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Compressed Chewing Gum Tablet Komprimierte Kaugummitablette Tablette De Chewing Gum Comprimé

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Compressed Chewing Gum Tablet Komprimierte Kaugummitablette Tablette De Chewing Gum Comprimé (19) TZZ __T (11) EP 2 229 157 B1 (12) EUROPEAN PATENT SPECIFICATION (45) Date of publication and mention (51) Int Cl.: of the grant of the patent: A61K 9/68 (2006.01) A61K 9/20 (2006.01) 10.08.2016 Bulletin 2016/32 (86) International application number: (21) Application number: 07846432.8 PCT/DK2007/000562 (22) Date of filing: 20.12.2007 (87) International publication number: WO 2009/080021 (02.07.2009 Gazette 2009/27) (54) COMPRESSED CHEWING GUM TABLET KOMPRIMIERTE KAUGUMMITABLETTE TABLETTE DE CHEWING GUM COMPRIMÉ (84) Designated Contracting States: • ARENT, Nicolai AT BE BG CH CY CZ DE DK EE ES FI FR GB GR DK-8700 Horsens (DK) HU IE IS IT LI LT LU LV MC MT NL PL PT RO SE • THORENGAARD, Bitten SI SK TR DK-7120 Vejle Øst (DK) • WITTORFF, Helle (43) Date of publication of application: DK-7120 Vejle Øst (DK) 22.09.2010 Bulletin 2010/38 (74) Representative: Patentgruppen (73) Proprietor: Fertin Pharma A/S Aaboulevarden 31, 4 7100 Vejle (DK) 8000 Aarhus C (DK) (72) Inventors: (56) References cited: • ANDERSEN, Carsten EP-A- 1 554 935 EP-A- 1 693 086 DK-7100 Vejle (DK) WO-A-2006/002622 WO-A-2006/079343 •LORENZEN,Gitte DK-7120 Vejle Ost (DK) Note: Within nine months of the publication of the mention of the grant of the European patent in the European Patent Bulletin, any person may give notice to the European Patent Office of opposition to that patent, in accordance with the Implementing Regulations. Notice of opposition shall not be deemed to have been filed until the opposition fee has been paid. (Art. 99(1) European Patent Convention). EP 2 229 157 B1 Printed by Jouve, 75001 PARIS (FR) EP 2 229 157 B1 Description FIELD OF THE INVENTION 5 [0001] The present invention relates to the field of compressed chewing gum. In particular, the present invention provides improved possibilities of controlling the release of active ingredients from a compressed chewing gum tablet. TECHNICAL BACKGROUND 10 [0002] Some compressed chewing gum tablets are known in the art. [0003] One example is European patent application EP 1 693 086 A1, which discloses compressed chewing gum tablets comprising a first and a second chewing gum module with CaCO3 in a first module and menthol in a second module. [0004] Another example is international patent application WO 2006/002622 A1, which discloses compressed chewing gum tablets comprising two GB-containing modules and one GB-free module. 15 [0005] A problem related to compressed chewing gum is that it may be difficult to obtain the same prolonged release of active ingredients as may be obtained in conventionally mixed chewing gum as compressed chewing gum tends to release active ingredients relatively fast. [0006] A further problem related to conventional compressed chewing gum is that active ingredients may differ sig- nificantly in nature as the active ingredients may be contained in different delivery systems if such systems are applied. 20 A further problem is that the desired release of the individual active ingredient may be difficult to control, thereby resultin g in a non-synchronized release of different active ingredients which need to be synchronized. [0007] It is therefore an object of the present invention to provide improved possibilities of designing a release profile according to a present desire. 25 SUMMARY [0008] The invention relates to a compressed chewing gum tablet comprising at least a first and a second chewing gum module, said first chewing gum module comprising a first chewing gum composition comprising at least a first active ingredient 30 and chewing gum granules containing gum base, said second chewing gum module comprising a second chewing gum composition comprising at least a second active ingredient and chewing gum granules containing gum base, wherein said first active ingredient is a pharmaceutically active ingredient, wherein said pharmaceutically active ingredient is nicotine and/or varenicline, and 35 said second active ingredient is selected from the group of enhancers and wherein in said enhancer comprises a pH control agent, wherein the gum base content of said first and second chewing gum modules is different. [0009] The invention facilitates that different pharmaceutically active ingredients in different modules may be affected individually by the content of gum base contained in the different respective modules, thereby obtaining an improved 40 administration of different pharmaceutically active ingredients with respect to a desired release and according to a desired synchronism. The desired synchronism may both involve that two different active ingredients are released at the same time and may also involve an offset. In some embodiments it may be desired to have a fast release of a first active ingredient and a slower release of a second active ingredient. 