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制造工艺对粉末压片能力的影响:茶碱与乳糖/纤维素或微晶纤维素制成的两种制剂的混合、研磨及喷雾干燥比较。

Influence of manufacturing process on tabletting ability of powder: comparison between blending, grinding, and spray drying of two formulations made of theophylline and lactose/cellulose or Cellactose.

作者信息

Viana M, N'Dri-Stempfer B, Vachon M G, Chulia D

机构信息

GEFSOD EA 2631-Groupe d'Etudes sur la Fonctionnalisation des Solides Divisés, Université de Limoges, Faculté de Pharmacie, France.

出版信息

Drug Dev Ind Pharm. 2002;28(2):119-27. doi: 10.1081/ddc-120002444.

DOI:10.1081/ddc-120002444
PMID:11926355
Abstract

Three manufacturing processes were applied to two formulations composed of 20% anhydrous theophylline associated with either 20% microcrystalline cellulose and 60% lactose or 80% Cellactose. The processing method (dry blending, grinding, or spray drying) and the formulation were investigated through the comparison of the physical and flow characteristics and the compactibility of the end products. The results demonstrated that the formulation had a major effect on the mechanical properties, with binary blends exhibiting a higher resistance than ternary ones, whereas flow properties and densification depended on the process. Nevertheless, it was also observed that spray drying decreased the difference between the mechanical properties of the two formulations, probably by modifying the texture of the Cellactose in suspension.

摘要

三种制造工艺应用于两种配方,这两种配方由20%无水茶碱与20%微晶纤维素和60%乳糖或80%的Cellactose组成。通过比较最终产品的物理和流动特性以及可压性,对加工方法(干混、研磨或喷雾干燥)和配方进行了研究。结果表明,配方对机械性能有重大影响,二元混合物比三元混合物表现出更高的抗性,而流动性能和致密化则取决于工艺。然而,还观察到喷雾干燥可能通过改变悬浮液中Cellactose的质地,减小了两种配方机械性能之间的差异。

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