Betel quid cessation therapy with nicotine and pilocarpine

Patent metadata

Field	Value
Publication number	US-2021361640-A1
Application number	US-201916962827-A
Country	US
Kind code	A1
Filing date	Jan 17, 2019
Priority date	Jan 17, 2018
Publication date	Nov 25, 2021
Grant date	—

Abstract

Provided herein are compositions comprising nicotine, or a salt thereof, and pilocarpine, or a salt thereof, useful for reducing the use of betel quid and/or achieving betel quid cessation (e.g., replacement therapy). Also provided herein are methods of using the compositions in reducing the risk of developing or reducing the progression of a disease (e.g., cancer, oral disease, neurological disease, or painful condition). Compositions of the present invention may be administered to a subject with an addiction, e.g., a betel quid addiction, areca nut addiction, and/or nicotine addiction.

First claim

1 .- 16 . (canceled)

17 . A composition comprising nicotine, or a salt thereof, pilocarpine, or a salt thereof, and optionally an acceptable carrier, adjuvant, excipient, or buffer for oral administration.

18 .- 43 . (canceled)

44 . A method for eliminating and/or reducing the severity of withdrawal symptoms due to the cessation of betel quid and/or areca nut use, the method comprising administering to a subject in need thereof a composition comprising nicotine, or a salt thereof, and a composition comprising pilocarpine, or a salt thereof.

45 . The method of claim 44 , wherein the betel quid and/or areca nut is in the form of smokeless or chewing betel quid, or an equivalent preparation.

46 . The method of claim 44 , wherein the subject also uses tobacco, betel leaves, roots, stems, or seeds, areca nut, slacked lime, or a combination thereof.

47 . The method of claim 44 , wherein the subject has attempted one or more nicotine-replacement therapies.

48 .- 67 . (canceled)

68 . A kit comprising a composition comprising nicotine, or a salt thereof, and a composition comprising pilocarpine, or a salt thereof.

69 . The kit of claim 68 , wherein the pilocarpine is a pilocarpine product extracted from Pilocarpus microphyllus.

70 . The kit of claim 68 , wherein the pilocarpine is substantially pure.

71 . The kit of claim 68 , wherein the pilocarpine is pilocarpine hydrochloride.

72 . The kit of claim 68 , wherein the total pilocarpine concentration in the composition is between 0.01% and 4%.

73 . The kit of claim 68 , wherein the composition is a gum.

74 . The kit of claim 73 , wherein the gum comprises between 1 mg and 4 mg nicotine, or a salt thereof.

75 . The kit of claim 68 , wherein the composition comprises between 1 mg and 5 mg nicotine, or a salt thereof.

76 . The kit of claim 68 , wherein the composition comprises 2 mg nicotine, or a salt thereof.

77 . The kit of claim 68 , wherein the composition comprises 4 mg nicotine, or a salt thereof.

78 . The kit of claim 68 , wherein the composition further comprises a gum base.

79 . The kit of claim 68 , wherein the composition is formulated for oral delivery.

80 . The kit of claim 68 , wherein the composition is formulated as a chewing gum.

81 . The kit of claim 68 , wherein the composition is formulated as a lozenge or tablet.

82 . The kit of claim 68 , comprising a container.

Assignees

• Univ Florida

Inventors

• Papke Roger L
• Glatman Samuel Leslie

Classifications

• A61K31/465 Primary

  Nicotine; Derivatives thereof · CPC title

• A61K31/4178

  not condensed 1,3-diazoles and containing further heterocyclic rings, e.g. pilocarpine, nitrofurantoin · CPC title

• A61P25/30

  for treating abuse or dependence · CPC title

• A61K9/0056

  Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals · CPC title

• A61K36/75

  Rutaceae (Rue family) · CPC title