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(12) United States Patent (10) Patent No.: US 8,722,022 B2

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(12) United States Patent (10) Patent No.: US 8,722,022 B2 USOO8722022B2 (12) UnitedO States Patent (10) Patent No.: US 8,722,022 B2 Andersen et al. (45) Date of Patent: May 13, 2014 (54) CHEWING GUM TABLET AND METHOD OF 2001, 0043907 A1 11, 2001 Luo et al. DOSING PHARMACEUTICALLY ACTIVE 38885 A. $39: E. et al. 1 INGREDIENTS IN SUCH CHEWING GUMI 565,680 A $565 list a. TABLET 2002/01 19915 A1 8, 2002 Portman 2002fO159955 A1 10, 2002 Luo et al. (75) Inventors: Carsten Andersen, Vejle (DK); Gitte 2003,000881.0 A1 1/2003 Portman Lorenzen, Vejle Øst (DK); Nicolai 2003/OO99741 A1 5, 2003 Gubler Arent, Horsens (DK); Bitten 2003/O124064 A1 7, 2003 Luo et al. 2003. O157213 A1 8, 2003 Jenkins Thorengaard, Vejle Ost (DK); Helle 2003/0206993 A1 11/2003 Gubler Wittorff, Vejle Øst (DK) 2003/0215417 A1 1 1/2003 Uchiyama et al. 2004/0001903 A1 1/2004 Lee et al. (73) Assignee: Fertin Pharma A/S (DK) 2004/0081713 A1 4/2004 Maxwell et al. 2004/O115305 A1 6/2004 Andersen et al. (*) Notice: Subject to any disclaimer, the term of this 2004/0136928 A1 7/2004 Holme et al. patent is extended or adjusted under 35 2005/OOO8732 A1 1/2005 Gebreselassie et al. U.S.C. 154(b) by 0 days. 2005.0025721 A1 2/2005 Holme et al. 2006/005.1455 A1 3/2006 Andersen et al. ................. 426/3 (21) Appl. No.: 12/819,921 2007.0043200 A1 2/2007 Yamamoto et al. (22) Filed: Jun. 21, 2010 FOREIGN PATENT DOCUMENTS O O CA 252351.0 A1 11 2004 (65) Prior Publication Data EP O711506 A2 5, 1996 EP 1474993 A1 11, 2004 US 2010/0266666A1 Oct. 21, 2010 EP 1554935 A1 7/2005 EP 1693O86 A1 8, 2006 Related U.S. Application Data EP 1545234 B1 T 2008 WO OO25598 A1 5, 2000 (63) Continuation of application No. WO 02102357 A1 12/2002 PCT/DK2007/000561, filed on Dec. 20, 2007. (Continued) (51) Int. Cl. OTHER PUBLICATIONS A6 IK9/68 (2006.01) (52) U.S. Cl. Food and Drug Administration, CFR, Title 21, Section 172,615, the USPC ............................................................ 424/48 Masticatory Substances, Synthetic; Apr. 1, 2005 edition; 2 pages. (58) Field of Classification Search International Preliminary Report on Patentability and Written Opin USPC ............................................................ 424/48 ion of the International Searching Authority; PCT/DK2007/000561; See application file for complete search history. Jun. 22, 2010; 6 pages. International Search Report; PCT/DK2007/000561; Sep. 16, 2008; 2 (56) References Cited pageS. H.P. Fiedler, Lexikon der Hilfstoffe für Pharmacie, Kosmetik and U.S. PATENT DOCUMENTS Angrenzende Gebiete, pp. 63-64 (1981). 5,227,154 A 7/1993 Reynolds 5,300,305 A 4/1994 Stapler et al. 5,378,131 A 1/1995 Greenberg Primary Examiner — Brian Gulledge 5,580,590 A 12/1996 Hartman Sni 5,679.397 A 10, 1997 Kuroda et al. Assistant Examiner — Snigdha Maewall 5,800,848 A 9, 1998 Yatka et al. (74) Attorney, Agent, or Firm — St. Onge Steward Johnston 5,866,179 A 2, 1999 Testa 6,013,287 A 1/2000 Bunczek et al. & Reens LLC 6,017,566 A 1/2000 Bunczek et al. 6,194,008 B1 2/2001 Li et al. 6,235,318 B1 5/2001 Lombardy, Jr. et al. (57) ABSTRACT 6,436,899 B2 8, 2002 Portman 6,468,962 B1 10/2002 Portman A method of dosing pharmaceutically active ingredients in a 6,471,945 B2 10/2002 Luo et al. compressed chewing gum tablet includes the steps of pro 6,485,7396.479,071 B2 11/2002 LuoHolme et al.et al. vidingidi one or morep h armaceuticalicall y active 1ngredients,di m1X 6,558,690 B2 5, 2003 Portman ing a chewing gum composition including the one or more 3. R ck 838 sielstad et al. .............. 424/439 pharmaceutically active ingredients and chewing gum gran 6,685,916wk - B1 2/2004 Holme et al. ules, the chewing gum granules including gum base, and 6,696,044 B2 2/2004 Luo et al. dosing the chewing gum composition to obtain a desired 6,716,815 B2 4/2004 Portman weight of the chewing gum composition and thereby obtain 2. f s3. s st al ing a desired dose of the pharmaceutically active ingredient in 6,838,431 B2 1/2005 PortmanCa. the chewing gum tablet. 6,846,500 B1 1/2005 Luo et al. 6,858.238 B2 2/2005 Lee et al. 2001, 0021694 A1 9, 2001 Portman 25 Claims, 3 Drawing Sheets US 8,722,022 B2 Page 2 (56) References Cited WO 2004O98305 A1 11 2004 WO 2006OOO232 A1 1, 2006 WO 2006002622 A1 1, 2006 FOREIGN PATENT DOCUMENTS WO WO 2006002622 A1 * 1, 2006 WO 2006O79.343 A1 8, 2006 WO 2004.004480 A1 1, 2004 WO 2006127618 A2 11/2006 WO 2004O2827O A1 4/2004 WO 200403.2644 A2 4, 2004 * cited by examiner U.S. Patent May 13, 2014 Sheet 1 of 3 US 8,722,022 B2 1O 1O C:Y YO Fig.1a Fig.1b 20 20 1 SJ, N-Na Fig.2a Fig.2b 20 20 Fig.2c Fig.2d U.S. Patent May 13, 2014 Sheet 2 of 3 US 8,722,022 B2 30 30 Y 31 Y 32 s (). Fig.3a Fig.3b 40 41 40 41 Y 42 Y O Fig. 4a Fig.4b 50 Y 5 Y 51 e G Fig.5a Fig.5b U.S. Patent May 13, 2014 Sheet 3 of 3 US 8,722,022 B2 70 Fig. 7a Fig. 7b US 8,722,022 B2 1. 