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chak ☆ 2007-12-17 12:07 (6771 d 06:51 ago) Posting: # 1386 Views: 4,526 |
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Dear all, This is regarding administration of Orally disintegrating tablet (ODT) in BE study. As per guideline ODT should disintegrates rapidly, usually within a matter of seconds (usually 30 second), when placed upon the tongue. In case the product does not disintegrates within the specified time or case where the reference product is disintegrating & test product does not, how do proceed for dosing. can we administer the tablet with water or can we instruct volunteers to suck the tablet and then swallow it. will this affect the PK ?? please share your view. chak |
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kasi ☆ 2007-12-21 09:16 (6767 d 09:42 ago) @ chak Posting: # 1411 Views: 3,762 |
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❝ As per guideline ODT should disintegrates rapidly, when placed upon the tongue. In case the product does not disintegrates within the specified time or case where the reference product is disintegrating & test product does not, how do proceed for dosing. Dear Chak, Usually, for rapid oral disintegrating tablets, it is advisable to disperse the tablet in protocol specified quantity of water/fluid and ask the volunteer/subject to consume the water with out spillage. If the difference between the disintegrating profiles of both Test & Reference is significantly high, then it is not advisable to use them to prove bioequivalence. Best Regards, Kasi — Regards, Raaz |
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chak ☆ 2007-12-21 16:52 (6767 d 02:05 ago) (edited on 2007-12-21 17:06) @ kasi Posting: # 1414 Views: 3,530 |
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Dear kasi, I am afraid you are misunderstanding the oral disintegrating tablets as dispersible tablet. Mr.helmut what is your view over this matter?? regards chak -- Edit: Full quote removed. Please see this post! [Ohlbe] |
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Virendra Patel ● 2007-12-26 15:10 (6762 d 03:48 ago) @ chak Posting: # 1425 Views: 3,647 |
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Dear Chak You are doing study on behalf of sponsor who develop the test product. You have to honestly follow the procedure and report to sponsor. You do not differentiate the procees of dosing subjectwise or formulation wise. If test product does not disinte....... do not worry it may happen based on the sponsor formulation properties. If it is happen with reference formulation than you have to worry. As per my experiance, you have to do the study with same procedure and report your data and your suggestion or observation during dosing to your sponsor for taking the decision. IF i am wrong, i am waiting for the correct answer from any one of the member group. Virendra Patel -- Edit: Full quote removed. Please see this post! [HS] |
Ing. Helmut Schütz