Scholarlink

<p>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&#xa0;nm (RS- 532), Proton Nuclear Magnetic Resonance Spectroscopy – 500&#xa0;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 <i>in vitro</i> 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.</p> Graphical Abstract <p></p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Reverse Engineering of Branded Mesalamine Prolonged Release Granules for Synthesis of QTPP and FMEA: A Systematic Approach for Oral Complex Generic Product Development

  • 期刊论文

  • 发表日期：

    2026年2月23日

查看全文
  • Sadhana Dhyagala,
  • Ankit Kumar,
  • Prakash Kumar Sirvi,
  • Sakshi Kunjir,
  • Ayush Rohila,
  • Rajkumar Malayandi

摘要

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.

Graphical Abstract