A-A-54515
15 November 1991
COMMERCIAL ITEM DESCRIPTION
PILOCARPINE OCULAR SYSTEM, USP
The General Services Administration has authorized the use of this Commercial Item Description as a replacement for Military Specification MIL-P-37784 which is cancelled.
Salient characteristics:
Shall be Pilocarpine Ocular System, USP, designed for insertion into the cul-de-sac of the eye for continuous release of the drug following placement.
Shall be in accordance with the requirements of the USP.
All ingredients shall be of a pharmaceutical grade.
For Strength 1 – The Pilocarpine Ocular System shall provide mcg of pilocarpine per hour over a seven-day period. Shall contain 5 mg of Pilocarpine within the applicable assay limits in a core with alginic acid. The core shall be surrounded by an ethylene-vinyl acetate copolymer membrane with di(2-ethylhexyl) phthalate which controls the diffusion of the Pilocarpine into the eye. The system shall measure 5.7 x 13.4 mm on its axis and 0.3 mm in thickness, and shall be surrounded by a white border consisting of ethylene-vinyl acetate copolymer membrane with titanium dioxide.
For Strength 2 – Pilocarpine Ocular System shall provide 40 mcg of Pilocarpine per hour over a seven-day period. Shall contain 11 mg of Pilocarpine within the applicable assay limits in a core with alginic acid. The core shall be surrounded by an ethylene-vinyl acetate copolymer membrane with di(2-ethylhexyl) phthalate which controls the diffusion of the Pilocarpine into the eye. The system shall measure 5.7 x 13.4 mm on its axis and 0.5 mm in thickness, and shall be surrounded by a white border consisting of ethylene-vinyl acetate copolymer membrane with titanium dioxide.
DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited.
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