Drug – bio-affecting and body treating compositions – Topical body preparation containing solid synthetic organic... – Ophthalmic preparation
Reexamination Certificate
1999-04-29
2001-07-17
Azpuru, Carlos A (Department: 1615)
Drug, bio-affecting and body treating compositions
Topical body preparation containing solid synthetic organic...
Ophthalmic preparation
C424S427000
Reexamination Certificate
active
06261546
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates generally to pharmaceutical acetylcholine products. In a preferred embodiment, the invention relates to ophthalmic acetylcholine products.
2. Description of the Related Art
Anterior segment surgery of the eye is relatively common today. These surgical procedures include cataract surgery, penetrating keratoplasty and iridectomy.
Post-surgical treatments are also common. A typical treatment which follows anterior segment surgery involves an immediate application of a pharmaceutical agent which increases the rate of miosis (i.e., constriction of the iris). A preferred miosis-inducing pharmaceutical is acetylcholine, and the chloride salt is the preferred salt. Acetylcholine is also called 2-(acetyloxy)-N,N,N-trimethyl-ethanamium; chloride; acecoline; or arterocoline.
An outstanding product for increasing the miosis rate is sold under the trademark Miochol®-E, which is an intraocular acetylcholine solution marketed by CIBA Vision Corporation, Duluth, Ga. Since aqueous acetylcholine solutions are unstable, the Miochol®-E product is packaged in a vial having two compartments or chambers which are separated from one another by a rubber stopper. The lower chamber contains 20 mg of acetylcholine chloride and 56 mg of mannitol. The upper chamber contains 2 ml of a diluent of sodium chloride, potassium chloride, magnesium chloride hexahydrate, calcium chloride dihydrate and sterile water for injection.
In use, an eye care professional turns a plunger-stopper mechanism a quarter turn and presses to cause the rubber stopper to dislodge and allow diluent from the upper chamber to pass into the lower chamber, thereby mixing the two solutions. The solution is then administered via injection into the anterior chamber (e.g., seconds after a lens has been inserted during cataract surgery), either before or after securing one or more sutures.
SUMMARY OF THE INVENTION
An object of the invention is to increase the stability of an acetylcholine pharmaceutical product.
An object of the invention is to improve the pH consistency of an acetylcholine pharmaceutical product without causing substantial degradation of the acetylcholine.
Another object of the invention is to provide an improved acetylcholine ophthalmic product.
This and other objects and advantages are achieved through the innovative stabilized product which includes two-compartment acetylcholine product. In one compartment, acetylcholine is stored. In a second compartment, a buffered diluent solution is stored. Upon mixing the buffered diluent, a buffered acetylcholine product is prepared for injection.
Another embodiment of the invention is a method of providing an acetylcholine product which has a substantially consistent final pH without substantial degradation of the acetylcholine. The method involves storing an unbuffered acetylcholine separate from a diluent solution which has been buffered, and mixing prior to use.
REFERENCES:
patent: 5009892 (1991-04-01), McKinzie
patent: 5565188 (1996-10-01), Wong
patent: 5705194 (1998-01-01), Wong
patent: WO 96/32951 (1996-10-01), None
patent: 911264 (1991-02-01), None
Solutions Containing Miotic Agents: Effects on Corneal Transendothelial Electrical Potential Difference, Ritsuko Akiyama, et al., Graefe's Arch Cli. Exp. Ophthalmol (1997), 235: 379-383.
Minno George Edward
Tsao Fu-Pao
Azpuru Carlos A
Lee Michael U.
Novartis AG
Wildman David E.
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