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mvgchakravarthi ☆ India, 2009-09-10 09:35 (6124 d 22:59 ago) Posting: # 4181 Views: 6,274 |
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Dear All kindly requesting you to give suggestion for following question Is it possible to develop Descriminatory dissolution for BCS Class I (High solubility and High permeability) type drug, kindly clarify? Thanks M.V.G.Chakravarthi |
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kaushalesh ☆ 2009-09-18 12:08 (6116 d 20:27 ago) @ mvgchakravarthi Posting: # 4214 Views: 4,917 |
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❝ Is it possible to develop Descriminatory dissolution for BCS Class I (High solubility and High permeability) type drug, kindly clarify? Dear Chakravarthy As far as IVIVC is concerned it is most feasible for BCS class II drugs, and it is highly unlikely for BCS class I drugs. For the discriminatory media, I think that is formulation specific and has to be developed on case by case basis. further clarification from the forum is most welcome. Regards Kaushalesh  |
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PG ☆ 2009-09-18 23:30 (6116 d 09:05 ago) @ mvgchakravarthi Posting: # 4219 Views: 4,827 |
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Dear Mr.Chakravarthi, It is possible, you can get dissolution done at lower RPM for Test and Reference. EX: Ur Release media is Purified Water at 50 RPM. U have data in all four media but no discrimination observed. Then in that case get the data generated at 30 RPM in only that media where u have proper profiling. We had the same problem, but this gave the answer for sample selection in BE study. Interestingly, Pivotal BE passed. Also, as per my understanding, we generate discrimination for PDR to justify, if at all there is any lack of excipient in formulation, then dissolution media should be robust in detecting... which is known as discrimination. This is still debatable... Regards, PG -- Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe] Edit: Please no SMS-style! [Helmut] |
Ing. Helmut Schütz