TOPICAL PHARMACEUTICAL COMPOSITIONS OF ANTI-MICROBIAL AGENTS AND ANTI-INFLAMMATORY AGENTS
The present invention provides sterile, storage-stable topical pharmaceutical compositions intended for application to the eye, ear or nose comprising Dexamethsone and Ciprofloxacin. The topical pharmaceutical compositions of invention comprises combination of ionic tonicity agent and non-ionic tonicity agent(s). The topical pharmaceutical compositions further comprises boric acid. The invention provides a process for preparing and sterilizing the compositions in order to reduce the amount of related compounds and impurities associated with the topical compositions on storage. The topical pharmaceutical compositions of invention found storage-stable, have easy resuspendability.
1 : A topical pharmaceutical composition intended for application to the eye, ear or nose comprising
a. anti-inflammatory agent(s);
b. anti-microbial agent(s);
c. ionic tonicity agent(s);
d. non-ionic tonicity agent(s),
wherein when the ionic tonicity agent is sodium chloride, the composition has osmolality of more than 272 mOsmol/kg at a pH of 4.5±0.5; and wherein the composition optionally comprises non-ionic polymer, non-ionic surfactant, boric acid, preservative, chelating agent or buffer.
2 : The topical pharmaceutical composition according to claim 1 , wherein anti-inflammatory agent(s) selected from Dexamethasone, Hydrocortisone or their pharmaceutically acceptable derivatives.
3 : The topical pharmaceutical composition according to claim 1 , wherein anti-microbial agent(s) selected from Ciprofloxacin, Moxifloxacin, Gatifloxacin, Norfloxacin, Perfloxacin, Amifloxacin, Pirfloxacin, Ofloxacin, Enoxacin or their pharmaceutically acceptable derivatives.
4 : The topical pharmaceutical composition according to claim 1 , wherein ionic tonicity agent(s) selected from sodium chloride, potassium chloride, magnesium chloride or calcium chloride.
5 : The topical pharmaceutical composition according to claim 1 , wherein non-ionic tonicity agent(s) selected from glycerine, dextrose or mannitol.
6 : A topical pharmaceutical composition intended for application to the eye, ear or nose comprising
a. anti-inflammatory agent(s);
b. anti-microbial agent(s);
c. ionic tonicity agent(s);
d. boric acid,
wherein ionic tonicity agent is present in an amount not more than 0.3% (wt.) and wherein the composition optionally comprises non-ionic tonicity agent, non-ionic polymer, non-ionic surfactant, preservative, chelating agent or buffer.
7 : A topical pharmaceutical composition intended for application to the eye, ear or nose comprising
a. 0.01-0.5% (wt.) Dexamethasone;
b. 0.1-0.4% (wt.) Ciprofloxacin;
c. ionic tonicity agent(s) in an amount not more than 0.3% (wt.);
d. 0.1-1.5% (wt.) boric acid,
wherein the composition has osmolality of about 250-350 mOsmol/kg at a pH of 4.5±0.5; and
wherein the composition optionally comprises non-ionic tonicity agent, non-ionic polymer, non-ionic surfactant, preservative, chelating agent or buffer.
8 : The topical pharmaceutical composition of claim 7 , wherein ionic tonicity agent(s) is sodium chloride.
9 : The topical pharmaceutical composition of claim 7 , is sterilized by using one or more methods selected from heat sterilization, gaseous sterilization, filtration sterilization or radiation sterilization.
10 : The topical pharmaceutical composition of claim 9 , comprises not more than 2.6% w/w of 20-carboxy-17-desoxy related compound when stored under conditions of 40° C./75% RH for period of 3 months.