2 CHEWING GUMITABLET AND METHOD OF an explicit or implicit weight determination of each tablet DOSING PHARMACEUTICALLY ACTIVE comprising the complete mixture. INGREDIENTS IN SUCH CHEWING GUMI An explicit determination of weight of the individual tab TABLET lets may e.g. be obtained through an exact measuring and dosing of the chewing gum composition prior to compres CROSS-REFERENCE TO RELATED Sion. APPLICATIONS An implicit determination of weight may e.g. be obtained through a compression process which is calibrated through The present application is a continuation of pending Inter the process to provide tablets within a certain weight toler national patent application PCT/DK2007/000561 filed on 10 ance band. In this case, a specific reference to a weight is Dec. 20, 2007 which designates the United States and the obtained through the calibration process. content of which is incorporated herein by reference. In an embodiment of the invention, said chewing gum granules are provided by the steps of FIELD OF THE INVENTION 15 preparing a chewing gum mixture comprising gum base, The present invention relates to the field of compressed forming said chewing gum granules by granulation of said chewing gum. In particular, the present invention provides a chewing gum mixture, and method of dosing pharmaceutically active ingredients in a measuring out a desired amount of said chewing gum gran chewing gum tablet. ules. In an embodiment of the invention, the step of forming said BACKGROUND OF THE INVENTION chewing gum granules comprises the step of granulation and a further step of grinding. A problem related to compressed chewing gum tablets Advantageous embodiments of the invention are obtained, comprising pharmaceuticals is that the requirements to the when the chewing gum granules are first granulated and Sub weight of the pharmaceutically active ingredient are quite 25 sequently further grinded. Hereby, granules of an advanta strict and that very little deviation is tolerated. This problem is geously small particle size have been obtained. relatively critical and requires attention to a degree which is In an embodiment of the invention, the chewing gum gran not typically required with respect to conventional confec ules are granulated to an average particle size of below 1500 tionery compressed chewing gum. On the other hand, com um and further grinded to an average particle size of below pressed chewing gum appears to be an attractive choice when 30 applying pharmaceuticals, as the manufacturing process is 800 um. more careful with respect to pharmaceuticals in relation to In an embodiment of the invention, a temperature of below e.g. temperature and mechanical stress. 0° C., preferably below -10°C. is kept during the step of A problem in relation to the obtaining of such dose is that further grinding. that a careful runtime measurement and dosing of the active 35 In an embodiment of the invention, the method further ingredient into each chewing gum tablet is difficult to estab comprises the step of compressing the composition into a lish. compressed chewing gum tablet. In an embodiment of the invention, the method further SUMMARY OF THE INVENTION comprises one or more steps of compressing one or more 40 further modules of chewing gum composition onto or into the The invention relates to a method of dosing pharmaceuti first module. cally active ingredients in a compressed chewing gum tablet, In an embodiment of the invention, the modules are layers. the method comprising the steps of In an embodiment of the invention, said compressed chew providing one or more pharmaceutically active ingredi ing gum tablet consist of one compressed module. ents, 45 In an embodiment of the invention, said compressed chew mixing a chewing gum composition comprising said one or ing gum tablet comprises at least two individual coherent more pharmaceutically active ingredients and chewing compressed modules. gum granules, said chewing gum granules comprising In an embodiment of the invention, said compressed chew gum base, and ing gum tablet comprises at least three individual coherent dosing said chewing gum composition to obtain a desired 50 compressed modules.
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