Chewing Gum Compositions Providing Rapid Release of Nicotine

• US 20100061940A1
• Filed: 03/16/2007
• Published: 03/11/2010
• Est. Priority Date: 03/16/2006
• Status: Active Application

• Current Assignee: Niconovum AB (British American Tobacco PLC)
• Original Assignee: Niconovum AB (British American Tobacco PLC)
• Inventors: Hansson, Henri, Axelsson, Anders, Kristensen, Arne
• Application Number:
  US12/225,260
• Publication Number:
  US 20100061940A1
• Time in Patent Office: Days
• US Class Current: 424/48
• CPC Class Codes: A23G 4/06 characterised by the composition containing organic or inorganic compounds
• CPC Class Codes: A23G 4/10 characterised by the carbohydrates used, e.g. polysaccharides containing dairy products A23G4/16
• CPC Class Codes: A61K 31/465 Nicotine; Derivatives thereof
• CPC Class Codes: A61K 9/0058 Chewing gums non-medicinal aspects, preparing chewing gum A23G4/00; chewing gum for care of the teeth or oral cavity, e.g. with breath freshener A61Q11/00
• CPC Class Codes: A61P 25/34 Tobacco-abuse

Abstract

Use of a nicotine-cellulose combination and a gum base for the preparation of a chewing gum composition for achieving a fast onset of nicotine effect after initiation of chewing the chewing gum composition by a subject. The chewing gum composition is preferably prepared by direct compression and it does not disintegrate during chewing. The invention also relates to chewing gum compositions comprising nicotine, which compositions provide a rapid release of nicotine.

Claims

1-58. -58. (canceled)

59. A chewing gum composition comprising a nicotine-cellulose combination and a gum base for achievement of a fast onset of action of nicotine after application of the chewing gum composition to the oral cavity of a subject.

60. The composition of claim 59 wherein the composition—

when subjected to an in vitro release test—

within the first 2 minutes after start of the test releases nicotine with a release rate corresponding to 10% w/w or more of the total content in the composition per minute.

61. The composition of claim 59 wherein the chewing gum composition is non-disintegrating.

62. The composition of claim 59 wherein the onset takes place within 3 minutes.

63. The composition of claim 59 wherein the application to the oral cavity includes initiation of chewing the chewing gum composition.

64. The composition of claim 59 wherein the gum base comprises one or more fats, waxes, emulsifiers, plasticizers, oils and/or flavoring agents.

65. The composition of claim 59 wherein the gum base is suitable for direct compression.

66. The composition of claim 59 wherein the chewing gum composition is prepared by direct compression.

67. The composition of claim 59 wherein the gum base comprises, Gum powder PG 11 TA, Gum powder PG 11 TA New, Gum powder PG 5 TA, Gum powder PG 5 TA New and Gum powder PG N12 TA.

68. The composition of claim 59 wherein the gum base is employed in powdered form and has a mean particle size of about 1 mm (as determined by sieving) or less.

69. The composition of claim 59 wherein the concentration of the gum base in the chewing gum composition is at the most 80% w/w.

70. The composition of claim 59 wherein the concentration of the gum base in the chewing gum composition is from about 25% w/w to about 80% w/w.

71. The composition of claim 59 wherein said release rate within the first 2 minutes after start of the test is 11% w/w or more of the total content of nicotine in the composition per minute.

72. The composition of claim 59 wherein at least 65% w/w of the total content of nicotine in the composition is released within 5 minutes when subjecting the chewing gum composition to an in vitro release test.

73. The composition of claim 59 wherein at least 75% w/w of the total content of nicotine in the composition is released within 10 minutes when subjecting the chewing gum composition to an in vitro release test.

74. The composition of claim 59 wherein onset of a nicotine effect is at the most 5 minutes after a subject has started chewing of the chewing gum composition.

75. The composition of claim 59 wherein the cellulose of the nicotine-cellulose combination comprises internal voids and/or pores.

76. The composition of claim 75 wherein said voids and/or pores at least partially comprise said nicotine.

77. The composition of claim 75 wherein the cellulose is a cellulose derived from a plant, an algae, a bacterium, a fungi, or combinations thereof.

78. The composition of claim 75 wherein the cellulose has a surface area of at least 0.7 m²/g.

79. The composition of claim 75 wherein the cellulose is a crystalline cellulose including a microcrystalline cellulose.

80. A method of treatment and/or prophylaxis of nicotine addiction comprising administering to a subject in need thereof a composition of claim 59.

82. A method for preparation of a chewing gum composition of claim 59 comprising mixing a nicotine-cellulose combination with one or more pharmaceutical acceptable excipients and forming the resulting mixture it into chewing gum by direct compression.

81. The method of claim 81 wherein the subject is identified as suffering from or susceptible to nicotine addiction.