Physiologically Based Biopharmaceutics Model of Vildagliptin Modified Release (MR) Tablets to Predict In Vivo Performance and Establish Clinically Relevant Dissolution Specifications
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DOI: 10.1208/s12249-022-02264-2
Abstract: The objective of the study was to predict pharmacokinetic (PK) and pharmacodynamic (PD) parameters of matrix-based modified release (MR) drug product of vildagliptin. Physiologically based biopharmaceutics modeling (PBBM) was developed using GastroPlus™ based on the… read more here.
Keywords: vildagliptin; dissolution specifications; drug product; modified release ... See more keywords
Dissolution Specifications for Ibuprofen Soft Gelatin Capsules: A Proposal
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DOI: 10.14227/dt300223p74
Abstract: USA. Analytical grade monobasic sodium phosphate, sodium hydroxide, potassium hydroxide, anhydrous ethanol, phosphoric acid, and methanol were acquired from J.T.Baker. Water was obtained from a Milli-Q Reference (Millipore-Merck) system. read more here.
Keywords: gelatin capsules; soft gelatin; dissolution specifications; specifications ibuprofen ... See more keywords
Developing Clinically Relevant Dissolution Specifications for Oral Drug Products—Industrial and Regulatory Perspectives
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DOI: 10.3390/pharmaceutics12010019
Abstract: A meeting that was organized by the Academy of Pharmaceutical Sciences Biopharmaceutics and Regulatory Sciences focus groups focused on the challenges of Developing Clinically Relevant Dissolution Specifications (CRDS) for Oral Drug Products. Industrial Scientists that… read more here.
Keywords: oral drug; relevant dissolution; dissolution specifications; clinically relevant ... See more keywords