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Claims for Patent: 4,328,213

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Claims for Patent: 4,328,213

Title: Stable injectable labetalol formulation
Abstract:An injectable formulation for the pharmaceutically acceptable acid addition salts of labetalol, its isomers and mixtures thereof is provided which has enhanced stability properties.
Inventor(s): Ecker; Varda (New York, NY), Shah; Yogendra M. (Piscataway, NJ), Chaudry; Imtiaz A. (Denville, NJ)
Assignee: Schering Corporation (Kenilworth, NJ)
Application Number:06/098,166
Patent Claims: 1. A stable injectable pharmaceutical formulation which comprises, per ml of solution

3-5 mg pharmaceutically acceptable acid addition salt of labetalol, or any of its four isomers or mixtures thereof;

10-60 mg non-ionic isotonic agent;

0.1-2.0 mg paraben preservative or mixtures thereof;

sufficient organic acid to obtain a pH of 3.0-4.0;

water for injection q.s. 1.0 ml.

2. A formulation according to claim 1 wherein the pharmaceutically acceptable acid addition salt is the hydrochloride salt.

3. A formulation according to claim 1 wherein the non-ionic isotonic agent is dextrose.

4. A formulation according to claim 2 wherein the non-ionic isotonic agent is glycine.

5. A formulation according to claim 2 wherein the organic acid is citric acid.

6. A formulation according to claim 2 wherein the paraben preservative is a mixture of methyl paraben and propyl paraben.

7. A formulation according to claim 2 wherein the pH is 3.5.+-.0.2.

8. A formulation according to claim 2 which additionally includes disodiuum edetate in an amount of 0.1 mg/ml.

9. A formulation according to claim 2 which, per ml, is:

3-5 mg labetalol hydrochloride;

45.00 mg dextrose;

0.80 mg methyl paraben;

0.10 mg propyl paraben;

0.10 mg edetate disodium;

0.11 mg citric acid monohydrate; and

water for injection q.s. 1.0 ml.

10. A formulation according to claim 2 which, per ml, is:

5.00 mg R,R-enantiomer hydrochloride of labetalol;

45.00 mg dextrose;

0.80 mg methyl paraben;

0.10 mg propyl paraben

0.10 mg edetate disodium;

0.12 mg citric acid monohydrate; and

water for injection q.s. 1.00 ml.
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