Patent
Chewing gum formulation and method of making the same
| العنوان: | Chewing gum formulation and method of making the same |
|---|---|
| Patent Number: | 7,208,186 |
| تاريخ النشر: | April 24, 2007 |
| Appl. No: | 10/422502 |
| Application Filed: | April 24, 2003 |
| مستخلص: | The present invention involves a novel chewing gum formulation and a method of making the same. The chewing gum formulation is used to form a final chewing gum composition which contains an active ingredient which is released from the chewing gum as the gum is masticated in the mouth of the user. The chewing gum made from the chewing gum composition of the present invention is initially a compressed body, such as a tablet, which quickly dissociates into a multiplicity of small pieces upon initial chewing followed by a reformation of the pieces into a coherent mass of chewing gum after a few seconds of chewing. Both the chewing gum formulation and the chewing gum composition are in the form of a free-flowing particulate which is capable of being directly compressed at high speed by a standard tableting machine into chewing gum tablets. |
| Inventors: | Norman, Gary T. (Middletown, DE, US); Amin, Arun F. (Wilmington, DE, US) |
| Assignees: | SPI Pharma, Inc. (New Castle, DE, US) |
| Claim: | 1. A method of producing a chewing gum tablet comprising a chewing gum formulation and at least one active ingredient, wherein the chewing gum tablet dissociates into at least two pieces upon initial chewing followed by a reformation of the pieces into a coherent mass after additional chewing, comprising the steps of: (a) dry mixing a gum base, a granulating agent and at least one processing aid to form a chewing gum formulation that contains less than 2% by weight water; (b) adding one or more additional ingredients, including an active ingredient, to the chewing gum formulation to form a chewing gum composition in the form of a free-flowing particulate that contains less than 2% by weight water; and (c) directly compressing the chewing gum composition into said chewing gum tablet; wherein the gum base is in the form of particles and during the dry mixing step, the temperature of the gum base is raised to an elevated temperature where at least the outer surfaces of the gum base particles melt and further wherein a portion of the processing aid is mixed with the gum base and granulating agent before the temperature is raised to said elevated temperature and at a first temperature that is below the melting point of the gum base and, after the temperature of the gum base is raised to said elevated temperature, mixing continues until a uniform mixture of the gum base, the granulating agent and the processing aid is obtained in the form of particles of said uniform mixture, at which time, the temperature of the gum base is reduced to a point that is below the melting point of the gum base and the remainder of the processing aid is added to and mixed with the particles of said uniform mixture until the remainder of the processing aid forms a partial coating on the outer surfaces of the particles of said uniform mixture. |
| Claim: | 2. The method of claim 1 , wherein after the chewing gum formulation is produced, it is maintained at temperatures in the range of 68 to 86° F. at all times before the tableting step. |
| Claim: | 3. The method of claim 1 , wherein in step (a), at least one sweetening agent is dry mixed with the gum base, granulating agent and at least one processing aid to form said chewing gum formulation. |
| Claim: | 4. The method of claim 1 , wherein in step (b), said additional ingredients are selected from the group consisting of sweetening agents, active ingredients, flavoring agents, coloring agents and lubricants. |
| Claim: | 5. The method of claim 1 , wherein the granulating agent is also a sweetening agent. |
| Claim: | 6. The method of claim 1 , wherein the granulating agent is water-soluble. |
| Claim: | 7. The method of claim 1 , wherein the processing aid is selected from the group consisting of silica substances and silicate substances. |
| Claim: | 8. The method of claim 1 , wherein the processing aid is selected from the group consisting of talc, silica gel, precipitated silica, fumed silica and colloidal silica. |
| Claim: | 9. The method of claim 1 , wherein the granulating agent is a sugar or a polyol. |
| Claim: | 10. The method of claim 1 , wherein the granulating agent is sorbitol. |
| Claim: | 11. The method of claim 1 , wherein the granulating agent is mannitol, isomalt or mixtures thereof. |
