Composition and method for vancomycin oral liquid
The invention relates to stable vancomycin hydrochloride powder for oral liquid formulations. Also provided herein are methods of using vancomycin oral liquid formulations for the treatment of certain diseases such as Clostridium difficile pseudomembranous colitis and Staphylococcal enterocolitis as well as kits and related products thereof.
1. A non-sterile stable liquid formulation formulated for oral administration, consisting of:
(a) a buffering agent, wherein the buffering agent is selected from the group consisting of citric acid, sodium citrate, sodium tartarate, sodium acetate, sodium carbonate, sodium polyphosphate, potassium polyphosphate, sodium pyrophosphate, potassium pyrophosphate, disodium hydrogen phosphate, trisodium phosphate, tripotassium phosphate, sodium acetate, potassium metaphosphate, magnesium oxide, magnesium carbonate, magnesium silicate, calcium acetate, calcium glycerophosphate, calcium chloride, calcium hydroxide, calcium lactate, calcium carbonate, calcium bicarbonate, and calcium salts,
(b) water,
(c) optionally a sweetener,
(d) a preservative, wherein the preservative is selected from the group consisting of sodium benzoate, parabens, benzoic acid, potassium sorbate, benzyl alcohol or salts thereof,
(e) optionally a flavoring agent and
(f) vancomycin hydrochloride,
wherein the non-sterile stable liquid formulation is homogenous and stable for at least 1 week at ambient and refrigerated temperature and has a pH of 2.5-4.5.
2. The liquid formulation of claim 1 , wherein the buffer is citric acid 0.12% w/v.
3. The liquid formulation of claim 1 , wherein the preservative is sodium benzoate 0.02-0.08% w/v.
4. The liquid formulation of claim 1 , wherein the sweetener is 0.1-0.3% w/v.
5. A non-sterile stable liquid formulation formulated for oral administration, consisting of:
(a) citric acid,
(b) water,
(c) optionally a sweetener,
(d) a preservative, wherein the preservative is selected from the group consisting of sodium benzoate, parabens, benzoic acid, potassium sorbate, benzyl alcohol or salts thereof,
(e) optionally a flavoring agent, and
(f) vancomycin hydrochloride,
wherein the non-sterile stable liquid formulation is homogenous and stable for at least 1 week at ambient and refrigerated temperature and has a pH of 2.5-4.5.
6. The liquid formulation of claim 5 , wherein the citric acid is 0.12% w/v.
7. The liquid formulation of claim 5 , wherein the preservative is sodium benzoate 0.02-0.08% w/v.
8. The liquid formulation of claim 5 , wherein the sweetener is 0.1-0.3% w/v.
9. The liquid formulation of claim 5 , wherein the formulation is free of flavoring agent.