Claims for Patent: 4,328,213
✉ Email this page to a colleague
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. |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.