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A-M-R

Egypt,
2013-02-04 08:34

Posting: # 9954
 

sublingual tablets [Regulatives / Guidelines]

Request

The necessity to do bioequivalence study for sublingual tablets especially isosorbid dinitrate 5mg tablets as it is totally absorbed from oromucosal cavity
very thanks
Amr hussein
The Outlaw Torn

Europe,
2013-02-04 08:52

@ A-M-R
Posting: # 9956
 

sublingual tablets

» The necessity to do bioequivalence study for sublingual tablets especially isosorbid dinitrate 5mg tablets as it is totally absorbed from oromucosal cavity

Hi Amr,

If you are considering an EU submission, this is what the EMA guideline says: Other oral formulations such as orodispersible films, buccal tablets or films, sublingual tablets and chewable tablets may be handled in a similar way as for ODTs. Bioequivalence studies should be conducted according to the recommended use of the product.

And, sublingual tablets are not eligible for a BCS-based biowaiver (even if isosorbid dinitrate was highly soluble, highly permeable).

It appears you would need to conduct a bioequivalence study if submitting to the EU.

Torn
drgunasakaran1

Chennai, India,
2013-02-06 08:40

@ A-M-R
Posting: # 9972
 

sublingual tablets

Dear Mr Amr Hussein,

» The necessity to do bioequivalence study for sublingual tablets especially isosorbid dinitrate 5mg tablets as it is totally absorbed from oromucosal cavity

Even FDA recommends to do Bioequivalence study for ANDA submission of Isosorbide dinitrate sublingual tablets.

Reference: FDA Docket No. 77N-0240; DESI 1786

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