Formulation design of an oral, fast-disintegrating dosage form containing taste-masked particles of famotidine

被引:15
作者
Mizumoto, Takao [1 ]
Tamura, Tetsuya [1 ]
Kawai, Hitoshi [1 ]
Kajiyama, Atsushi [1 ]
Itai, Shigeru [2 ]
机构
[1] Astellas Pharma Inc, Pharmaceut Res & Technol Labs, Shizuoka 4250072, Japan
[2] Univ Shizuoka, Sch Pharmaceut Sci, Dept Pharmaceut Engn & Drug Delivery Sci, Suruga Ku, Shizuoka 4228526, Japan
关键词
fast-disintegrating; famotidine; taste-masking; ambient humidity; oral disintegration time;
D O I
10.1248/cpb.56.946
中图分类号
R914 [药物化学];
学科分类号
100701 [药物化学];
摘要
A fast-disintegrating dosage form has been developed as a user-friendly formulation that disintegrates in the mouth immediately. Patients can take it without water like a liquid formulation. In this study famotidine taste-masking technology was applied to the new fast-disintegrating tablet in an attempt to produce a novel, taste-masked, fast-disintegrating tablet. Partial granulation was found to be an effective and practical way to address content uniformity, however, oral disintegration time tended to become longer as content uniformity improved. The disintegration time was improved considerably by controlling ambient humidity during the compression process (>50% RH). Furthermore, since the new fast-disintegrating technology made it possible to use low compression force, there was no change in the structure or dissolution rate of the taste-masked particles after compression. Therefore, this system can produce a taste-masked fast-disintegrating tablet with satisfactory attributes.
引用
收藏
页码:946 / 950
页数:5
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