Formulation Study for Lansoprazole Fast-disintegrating Tablet. I. Effect of Compression on Dissolution Behavior

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概要

• 論文の詳細を見る

• Lansoprazole fast-disintegrating tablet (LFDT) is a new patient-friendly formulation of lansoprazole. Since lansoprazole is an antiulcer agent and is unstable under acidic conditions, we have developed LFDT as an orally disintegrating tablet containing enteric-coated microgranules. The effect of compression on dissolution behavior was investigated, as compression affected cleavage and crushing of the enteric layer. To decrease cleavage and crushing of the enteric layer, the effects of the combined ratio of methacrylic acid copolymer dispersion to ethyl acrylate-methyl methacrylate copolymer dispersion and the concentration of triethyl citrate on the dissolution in the acid stage and the dissolution in the buffer stage were evaluated. By adjusting the ratio of methacrylic acid copolymer dispersion to ethyl acrylate-methyl methacrylate copolymer dispersion to 9:1 and adding a 20% triethyl citrate concentration, sufficient flexibility of the enteric layer and sufficient stability against compression forces were achieved. Agglomeration of enteric-coated microgranules during the coating process was decreased at the optimized concentration of triethyl citrate and glyceryl monostearate. We compared the absorption properties of LFDT and lansoprazole capsules in dogs. The absorption profiles of LFDT were similar to those of lansoprazole capsules.

• 公益社団法人日本薬学会の論文
• 2003-08-01

著者

• 村田 聡

  Department Of Pharmacology Osaka University Of Pharmaceutical Sciences

• Hamaguchi N

  Pharmaceutical Development Laboratories Pharmaceutical Production Division Takeda Chemical Industrie

• Nakano Yoshinori

  Pharmaceutical Development Laboratories Pharmaceutical Production Division Takeda Chemical Industrie

• Shimizu Toshihiro

  Pharmaceutical Development Laboratories Pharmaceutical Production Division Takeda Chemical Industrie

• Murata S

  Department Of Pharmacology Osaka University Of Pharmaceutical Sciences

• TABATA Tetsuro

  Pharmaceutical Development Laboratories, Pharmaceutical Production Division, Takeda Chemical Industr

• HAMAGUCHI Naoru

  Pharmaceutical Development Laboratories, Pharmaceutical Production Division, Takeda Chemical Industr

• IGARI Yasutaka

  Pharmaceutical Development Laboratories, Pharmaceutical Production Division, Takeda Chemical Industr

• Morimoto Shuji

  Pharmaceutical Development Laboratories, Pharmaceutical Production Division, Takeda Chemical Industr

• Tabata T

  Pharmaceutical Development Laboratories Pharmaceutical Production Division Takeda Chemical Industrie

• Igari Yasutaka

  Pharmaceutical Development Laboratories Pharmaceutical Production Division Takeda Chemical Industrie

• Morimoto S

  Pharmaceutical Development Laboratories Pharmaceutical Production Division Takeda Chemical Industrie

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