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Claims for Patent: 6,261,546

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Claims for Patent: 6,261,546

Title: Methods and compositions for stabilizing acetylcholine compositions
Abstract:A pharmaceutical product which includes two-chambers, one having a buffered diluent and the other having acetylcholine. Upon mixing the chamber contents, a buffered efficacious acetylcholine product is prepared for post-surgical ophthlamic 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.
Inventor(s): Tsao; Fu-Pao (Lawrenceville, GA), Minno; George Edward (Suwanee, GA)
Assignee: Novartis AG (Basel, CH)
Application Number:09/301,895
Patent Claims: 1. A pharmaceutical product, comprising a container which includes:

(a) a first chamber in which is disposed an aqueous diluent solution consisting essentially of water, inorganic salts, and at least one buffer; and

(b) a second chamber in which is disposed a pharmaceutically active agent comprising acetylcholine,

wherein, the amount of buffer in the first chamber is sufficient to buffer the pH of a mixed solution resulting from mixture of the aqueous diluent solution and the pharmaceutically active agent to an ophthalmically acceptable level.

2. A pharmaceutical product of claim 1, wherein the pH of the mixed solution is above about 5.0.

3. A pharmaceutical product of claim 1, wherein the buffer is selected from the group consisting of acetates, borates, phosphates, carbonate, citrates and mixtures thereof.

4. A pharmaceutical product of claim 3, wherein the buffer includes at least one acetate.

5. A pharmaceutical product of claim 4, wherein the buffer includes sodium acetate.

6. A pharmaceutical product of claim 5, wherein the sodium acetate is present at a concentration of 0.05 to 0.50 weight percent, based on the total weight of the mixed solution.

7. A pharmaceutical product of claim 1, wherein the aqueous diluent solution disposed in the first chamber consists essentially of:

(a) potassium chloride;

(b) magnesium chloride hexahydrate;

(c) calcium chloride dehydrate;

(d) sodium acetate; and

(e) sterile water for injection.

8. A pharmaceutical product of claim 7, wherein the first chamber comprises about 1 to 5 milliliters of a solution comprising:

(a) about 0.005 to 0.10% potassium chloride;

(b) about 0.005 to 0.10% magnesium chloride hexahydrate;

(c) about 0.005 to 0.10% calcium chloride dehydrate;

(d) about 0.10 to 0.20% sodium acetate; and

(e) sterile water for injection,

wherein concentrations are weight percentages based on the total weight of the mixed solution.

9. A pharmaceutical product of claim 1, wherein the pharmaceutically active agent in the second chamber comprises:

(a) lyophilized acetylcholine; and

(b) a tonicity adjusting agent.

10. A pharmaceutical product of claim 9, wherein the tonicity adjusting agent includes mannitol.

11. A pharmaceutical product of claim 10, wherein the pharmaceutically active agent in the second chamber comprises:

(a) about 0.5% to 5% lyophilized acetylcholine; and

(b) about 1% to 10% of mannitol

wherein concentrations are weight percentages based on the total weight of the mixed solution.

12. A method for treating an eye following surgery comprising administering a pharmaceutical product of claim 1 following a member selected from the group consisting of cataract surgery, penetrating keratoplasty, and iridectomy.

13. A pharmaceutical product of claim 1, wherein the pharmaceutically active agent disposed within the second chamber is substantially free of buffer.

14. An ophthalmic pharmaceutical product, comprising:

(a) a first chamber in which is disposed an aqueous diluent solution consisting essentially of:

(i) about 0.005 to 0.10% potassium chloride;

(ii) about 0.005 to 0.10% magnesium chloride hexahydrate;

(iii) about 0.005 to 0.10% calcium chloride dehydrate;

(iv) about 0.10 to 0.20% sodium acetate; and

(v) sterile water for injection, and

(b) a second chamber in which is disposed a pharmaceutically active agent, comprising:

(i) about 0.5% to 5% lyophilized acetylcholine; and

(ii) about 1% to 10% of mannitol

wherein, the amount of buffer in the first chamber is sufficient to buffer the pH of a mixed solution resulting from mixture of the contents of the aqueous diluent solution and the pharmaceutically active agent to above about 5.0, and

wherein concentrations are weight percentages based on the total weight of the mixed solution.

15. A method of stabilizing a pharmaceutical product comprising acetylcholine, comprising the steps of:

(a) providing a diluent solution consisting essentially of water, inorganic salts, and at least one buffer in a first container; and

(b) providing a composition to be dissolved comprising acetylcholine in a second container; and

(c) mixing the diluent solution from the first container with the composition to be dissolved to form a mixed solution, wherein buffer is present in sufficient quantity in the mixed solution to buffer the pH of the mixed solution to an ophthalmically acceptable pH.

16. A method of claim 15, wherein the first container is affixed to the second container.

17. A method of claim 15, wherein the pH of the mixed solution is above about 5.0.

18. A method of claim 15, wherein the buffer is an acetate.

19. A method of claim 18, wherein the buffer is sodium acetate and the concentration is 0.05 to 0.50 weight percent wherein the concentration is based on the total weight of the mixed solution.
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