45 [0010] The release may be controlled by the different gum base content of the modules, whereby a number of possi- bilities arise of designing a release profile of the active ingredients as desired. [0011] According to the invention, the first and second active ingredients are different. [0012] Using different active ingredients may e.g. be advantageous when the two ingredients are collaborating, e.g. the one active ingredient enhances the uptake of the other, or the first ensures an advantageous pH-level for the second 50 active ingredient. However in some embodiments it may also be advantageous to have two or more independent active ingredients in the same chewing gum tablet. [0013] In an embodiment of the invention, said first chewing gum composition comprises a further active ingredient different from said first active ingredient. [0014] According to embodiments of the invention two or more active ingredients may be present in said first chewing 55 gum composition. In this manner a number of combinations of active ingredients may be delivered from a single chewing gum tablet. [0015] In an embodiment of the invention, wherein said second chewing gum composition comprises a further active ingredient different from said second active ingredient. 2 EP 2 229 157 B1 [0016] According to embodiments of the invention two or more active ingredients may be present in said second chewing gum composition. In this manner a number of combinations of active ingredients may be delivered from a single chewing gum tablet. [0017] In an embodiment of the invention, wherein said active ingredients in said first chewing gum module are at 5 least partly contained within said chewing gum granules. [0018] In an embodiment of the invention, wherein said active ingredients in said second chewing gum module are at least partly contained within said chewing gum granules. [0019] In an embodiment of the invention, the gum base content is different with respect to composition. [0020] With a gum base content different with respect to composition, release profiles may be adjusted in that an 10 active ingredient contained within a chewing gum granule will be released slower than an active ingredient which is added to the chewing gum layer outside the granules prior to compression. Hereby a desired amount of an active ingredient which is to be released relatively slowly may be added into the granules of the composition and another amount of the same or another active ingredient which is to be released relatively slowly may be added to the composition outside the granules, whereby a faster release of these are ensured. 15 [0021] In an embodiment of the invention, the gum base content is different with respect to weight. [0022] With a gum base content different with respect to weight, release profiles may be adjusted in that e.g. an active ingredient in a module without any gum base may tend to release faster than an active ingredient in a module with a relatively large amount of gum base. Hence it seems that release profile control may be controlled by selecting a certain amount of gum base for each module. 20 [0023] In an embodiment of the invention, the gum base content is different with respect to the size of applied chewing gum granules. [0024] With a gum base content different with respect to the size of applied chewing gum granules, release profiles may be adjusted in that indications have been seen that the release rate is different depending on an average size of the granules of the module, in which the active ingredient is positioned. 25 [0025] In an embodiment of the invention, wherein the size of the applied chewing gum granules is less in said first chewing gum module than in said second chewing gum module. [0026] In an embodiment of the invention, the gum base content is different with respect to the degree of mixing with the active ingredient. [0027] A further way to have different gum base content of two modules is to mix the two compositions with active 30 ingredients differently, e.g. mixing the active ingredient more thoroughly into one composition than into the other. [0028] In an embodiment of the invention, at least one of said first and second chewing gum composition facilitates a bi-phasic release of said second active ingredient. [0029] In an embodiment of the invention, wherein said compressed chewing gum tablet comprises control means to at least partly synchronize the release of said at least one pharmaceutically active ingredient and the release of said pH 35 control agen. [0030] In some embodiments nicotine is added as a salt such as nicotine bitartrate, nicotine pftalate, nicotine polacrilex, nicotine sulphate, nicotine tartrate, nicotine citrate, or nicotine lactate. Varenicline is often added as varenicline tartrate . [0031] In an embodiment of the invention, pharmaceutically active ingredients are selected from the group consisting of antihistamines, anti-smoking agents, agents used for diabetes, decongestrants, peptides, pain-relieving agents, ant- 40 acids, nausea-relieving agents, statines, or any combination thereof.
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