Purpose: To formulate and characterize tablets containing Pitavastatin that have been loaded with a self-nano emulsifying drug delivery system (SNEDDS). Methods: Pitavastatin SNEDDS were prepared with a variety of oils, surfactants, co-surfactants, and solvents to improve the dissolution rate and bioavailability of the HMG-CoA reductase inhibitor. The SNEDDS components were preliminarily investigated for drug solubility in various vehicles, excipient miscibility, emulsification rate, and ternary phase diagrams. The tablets were made using a porous carrier made of Aerosil 200 and then loaded with SNEDDS using a simple absorption method. Physical parameters such as tablet hardness, weight variation, disintegration, drug content, and in-vitro drug release were then measured on the tablets. Results: Labrafac Lipophilewl1349 (Oil), Tween 80 (Surfactant) and Egg lecithin (Co-surfactant) were selected for the preparation of SNEDDS. Tablets with high porosity suitable for loading with SNEDDS and containing the super-disintegrants, achieved complete dissolution of Pitavastatin from the tablets. In vitro release of Pitavastatin from SNEDDS and the tablets was similar (p < 0.05). Conclusion: SNEDDS of Pitavastatin is a promising approach to achieving a solid dosage form of the liquid-loaded drug delivery systems for enhancing the solubility and dissolution rate of the drug, and hence also its bioavailability.

中文翻译：

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含有匹伐他汀-自纳米乳化给药系统的片剂的处方和统计评价

目的：配制和表征含有自纳米乳化药物递送系统 (SNEDDS) 的匹伐他汀片剂。方法：用多种油、表面活性剂、辅助表面活性剂和溶剂制备匹伐他汀 SNEDDS，以提高 HMG-CoA 还原酶抑制剂的溶出度和生物利用度。初步研究了 SNEDDS 组分的药物在各种载体中的溶解度、赋形剂混溶性、乳化率和三元相图。片剂使用由 Aerosil 200 制成的多孔载体制成，然后使用简单的吸收方法加载 SNEDDS。然后测量片剂的物理参数，如片剂硬度、重量变化、崩解、药物含量和体外药物释放。结果：Labrafac Lipophilewl1349（油），选择吐温 80（表面活性剂）和卵磷脂（辅助表面活性剂）来制备 SNEDDS。适合装载 SNEDDS 并含有超级崩解剂的高孔隙率片剂实现了匹伐他汀从片剂中的完全溶出。SNEDDS 和片剂中匹伐他汀的体外释放相似 (p < 0.05)。结论：匹伐他汀的 SNEDDS 是一种很有前途的方法，可以实现液体负载药物递送系统的固体剂型，以提高药物的溶解度和溶出速率，从而提高其生物利用度。SNEDDS 和片剂中匹伐他汀的体外释放相似 (p < 0.05)。结论：匹伐他汀的 SNEDDS 是一种很有前途的方法，可以实现液体负载药物递送系统的固体剂型，以提高药物的溶解度和溶出速率，从而提高其生物利用度。SNEDDS 和片剂中匹伐他汀的体外释放相似 (p < 0.05)。结论：匹伐他汀的 SNEDDS 是一种很有前途的方法，可以实现液体负载药物递送系统的固体剂型，以提高药物的溶解度和溶出速率，从而提高其生物利用度。