US2022062424A1PendingUtilityA1

Preservative containing compositions

69
Assignee: JOHNSON & JOHNSON CONSUMER INCPriority: Mar 4, 2016Filed: Nov 9, 2021Published: Mar 3, 2022
Est. expiryMar 4, 2036(~9.6 yrs left)· nominal 20-yr term from priority
Inventors:Mingqi BaiKenneth T. Holeva
A61P 31/10A61P 29/02A61K 47/38A61K 33/22A61K 33/14A61K 31/728A61K 31/4164A61K 31/19A61K 31/14A01N 59/14A01N 43/50A01N 43/16A01N 43/08A01N 37/44A01N 37/36A01N 33/12A01N 31/02A61K 31/4402A61P 27/14A61P 27/04A61P 37/08A61K 47/12A61K 9/0048A61P 25/04A61K 47/02Y02A50/30A61P 31/04A61K 47/22A61K 47/186A61K 47/26A61K 47/10A61P 31/00A61P 27/06A61P 27/02A61P 9/00A61P 29/00A61K 9/08A61K 47/34
69
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Claims

Abstract

The present invention relates to compositions providing improved preservative efficacy. The present invention further relates to polyquaternium compound containing compositions having improved the antifungal activity. In certain embodiments, the present invention relates to ophthalmic compositions comprising a polyquaternium compound, a polyol or combination of polyols, borate compound, and an antimicrobial mixture comprising electrolytes and nutrients.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A composition, comprising:
 a) from about 0.0005% w/v to about 0.1000% w/v, of the total composition, of a polyquaternium compound;   b) optionally, from about 0.2% w/v to about 2.0% w/v, of the total composition, of an amount of a polyol or combination polyols;   c) from about 0.02% w/v to about 1.5% w/v, of the total composition, of a borate; and   e) an antimicrobial mixture comprising:
 iii. one or more nutrients; and 
 iv. optionally, one or more electrolytes 
 such that: 
 a. the total nutrient concentration, in the total composition, is from about 1.0 mMol/L to about 4.0 mMol/L of the composition; and 
 b. when present, the total electrolyte concentration, in the total composition, is from about 20.0 mMol/L to about 80.0 mMol/L of the composition. 
   
     
     
         2 . The composition of  claim 1  wherein the polyquaternium compound has a weight average molecular weight of from about 150 to about 15,000 Daltons. 
     
     
         3 . The composition of  claim 2 , wherein the polyquaternium compound has a weight average molecular weight of from about 200 to about 13,500 Daltons 
     
     
         4 . The composition of  claim 3 , wherein the polyquaternium compound has a weight average molecular weight of from about 250 to about 12,000 Daltons. 
     
     
         5 . The composition of  claim 1 , wherein the composition comprises from about 0.0010% w/v to about 0.0200% w/v, of the total composition, of the polyquaternium compound. 
     
     
         6 . The composition of  claim 5 , wherein the composition comprises from about 0.0010% w/v to about 0.0050% w/v, of the total composition, of the polyquaternium compound. 
     
     
         7 . The composition of  claim 1 , wherein the polyquaternium compound is selected from the group consisting of polyquatemium-1, polyquaternium-10, polyquaternium-42 or mixtures. 
     
     
         8 . The composition of  claim 7 , wherein the polyquaternium compound is polyquaternium-42. 
     
     
         9 . The composition of  claim 1 , wherein the composition comprises from about 0.2% w/v to about 1.7% w/v, of the total composition, of the polyol. 
     
     
         10 . The composition of  claim 9 , wherein the composition comprises from about 0.4% w/v to about 1.5% w/v, of the total composition, of the polyol. 
     
     
         11 . The composition of  claim 1 , wherein the polyol is selected from the group consisting of sugars, sugar alcohols, sugar acids, uronic acids and mixtures thereof. 
     
     
         12 . The composition of  claim 11 , wherein the polyol is selected from the group consisting of sugars, sugar alcohols, sugar acids and mixtures thereof. 
     
     
         13 . The composition of  claim 12 , wherein the polyol is selected from the group consisting of mannitol, glycerin, polysorbate 80, propylene glycol, polyethylene glycol, sorbitol and mixtures thereof. 
     
     
         14 . The composition of  claim 1 , wherein the composition comprises from about 0.04% w/v to about 1.0% w/v, of the total composition, of the borate. 
     
     
         15 . The composition of  claim 14 , wherein the composition comprises from about 0.06% w/v to about 0.60% w/v, of the total composition, of the borate. 
     
     
         16 . The composition of  claim 1 , wherein the borate is selected from the group consisting of sodium borate, potassium borate, calcium borate, magnesium borate, manganese borate; and mixtures thereof. 
     
     
         17 . The composition of  claim 1 , wherein the total nutrient concentration, in the total composition, is from about 2.0 mMol/L to about 3.0 mMol/L of the composition. 
     
     
         18 . The composition of  claim 17 , wherein the total nutrient concentration, in the total composition, is from about 2.8 mMol/L to about 3.0 mMol/L of the composition. 
     
     
         19 . The composition of  claim 1 , wherein the total nutrient concentration of the composition comprises one or more of:
 a. lactate at a concentration of from about 0 mMol/L to about 10.0 mMol/L of the total composition;   b. citrate at a concentration of from about 0 mMol/L to about 0.5 mMol/L of the total composition;   c. phosphate at a concentration of from about 0 mMol/L to about 10 mMol/L of the total composition   d. glucose at a concentration of from about 0.1 mMol/L to about 25 mMol/L of the total composition;   e. ascorbic acid at a concentration of from about 0.0003 mMol/L to about 0.0010 mMol/L of the total composition.   
     
