Monitoring Oral Solid Dosage Forms Quality by NIR Spectroscopy and IDAS2

Johayra Simithy1, Carlos Jiménez-Romero1, Anthony Severdia2, Daniel Álvarez3, Manuel Grosso1, Antonio Arias1,
Nicole Spivey2, Jibin Li2,  Pablo N. Solís3, and Ismael J. Hidalgo1,2
1Absorption Systems Panama, Inc, Panama City, Panama; 2Absorption Systems LP, Exton, Pennsylvania, USA; 3Laboratorios MEDIPAN S.A., Panama City, Panama

This poster was presented at CRS, July 2019

Regulatory agencies in developing countries often struggle to assure the quality, safety and efficacy of drugs and one concern is that unreported changes in formulation excipients or manufacturing processes can alter product performance. The present work proposed an analytical strategy for distinguishing between standard (reference) and modified oral solid dosage forms for two drugs: acyclovir and amlodipine, through the combined use of near-infrared (NIR) spectroscopy and chemometrics, as a first step towards the development of approaches to identify lot-to-lot changes of registered products; followed by evaluating in vitro dissolution and permeation of drug dosage forms using a newly developed in vitro dissolution absorption system (IDAS2). For this purpose, tablets of acyclovir 400 mg (Virax®) and amlodipine 5 mg (Amlopin®) with deliberate modifications in the percentage of active pharmaceutical ingredient (API) or the individual excipients were manufactured.