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首页> 美国卫生研究院文献>other >Formulation and Evaluation of Fixed-Dose Combination of Bilayer Gastroretentive Matrix Tablet Containing Atorvastatin as Fast-Release and Atenolol as Sustained-Release
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Formulation and Evaluation of Fixed-Dose Combination of Bilayer Gastroretentive Matrix Tablet Containing Atorvastatin as Fast-Release and Atenolol as Sustained-Release

机译：含阿托伐他汀作为快速释放和阿替洛尔作为持续释放的双层胃滞留基质片剂的固定剂量组合的研制与评价

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摘要

The objective of the present study was to develop bilayer tablets of atorvastatin and atenolol that are characterized by initial fast-release of atorvastatin in the stomach and comply with the release requirements of sustained-release of atenolol. An amorphous, solvent evaporation inclusion complex of atorvastatin with β-cyclodextrin, present in 1 : 3 (drug/cyclodextrin) molar ratio, was employed in the fast-release layer to enhance the dissolution of atorvastatin. Xanthan gum and guar gum were integrated in the sustained-release layer. Bilayer tablets composed of sustained-release layer (10% w/w of xanthan gum and guar gum) and fast-release layer [1 : 3 (drug/cyclodextrin)] showed the desired release profile. The atorvastatin contained in the fast-release layer showed an initial fast-release of more than 60% of its drug content within 2 h, followed by sustained release of the atenolol for a period of 12 h. The pharmacokinetic study illustrated that the fast absorption and increased oral bioavailability of atorvastatin as well as therapeutic concentration of atenolol in blood were made available through adoption of formulation strategy of bilayer tablets. It can be concluded that the bilayer tablets of atorvastatin and atenolol can be successfully employed for the treatment of hypertension and hypercholesterolemia together through oral administration of single tablet.
机译：本研究的目的是开发阿托伐他汀和阿替洛尔的双层片剂，其特征是阿托伐他汀在胃中最初快速释放，并符合阿替洛尔缓释的释放要求。阿托伐他汀与β-环糊精的无定形溶剂蒸发包合物，以1∶3∶3（药物/环糊精）的摩尔比存在于快速释放层中，以增强阿托伐他汀的溶解。黄原胶和瓜尔豆胶被整合在缓释层中。由缓释层（黄原胶和瓜尔胶的10％w / w）和速释层[1 :: 3（药物/环糊精）]组成的双层片剂显示出所需的释放曲线。速释层中包含的阿托伐他汀在2？h内显示出其药物含量的60％以上的初始速释，随后在12？h内持续释放阿替洛尔。药代动力学研究表明，通过采用双层片剂的配制策略，可实现阿托伐他汀的快速吸收和口服生物利用度的提高以及血液中阿替洛尔的治疗浓度。可以得出结论，阿托伐他汀和阿替洛尔的双层片剂可以通过单片口服一起成功地用于治疗高血压和高胆固醇血症。

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