Quality by Design (QbD)

This study aimed to advance the development of intestinal colon-coated sustained-release matrix tablets of metronidazole for diverticulitis treatment, employing the Quality by Design (QbD) methodology. Comprehensive Risk analysis and Risk evaluation were conducted to assess the potential risks…
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Oral Thin Film (OTF) is a promising dosage form, easy to use and patient-friendly drug delivery systems suitable for every consumer profile. This dosage form ensures safety, stability, and acceptability of the drug, that’s why it can be a good alternative for tablets and capsules for children and…
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Abstract Melatonin’s antioxidant properties make it a valuable component in anti-aging semisolid topical products. This study explores the role of Pemulen®, an acrylic-based viscosifying agent, in stabilizing cream-gel formulations. Remarkably, even at low concentrations (0.4%), Pemulen® …
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The phospholipids complexation technique is the best solubility enhancement technology, and as a result, many authors have successfully used it to increase the solubility, permeability, and oral bioavailability of numerous drug molecules. The drug belongs to BCS calss II which having poor solubility…
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Abstract Background and purpose: Sorafenib tosylate (SFN), a potent multikinase inhibitor, is used for the treatment of various cancers. However, it shows limited therapeutic applications due to its poor biopharmaceutical properties. The aim of the present investigation is to develop surface solid…
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This study employed a Quality by Design (QbD) approach to spray dry amorphous clotrimazole nanosuspension (CLT-NS) consisting of Soluplus® and microcrystalline cellulose. Using the Box-Behnken Design, a systematic evaluation was conducted to analyze the impact of in let temperature, % aspiration,…
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Abstract This study explored the combined administration of docetaxel (DOC) and erlotinib (ERL) using nanostructured lipid carriers (NLCs), with folic acid (FA) conjugation to enhance their synergistic anticancer efficacy against triple-negative breast cancer. NLCs were developed through hot melt…
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Resveratrol (RSV) has powerful antioxidant activities. However, the bioavailability is still limited due to low solubility and transport issues. Nanocrystal technology has been introduced to address these issues; however, the bulky formulation of the nanocrystal process through nanosuspension faces…
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Abstract Aim: The current study aims to develop and optimize microemulsions (ME) through Quality-by-Design (QbD) approach to improve the aqueous solubility and dissolution of poorly water-soluble drug disulfiram (DSF) for repurposing in melanoma and breast cancer therapy. Materials &…
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Abstract The preparation of pellets using a high-shear granulator in a rapid single-step is considered a good economic alternative to the extrusion spheronization process. As process parameters and material attributes greatly affect pellet qualities, successful process optimization plays a vital…
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