Dental gel composition of papain for the atraumatic treatment of caries and method of preparing same
AssigneeBrix USA, LLC
InventorMauricio DOBBOLETTA
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Abstract
A papain dental gel composition is disclosed for the atraumatic treatment of caries which comprises papain with a final activity of at least 3,000 U/mg, wherein the papain is bio-encapsulated in a mixture of pH=7 buffer-C3-6 polyol-pectin-C2-6 alkanolamine-nonionic emulsifier, together with pharmaceutically acceptable coloring agents, preservatives and solvents. A method of preparing said papain composition is also disclosed.
Claims24
A dental composition of papain in the form of a gel for the atraumatic treatment of caries comprising papain with a final activity of at least 3,000 U/mg, wherein the papain is bio-encapsulated in a mixture of pH=7 buffer-C3-6 polyol-pectin-C2-6 alkanolamine-nonionic emulsifier, together with pharmaceutically acceptable coloring agents, preservatives and solvents.
A dental composition of papain in the form of a gel for the atraumatic treatment of caries, said composition comprising papain (30,000 U/mg) 10.00% w/w, citrus pectin 8.00% w/w, propyleneglycol 8.00% w/w, triethanolamine (99%) 0.72% w/w, polyoxyethylene sorbitan monooleate with 20 EO (TW 80) 0.50% w/w, KH2PO4 0.0378% w/w, Na2HPO4 0.1283%, toluidine blue (1% w/w aq. sol.) 0.09% w/w, methylparaben 0.10% w/w, propylparaben 0.05% w/w, and distilled water 72.37% w/w.
A method of preparing a papain dental composition for the atraumatic treatment of caries, said method comprising:
- a) adding to distilled water while stirring at approximately 1,500 rpm the components of a pH=7 buffer, one or more pharmaceutically acceptable preservatives, and finally 30,000 U/mg papain until complete dispersion to a final neutral pH (pH=7);
- b) wetting pectin while stirring in a C3-6 polyol, then adding the non-ionic emulsifier, and finally a C2-6 alkanolamine until neutralization of the pectin acidity thus forming a neutral encapsulating emulsion (pH=7);
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- c) adding the neutral encapsulating emulsion from step b) to the dispersion obtained in step a) under low speed stirring to obtain a buffer encapsulating emulsion (BEE), in the form of a stable gel of the papain dispersion.
A method of preparing a papain dental composition for the atraumatic treatment of caries, said method comprising:
- a) adding to distilled water while stirring at approximately 1,500 rpm potassium monobasic phosphate, sodium diacid phosphate, methylparaben, propylparaben, and finally 30,000 U/mg papain until complete dispersion to a final neutral pH (pH=7);
- b) wetting while stirring citrus pectin in propyleneglycol, adding polyoxyethylene sorbitan monooleate 20 (Tween 80), and finally triethanolamine until neutralization of the citrus pectin thus forming a neutral encapsulating emulsion (pH=7), wherein the concentration ratio of citrus pectin/propyleneglycol/triethanolamine employed ranges from 4/4/0.36 to 10/10/0.90 expressed in % w/w, respectively;
- c) adding the neutral encapsulating emulsion from step b) to the dispersion obtained in step a) under low speed stirring between approximately 20 and approximately 150 rpm to obtain a buffer encapsulating emulsion (BEE), in the form of a stable gel of the papain dispersion;
- d) adding under stirring to the stable gel of the papain dispersion blue toluidine as coloring agent dissolved in a pharmaceutically acceptable solvent;
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- e) packing the obtained gel into multi-dose syringes.
Dependencies are inferred from the claim text.