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Development of a novel method utilising dissolution imaging for the measurement of swelling behaviour in hydrophilic matrices

This work for the first time aims at developing an appropriate testing imaging methodology using a surface dissolution imaging instrument (SDI2) for determining the swelling of whole compacts using hypromellose as a model hydrophilic matrix former.

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Studies on dissolution testing of the nifedipine gastrointestinal therapeutic system. I. Description of a two-phase in vitro dissolution test Studies on dissolution testing of the nifedipine gastrointestinal therapeutic system. I. Description of a two-phase in vitro dissolution test

The nifedipine gastrointestinal therapeutic system (GITS) incorporates a push–pull osmotic pump to release–in zero-order fashion–a finely-divided suspension of nifedipine, which must then undergo dissolution in the GI tract before the drug can be absorbed. Classical, differential (ALZA) and flow-through type dissolution methods adequately characterize the in vitro nifedipine suspension release rate from the nifedipine GITS: however, these methods fail to measure the in vitro dissolution rate of the suspended particles–a potentially significant shortcoming considering that nifedipine is poorly water-soluble

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Predicting in vivo absorption behavior of oral modified release dosage forms containing pH-dependent poorly soluble drugs using a novel pH-adjusted biphasic in vitro dissolution test Predicting in vivo absorption behavior of oral modified release dosage forms containing pH-dependent poorly soluble drugs using a novel pH-adjusted biphasic in vitro dissolution test

The focus of in vitro dissolution testing during early development of modified release (MR) formulations is to provide predictive estimates of drug release in respect to in vivo performance of a drug product. However, there are enormous challenges in MR drug development to establish proper dissolution conditions for a predictive test. To overcome limitations of dissolution testing at constant pH, a modified USP apparatus 2 was developed, combining biphasic dissolution with a pH-gradient in the aqueous dissolution medium

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Toward Biorelevant Dissolution: Application of a Biphasic Dissolution Model as a Discriminating Tool for HPMC Matrices Containing a Model BCS Class II Drug Toward Biorelevant Dissolution: Application of a Biphasic Dissolution Model as a Discriminating Tool for HPMC Matrices Containing a Model BCS Class II Drug

The potential of a biphasic dissolution system to assist with the analysis of controlled-release (CR), Biopharmaceutics Classification System (BCS) Class II pharmaceutical products has been investigated. Use of a biphasic dissolution medium (aqueous/octanol) provided sink conditions and afforded complete dissolution of nifedipine formulated in a CR matrix tablet while maintaining the dosage form in an aqueous environmen

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Overcoming sink limitations in dissolution testing:a review of traditional methods and the potential utility of biphasic systems Overcoming sink limitations in dissolution testing:a review of traditional methods and the potential utility of biphasic systems

The conventional dissolution test, particularly the USP apparatus I andII, remains an important tool in the armory of the pharmaceutical development sci-entist. For realistic dissolution characterization, sink conditions, where saturationsolubility of a drug in the dissolution medium is at least three times more than thedrug concentration, are critical

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Mechanistic analysis of solute transport in an in vitro physiological two-phase dissolution apparatus Mechanistic analysis of solute transport in an in vitro physiological two-phase dissolution apparatus

This paper presents the theory and derivation of our analysis, compares it with a recent kinetic approach, and demonstrates its effectiveness in predicting in vitro partitioning profiles of three BCS II weak acids in four different in vitro two-phase dissolution apparatuses. Very importantly, the paper discusses how a two-phase apparatus can be scaled to reflect in vivo absorption kinetics and for which drug substances the two-phase dissolution systems may be appropriate tools for measuring oral bioperformance

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In vivo predictive mini-scale dissolution for weak bases: Advantages of pH-shift in combination with an absorptive compartment In vivo predictive mini-scale dissolution for weak bases: Advantages of pH-shift in combination with an absorptive compartment

The purpose was the evaluation of a new miniscale biphasic dissolution model with pH-shift (miBIdi-pH). Its capability to predict supersaturation and precipitation of weak bases (e.g. dipyridamole) and the in vivo performance of various formulations of the model compound BIXX (weak base, poor solubility, good permeability) was investigated with respect to dissolution, precipitation and re-dissolution.

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Evaluation of a biphasic in vitro dissolution test for estimating the bioavailability of carbamazepine polymorphic forms Evaluation of a biphasic in vitro dissolution test for estimating the bioavailability of carbamazepine polymorphic forms Login
Development of a discriminative biphasic in vitro dissolution test and correlation with in vivo pharmacokinetic studies for differently formulated racecadotril granules Development of a discriminative biphasic in vitro dissolution test and correlation with in vivo pharmacokinetic studies for differently formulated racecadotril granules

The purpose of this study was to discriminate the release behavior from three differently formulated racecadotril (BCS II) granules and to establish an in vitro-in vivo correlation. Three granule formulations of the lipophilic drug were prepared with equivalent composition but prepared with different manufacturing processes (dry granulation, wet granulation with or without binder). In vitro release of the three granules was investigated using a biphasic dissolution system (phosphate buffer pH 6.8 and octanol) and compared to the conventional single phase USP II dissolution test performed under sink and non-sink conditions

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Development of a biphasic dissolution test for Deferasirox dispersible tablets and its application in establishing an in vitro-in vivo correlation Development of a biphasic dissolution test for Deferasirox dispersible tablets and its application in establishing an in vitro-in vivo correlation

In a biphasic dissolution medium, the integration of the in vitro dissolution of a drug in an aqueous phase and its subsequent partitioning into an organic phase is hypothesized to simulate the in vivo drug absorption. Such a methodology is expected to improve the probability of achieving a successful in vitro–in vivo correlation

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