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Development and in vitro Evaluation of an Intra-oral Controlled-release Delivery System for Chlorhexidine

Epidemiology and Oral Disease Prevention Program, National Institute of Dental Research, National Institutes of Health, Westwood Building, Room 534, Bethesda, Maryland 20892

A. Bartkiewicz

Epidemiology and Oral Disease Prevention Program, National Institute of Dental Research, National Institutes of Health, Westwood Building, Room 534, Bethesda, Maryland 20892

R.J. Shern

Epidemiology and Oral Disease Prevention Program, National Institute of Dental Research, National Institutes of Health, Westwood Building, Room 534, Bethesda, Maryland 20892

W.A. Little

Epidemiology and Oral Disease Prevention Program, National Institute of Dental Research, National Institutes of Health, Westwood Building, Room 534, Bethesda, Maryland 20892

Copolymers of hydroxyethyl methacrylate (HEMA) and methyl methacrylate (MMA) were prepared and used to fabricate a membrane-controlled reservoir-type controlled-release delivery system for chlorhexidine that should be suitable for intra-oral use. The reservoir of the system was prepared bys softening an 80:20 mixture of chlorhexidine diacetate and 50:50 HEMA:MMA copolymer with methyl ethyl ketone (MEK), and pressing standard amounts of the resulting dough-like mixture into silicone rubber molds. A membrane was applied to the reservoirs by rotating them through a solution of 30:70 HEMA:MMA copolymer in MEK. The finished oval-shaped controlled-release pellets were approximately 4. 7 mm wide, 3.3 mm high, and 7.4 mm long, and contained 45.0 ± 3.7 mg of chlorhexidine diacetate. The mean in vitro release rate of chlorhexidine diacetate from the pellets into 37°C water was 608 ± 55 µg/24 h for days 2 through 11, and 389 ± 50 µg/24 h for days 15 to 30 of the test period. The chlorhexidine released on day 30 was biologically active, as determined by a serial dilution assay against Streptococcus mutans. The extended release of biologically active chlorhexidine at a controlled rate from this system suggests that it is worthy of further evaluation for the intra-oral therapy of chlorhexidine-treatable oral infections in non-compliant and physically or mentally compromised individuals.

Journal of Dental Research, Vol. 68, No. 8, 1285-1288 (1989)
DOI: 10.1177/00220345890680081401


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