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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 FournierĀ®200mg capsule, LipidilĀ®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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Dissolution of poorly water-soluble drugs in biphasic media using USP 4 and fiber optic system Dissolution of poorly water-soluble drugs in biphasic media using USP 4 and fiber optic system

A novel in-vitro dissolution system based on the principle of flow-through technique has been designed to evaluate the in-vitro release rate of poorly water-soluble compounds. The flow through apparatus (USP 4) has been coupled with the compendial dissolution apparatus (USP apparatus 2). A bi-phasic dissolution medium is used to achieve sink conditions.

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Evolution of a mini-scale biphasic dissolution model: Impact of model parameters on partitioning of dissolved API and modelling of in vivo-relevant kinetics Evolution of a mini-scale biphasic dissolution model: Impact of model parameters on partitioning of dissolved API and modelling of in vivo-relevant kinetics

Biphasic dissolution models are proposed to have good predictive power for the in vivo absorption. The aim of this study was to improve our previously introduced mini-scale dissolution model to mimic in vivo situations more realistically and to increase the robustness of the experimental model.

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Supersaturation, nucleation, and crystal growth during single- and biphasic dissolution of amorphous solid dispersions: Polymer effects and implications for oral bioavailability enhancement of poorly water soluble drugs Supersaturation, nucleation, and crystal growth during single- and biphasic dissolution of amorphous solid dispersions: Polymer effects and implications for oral bioavailability enhancement of poorly water soluble drugs

The influence of polymers on the dissolution, supersaturation, crystallization, and partitioning of poorly water soluble compounds in biphasic media was evaluated. Amorphous solid dispersions (ASDs) containing felodipine (FLD) and itraconazole (ITZ) were prepared by hot melt mixing (HMM) using various polymers. The ASDs were analyzed using powder X-ray diffraction (PXRD), differential scanning calorimetry (DSC), and HPLC

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Insight into the Development of Dissolution Media for BCS Class II Drugs: A Review from Quality Control and Prediction of In Vivo Performance Perspectives Insight into the Development of Dissolution Media for BCS Class II Drugs: A Review from Quality Control and Prediction of In Vivo Performance Perspectives

To assess in vivo behavior through in vitro method, the dissolution test is mostly used, both for quality control (QC) and for development purpose. In view of the fact that a dissolution test can hardly achieve two goals at the same time, the design of dissolution testing generally varies along with the development stage of drug products and therefore the selection of dissolution media may change with the goals of the dissolution test.

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Application of a Biphasic Test for Characterization of In Vitro Drug Release of Immediate Release Formulations of Celecoxib and Its Relevance to In Vivo Absorption Application of a Biphasic Test for Characterization of In Vitro Drug Release of Immediate Release Formulations of Celecoxib and Its Relevance to In Vivo Absorption

A biphasic in vitro test method was used to examine release profiles of a poorly soluble model drug, celecoxib (CEB), from its immediate release formulations. Three formulations of CEB were investigated in this study, including a commercial Celebrex capsule, a solution formulation (containing cosolvent and surfactant) and a supersaturatable self-emulsifying drug delivery system (S-SEDDS). The biphasic test system consisted of an aqueous buffer and a water-immiscible organic solvent (e.g., octanol) with the use of both USP II and IV apparatuses.

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