AQUEOUS GEL FORMULATION AND METHOD FOR INDUCING TOPICAL ANESTHESIA
First Claim
1. An aqueous gel formulation comprising water, an anesthetic, a viscoelastic polymer, and a tonicity modifier, wherein the anesthetic is present in an amount of 15 mg per ml to about 50 mg per ml of the formulation, wherein the aqueous gel formulation is free of preservatives and phosphate buffer, is isotonic with physiological fluids, and is sterile having less than about 100 particles of 50 microns particle size or more per ml of the aqueous gel formulation.
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Abstract
Disclosed is a stable aqueous gel formulation suitable for topical use comprising water, an anesthetic (e.g., lidocaine hydrochloride), a viscoelastic polymer, and a tonicity modifier, wherein the aqueous gel formulation is free of preservatives and phosphate buffer, is isotonic with physiological fluids, and is sterile and has low particulate count. Also disclosed is a method of inducing topical anesthesia on a tissue or organ, e.g., the eye, of an animal comprising providing a stable aqueous gel formulation comprising water, an anesthetic, a viscoelastic polymer, and a tonicity modifier, wherein the aqueous gel formulation is free of preservatives and phosphate buffer, is isotonic with physiological fluids, and is sterile, and topically administering an effective amount of the aqueous gel formulation to the tissue or organ of the animal.
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Citations
26 Claims
- 1. An aqueous gel formulation comprising water, an anesthetic, a viscoelastic polymer, and a tonicity modifier, wherein the anesthetic is present in an amount of 15 mg per ml to about 50 mg per ml of the formulation, wherein the aqueous gel formulation is free of preservatives and phosphate buffer, is isotonic with physiological fluids, and is sterile having less than about 100 particles of 50 microns particle size or more per ml of the aqueous gel formulation.
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11. A method of inducing topical anesthesia in a tissue or organ of an animal comprising:
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a) providing an aqueous gel formulation comprising water, an anesthetic, a viscoelastic polymer, and a tonicity modifier, wherein the anesthetic is present in an amount of 15 mg per ml to about 50 mg per ml of the formulation, and the gel formulation is free of preservatives and phosphate buffer, is isotonic with physiological fluids, and is sterile having less than about 100 particles of 50 microns particle size or more per ml of the aqueous gel formulation; and b) topically administering an effective amount of the aqueous gel formulation to the tissue or organ of the animal; whereby anesthesia is induced on the tissue or organ of the animal. - View Dependent Claims (12, 13, 14, 15, 16, 17, 21, 22, 23, 24)
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- 18. An aqueous gel formulation comprising water, an anesthetic or a salt thereof, a viscoelastic polymer, and a tonicity modifier, wherein the anesthetic is present in an amount of 25 mg per ml to 38 mg per ml of the formulation, and the aqueous gel formulation is free of preservatives and phosphate buffer, is isotonic with physiological fluids, and is sterile having less than about 100 particles of 50 microns particle size or more per ml of the aqueous gel formulation and suitable for topical administration to the eye.
- 25. An aqueous gel formulation consisting essentially of water, lidocaine hydrochloride, hydroxypropylmethylcellulose, and sodium chloride, wherein the lidocaine hydrochloride is present in an amount so as to provide a 1.5%, 2.5%, or 3.5% by weight of lidocaine in the formulation, wherein the aqueous gel formulation is isotonic with physiological fluids and is sterile having less than about 100 particles of 50 microns particle size or more per ml of the aqueous gel formulation.
Specification