Bioequivalence and Bioavailability Forum • Postural restriction

lakshmiprasad
☆

India,
2018-03-17 10:20
(2616 d 10:01 ago)

Posting: # 18563
Views: 6,688

Postural restriction [Design Issues]

Hi,

Good afternoon to all,

Please any one help to me on below mentioned.

I would like to know about the postural restriction of subjects after dosing. I have doubt on supine postural restriction.

Ex:

Generally Whenever i was wrote the protocol, based on product prescribed information i will make it the postural restriction 02 hours or 04 hours (based on the molecule Tmax i.e., 2, 4) supine position in case molecule will be created the somnolence.

Now my doubt is if molecule Tmax is 6 or 8 hours. Then can I keep up to 06 or 08 hours supine position postural restriction....

Please guide me...

Thanks & regards

N. L. D. Prasad

Edit: Category changed; see also this post #1. [Helmut]

jag009 ★★★ NJ, 2018-03-22 20:18 (2611 d 00:02 ago) @ lakshmiprasad Posting: # 18584 Views: 5,751	Postural restriction Post reply
	Correct me if I am wrong but 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. J

lakshmiprasad
☆

India,
2018-03-23 07:50
(2610 d 12:31 ago)

@ jag009
Posting: # 18587
Views: 5,698

Postural restriction

Post reply

❝ […] 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]

Relaxation
★

Germany,
2018-03-23 10:38
(2610 d 09:42 ago)

@ lakshmiprasad
Posting: # 18588
Views: 5,724

Postural restriction

Post reply

Dear Lakshmi.

Just a short comment on the whole procedure.

❝ postural restriction useful for floating the tablet.

To me that is the whole point: getting the tablet out of the stomach in a standardized way. And by the way, well,there is not much to float on in a fasted stomach.

❝ But considering the PK (absorption) point of view,

I do not believe that the absorption/PK of the drug compound is of relevance. See, under fasted conditions gastric emptying of a dosage form is somewhat variabel. I have seen tablets passing through the gaster within seconds as well as taking it easy and remaining for hours in the fundus.
Most people live well by assuming that on average there will be a cleansing movement forcing the tablet from the stomach within not more than 90 minutes. This is roughly 2 hours (we are pharmacists not mathematicians ;-)

), double to be on the safe side.

So to me its physiology we need to handle and not pharmacokinetics here.

Best regards,

Relaxation.

lakshmiprasad ☆ India, 2018-03-23 12:14 (2610 d 08:07 ago) (edited on 2018-03-23 13:42) @ Relaxation Posting: # 18590 Views: 5,666	Postural restriction Post reply
	OK, Thank you very much...... 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! [Ohlbe]

jag009
★★★

NJ,
2018-03-23 17:39
(2610 d 02:41 ago)

@ lakshmiprasad
Posting: # 18591
Views: 5,602

Postural restriction

Post 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.

Note that my previous reply is for night dosing (10pm). We were dosing chrono-technology drug which Tmax at 6 hours and designed to be given at night. You can't ask the subject to restrict his posture throughout the night.

❝ 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.

Yes and no. If you go by Tmax alone then it's kind of a flaw logic. An example drug is COVERA HS which as a Tmax of 11 hours. Are you going to ask the subjects to follow a 11 hour postural restriction?

J

lakshmiprasad ☆ India, 2018-03-27 12:17 (2606 d 09:04 ago) @ jag009 Posting: # 18597 Views: 5,497	Postural restriction Post reply
	OK sir, I understood the whole procedure Now. Thank you very much... 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]