Small differences in acidic pH condition significantly affect dissolution equivalence between drug products of acidic drug salt
Sign Up to like & getrecommendations! Published in 2021 at "Journal of Drug Delivery Science and Technology"
DOI: 10.1016/j.jddst.2021.102546
Abstract: Abstract The dissolution profile of a drug product in the stomach has been assessed by an in vitro dissolution test using a single acidic pH condition (typically pH 1.2). However, there are inter- and intra-individual… read more here.
Keywords: drug products; drug; dissolution test; dissolution ... See more keywords
In Vitro Predictive Dissolution Test Should Be Developed and Recommended as a Bioequivalence Standard for the Immediate-Release Solid Oral Dosage Forms of the Highly Variable Mycophenolate Mofetil.
Sign Up to like & getrecommendations! Published in 2022 at "Molecular pharmaceutics"
DOI: 10.1021/acs.molpharmaceut.1c00792
Abstract: The prodrug mycophenolate mofetil (MMF), which is presystemically hydrolyzed into the pharmacologically active compound mycophenolic acid (MPA), has been widely used for the prophylaxis of acute allograft rejection in solid organ transplantation. However, the huge… read more here.
Keywords: dissolution test; dissolution; variability; highly variable ... See more keywords
Development of In Vivo Predictive pH-Gradient Biphasic Dissolution Test for Weakly Basic Drugs: Optimization by Orthogonal Design
Sign Up to like & getrecommendations! Published in 2021 at "Dissolution Technologies"
DOI: 10.14227/dt280321p24
Abstract: The aim of this study was to develop a method for set up and optimization of a pH-gradient biphasic dissolution model by orthogonal test design in light of the correlation with published in vivo data… read more here.
Keywords: biphasic dissolution; dissolution test; dissolution; test ... See more keywords
Development of a Discriminative and Biorelevant Dissolution Test Method for Atorvastatin/Fenofibrate Combination with Appliance of Derivative Spectrophotometry
Sign Up to like & getrecommendations! Published in 2019 at "Turkish Journal of Pharmaceutical Sciences"
DOI: 10.4274/tjps.77698
Abstract: Objectives: Nowadays, the market is flooded with combinations of drugs in various dosage forms, but there is a lack of official methods to quantify them. A single dissolution test method for the analysis of combined… read more here.
Keywords: atorvastatin fenofibrate; dissolution test; method; test method ... See more keywords