Method for anesthetizing a body part, organ, or tissue utilizing an anesthetic comprising tetracaine and a vasoconstrictor
The present invention relates to tetracaine based anesthetic formulations and methods of use thereof The invention further relates to topical formulations of tetracaine and methods of topically anesthetizing body tissues. The present invention also relates to tetracaine based dental anesthetic formulations and methods for anesthetizing the maxillary dental arch using these formulations.
1 - 20 . (canceled)
21 . A method for anesthetizing at least a portion of a body part, organ, or tissue by delivering a pharmaceutical composition comprising:
2 . 5-3.5% (w/v) tetracaine, or a pharmaceutically acceptable salt thereof;
a vasoconstrictor; and
a pharmaceutically acceptable carrier, wherein said pharmaceutical composition has a pH of about 4.0-7.5.
22 . The method according to claim 21 , wherein said pharmaceutical composition is delivered by nebulization or spraying.
23 . The method according to claim 22 , wherein said delivered spray is a stream or a plume.
24 . The method according to claim 21 , wherein about 12-50 mg of tetracaine is delivered to said subject.
25 . The method according to claim 21 , wherein about 15-24 mg of tetracaine is delivered to said subject.
26 . The method according to claim 22 , wherein the particle size of said pharmaceutical composition that is delivered to said subject is about 5-50 microns.
27 . The method according to claim 22 , wherein the particle size of said pharmaceutical composition is about 10-20 microns.
28 . The method according to claim 22 , wherein the particle size of said pharmaceutical composition is about 10 microns or larger.
29 . The method according to claim 22 , wherein at least 85% of the particles of the pharmaceutical composition are about 10 microns or larger.
30 . The method according to claim 21 , wherein said tissue is epithelial tissue.
31 . The method according to claim 21 , wherein said tissue is mucosal tissue.
32 . The method according to claim 21 , wherein said body part, organ, or tissue is present in the ear, mouth, eye nose, rectal area or urogenital tract.
33 . The method according to claim 21 , wherein said pharmaceutical composition is delivered topically.
34 . The method according to claim 21 , wherein said pharmaceutical composition is injected into said body part, organ, or tissue.
35 . The method according to claim 21 , wherein said pharmaceutical composition is delivered by nebulization, iontophoresis, laser, ultrasound or spraying.
36 . The method according to claim 21 , wherein said pharmaceutical composition comprises:
Ingredient
Formulation (% w/v)
Tetracaine hydrochloride, USP
3.00
Oxymetazoline hydrochloride, USP
0.05
Citric acid anhydrous, USP
1.00
Sodium hydroxide, NF
q.s.
Benzyl alcohol, NT
0.90
Hydrochloric acid, NF
q.s.
Hydroxyethylcellulose, NF (5000 cps)
0.05
Purified water, USP
q.s. to 100
37 . The method according to claim 21 , wherein the particle size of said delivered pharmaceutical composition is about 5-50 microns (μm).
38 . The method according to claim 21 , wherein the particle size of said delivered pharmaceutical composition is about 10-20 microns (μm).
39 . The method according to claim 21 , wherein the particle size of said pharmaceutical composition is delivered in a manner such that at least 85% of the particles are at least about 10 microns (μm) or larger.
40 . The method according to claim 21 , wherein the particle size of said delivered pharmaceutical composition is about 10 microns (μm) or larger.