Formulation design of an oral, fast-disintegrating dosage form containing taste-masked particles of famotidine.
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.
Mizumoto
Takao
T
Pharmaceutical Research and Technology Labs, Astellas Pharma Inc, Shizuoka, Japan. takao.mizumoto@jp.astellas.com
Tamura
Tetsuya
T
Kawai
Hitoshi
H
Kajiyama
Atsushi
A
Itai
Shigeru
S
D000284:Administration, Oral; D002626:Chemistry, Pharmaceutical; D015738:Famotidine / Q000737:chemistry*; D008320:Maltose / Q000737:chemistry; D012995:Solubility; D013649:Taste; D013678:Technology, Pharmaceutical
D015738:Famotidine; D008320:Maltose