title: Use of the polymeric matrix as internal standard for quantitation of in vivo delivery of tetracycline HCl from Actisite tetracycline fiber during periodontal treatment.
abstract: Actisite (tetracycline hydrochloride) periodontal fiber is a 23 cm monofilament containing 12.7 mg tetracycline HCl homogeneously dispersed in a polymer. This product is indicated as an adjunct to scaling and root planing to reduce pocket depth and bleeding on probing in patients with adult periodontitis. The sustained-release system, placed in the periodontal pocket for 10 d, releases the antibiotic through mechanisms of diffusion and osmosis. A study was conducted in 13 patients with moderate to severe adult periodontitis to evaluate the amount of tetracycline HCl released during therapy (based on residual drug content). Fibers placed in the pocket remained in place for an average of 9 d. Each patient had 1-4 teeth treated with fiber therapy. At the termination of therapy samples from 29 teeth were retrieved and analyzed. The amount of matrix polymer was used as an internal standard for the quantitation of tetracycline, eliminating any uncertainties with respect to recovery or contamination. An average of 31% (SD 9%) of the tetracycline HCl content was released from the fiber during the treatment period. No single fiber had less than 50% of the original drug remaining. The study demonstrated that a substantial amount of the tetracycline remains in the Actisite fiber at removal (about 70%), which indicates that substantial drug concentrations are maintained in the pocket for the duration of treatment.
authors.affiliation: ALZA Corporation, Palo Alto, CA 94303-0802, USA.
authors.forename: J M
authors.initials: JM
authors.lastname: Litch
authors.forename: M
authors.initials: M
authors.lastname: Encarnacion
authors.forename: S
authors.initials: S
authors.lastname: Chen
authors.forename: J
authors.initials: J
authors.lastname: Leonard
authors.forename: T L
authors.initials: TL
authors.lastname: Burkoth
mesh_terms: D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000032:analysis / Q000737:chemistry / Q000627:therapeutic use*; D002851:Chromatography, High Pressure Liquid; D003131:Combined Modality Therapy; D003692:Delayed-Action Preparations; D012534:Dental Scaling; D004058:Diffusion; D004337:Drug Carriers; D005260:Female; D005884:Gingival Hemorrhage / Q000188:drug therapy / Q000628:therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D009995:Osmosis; D010514:Periodontal Pocket / Q000188:drug therapy / Q000628:therapy; D010518:Periodontitis / Q000188:drug therapy* / Q000628:therapy; D011145:Polyvinyls / Q000032:analysis / Q000737:chemistry; D016745:Root Planing; D013752:Tetracycline / Q000008:administration & dosage / Q000032:analysis / Q000737:chemistry / Q000627:therapeutic use*
chemical_list: D000900:Anti-Bacterial Agents; D003692:Delayed-Action Preparations; D004337:Drug Carriers; D011145:Polyvinyls; C016438:ethylenevinylacetate copolymer; D013752:Tetracycline