alexa Abstract | In Vitro-In Vivo Correlation Of Different Modified Release Formulations Of Theophylline

Indian Journal of Pharmaceutical Sciences
Open Access

OMICS International organises 3000+ Global Conferenceseries Events every year across USA, Europe & Asia with support from 1000 more scientific Societies and Publishes 700+ Open Access Journals which contains over 50000 eminent personalities, reputed scientists as editorial board members.

Open Access Journals gaining more Readers and Citations

700 Journals and 15,000,000 Readers Each Journal is getting 25,000+ Readers

This Readership is 10 times more when compared to other Subscription Journals (Source: Google Analytics)

Research Paper Open Access


Using the in vitro dissolution data and bioavailability data we present our results of in vitro-in vivo correlation of different modified release formulations of theophylline. As part of our ongoing study an experimental modified release capsule formulation, containing theophylline (200 mg)- loaded microspheres (Formulation F4), was developed, characterised and its in vitro and in vivo performance was then compared with that of the three market modified release formulations of theophylline (200 mg) - two tablets (Formulations F2 and F3) and one capsule (Formulation F1). Formulations F1, F2 and F3 were analysed to find out the best market sample with acceptable bioavailability. All the four formulations were evaluated for in vitro theophylline release using different dissolution test conditions. Pharmacokinetic evaluation of these formulations was carried out in six healthy volunteers and the parameters were established using non-compartmental analysis. In vitro-in vivo correlations were established from the generated dissolution and bioavailability data. In vitro studies indicated that only formulation F1 showed pH-dependent drug release while the other three formulations, including experimental formulation F4, showed almost condition-independent dissolution behaviour. The bioavailability studies indicated that amongst the market formulations (F1, F2, F3), formulations F1 and F2 were bioequivalent but F3 failed to demonstrate acceptable dissolution and bioavailability. Thus, switchability of formulation F3 for formulations F1 or F2 is questionable. A good correlation (R²=0.9986, slope=1.0614 and intercept= 0.1824, supporting Level A correlation) was observed for microsphere formulation, F4, under conditions of Test # 1. Although experimental formulation F4 showed acceptable dissolution behavior and bioavailability, it did not, however, exhibit bioequivalence with two other market samples, either F1 or F2. Dissoluton conditions of Test # 1 (dissolution medium, pH 1.2 simulated gastric fluid without pepsin for 1 h followed by pH 6 phosphate buffer for rest period) reflects highly significant correlation (R² > 0.98) with corresponding bioavailability for all the four formulations.

To read the full article Peer-reviewed Article PDF image

Author(s): C J Shishoo S S Savale S A Shah I S Rathod P K Mukherjee

Peer Reviewed Journals
Make the best use of Scientific Research and information from our 700 + peer reviewed, Open Access Journals
International Conferences 2017-18
Meet Inspiring Speakers and Experts at our 3000+ Global Annual Meetings

Contact Us

© 2008-2017 OMICS International - Open Access Publisher. Best viewed in Mozilla Firefox | Google Chrome | Above IE 7.0 version