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Fig. 1A COMPRESSED CHEWING GUM TABLET

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Fig. 1A COMPRESSED CHEWING GUM TABLET (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (43) International Publication Date (10) International Publication Number 2 July 2009 (02.07.2009) PCT WO 2009/080022 Al (51) International Patent Classification: (74) Agent: PATENTGRUPPENA/S; Arosgaarden, Aaboule- A61K 9/68 (2006.01) A61K 9/20 (2006.01) varden 31, DK-8000 Aarhus C (DK). (81) Designated States (unless otherwise indicated, for every (21) International Application Number: kind of national protection available): AE, AG, AL, AM, PCT/DK2007/000563 AT,AU, AZ, BA, BB, BG, BH, BR, BW, BY,BZ, CA, CH, CN, CO, CR, CU, CZ, DE, DK, DM, DO, DZ, EC, EE, EG, (22) International Filing Date: ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, 20 December 2007 (20.12.2007) IN, IS, JP, KE, KG, KM, KN, KP, KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY,MA, MD, ME, MG, MK, MN, MW, (25) Filing Language: English MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PG, PH, PL, PT, RO, RS, RU, SC, SD, SE, SG, SK, SL, SM, SV, SY, (26) Publication Language: English TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW (71) Applicant (for all designated States except US): FERTIN (84) Designated States (unless otherwise indicated, for every PHARMA A/S [DK/DK]; Dandyvej 19, DK-7100 Vejle kind of regional protection available): ARIPO (BW, GH, (DK). GM, KE, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), (72) Inventors; and European (AT,BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, (75) Inventors/Applicants (for US only): ANDERSEN, FR, GB, GR, HU, IE, IS, IT, LT,LU, LV,MC, MT, NL, PL, Carsten [DK/DK]; Pedersholms 61, DK-7100 Vejle (DK). PT, RO, SE, SI, SK, TR), OAPI (BF, BJ, CF, CG, CI, CM, LORENZEN, Gitte [DK/DK]; Boelskilde 34, DK-7120 GA, GN, GQ, GW, ML, MR, NE, SN, TD, TG). Vejle Ost (DK). ARENT, Nicolai [DK/DK]; Dalagervej 71, DK-8700 Horsens (DK). THORENGAARD, Bitten Declaration under Rule 4.17: [DK/DK]; Prangerager 55, DK-7120 Vejle 0st (DK). — of inventorship (Rule 4.17(iv)) WITTORFF, Helle [DK/DK]; Johannebjergparken 25, Published: DK-7120 Vejle 0st (DK). — with international search report (54) Title: COMPRESSED CHEWING GUM TABLET (57) Abstract: The invention relates to compressed chewing gum tablet comprising one or more pharmaceutically active ingredients and 10 one or more enhancers, wherein the chewing gum tablet comprises at least one chewing gum module comprising a chewing gum composition, and wherein the chewing gum composition comprises chewing gum granules containing gum base, and wherein said enhancers are at least partly contained within at least a part of said chewing gum granules. Fig. 1a COMPRESSED CHEWING GUM TABLET FIELD OF THE INVENTION The present invention relates to the field of compressed chewing gum. In particular, the present invention provides a compressed chewing gum tablet comprising pharmaceutically active ingredients and an enhancer. TECHNICAL BACKGROUND A problem related to compressed chewing gum is that for pharmaceutically active ingredients, which has to be accompanied by an enhancer in order for a desirable uptake of the pharmaceutically active ingredient, it is difficult to obtain a desired and satisfying release for both the pharmaceutically active ingredients and the enhancer. The problem is found in particular when dealing with compressed chewing gums as compared to conventionally mixed chewing gum, as compressed chewing gum tends to release active ingredients and enhancer relatively fast. Hereby the user of the compressed chewing gum will typically not achieve the optimal effect of neither the pharmaceutically active ingredient nor the enhancer, as the release of different active ingredients and enhancers are not possible to synchronize satisfyingly. It is therefore an object of the present invention to provide improved possibilities of designing a release profile of both pharmaceutically active ingredients and enhancers according to a present desire. SUMMARY The invention relates to compressed chewing gum tablet comprising one or more pharmaceutically active ingredients and one or more enhancers, wherein the chewing gum tablet comprises at least one chewing gum module comprising a chewing gum composition, and wherein the chewing gum composition comprises chewing gum granules containing gum base, and wherein said enhancers are at least partly contained within at least a part of said chewing gum granules. By the present invention there is provided a chewing gum in the form of a compressed tablet, which facilitates both a careful incorporation of pharmaceutically active ingredient and a controlled delivery of the pharmaceutically active ingredient and an associated enhancer to a person when chewing the tablet. A particular advantage has been obtained when incorporating at least a part of the enhancer in the chewing gum granules. Hereby, at least a part of the enhancer is release-administered by the chewing gum granules, and a release of enhancer matching the release of the pharmaceutically active ingredient has been