Quality by Design (QbD)

Press Release Abstract This research article outlines a systematic and science-based approach to formulate extended-release tablets of brivaracetam (BRV) by means of quality by design (QbD) method. BRV, a potent antiepileptic drug, faces challenges due to its short half-life, necessitating…
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Abstract Purpose Heart failure, a progressive cardiovascular disorder, significantly affects patient morbidity and mortality. Valsartan, an angiotensin II receptor antagonist, is widely used to mitigate the effects of heart failure, but its oral administration faces challenges such as poor…
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Abstract Although the development of extended release (ER) matrices has been extensively investigated, understanding the most appropriate mechanism of drug release to achieve the desired release remains a cost- and time-consuming challenge in the early stages of formulation development. This study…
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Abstract This paper presents a comprehensive investigation of the manufacturing of itraconazole (ITZ) amorphous solid dispersions (ASDs) with Kollidon® VA64 (KVA64) using hot-melt extrusion (HME) and in-line process monitoring, employing a Quality by Design (QbD) approach. A sequential Design of…
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Abstract Amphotericin-b (AmB) is a broad-spectrum polyene macrolide antifungal and anti-Leishmaniosis. We addressed HSPiP and QbD (quality by design) oriented HPLC (high-performance liquid chromatography) method development and validation, followed by identifying critical attributes on retention…
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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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