Quality by Design (QbD)

Purpose Understanding batch-to-batch variation of excipients and correlating this to process performance is a key concept of Quality-by-Design for pharmaceutical product development. In this study, the effect of batch-to-batch variation in material properties of milled lactose monohydrate on…
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Itraconazole (ITZ), a BCS Class II drug exhibiting low solubility (1-4 ng/ mL in water) requires formulation enhancement to achieve enhanced bioavailability. To tackle this problem amorphous solid dispersions (ASDS) of ITZ in a polymer matrix (Kollidon® VA64) were produced using the Hot Melt…
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Hydroxypropyl methylcellulose (HPMC) is a commonly used excipient to enable controlled release (CR) performance from a hydrophilic matrix tablet. Quality-by-Design (QbD) initiatives have prompted formulators to proactively characterize and account for variabilities in process parameters and…
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Abstract This study hypothesizes that phospholipid-based naturosoomal nanocarriers can significantly enhance the oral solubility and bioavailability of naringin (NARNs) by improving its absorption and pharmacokinetic profile. The NARNs were prepared using solvent evaporation techniques employing a…
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Abstract In response to recent regulatory guidelines, including ICH (International Council for Harmonisation) Q2 (R2) and Q14, we developed a UPLC-ELSD method to quantify Medium-Chain Triglycerides (MCTs) in Labrafac™ WL 1349 for nanoemulsion applications. This procedure, crafted using Analytical…
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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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