obtained. According to advantageous embodiments of the invention, there has been provided compressed chewing gum tablets facilitating a concerted release of pharmaceutically active ingredients and one or more enhancers. By incorporating at least a part of the enhancers in the chewing gum granules, the release of enhancer has been prolonged thereby optimizing the uptake of pharmaceutically active ingredients. In an embodiment of the invention, said compressed chewing gum tablet comprises at least two individual coherent compressed modules. In an embodiment of the invention, said compressed chewing gum tablet comprises at least three individual coherent compressed modules. In an embodiment of the invention, the compressed chewing gum tablet comprises one or more gum base free modules. In an advantageous embodiment of the invention, there are applied gum base granules and bulk sweetener particles having comparable particle sizes. According to embodiments of the invention, powder segregation is reduced and a more even distribution of pharmaceutically active ingredients in the chewing gum composition is obtained by applying gum base granules and bulk sweetener particles having comparable particle sizes. Small particles of the pharmaceutically active ingredients are advantageously adhered to the larger particles by way of flavoring material or by way of a dry-binder. In an embodiment of the invention, the compressed chewing gum tablet comprises two or more chewing gum modules. In an embodiment of the invention, the compressed chewing gum tablet comprises 2, 3, 4, or 5 modules. In an embodiment of the invention, the modules are layers. In an embodiment of the invention, at least one of the pharmaceutically active ingredients is separated from at least one of the enhancers by location in different modules. When incorporating a pharmaceutically active ingredients and an enhancer which may affect each other negatively if located in the same chewing gum composition, an advantageous embodiment of the invention may be obtained by locating the pharmaceutically active ingredient in one module and the enhancer in another module. By e.g. locating pharmaceutically active ingredient and enhancer in different layers, stability problems during storage may be avoided. A particularly advantageous embodiment of the invention has been obtained with nicotine located in one layer and a pH control agent, such as sodium carbonate, located in another layer. In an embodiment of the invention, two different pharmaceutically active ingredients are located in two different modules. Advantageously, different pharmaceutically active ingredients which may affect each other negatively if located in the same chewing gum composition, or which are intended to be released from the chewing gum differently, may be located in different modules, such as layers, of the chewing gum tablet. In an embodiment of the invention, at least one pharmaceutically active ingredient and at least one enhancer are located in the same module. In an embodiment of the invention, at least a part of the pharmaceutically ingredients are incorporated in at least a part of the chewing gum granules. In an embodiment of the invention, at least a part of the pharmaceutically active ingredients are adhered to bulk sweetener particles by way of flavor. In an embodiment of the invention, at least a part of the pharmaceutically active ingredients are adhered to chewing gum granules by way of flavor. By the phrase "adhered to" it is implied that the association of two kinds of particles, e.g. pharmaceutically active ingredient particles and chewing gum granules or bulk sweetener in some cases is mediated by a third kind of particle, e.g. flavor particles. In an embodiment of the invention, at least a part of the pharmaceutically active ingredients are adhered to dry-binder particles. The pharmaceutically active ingredients have average particle sizes which are relatively small, such as below 100 µm. It has been found advantageous to bind the pharmaceutically active ingredients to a dry-binder and/or to the surrounding chewing gum granules and/or bulk sweetener particles. The free flowability of the pharmaceutically active ingredients in the chewing gum composition has thereby been reduced and thereby the tendency to segregation has been reduced. A relatively even distribution of pharmaceutically active ingredients in the chewing gum composition has been the result. In an embodiment of the invention, the dry binders are selected from the group consisting of mikro-crystalline cellulose (MCC), silicified micro-crystalline cellulose (SMCC), spray dried lactose, fast flow lactose, anhydrous lactose, sucrose, mannitol, mannitol EZ, dextrose, fructose, sorbitol, povidone, copovidone, dicalcium phosphate (DCP), starch (corn, potato and rice), pre-gelatinized starch, or any combination thereof. In an embodiment of the invention, at least a part of the pharmaceutically active ingredients are interspersed between said chewing gum granules. In an embodiment of the invention, at least a part of said enhancers are interspersed between said chewing gum granules.
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