# US 5,707,996 A · Pharmaceutical solution and methods for preparation thereof > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 5,707,996 A - Document ID: US5707996A - Status: Granted - Kind: A - Application number: 08/554,041 - Filed: 1995-11-06 - Granted: 1998-01-13 - Earliest claimed: 1995-11-06 - Assignees: Macleod Pharmaceuticals, Inc. - Inventors: Giovanni Parrinello - Web page: https://patentgrep.com/patent/US5707996A ## CPC - A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)} - A61K 31/635: having a heterocyclic ring, e.g. sulfadiazine - A61K 47/02: Inorganic compounds - A61K 47/22: Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones - Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE ## Abstract A liquid pharmaceutical solution having antimicrobial agent(s), an organic solvent, and an acidic or basic aqueous medium therein. Most preferred solutions include trimethoprim, sodium hydroxide, sulfadiazine, N-methylpyrrolidone and water. The present invention is also directed toward making these solutions. A most preferred composition includes: trimethoprim in an amount of about 40 mg/ml of liquid pharmaceutical solution; sulfadiazine in an amount of about 200 mg/ml of liquid pharmaceutical solution; N-methylpyrrolidone in an amount of about 514 mg/ml of liquid pharmaceutical solution, sodium hydroxide in an amount of about 30 mg/ml of liquid pharmaceutical solution and water. Methods of making the pharmaceutical solution preferably include combining the following in any order: trimethoprim, N-methylpyrrolidone, sulfadiazine, and an acidic or basic aqueous medium. Other additives, such as antioxidants and preservatives, can also be added to the liquid pharmaceutical solution. ## Claims ### Claim 1 A stable liquid pharmaceutical solution comprising: about 3 to about 50 mg trimethoprim per ml liquid pharmaceutical solution, about 16 to about 250 mg sulfadiazine per ml liquid pharmaceutical solution, about 42 to about 645 mg N-methylpyrrolidone per ml liquid pharmaceutical solution, and a remainder of an acidic or basic aqueous medium. ### Claim 2 (depends on 1) The solution of claim 1, further comprising a preservative. ### Claim 3 (depends on 1) The solution of claim 1, further comprising an antioxidant. ### Claim 4 A liquid pharmaceutical solution comprising: (a) trimethoprim in an amount of at least about 3 mg/ml of liquid pharmaceutical solution; (b) sulfadiazine in an amount of at least about 16 mg/ml of liquid pharmaceutical solution; (c) N-methylpyrrolidone in an amount of at least about 42 mg/ml of liquid pharmaceutical solution; (d) sodium hydroxide in an amount of at least about 2 mg/ml liquid pharmaceutical solution; and (e) water in an amount to complete the solution. ### Claim 5 (depends on 4) The solution of claim 4, further comprising benzyl alcohol in an amount of at least about 0.8 mg/ml of liquid pharmaceutical solution. ### Claim 6 A method of preparing a stable liquid pharmaceutical solution, the method comprising: combining in any order about 3 to about 50 mg trimethoprim per ml liquid pharmaceutical solution, about 42 to about 645 mg N-methylpyrrolidone per ml liquid pharmaceutical solution, about 16 to about 250 mg sulfadiazine per ml liquid pharmaceutical solution, and a remainder of an acidic or basic aqueous medium to form a stable liquid pharmaceutical solution. ### Claim 7 (depends on 6) The method of claim 6, further comprising combining a preservative to form a liquid pharmaceutical solution. ### Claim 8 A method for treating a bacterial infection in an animal comprising: (a) administering to the animal a stable liquid pharmaceutical solution in an amount effective to treat the bacterial infection; wherein the stable liquid pharmaceutical solution comprises: about 3 to about 50 mg trimethoprim per ml liquid pharmaceutical solution, about 16 to about 250 mg sulfadiazine per ml liquid pharmaceutical solution, about 42 to about 645 mg N-methylpyrrolidone per ml liquid pharmaceutical solution, and a remainder of an acidic or basic aqueous medium. ### Claim 9 (depends on 8) The method of claim 8, wherein administering includes orally administering the solution to the animal. ### Claim 10 A method of preparing a stable liquid pharmaceutical solution, the method comprising: combining in any order about 3 to about 50 mg trimethoprim per ml liquid pharmaceutical solution, about 42 to about 645 mg N-methylpyrrolidone per ml liquid pharmaceutical solution, about 16 to about 250 mg sodium sulfadiazine per ml liquid pharmaceutical solution, and a remainder of water to form a stable liquid pharmaceutical solution.