| Claim: | 12. A method of producing a chewing gum tablet comprising a chewing gum formulation and at least one active ingredient, wherein the chewing gum tablet dissociates into at least two pieces upon initial chewing followed by a reformation of the pieces into a coherent mass after additional chewing, comprising the steps of: (a) dry mixing a gum base, a granulating agent and at least one processing aid to form a chewing gum formulation that contains less than 2% by weight water; (b) adding one or more additional ingredients, including an active ingredient, to the chewing gum formulation to form a chewing gum composition in the form of a free-flowing particulate that contains less than 2% by weight water; and (c) directly compressing the chewing gum composition into said chewing gum tablet; wherein the gum base is in the form of particles and during the dry mixing step, the temperature of the gum base is raised to an elevated temperature where at least the outer surfaces of the gum base particles melt, and further wherein a portion of the processing aid is mixed with the gum base and granulating agent before the temperature is raised to said elevated temperature and at a first temperature that is below the melting point of the gum base and, after the temperature of the gum base is raised to said elevated temperature, mixing continues until a uniform mixture of the gum base, the granulating agent and the processing aid is obtained in the form of particles of said uniform mixture, at which time the remainder of the processing aid is added to and mixed with the particles of said uniform mixture until the remainder of the processing aid forms a partial coating on the outer surfaces of the particles of said uniform mixture. |
| Claim: | 13. The method of claim 12 , wherein after the chewing gum formulation is produced, it is maintained at temperatures in the range of 68 to 86 °F at all times before the tableting step. |
| Claim: | 14. The method of claim 12 , wherein in step (a), at least one sweetening agent is dry mixed with the gum base, granulating agent and at least one processing aid to form said chewing gum formulation. |
| Claim: | 15. The method of claim 12 , wherein in step (b), said additional ingredients are selected from the group consisting of sweetening agents, active ingredients, flavoring agents, coloring agents and lubricants. |
| Claim: | 16. The method of claim 12 , wherein the granulating agent is also a sweetening agent. |
| Claim: | 17. The method of claim 12 , wherein the granulating agent is water-soluble. |
| Claim: | 18. The method of claim 12 , wherein the processing aid is selected from the group consisting of silica substances and silicate substances. |
| Claim: | 19. The method of claim 12 , wherein the processing aid is selected from the group consisting of talc, silica gel, precipitated silica, fumed silica and colloidal silica. |
| Claim: | 20. The method of claim 12 , wherein the granulating agent is a sugar or a polyol. |
| Claim: | 21. The method of claim 12 , wherein the granulating agent is sorbitol. |
| Claim: | 22. The method of claim 12 , wherein the granulating agent is mannitol, isomalt or mixtures thereof. |
| Current U.S. Class: | 426/3 |
| Patent References Cited: | 2290120 July 1942 Thomas 3262784 July 1966 Bucher 4000321 December 1976 Mochizuki et al. 4161544 July 1979 Kaul 4370350 January 1983 Fisher et al. 4405647 September 1983 Fisher et al. 4737366 April 1988 Gergely et al. 4741905 May 1988 Huzinec 4753805 June 1988 Cherukuri et al. 5711961 January 1998 Reiner et al. 5824291 October 1998 Howard 5866179 February 1999 Testa 6582738 June 2003 Gubler 6767567 July 2004 Douaire et al. 2005/0074518 April 2005 Soldani 0 151 344 August 1985 0214834 March 1987 0 298 922 January 1989 0 399 479 November 1990 WO-97/21424 June 1997 99/66905 December 1999 WO-00/56281 September 2000 WO-02/078459 October 2002 |
| Other References: | Sangalli et al, “Inert Monolithic Device with a Central Hole for Constant Drug Release”, European Journal of Pharmaceutics,40(1994)Dec., No. 6, Stuttgart, Germany. cited by examiner Patent abstracts of Japan, vol. 1995, No. 06, Jul. 31, 1995 & JP 07 067541 A (Korisu KK), Mar. 14, 1995, abstract. cited by other English language abstract for EP 0 399 479 (Nov. 28, 1990). cited by other Chewing & Bubble Gum Workshop Presentation; National Confectioners Association; Doug Fritz et al., Apr. 2-4, 2001. cited by other |
| Primary Examiner: | Corbin, Arthur L. |
| Attorney, Agent or Firm: | Connolly Bove Lodge & Hutz LLP |
| رقم الانضمام: | edspgr.07208186 |
| قاعدة البيانات: | USPTO Patent Grants |
| الوصف غير متاح. |