lakshmiprasad
☆    

India,
2018-03-17 09:20
(1359 d 15:35 ago)

Posting: # 18563
Views: 5,142
 

 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 19:18
(1354 d 05:37 ago)

@ lakshmiprasad
Posting: # 18584
Views: 4,494
 

 Postural restriction

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 06:50
(1353 d 18:06 ago)

@ jag009
Posting: # 18587
Views: 4,460
 

 Postural restriction

» […] 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 09:38
(1353 d 15:17 ago)

@ lakshmiprasad
Posting: # 18588
Views: 4,423
 

 Postural restriction

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 11:14
(1353 d 13:42 ago)

(edited by Ohlbe on 2018-03-23 13:42)
@ Relaxation
Posting: # 18590
Views: 4,391
 

 Postural restriction

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 16:39
(1353 d 08:16 ago)

@ lakshmiprasad
Posting: # 18591
Views: 4,337
 

 Postural restriction

» 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 10:17
(1349 d 15:38 ago)

@ jag009
Posting: # 18597
Views: 4,242
 

 Postural restriction

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]
Activity
 Admin contact
21,786 posts in 4,557 threads, 1,548 registered users;
online 11 (1 registered, 10 guests [including 6 identified bots]).
Forum time: Monday 00:56 CET (Europe/Vienna)

The history of statistics is like a telephone directory:
the plot is boring, full of numbers and the cast is endless.    Stephen Senn

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5