Development and Evaluation of Fixed Dose Combination Orally Disintegrating Tablets of Antiretroviral Drugs for Pediatrics

Anjali Joshi

Defense Date

12-17-2012

Graduation Date

Spring 1-1-2013

Availability

Immediate Access

Submission Type

thesis

Degree Name

MS

Department

Pharmaceutics

School

School of Pharmacy

Committee Chair

Wilson Meng

Committee Member

Moji Adeyeye

Committee Member

Peter Wildfong

Committee Member

Aleem Gangjee

Keywords

Pharmaceutics, Pediatrics, Antiretroviral drugs

Abstract

The thesis work entails a bench-to-bedside translational research approach to the development of pediatric fixed dose combination of zidovudine/lamivudine/nevirapine (60/30/50mg) orally disintegrating tablets. A simple and cost-effective, direct compression method was used. Preformulation studies that included analytical and bio-analytical assay development, excipient selection and characterization of drug-excipient interaction for initial formulation were conducted. Response surface methodology was utilized to optimize the formulation in terms of disintegration time and crushing strength. Stable ODT tablet was developed with desired friability (< 1%), reasonable crushing strength, disintegration time (< 30sec) and other quality attributes such as potency and dissolution. An open label randomized two-way cross-over bioequivalence of the product (with approved IRBs), conducted in 24 healthy adult volunteers, indicated the product to be bioequivalent with the innovators. 90% C.I of the point estimates of PK parameters evaluated were in the range of 80-125% as specified by FDA.

Format

PDF

Language

English

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