Om Shelke, Krishna Phani Chandra Susarla, Manish Bankar
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引用次数: 0
Abstract
Vitamin C is extensively used in cosmetic formulation, howbeit stability is the supreme demerit that limits its use in beautifying products. Numerous techniques are being employed to inhibit the degradation of vitamin C caused by formulation components to facilitate the use in skin rejuvenating products. Diverse materials are being exercised in formulation to stabilize the ascorbic acid and ingredients selected in this formulation composition help for stabilization. The initial stable prototype is developed and further optimization is accomplished by applying the design of experiment tools. The stable pharmaceutical formulations were evaluated for the evaluation parameters and designated as two optimized formulations. The analytical method for the assay of ascorbic acid from the United States pharmacopeia and the related substance method from European pharmacopeia has been modified to be used for cream formulation. The DoE design exhibited that the stability of formulation is impacted by citric acid and tartaric acid but not by propylene glycol and glycerin. The analysis results of topical formulations for the evaluation parameter exhibited satisfactory results. The in-vitro release study method has been developed, optimized, and validated to fit the analysis. The in-vitro studies have been performed for selected compositions and both the formulation has similar kinds of release patterns. The stability study as per ICH guidelines exhibited that the product is stable for accelerated, intermediate, and room-temperature storage conditions. The optimized formulation shows constant release and permeation of ascorbic acid through the skin. The formulation with the combinations of citric acid, tartaric acid, and tocopherol is more stable and the degradation of vitamin C has been reduced significantly. The beaucoup strategies in the unique composition help to protect the degradation by inhibiting the multitudinous degradation pathways.
维生素 C 被广泛用于化妆品配方中,但其稳定性是限制其在美容产品中使用的最大缺点。为了抑制配方成分对维生素 C 的降解,以便于在嫩肤产品中使用,人们采用了许多技术。配方中使用了多种材料来稳定抗坏血酸,本配方中选用的成分有助于稳定抗坏血酸。最初的稳定原型已经开发出来,并通过应用实验设计工具完成了进一步优化。对稳定的药物制剂进行了评价参数评估,并将其定为两个优化制剂。对美国药典中测定抗坏血酸的分析方法和欧洲药典中相关物质的方法进行了修改,以用于乳膏制剂。DoE 设计表明,配方的稳定性受柠檬酸和酒石酸的影响,但不受丙二醇和甘油的影响。外用制剂评价参数的分析结果令人满意。体外释放研究方法经过开发、优化和验证,符合分析要求。对选定的组合物进行了体外研究,两种配方都有类似的释放模式。根据 ICH 指南进行的稳定性研究表明,该产品在加速、中间和室温储存条件下都很稳定。优化配方显示出抗坏血酸在皮肤中的持续释放和渗透。含有柠檬酸、酒石酸和生育酚组合的配方更为稳定,维生素 C 的降解显著减少。独特成分中的多种策略有助于通过抑制多种降解途径来保护降解。