Postural restriction [Design Issues]

posted by lakshmiprasad – India, 2018-03-23 06:50 (1400 d 13:40 ago) – Posting: # 18587
Views: 4,484

» […] the whole point of 4 hr restriction is to ensure that the pill/tablet has passed the stomach and into the intestines(Even with floating tablets i think 4hrs is more than enough).
» For night (meaning 10pm) dosing we usually do 2 hr restriction follow by lying down on the right side, or a 1 hr restriction follow by lying down on the right side.

Dear Sir,

thank your for your reply.

As per your above mentioned post, the statement state that, 02 or 01 hour postural restriction useful for floating the tablet. But considering the PK (absorption) point of view, for example drug cmax is 4 hours. if we kept 02 hours restriction. after 02 hours if subject will move that will impact on the absorption phase of drug. so better we need keep 04 hours and followed up to Tmax.

Now, My question is if Tmax 6 hours, we cant tell to subject follow the 6 hours postural restriction. But considering absorption phase it will be required. This cases what wee need to do.

Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5[Helmut]

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