Title

Nondestructive Prediction of Drug Release from Tablets Using Near-Infrared Spectroscopy

Defense Date

11-28-2007

Graduation Date

Spring 1-1-2007

Availability

Campus Only

Submission Type

thesis

Degree Name

MS

Department

Pharmaceutics

School

School of Pharmacy

Committee Chair

James K. Drennen, III

Committee Member

Carl A. Anderson

Committee Member

Peter L. D. Wildfong

Committee Member

David A. Johnson

Keywords

chemometrics, near-infrared spectroscopy (NIR), pharmaceutics, process analytical technology (PAT, tablet disintegration, tablet dissolution

Abstract

The use of Process Analytical Technology (PAT) calls for rapid, accurate, and reliable sensors to detect physical and chemical variance in samples. Near-infrared spectroscopy has been the most popular PAT tool for these reasons. Tablet dissolution testing has been a quality control standard of practice for several years. Dissolution testing, however, is a time-consuming and labor-intensive experiment. In this study, NIR spectroscopy was evaluated as a potential replacement to traditional in vitro dissolution and disintegration testing as quality control methods. The percent dissolution efficiency (%DE), percent dissolved and disintegration time were predicted for tablets manufactured by direct compression, roll compaction, and wet granulation. Predictions were made by first correlating dissolution metrics to the spectral data by partial least squares regression. Prediction of %DE, percent dissolved, and disintegration times were successfully made with low root mean squared error and high R2 for tablets analyzed by reflectance and transmittance NIR.

Format

PDF

Language

English

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