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Ken Peh ★ Malaysia, 2014-10-26 18:18 (4252 d 14:35 ago) Posting: # 13804 Views: 7,392 |
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Dear Members, Is it essential to look at the effect of bile salt and enzymes on a product dissolution profile before carrying out fed BE study on the product ? Is it sufficient to look only at the effect of enzymes using simulated gastric fluid and intestinal fluid test solutions given in USP for dissolution study ? Your feedback is highly appreciated. Thank you. Regards, Ken |
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Dr_Dan ★★ Germany, 2014-10-29 09:47 (4249 d 23:06 ago) @ Ken Peh Posting: # 13812 Views: 5,841 |
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Dear Ken Looking at the effect of bile salt and enzymes on a product dissolution profile will give you an idea how similar your formulation is in comparison with the originator in vitro, not less and not more. It is up to you to decide whether your formulation could be suitable for an in vivo comparison. In the event that the results of comparative in vitro dissolution of the biobatches do not reflect bioequivalence as demonstrated in vivo the latter prevails. For a more detailed answer you should provide more Information, e.g. IR or MR formulation, BCS class of the drug etc. Kind regards Dr_Dan — Kind regards and have a nice day Dr_Dan |
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Ken Peh ★ Malaysia, 2014-11-01 06:05 (4247 d 02:48 ago) @ Dr_Dan Posting: # 13817 Views: 5,610 |
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Dear Dr Dan, The product is enteric coated pantoprazole tablets. Need to carry out fasted and fed BE studies. There are in-vitro dissolution methods proposed to simulate fasted and fed conditions. We would like to know how extensive we should run the in-vitro dissolution studies. Your kind comment on this matter is highly appreciated. Thank you. Regards, Ken |
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