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Phosphate buffer interferes dissolution of prazosin hydrochloride in compendial dissolution testing
Drug Metabolism and Pharmacokinetics, 2023The purpose of this study was to elucidate the lack of supersaturation behavior in the dissolution profile of prazosin hydrochloride (PRZ-HCl) in the compendial dissolution test. The equilibrium solubility was measured by a shake-flask method. Dissolution tests were performed by a compendial paddle method with a phosphate buffer solution (pH 6.8, 50 mM
Hiroshi, Sudaki +3 more
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Dynamic Dissolution: A Step Closer to Predictive Dissolution Testing?
Molecular Pharmaceutics, 2010The use of compendial dissolution techniques to characterize the performance of oral drug delivery systems is an established area of pharmaceutical science. However, compendial equipment is recognized as being limited in its ability to replicate the dynamic aspects of in vivo dissolution that are associated with dosage form transit through a rapidly ...
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Dissolution Apparatus with Multiple Testing Stations
Journal of Pharmaceutical Sciences, 1968An apparatus in which 20 dissolution tests may be conducted simultaneously is described. A single set of controls maintains the test conditions in all 20 dissolution vessels. Provisions have been made to sample automatically and simultaneously from each vessel at predetermined time intervals.
R A, Castello +4 more
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Dissolution testing of amorphous solid dispersions
International Journal of Pharmaceutics, 2013The main purpose of this study was to investigate the effect of different polymers, with varying physicochemical properties and molecular weight on the stability and dissolution of co-milled amorphous solid dispersions (ASDs) of piroxicam (PRX). The stability of amorphous PRX (aPRX) in ASDs was significantly improved by the polymers.
K, Kogermann +6 more
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Pharmaceutical Dissolution Testing
2005Historical Development of Dissolution Testing. Compendial Testing Equipment: Calibration, Qualification, and Sources of Error. Compendial Requirements of Dissolution Testing. The Role of Dissolution Testing in the Regulation of Pharmaceuticals: The FDA Perspective.
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New In Vitro Dissolution Test Apparatus
Journal of Pharmaceutical Sciences, 1979A new in vitro dissolution test apparatus was designed and evaluated. Compressed tablets of drugs representing different solubility characteristics were tested at various air pressures and compared to dissolution patterns of similar tablets by the Levy beaker and USP methods.
S S, Nasir, L O, Wilken, S M, Nasir
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2008
Dissolution can be defined as a process by which the drug substance in a formulation dissolves into solution. Although dissolution appears to be a simple process, developing a suitable dissolution test requires careful considerations of the physicochemical properties of the drug substance, excipients, dosage form designs, dissolution media, and other ...
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Dissolution can be defined as a process by which the drug substance in a formulation dissolves into solution. Although dissolution appears to be a simple process, developing a suitable dissolution test requires careful considerations of the physicochemical properties of the drug substance, excipients, dosage form designs, dissolution media, and other ...
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USP Dissolution Test II: Sigmoid Dissolution Profiles from Directly Compressed Tablets
Journal of Pharmaceutical Sciences, 1978The basic steps involved in the dissolution of a directly compressed tablet in a USP basket dissolution apparatus were examined via data generation. The proposed model explains why a dissolution curve can be sigmoid shaped and why the portion past the lag time has a log-linear undissolved mass versus time correlation.
J T, Carstensen +3 more
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Dissolution testing measures the rate and extent of drug release from pharmaceutical dosage forms. USP apparatus types 1-7 simulate in-vivo conditions with specific designs for various dosage forms, each requiring proper calibration and qualification.
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Third Generation Dissolution Testing: Dissolution as a Batch Phenomenon
Drug Information Journal, 1996This paper provides an historical review of dissolution testing conducted by US Pharmacopeia, Inc. (USP). Current USP initiatives are also covered, including those designed to move USP to where it wants to be five and 10 years from now. There will be a lot happening with dissolution testing in the next few years.
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