Chewing gum composition with accelerated, controlled release of active agents

• US 5,487,902 A
• Filed: 09/19/1994
• Issued: 01/30/1996
• Est. Priority Date: 07/24/1989
• Status: Expired due to Term

• Current Assignee: Fertin Pharma AS (Philip Morris Limited)
• Original Assignee: Fertin Laboratories A/S
• Inventors: Pedersen, Morten, Andersen, Carsten
• Primary Examiner(s): HUNTER, JEANETTE M
• Application Number:
  US08/308,620
• Time in Patent Office: 498 Days
• Field of Search: 426/36, 426/654
• US Class Current: 426/3
• CPC Class Codes: A23G 4/00 Chewing gum
• CPC Class Codes: A23G 4/02 Apparatus specially adapted for manufacture or treatment of chewing gum
• CPC Class Codes: A23G 4/06 characterised by the composition containing organic or inorganic compounds
• CPC Class Codes: A23G 4/08 of the chewing gum base
• 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

Abstract

A chewing gum composition with accelerated, controlled release of active agents comprising one or more active agents, a chewing gum base and optionally conventional auxiliary agents and additives. The chewing gum is prepared on the basis of a chewing gum base having a resin component containing at least 25 weight % of a particular resin. The accelerated, controlled release of the active agents is obtained by adding at least one solubilizer having an HLB of 14-20 in a quantity of 0.1-10 weight % to the chewing gum composition.

Claims

1. Chewing gum composition with accelerated, controlled release of substantially fat-soluble active agents, produced by combining

i) a chewing gum base having a resin component, wherein said resin component of the chewing gum base comprises at least 25 weight % of a resin selected from the group consisting of terpene resins, glycerol ester of polymerized rosin, pentaerythritol ester of wood or gum rosin, pentaerythritol ester of partially hydrogenated wood or gum rosin, glycerol ester of partially hydrogenated wood or gum rosin, and high molecular weight polyvinyl acetate resins with a molecular weight of at least 30,000, with

ii) one or more substantially fat-soluble active agents, additives, and at least one solubilizer in a quantity of 1-10 weight %, said solubilizer having an HLB value of 14-20.

2. Chewing gum composition as claimed in claim 1 wherein the resin component of the chewing gum base contains at least 40% of a resin selected from the group consisting of terpene resins, glycerol ester of polymerized rosin, pentaerythritol ester of wood or gum rosin, pentaerythritol ester of partially hydrogenated wood or gum rosin, glycerol ester of partially hydrogenated wood or gum rosin and high molecular weight polyvinyl acetate resins with a molecular weight of at least 30,000.

3. Composition as claimed in claim 1 wherein the resin component of the chewing gum base contains a terpene resin of natural or synthetic origin.

4. Composition as claimed in claim 1 wherein the solubilizer of the composition is selected from the group consisting of lecithin, polyoxyethylene sorbitan fatty acid esters, fatty acid salts, mono and diacetyl tartaric acid esters of mono and diglycerides of edible fatty acids, citric acid esters of mono and diglycerides of edible fatty acids, saccharose esters of fatty acids, polyglycerol esters of fatty acids, polyglycerolesters of internal esterified castor oil acid, sodium stearoyllactylate, sodium lauryl sulfate, sorbitan esters of fatty acids, polyoxyethylated hydrogenated castor oil, blockcopolymers of ethylene oxide and propylene oxide, polyoxyethylene fatty alcohol ether, sorbitan ester of fatty acid and polyoxyethylene steraric acid ester.

5. Chewing gum composition as claimed in claim 4 wherein the solubilizer is selected from the group consisting of polyoxyethylene stearate, polyoxyethylene sorbitan fatty acid ester, mono and diacetyl tartaric acid esters of mono and diglycerides of edible fatty acids, citric acid ester of mono and diglycerides of edible fatty acids, sodium stearoyllactylate, sodium laurylsulfate, polyoxyethylated hydrogenated castor oil, blockcopolymers of ethylene oxide and propylene oxide and polyoxyethylene fatty alcohol ether.

6. Chewing gum composition as claimed in claim 1 wherein 3-6 weight % solubilizer is added to the chewing gum composition.

7. Chewing gum composition as claimed in claim 1 wherein the composition further contains up to 60 weight % of at least one carrier, which carrier forms a solid dispersion together with the active agent.

8. Composition as claimed in claim 7 wherein the carrier is selected from the group consisting of polyethylene glycol and polyvinyl pyrrolidone.

9. Composition as claimed in claim 8 wherein the carrier is polyethyleneglycol 1000-20,000.

10. Composition as claimed in claim 1 wherein the active agent has a water-solubility of less than 10 g/100 ml.

11. Chewing gum composition as claimed in claim 10 wherein the active agent is selected from the group consisting of dietary supplement, oral and dental compositions, antiseptics, pH adjusting agents, anti-smoking agents, sweeteners, flavorings, aroma agents and medicines.

12. Chewing gum composition as claimed in claim 11 wherein the active agent is selected from the group consisting of paracetamol, benzocaine, cinnarizine, menthol, carvone, coffeine, chlorhexidine-diacetate, cyclizine hydrochloride, 1,8-cineol, nandrolone, miconazole, nystatin, aspartame, sodium fluoride, nicotine, saccharin, cetylpyridinium chloride, other quaternary ammonium-compounds, vitamin E, vitamin A, vitamin D, glibenclamide or derivatives thereof, progesterone, acetylsalicylic acid, dimenhydrinate, cyclizine, metronidazole, sodium hydrogencarbonate, the active components from ginkgo, the active components from propolis, the active components from ginseng, methadone, oil of peppermint, salicylamide, hydrocortisone and astemizole.

13. Process for the preparation of a chewing gum composition as claimed in claim 1 comprising the steps of preparing a chewing gum base on the basis of conventional chewing gum base ingredients including a resin portion, wherein the resin portion comprises at least 25 weight % of a resin selected from the group consisting of terpene resins, glycerol ester of polymerized rosin, pentaerythritol ester of polymerized rosin, pentaerythritol ester of wood or gum rosin, pentaerythritol ester of partially hydrogenated wood or gum rosin, glycerol ester of partially hydrogenated wood or gum rosin and high molecular weight polyvinyl acetate resins with a molecular weight of at least 30,000, and then preparing a chewing gum composition while adding at least one substantially fat-soluble active agent and 1-10 weight % of at least one solubilizer, said solubilizer having an HLB value of 14-20.

14. Process as claimed in claim 13 comprising the further step of mixing the active agent intimately with the solubilizer to form a mixture and then admixing the mixture to the chewing gum composition.

15. Process as claimed in claim 14 comprising the further step of forming a solid dispersion of the active agent in a carrier prior to mixing the active agent with the solubilizer.

16. Process for making a chewing gum composition, comprising the step of combining a solubilizer for accelerated, controlled release of substantially fat-soluble active agents with a composition comprising a chewing gum base having a resin component comprising at least 25 weight % of a resin selected from the group consisting of terpene resins, glycerol ester of polymerized rosin, pentaerythritol ester of wood or gum rosin, pentaerythritol ester of partially hydrogenated wood or gum rosin, glycerol ester of partially hydrogenated wood or gum rosin and high molecular weight polyvinyl acetate resins with a molecular weight of at least 30,000, said solubilizer being present in a quantity of 1-10 weight % of said chewing gum composition and having an HLB value of 14-20.