ATRIDOX | 合法醫療器材資訊網

Packager:Den-MatHoldings,LLC.Category:HUMANPRESCRIPTIONDRUGLABEL;DEASchedule:None;MarketingStatus:NewDrugApplication ...

(doxycycline hyclate) 10% in the ATRIGEL® Delivery System for controlled release in subgingival application

The ATRIDOX® product* is a subgingival controlled-release product composed of a two syringe mixing system. Syringe A contains 450 mg of the ATRIGEL® Delivery System, which is a bioabsorbable, flowable polymeric formulation composed of 36.7% poly(DL-lactide) (PLA) dissolved in 63.3% N-methyl-2-pyrrolidone (NMP). Syringe B contains 50 mg of doxycycline hyclate which is equivalent to 42.5 mg doxycycline. The constituted product is a pale yellow to yellow viscous liquid with a concentration of 10% of doxycycline hyclate. Upon contact with the crevicular fluid, the liquid product solidifies and then allows for controlled release of drug for a period of 7 days.

*ATRIDOX® is a registered trademark of TOLMAR Inc. ATRIGEL® is a registered trademark of TOLMAR Therapeutics, Inc.

Doxycycline is a broad-spectrum antibiotic synthet...