vivekanand
☆    

India,
2012-11-16 12:16
(4150 d 02:43 ago)

Posting: # 9538
Views: 5,520
 

 Difference between tablet and film tablet [Regulatives / Guidelines]

Dear All

I have two questions

1. What is the difference between tablet and film tablet/MR film tablet.

What is the impact in obtaining the consent form healthy volunteers in a BA/BE study when study information consent(ICF/ICD) cpatured drug name xxxx tablet, where as in product IP name mentioned as XXXXX film tablet or XXXXX MR film tablet.

2. In general for any BA/BE studies once IPs are received at the clinical site/CRO from sponsor and found if any discrepancy in receipt of IPs the same shall be informed to sponsor.

whether dispensing of drugs can be proceeded before receiving/closure of IP discrepancies from sponsor end.

Regards
G.Balavivekanand
ElMaestro
★★★

Denmark,
2012-11-16 14:24
(4150 d 00:35 ago)

@ vivekanand
Posting: # 9540
Views: 4,700
 

 Difference between tablet and film tablet

Hello Vivekanand,

❝ 1. What is the difference between tablet and film tablet/MR film tablet.


If a tablet is not modified release then I will assume it is immediate release. The difference is then largely time to drug release. Film tablet (film coated tablet) can mean any of the two categories. The film may be one that just makes it easier to swallow the tablet, or it may be a film that controls drug release, typically gastro-resistant film coating.

❝ What is the impact in obtaining the consent form healthy volunteers in a BA/BE study when study information consent(ICF/ICD) cpatured drug name xxxx tablet, where as in product IP name mentioned as XXXXX film tablet or XXXXX MR film tablet.


If the subjects have been informed that they are only going to be administered XXX, then you cannot dose both XXX and YYY. At the end it comes down to wording which has to be accurate and specific. If the wording leaves any room for misinterpretation of what the subjects get when and how and why then the consent can be argued not to be 'informed'.

❝ 2. In general for any BA/BE studies once IPs are received at the clinical site/CRO from sponsor and found if any discrepancy in receipt of IPs the same shall be informed to sponsor.


❝ whether dispensing of drugs can be proceeded before receiving/closure of IP discrepancies from sponsor end.


If there is a discrepancy your pharmacist can impound the IMP until things have been sorted. Some discrepancies may be of less serious nature than others. If the CoA says the tablets are "Amoxycillin BogusPharma" and the label/box/blister says "Amoxicillin BogusPharma" then I would worry less than if the CoA identifies the tablets as white round in a situation where you received pink ovals. But all things are relative, they say. What type of discrepancy are we talking about here?

Pass or fail!
ElMaestro
wienui
★    

Germany/Oman,
2015-11-24 19:46
(3046 d 19:13 ago)

(edited by wienui on 2015-11-25 15:14)
@ ElMaestro
Posting: # 15667
Views: 3,288
 

 Difference between tablet and film tablet

Dear ElMaestro,

I have a question regarding to the Bioequivalence (BE) Study of IR tablets vs IR Film coated (F.C.) tablets.

If the BE study is done for the IR Tablets formulation and the manufacture want to register the IR Film coated tablets formulation, should he need to conduct a new BE study for this formulation?
What I think is that the Pk behaviour for the two formulations (especially the absorption process) will be totally different which could definitely different consequences of therapeutic effect. Please correct me if I'm wrong.
Best regards,
O. A

Cheers,
Osama
ElMaestro
★★★

Denmark,
2015-11-24 23:01
(3046 d 15:58 ago)

@ wienui
Posting: # 15669
Views: 3,299
 

 Difference between tablet and film tablet

Hi wienui,

❝ I have a question regarding to the Bioequivalence (BE) study of IR tablets vs IR Film coated (F.C.) tablets.


❝ if the BE study is done for the IR Tablets formulation and the manufacture want to register the IR Film coated tablets formulation, should he need to conduct a new BE study for this formulation?

❝ what I think is that the Pk behaviour for the two formulations ( especially the absorption process) will be totally different which could definitely different consequences of therapeutic effect. Please correct me if I'm wrong.


Since a film coat usually does not modify the release, this might be a situation where you can argue to use just dissolution. Show that the fc tablets behave like the ordinary tablet.

Pass or fail!
ElMaestro
AngusMcLean
★★  

USA,
2015-12-03 04:25
(3038 d 10:33 ago)

@ ElMaestro
Posting: # 15690
Views: 3,016
 

 Difference between tablet and film tablet

I think for a Class 1 drug the both IR formulations can be approved by dissolution similarity.
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