ArticleAAPS PharmSciTech2026
Reverse Engineering of Branded Mesalamine Prolonged Release Granules for Synthesis of QTPP and FMEA: A Systematic Approach for Oral Complex Generic Product Development.
Article in AAPS PharmSciTech, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
1 citing paper in PubMed.
Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Reverse engineering (RE) of reference-listed drugs (RLD) plays a major role in developing cost- and time-effective, high-quality generic products for affordable therapies without compromising healthcare quality. The present study attempted to develop the RE protocol using Pentasa™- Mesalamine prolonged-release granules (PRGs) as a model drug product. RE of three different RLD lots was carried out using analytical techniques such as UV spectroscopy, moisture content using water activity and IR moisture balance, High Performance Liquid Chromatography - Reverse Phase (HPLC) for assay, Fourier-Transform Infrared spectroscopy (FT-IR), Raman Spectroscopy- 532 nm (RS- 532), Proton Nuclear Magnetic Resonance Spectroscopy - 500 MHz (NMR) for drug excipient compatibility/interaction studies, Optical and Scanning Electron Microscopy (SEM) for surface morphology, Raman Chemical Imaging (RCI) and Focal Plane Array-FTIR (FPA-FTIR) chemical imaging for drug and excipient distribution in intact granules, surface area and porosity by BET, thermal analysis by DSC, crystallinity using PXRD, metallic impurities using LC Inductively Coupled Plasma Mass Spectrometry (LC ICP-MS) and particle size by laser diffraction, Head Space Gas Chromatography-Mass spectrometry (HS GC-MS) for residual solvents, size exclusion chromatography for molecular weight determination of PVP and ethyl cellulose, texture analysis for deformation studies, packaging evaluation, and in vitro multimedia dissolution using validated USP method. The resulting data was useful in finalising qualitative and quantitative compositions, selecting the technical grade of excipients, understanding the innovator manufacturing process, establishing QTPP, FMEA, and packaging material selection. This work shall serve as a model protocol for RE of RLD formulation for developing complex generic products.
Indexed as
Identifiers
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.