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.
摘要：
维生素C广泛用于化妆品配方，然而，稳定性是限制其在美化产品中使用的最高缺点。许多技术被用于抑制由制剂组分引起的维生素C的降解,以促进在皮肤更新产品中的使用。在制剂中使用多种材料来稳定抗坏血酸,并且在该制剂组合物中选择的成分有助于稳定。开发了初始稳定的原型，并通过应用实验工具的设计实现了进一步的优化。评价稳定的药物制剂的评价参数并指定为两种优化的制剂。美国药典的抗坏血酸分析方法和欧洲药典的相关物质方法已修改为用于乳膏制剂。DoE设计显示制剂的稳定性受柠檬酸和酒石酸影响,但不受丙二醇和甘油影响。局部制剂对评价参数的分析结果表现出令人满意的结果。建立了体外释放研究方法,优化,并进行了验证以符合分析。已经对选定的组合物进行了体外研究,并且两种制剂具有相似种类的释放模式。根据ICH指南的稳定性研究表明，产品在加速时是稳定的，中间,和室温储存条件。优化的制剂显示出抗坏血酸通过皮肤的恒定释放和渗透。与柠檬酸的组合的配方，酒石酸,和生育酚更稳定，维生素C的降解明显减少。独特组合物中的beaucoup策略有助于通过抑制多种降解途径来保护降解。
