INTAC® maintains the efficacy of FDA-approved drugs without compromising safety and tolerability

 

Different approaches for a clinical trial program are possible for bringing ER / IR ADF products onto the market.

 

 

DISCOVER THE VERSATILITY OF INTAC®

 

 

 

 

Clinical trials validating INTAC® bioequivalence


In clinical trials, excellent congruence of the serum concentration time profiles are observed for INTAC® and conventional marketed IR and ER formulations.

 

Results of INTAC® IR bioavailability trial1

Results of INTAC® ER bioavailability bridging program2

Geometric mean concentrations of analgesic drug [ng/mL] versus time [h] following SD and MD oral administration of test and reference (n=44).

 

Conclusions:


a For some products post-marketing reports of difficulty in swallowing the tablets have been noted

 

References:
1. Stahlberg HJ, Brett M, Ossig J, Philipp AA, Schwier S. Bridging from conventional marketed immediate release formulations to new tamper resistant alternatives. Clinical poster. Grünenthal GmbH; Aachen, Germany.
2. Stahlberg HJ, Brett M, Galia E, Ossig J, Wenge B. Bridging from conventional marketed extended release formulations to new tamper resistant alternatives. Clinical poster. Grünenthal GmbH; Aachen, Germany.

 

INTAC®