# US 9,433,580 B2 · Topical pharmaceutical composition comprising nanonized silver sulfadiazine > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 9,433,580 B2 - Document ID: US9433580B2 - Status: Granted - Kind: B2 - Application number: 13/762,792 - Filed: 2013-02-08 - Published: 2014-03-06 - Granted: 2016-09-06 - Earliest claimed: 2012-08-30 - Assignees: Sun Pharmaceutical Industries Limited - Applicants: Ranbaxy Laboratories Limited - Inventors: Neeta Gupta; Simrata Bedi; Jyoti Srivastava; Vinod Kumar Arora; Manisha Pandya; Vyas M. Shingatgeri; Jaiprakash Jaysingrao Bhelonde; Monika Obrah; Sanjay Kumar Sharma; Rajinder K. Jalali; Sudershan Kumar Arora - Web page: https://patentgrep.com/patent/US9433580B2 ## CPC - A61K 9/14: Particulate form, e.g. powders, {Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles (microspheres A61K9/16; microcapsules A61K9/50; nanocapsules, nanoparticles of the matrix type A61K9/51)} - A61K 9/0014: {Skin, i.e. galenical aspects of topical compositions (non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00)} - A61K 31/155: Amidines ([IMAGE cpc-sch-A61K-1029.gif]), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2) - A61K 31/555: containing heavy metals, e.g. hemin, hematin, melarsoprol - A61K 31/635: having a heterocyclic ring, e.g. sulfadiazine - A61K 33/38: Silver; Compounds thereof - 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) ## Abstract The invention relates to a topical pharmaceutical composition for burn treatment and microbial infections on human beings or animals. The pharmaceutical composition comprises 0.1% w/w to 1.0% w/w of an antimicrobial drug, i.e., silver sulfadiazine and 0.2% w/w antiseptic, i.e., chlorhexidine gluconate, wherein silver sulfadiazine is in nanonized form. ## Claims ### Claim 1 A topical pharmaceutical composition consisting of 0.1% w/w to 1.0% w/w silver sulfadiazine, 0.2% w/w chlorhexidine gluconate, and one or more pharmaceutically acceptable excipients wherein silver sulfadiazine has a Z-average particle size between 150 nm and 500 nm. ### Claim 2 (depends on 1) The topical pharmaceutical composition according to claim 1, wherein silver sulfadiazine having dose 0.5% w/w to 0.75% w/w has the same efficacy as a composition containing 1.0% w/w micronized silver sulfadiazine. ### Claim 3 (depends on 2) The topical pharmaceutical composition of claim 2, wherein the efficacy is determined by: a) proportion of patients achieving complete wound closure by day 21 of the treatment period; or b) microbial log reduction of Pseudomonas aeruginosa count in thermal injury model in rats. ### Claim 4 (depends on 3) The topical pharmaceutical composition of claim 3, wherein the application of the nanonized composition to patients leads to complete wound closure by day 21 of treatment period in at least 90% of the total patient population. ### Claim 5 (depends on 3) The topical pharmaceutical composition of claim 3, wherein the microbial log reduction of Pseudomonas aeruginosa count in a thermal injury model in rats using the topical pharmaceutical composition is comparable to that caused by the composition containing 1.0% w/w micronized silver sulfadiazine. ### Claim 6 (depends on 1) The topical pharmaceutical composition of claim 1, wherein the composition further comprises pharmaceutically acceptable excipients selected from one or more of thickening agents, emulsifying agents, preservatives, chelating agents, pH modifiers, coloring agents, perfumes, and antioxidants. ### Claim 7 (depends on 6) The topical pharmaceutical composition of claim 6, wherein the thickening agent is selected from one or more of soft paraffin, aluminum stearate, cetostearyl alcohol, propylene glycol, polyethylene glycols, povidone, wool-fat, hydrogenated lanolin, or beeswax. ### Claim 8 (depends on 6) The topical pharmaceutical composition of claim 6, wherein the emulsifying agent is selected from one or more of cetomacrogol, non-ethoxylated glyceryl monostearate, carbopols, cetearyl alcohol, sodium stearoyl lactylate, or lecithin. ### Claim 9 (depends on 6) The topical pharmaceutical composition of claim 6, wherein the preservative is selected from one or more of methylparaben, propylparaben, benzyl alcohol, benzoic acid, sodium benzoate, chlorocresol, sorbic acid and its salt, or phenylethyl alcohol. ### Claim 10 (depends on 6) The topical pharmaceutical composition of claim 6, wherein the chelating agent is selected from one or more of dimercaprol, ethylene diamine tetra acetic acid (EDTA), ethylene glycol tetraacetic acid, deferoxamine, or alfa lipoic acid. ### Claim 11 (depends on 6) The topical pharmaceutical composition of claim 6, wherein the pH modifier is selected from one or more of citric acid, sodium citrate, acetic acid, sodium acetate, phosphoric acid, sodium phosphate, borax, or sodium hydroxide. ### Claim 12 (depends on 1) The topical pharmaceutical composition according to claim 1, wherein the composition is in the form of a cream, lotion, ointment, or gel.