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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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In vitro biphasic dissolution tests and their suitability for establishing in vitro-in vivo correlations: A historical review In vitro biphasic dissolution tests and their suitability for establishing in vitro-in vivo correlations: A historical review

This review provides an overview of the origin and the evolution over time of the biphasic systems and the growing interest among scientists regarding their suitability for establishing in vitro-in vivo correlations. The evolution of these systems and their applications from the 1960s to the present day, such as in system variants and improvements, analysis of complex formulations, discriminatory power, bio-relevance, precipitation and supersaturation visualization, etc.

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Biphasic dissolution method for quality control and assurance of drugs containing active substances in the form of weak acid salts Biphasic dissolution method for quality control and assurance of drugs containing active substances in the form of weak acid salts

Substances in the form of weak acid salts have been found to be problematic for dissolution testing. Their absorption can start only after they are turned into the form of an acid following the gastric passage although they were administered in the form of a salt. Due to poor solubility, they cannot be tested in acidic gastric environment for a biased dissolution profi le. The biphasic dissolution method is promising for overcoming this obstacle

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Developing Quantitative In Vitro-In Vivo Correlation for Fenofibrate Immediate-Release Formulations With the Biphasic Dissolution-Partition Test Method Developing Quantitative In Vitro-In Vivo Correlation for Fenofibrate Immediate-Release Formulations With the Biphasic Dissolution-Partition Test Method

This study is to evaluate 3 fenofibrate (FEN) formulations including Fournier®200mg capsule, Lipidil®145 mg tablet, and a clinical HME 160 mg tablet by an in vitro biphasic method. Key experimental parameters were evaluated including the selection of biorelevant media, the United States Pharmacopeia IV flow rate, and the United States Pharmacopeia paddle speed.

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Discriminatory Potential Of Biphasic Medium Over Compendial And Biorelevant Medium For Assessment Of Dissolution Behavior Of Tablets Containing Meloxicam Nanoparticles Discriminatory Potential Of Biphasic Medium Over Compendial And Biorelevant Medium For Assessment Of Dissolution Behavior Of Tablets Containing Meloxicam Nanoparticles

n this study, the nanoparticles of meloxicam were prepared using wet media milling and the milled samples were dried using spray drier. The dried nanoparticles were converted into tablet dosage form by varying the type of diluent. To one batch lactose was used and another one was containing dicalcium phosphate (DCP). The assessment of release of meloxicam from these two batches was evaluated in various dissolution media.

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Selection of a discriminant and biorelevant in vitro dissolution test for the development of fenofibrate self-emulsifying lipid-based formulations Selection of a discriminant and biorelevant in vitro dissolution test for the development of fenofibrate self-emulsifying lipid-based formulations

Fenofibrate, a BCS class II compound, has a low bioavailability especially when taken orally on an empty stomach. The challenge to find a new formulation for providing bioavailability, independent of food, is still ongoing.

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