ArticleFrontiers in nutrition2025
Quality by design-based optimization and HP-TLC densitometric standardization of
Article in Frontiers in nutrition, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: Our previous studies identified the hydroalcoholic extract of defatted Methods: An analytical method for phytochemical standardization was developed, and acute oral toxicity was studied in female Wistar rats following the OECD 423 guidelines. In brief, the CE was extracted using an 80:20 alcohol-water (% v/v) mixture through cold maceration, followed by spray drying to obtain powdered CE. Utilizing a Quality by Design (QbD) approach with Design Expert (DoE) software, we optimized CE tablets via direct compression. The central composite design (CCD) included five center points, with Avicel PH - 101 and croscarmellose sodium (CCS) as factors, and disintegration time, hardness, and % loss due to friability as measurements. Results: Among the 13 formulations, batch F-9 emerged as the optimized one within the design space, containing 35% Avicel PH - 101 and 5% CCS. The optimized formulation exhibited a disintegration time of 5.2 min, hardness of 4.2 kg/cm Conclusion: In conclusion, the novel, validated HP-TLC method simultaneously detects EGCG and CTN in the cocoa extract. Tablets formulated by direct compression are safe as nutraceuticals and hold promise as supplements in palliative cancer therapy.
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