Formulation Study for Lansoprazole Fast-disintegrating Tablet. III. Design of Rapidly Disintegrating Tablets

Shimizu Toshihiro, Sugaya Masae, Nakano Yoshinori, Izutsu Daisuke, Mizukami Yoshio, Okochi Kazuhiro, Tabata Tetsuro, Hamaguchi Naoru, Igari Yasutaka

doi:10.1248/cpb.51.1121

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Formulation Study for Lansoprazole Fast-disintegrating Tablet(3)Design of Rapidly Disintegrating Tablets

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Lansoprazole fast-disintegrating tablets (LFDT) are a patient-friendly formulation that rapidly disintegrates in the mouth. LFDT consist of enteric-coated microgranules (mean particle size, approximately 300 μm) and inactive granules. In the design of the inactive granules, mannitol was used as a basic excipient. Microcrystalline cellulose, low-substituted hydroxypropyl cellulose (L-HPC), and crospovidone were used as binders and disintegrants. A new grade of L-HPC (L-HPC-33), with a hydroxypropoxy group content of 5.0—6.9%, was developed and it has no rough texture due to a decrease in water absorption. It was clarified that L-HPC-33 could be useful as a binder and disintegrant in rapidly disintegrating tablets. LFDT contain enteric-coated microgranules in tablet form. The enteric-coated microgranule content in LFDT affect qualities such as tensile strength, disintegration time in the mouth, and dissolution behavior in the acid stage and in the buffer stage of LFDT. The 47.4% content of the enteric-coated microgranules was selected to give sufficient tensile strength (not less than 30 N/cm²), rapid disintegration time in the mouth (not more than 30 s), and dissolution behavior in the acid stage and buffer stage similar to current lansoprazole capsules. Compression force affected the tensile strength and the disintegration time in the mouth, but did not affect the dissolution behavior in the acid and buffer stages.

Journal

Chemical and Pharmaceutical Bulletin

Chemical and Pharmaceutical Bulletin 51 (10), 1121-1127, 2003

The Pharmaceutical Society of Japan

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CRID: 1390001204167409280

NII Article ID: 110003615168

NII Book ID: AA00602100

DOI: 10.1248/cpb.51.1121

ISSN: 13475223; 00092363

NDL BIB ID: 6696388

PubMed: 14519914

Web Site: http://id.ndl.go.jp/bib/6696388; https://ndlsearch.ndl.go.jp/books/R000000004-I6696388; http://www.jstage.jst.go.jp/article/cpb/51/10/51_10_1121/_pdf

Text Lang: en

Article Type: journal article

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