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Last Updated: April 24, 2024

Claims for Patent: 4,328,213

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Summary 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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