pash413
★    

India,
2015-01-09 15:53
(3366 d 03:30 ago)

Posting: # 14266
Views: 3,002
 

 Chewable Tablet administration [Regulatives / Guidelines]

Dear all
Please let us know how to administer Chewable Tablet in USFDA BE study.
Product is OTC Chewable Tablet and label stats that "Chew the tablet"
Whether tablet should be chewed and swallowed without water or with water or Swallow as a whole
pravin17
★    

India,
2015-01-12 12:35
(3363 d 06:47 ago)

@ pash413
Posting: # 14270
Views: 2,447
 

 Chewable Tablet administration

Dear

Please refere OGD of that drug if not mentioned on OGD refer dosage administration section of prescribing information i.e. chew or swallow whole.

Pravin


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! [Helmut]
pash413
★    

India,
2015-01-13 07:46
(3362 d 11:37 ago)

@ pravin17
Posting: # 14274
Views: 2,320
 

 Chewable Tablet administration

In OGD guidance administration procedure is not mentioned.
Since it is OTC drug product label states that "Chew the tablet"
My question is whether we have to administer water/not after chewing the tablet and how much time required to chew the tablet??
pash413
★    

India,
2015-01-16 12:37
(3359 d 06:46 ago)

@ pash413
Posting: # 14297
Views: 2,457
 

 Chewable Tablet administration

Dear All
Kindly guide
Dr_Dan
★★  

Germany,
2015-01-16 13:08
(3359 d 06:15 ago)

@ pash413
Posting: # 14298
Views: 2,178
 

 Chewable Tablet administration

Dear pash413

If the reference medicinal product can be taken with or without water, bioequivalence should be demonstrated without water as this condition best resembles the intended use of the formulation. This is especially important if the substance may be dissolved and partly absorbed in the oral cavity. If bioequivalence is demonstrated when taken without water, bioequivalence when taken with water can be assumed. If bioequivalence between chewable test formulation taken without water and reference formulation with water is demonstrated in a 2-period study, bioequivalence of chewable taken with water can be assumed.

In studies evaluating chewable tablets without water, it is recommended to wet the mouth by swallowing 20 ml of water directly before applying the chewable tablet on the tongue. It is recommended not to allow fluid intake earlier than 1 hour after administration.

I hope this helps
Kind regards
Dr_Dan

Kind regards and have a nice day
Dr_Dan
UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
86 visitors (0 registered, 86 guests [including 8 identified bots]).
Forum time: 19:23 CET (Europe/Vienna)

Nothing shows a lack of mathematical education more
than an overly precise calculation.    Carl Friedrich Gauß

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