reversed procedure? The Outlaw Torn 2018-07-04 11:50
- BioBridges Helmut 2018-07-04 12:03
- Reversed procedure? The Outlaw Torn 2018-07-04 11:50
- Reversed procedure? Helmut 2018-07-03 15:33
- Solutions (T) vs Tablets (R) or Vice Versa= Invivo BE Study The Outlaw Torn 2018-07-03 15:02
- Solutions (T) vs Tablets (R) or Vice Versa= Invivo BE Study Obinoscopy 2018-07-01 02:06
- BE of solutions Helmut 2018-06-21 13:33
- BCS-based biowaivers for Class III: Syrups The Outlaw Torn 2018-06-21 12:47
- BCS-based biowaivers for Class III nobody 2018-06-21 10:33
- BCS-based biowaivers for Class III Helmut 2018-04-20 12:15
Ing. Helmut Schütz