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Solid Dispersion
Preparation and Evaluation of Berberine-Excipient Complexes in Enhancing the Dissolution Rate of…
Berberine is used in the treatment of metabolic syndrome and its low solubility and very poor oral bioavailability of berberine was one of the primary hurdles for its market approval. This study aimed to improve the solubility and bioavailability of berberine by preparing pellet formulations…
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Quantification of Soluplus for Dissolution Tests: SEC Method Development and Validation
The quantification of both polymer and drug during the dissolution of an amorphous solid dispersion (ASD) in aqueous media arouses great interest and may aid in the formulation. However, the available quantification methods for polymer excipients are limited, expensive, and challenging compared to…
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Nucleotides as new co-formers in co-amorphous systems: Enhanced dissolution rate, water solubility…
Abstract
Developing co-amorphous systems is an attractive strategy to improve the dissolution rate of poorly water-soluble drugs. Various co-formers have been investigated. However, previous studies revealed that it is a challenge to develop satisfied acidic co-formers, e.g., acidic amino acids…
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An emerging terpolymeric nanoparticle pore former as an internal recrystallization inhibitor of…
Solid oral controlled release formulations feature numerous clinical advantages for drug candidates with adequate solubility and dissolution rate. However, most new chemical entities exhibit poor water solubility, and hence are exempt from such benefits. Although combining drug amorphization with…
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Using Βeta-cyclodextrin and Plasdone K-30 Polymers for Enhancing Drug Solubility by Spray Drying
Abstract
The purpose of this study was to investigate improving solubility using hydrophilic/water-soluble polymers as β-Cyclodextrin and Plasdone K-30 in a solid dispersion formulation of Carvedilol a poorly soluble drug. The developed solid dispersion consisted of two components, a drug…
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Synergistic effect of polymers in stabilizing amorphous pretomanid through high drug loaded…
Pretomanid (PTM), an oral antibiotic used in the treatment of adults with pulmonary extensively drug-resistant, nonresponsive multidrug-resistant tuberculosis (MDR-TB). It is a poor glass former, that shows high recrystallization tendency from the amorphous and supersaturated state, resulting in low…
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Data-Driven Modeling of the Spray Drying Process. Process Monitoring and Prediction of the Particle…
Abstract
Spray drying is used in the pharmaceutical industry for particle engineering of amorphous solid dispersions (ASDs). The particle size of the spray-dried (SD) powders is one of their key attributes due to its impact on the downstream processes and the drug product’s functional properties.…
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Systematic Development of Hot Melt Extrusion-Based Amorphous Solid Dispersion: Integrating Quality…
Abstract
Purpose
The study aimed to develop and optimize apremilast (APST) solid dispersion formulations using copovidone (Kollidon VA64) as the carrier and vitamin E TPGS as the surfactant to enhance solubility and dissolution, and to utilize in silico Physiologically Based Biopharmaceutics…
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Impact of Methods of Preparation on Mechanical Properties, Dissolution Behavior, and Tableting…
This study aims to improve the biopharmaceutical, mechanical, and tableting properties of a poorly soluble drug, ibuprofen (IBP), by preparing amorphous solid dispersion (ASD) followed by a sustained-release tablet formulation. A suitable polymer to develop an ASD system was chosen by utilizing the…
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Trends in amorphous solid dispersion drug products approved by the U.S. Food and Drug Administration…
Abstract
Forty-eight (48) drug products (DPs) containing amorphous solid dispersions (ASDs) have been approved by the U.S. Food and Drug Administration in the 12-year period between 2012 and 2023. These DPs comprise 36 unique amorphous drugs. Ten (10) therapeutic categories are represented, with…
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