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Stabilizer
Investigation on the Combined Effect of Hydroxypropyl Beta-Cyclodextrin (HPβCD) and Polysorbate in…
Monoclonal antibodies require careful formulation due to their inherent stability limitations. Polysorbates are commonly used to stabilize mAbs, but they are prone to degradation, which results in unwanted impurities. KLEPTOSE® HPβCD (hydroxypropyl beta-cyclodextrin) has functioned as a stable…
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Development of a stability indicating high-performance liquid chromatography method for…
Abstract
This study presents a stability indicating high-performance liquid chromatography HPLC method for the determination of cenobamate (CNB) in presence of its main impurity (CNB H-impurity) and degradation products. The chromatographic separation was carried out on a Thermo BDS Hypersil-C18…
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Preparation of antibody-loaded protein microbeads for pulmonary delivery via Shirasu porous glass…
Reversible protein precipitates (protein microbeads) have been developed using Shirasu porous glass (SPG) membrane emulsification. Microbeads have a mean size of a few micrometers (2–5 μm), and their formation is reversible upon rehydration. Their feasibility was examined as dry powders for…
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Excipient Reactivity and Drug Stability in Formulations
This is about the excipient used for achieving sustained release function undergone chemical reaction with the stabilizing agent used for the drug product leading to product quality failure from the desired dissolution behavior. The generic version of Bupropion HCl SR 150 mg, i.e. sustained (12…
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Effects of omitting titanium dioxide from the film coating of a pharmaceutical tablet
An industrial case study of attempting to comply with EU regulation 2022/63
Recently, concerns have been raised about the safety of titanium dioxide (TiO2), a commonly used component of pharmaceutical film coatings. The European Union has recently prohibited the application of this material in the…
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Lipid-coated nanocrystals of paclitaxel as dry powder for inhalation: Characterization, in-vitro…
Abstract
Background
Nanocrystals can be produced as a dry powder for inhalation (DPIs) to deliver high doses of drug to the lungs, owing to their high payload and stability to the shear stress of aerosolization force. Furthermore, lipid-coated nanocrystals can be formulated to improve the drug…
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Development of solid lipid microparticles (SLMs) containing asiatic acid for topical treatment of…
Solid lipid microparticles (SLMs) represent a promising approach for drug delivery in anti-acne applications. In this study, asiatic acid-loaded SLMs (AASLMs) were prepared by melt emulsification method in conjunction with freeze-drying. Comprehensive evaluations comprised particle size, %entrapment…
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Fabrication and characterization of shellac nanofibers with colon-targeted delivery of quercetin and…
In this study, the feasibility of shellac nanofibers as carrier system for colonic delivery of quercetin was evaluated. Firstly, the nanofibers without and with different amounts (2.5 %, 5.0 %, and 7.5 %) of quercetin were fabricated using pure shellac as a carrier by electrospinning. The morphology…
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Overcoming the Low-Stability Bottleneck in the Clinical Translation of Liposomal Pressurized…
Abstract
Currently, several types of inhalable liposomes have been developed. Among them, liposomal pressurized metered-dose inhalers (pMDIs) have gained much attention due to their cost-effectiveness, patient compliance, and accurate dosages. However, the clinical application of liposomal pMDIs…
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Ternary solid dispersions of lacidipine: Enhancing dissolution and supersaturation maintenance…
The study aimed to address the challenges related to insufficient dissolution and maintenance of supersaturation in binary solid dispersions. Lacidipine, categorized as a BCS class II drug, was employed as the model drug. A systematic screening of excipients was conducted to determine the most…
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