Near infrared (NIR)-spectroscopy and in-vitro dissolution absorption system 2 (IDAS2) can help detect changes in the quality of generic drugs

Jiménez-Romero, Carlos and Simithy, Johayra and Severdia, Anthony and Álvarez, Daniel and Grosso, Manuel and Spivey, Nicole and Arias, Antonio and Solís, Pablo N. and Li, Jibin and Hidalgo, Ismael J. (2020) Near infrared (NIR)-spectroscopy and in-vitro dissolution absorption system 2 (IDAS2) can help detect changes in the quality of generic drugs. Drug Development and Industrial Pharmacy, 46 (1). pp. 1-33. ISSN 1520-5762

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Official URL: https://doi.org/10.1080/03639045.2019.1701004

Abstract

While Health authorities in Panama strive to increase generic drug use to contain the rising costs of medicines, there is still hesitation to embrace generic drugs. Thus, regulators and drug companies need to ensure the quality, safety and efficacy of generic drugs. One prevailing concern is the absence of control over lot-to-lot changes, which may impact consistent therapeutic performance. The objective of this work was to determine whether near-infrared spectroscopy (NIR) could detect product changes. Calibration models were built using reference (standard) tablets of two products: Virax® (200 mg acyclovir) and Amlopin® (5 mg amlodipine). Then, to assess the sensitivity of NIR to product changes we compared reference versus deliberately-modified formulations of these products. Comparisons were made using principal component analysis (PCA) and partial least squares-discriminant analysis (PLS-DA) of NIR spectra. Several modified lots were different from reference lots, and 3D score plots showed greater discrimination by PLS-DA than PCA. The Kth nearest neighbour scores (KNN) of the modified batches were used to classify formulations as identical or not identical versus the reference. In addition, the differences detected by NIR were correlated with different in vitro dissolution and/or permeation in the in vitro dissolution absorption system 2 (IDAS2): NIR and IDAS2 yielded the same difference rank-order of difference for the modified lots tested. This study suggests that NIR and IDAS2 can help detect lots of generic drugs that differ from the reference lots. This strategy may help regulatory agencies in developing countries to safeguard patients against changes in generic products.

Item Type:	Article
Uncontrolled Keywords:	Formulation; dissolution; permeability; near-infrared spectroscopy; IDAS2.A
Subjects:	R Medicine > R Medicine (General) R Medicine > RM Therapeutics. Pharmacology R Medicine > RZ Other systems of medicine
Depositing User:	Fergie Pineda
Date Deposited:	02 Nov 2023 03:33
Last Modified:	02 Nov 2023 03:33
URI:	http://up-rid.up.ac.pa/id/eprint/6893

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