Development of dividable one-step dry-coated tablets (dividable-OSDRC) and their evaluation as a new platform for controlled drug release.
OBJECTIVE
The purpose of this study is to develop novel dividable coated tablets that retain their characteristics even after they are divided.


METHODS
We prepared dividable one-step dry-coated tablets (dividable-OSDRC) using our own manufacturing process with double structure punches. The release pattern of the dividable-OSDRC with hydroxypropyl methylcellulose (HPMC) or methacrylic acid copolymer LD (Eudragit) as an outer layer was investigated before and after the division, and dissolution profiles were statistically compared using difference factor f1 and similarity factor f2.


RESULTS
The dividable-OSDRC with HPMC for sustained-release (compression pressure, 150 MPa; crashing strength, 6.1 N; friability, 0.05%; CV of divided tablet weight, 7.8%) showed statistically equivalent release patterns between the one-half and the whole (f1, 13.9; f2, 55.5) and between the one-half and the two-halves (5.5, 72.5). The surface area of the tablets affected the sustained-release profiles. Furthermore, the tablets made with Eudragit LD for timed-release (150 MPa. 12.8 N, 0.18%, 9.6%) also showed approximated release patterns before and after the division.


CONCLUSIONS
We proved that dividable-OSDRC maintain their release characteristics after they are divided. We conclude that the dividable-OSDRC could be used as a new platform for the controlled release of drugs.
Ozeki
Yuichi
Y
Pharmaceutical Research & Technology Laboratory, Sanwa Kagaku Kenkyusho Co. Ltd., Gifu-City, Japan. yu_ozeki@skk-net.com
Watanabe
Yukinao
Y
Okamoto
Hirokazu
H
Danjo
Kazumi
K
D000082:Acetaminophen / Q000737:chemistry; D055598:Chemical Phenomena; D002626:Chemistry, Pharmaceutical; D002627:Chemistry, Physical; D019245:Compressive Strength; D003692:Delayed-Action Preparations / Q000737:chemistry*; D004339:Drug Compounding; D005079:Excipients / Q000737:chemistry; D065347:Hypromellose Derivatives; D007700:Kinetics; D008747:Methylcellulose / Q000031:analogs & derivatives* / Q000737:chemistry; D012995:Solubility; D013608:Tablets, Enteric-Coated / Q000737:chemistry*; D013997:Time Factors
D003692:Delayed-Action Preparations; D005079:Excipients; D013608:Tablets, Enteric-Coated; D000082:Acetaminophen; D065347:Hypromellose Derivatives; D008747:Methylcellulose