     
         20 . The composition of  claim 1 , wherein the total electrolyte concentration, in the total composition, is from about 30 mMol/L to about 70 mMol/L of the total composition. 
     
     
         21 . The composition of  claim 20 , wherein the total electrolyte concentration, in the total composition, is from about 40 mMol/L to about 60 mMol/L of the composition. 
     
     
         22 . The composition of  claim 1 , wherein the total electrolyte concentration comprises one or more of:
 a. potassium at a concentration of from about 24 mMol/L to about 28 mMol/L of the total composition;   b. sodium at a concentration of from about 5 mMol/L to about 10 mMol/L of the total composition;   c. magnesium at a concentration of from about 0.50 mMol/L to about 0.80 mMol/L of the total composition; and   d. chloride at a concentration of from about 23 mMol/L to about 28 mMol/L of the total composition.   
     
     
         23 . A method for treating or preventing dry eye comprising the step of applying the composition of  claim 1  to a subject in need of such treatment or prevention. 
     
     
         24 . A method for treating or preventing minor eye irritation comprising the step of applying the composition of  claim 1  to a subject in need of such treatment or prevention. 
     
     
         25 . A method for treating or preventing eye allergy comprising the step of applying the composition of  claim 1  to a subject in need of such treatment or prevention. 
     
     
         26 . A method for improving overall preservative efficacy of a liquid composition, comprising the step of combining:
 a) from about 0.0005% w/v to about 0.1000% w/v, of the total composition, of a polyquaternium compound;   b) optionally, from about 0.2% w/v to about 2.0% w/v, of the total composition, of an amount of a polyol or combination polyols;   c) from about 0.02% w/v to about 1.5% w/v, of the total composition, of a borate; and   d) an antimicrobial mixture comprising:
 i. one or more nutrients; and 
 ii. optionally, one or more electrolytes 
 such that: 
 a. the total nutrient concentration, in the total composition, is from about 1.0 mMol/L to about 4.0 mMol/L of the composition; and 
 c. when present, the total electrolyte concentration, in the total composition, is from about 20.0 mMol/L to about 80.0 mMol/L of the composition. 
   
     
     
         27 . The method of  claim 26 , wherein the preservative efficacy of the liquid composition satisfies the criteria of the EP B Criteria described in the Specification. 
     
     
         28 . The method of  claim 27 , wherein the liquid composition is an aqueous liquid preparation. 
     
     
         29 . A method for improving antifungal activity of a liquid composition, comprising the step of combining:
 a) from about 0.0005% w/v to about 0.1000% w/v, of the total composition, of a polyquaternium compound;   b) optionally, from about 0.2% w/v to about 2.0% w/v, of the total composition, of an amount of a polyol or combination polyols;   c) from about 0.02% w/v to about 1.5% w/v, of the total composition, of a borate; and   d) an antimicrobial mixture comprising:
 i. one or more nutrients; and 
 ii. optionally, one or more electrolytes 
 such that: 
 a. the total nutrient concentration, in the total composition, is from about 1.0 mMol/L to about 4.0 mMol/L of the composition; and 
 c. when present, the total electrolyte concentration, in the total composition, is from about 20.0 mMol/L to about 80.0 mMol/L of the composition. 
   
     
     
         30 . The method of  claim 29 , wherein, when tested accordance with the EP B Critera described in the Specification, the liquid composition provides fungicidal effect of greater than or equal to 1 log reduction of viable cell count of fungi 14 days after inoculation of the composition with the fungi. 
     
     
         31 . The method of  claim 30 , wherein, when tested accordance with the EP B Critera described in the Specification, the liquid composition provides fungicidal effect of greater than or equal to about 2 log reduction of viable cell count of fungi 14 days after inoculation of the composition with the fungi. 
     
     
         32 . A composition comprising the following formulation:
 a. from about 0.01% w/v to about 0.2% w/v vasoconstrictor;   b. from about 0.0015% w/v to about 0.0036% w/v polyquaternium 42;   c. from about 0.2% w/v to about 1.2% w/v polyethylene glycol 400;   d. from about 0.2% w/v to about 1.3% w/v glycerin;   e. from about 0.004% w/v to about 0.6% w/v borate;   f. from about 0.05% w/v to about 0.2% w/v lactate or pharmaceutically acceptable salt thereof;   g. from about 0.003% w/v to about 0.4% w/v, optionally 0.003% to about 0.04% w/v glucose;   h. from about 0% w/v to about 2.5% w/v hypromellose; and   i. water.   
     
     
         33 . The composition of  claim 32  wherein the pharmaceutically active compound is selected from glaucoma therapeutics, pain relievers, anti-inflammatory, vaso-constrictors, dry eye relievers and anti-allergy medications, anti-infectives or mixtures thereof. 
     
     
         34 . A composition, comprising:
 a) from about 0.0005% w/v (weight to volume) to about 0.1000% w/v, of the total composition, of a polyquaternium compound; and   b) from about 0.002% w/v to about 1% w/v, of saccharide selected from monosaccharide, disaccharide, isomers thereof or mixtures thereof.   
     
     
         35 . The composition of  claim 34  wherein the saccharide is a monosaccharide. 
     
     
         36 . A method for preventing the growth of or reducing the number of viable fungal organisms in an environment or medium, comprising the steps of;
 a.) preparing a composition comprising:
 i) from about 0.0005% w/v (weight to volume) to about 0.1000% w/v, of the total composition, of a polyquaternium compound; and 
 ii) from about 0.002% w/v to about 1% w/v, of saccharide selected from monosaccharide, disaccharide, isomers thereof or mixtures thereof; and 
   b.) administering the composition to the environment or medium.   
     
     
         37 . The method of  claim 36 , wherein the fungal organism is mold. 
     
     
         38 . The method of  claim 36  wherein the saccharide is a monosaccharide.

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