Bioequivalence and Bioavailability Forum • Ambroxol Sustained Release 75 mg

MaggieSantos
☆

Portugal,
2016-10-28 20:16
(2735 d 19:49 ago)

Posting: # 16755
Views: 3,409

Ambroxol Sustained Release 75 mg [Design Issues]

Dear colleagues,

I have been asked to perform a bioequivalence study on ambroxol, sustained release formulations containing 75 mg. according to guideline a single dose fast study as well as a single dose fed may be applicable. The multiple dose study is also required due to accumulation, according to ambroxol half-life between 7 and 12 hours.

I would like to have inputs from experienced researchers in order to aware of any concerns related to this substance.

Kind Regards

DavidManteigas
★

Portugal,
2016-11-02 11:51
(2731 d 03:14 ago)

@ MaggieSantos
Posting: # 16764
Views: 2,677

Ambroxol Sustained Release 75 mg

Post reply

Hi Maggie,

Which guideline are you refering? EMA or FDA? Didn't find any product-specific guideline on ambroxol bioequivalence...

If you're refering to a more general guidance, FDA guideline for BE studies with pharmacokinetic endpoints states de following (section IV, D, 3):

For modified release products, we recommend the following studies: (1) a single-dose, fasting study comparing the highest strength of the test with the RLD, and (2) a single-dose fed BE study comparing the highest strength of the test with the RLD product. Because single-dose studies are considered more sensitive in addressing the primary question of BE (e.g., release of the drug substance from the drug product into the systemic circulation), multiple-dose studies are generally not recommended