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WO 2008/019854 Al (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 21 February 2008 (21.02.2008) PCT WO 2008/019854 Al (51) International Patent Classification: (74) Agents: BEST, Michael et al.; Lederer & Keller, Prinzre- A61K 9/00 (2006.01) A61K 9/50 (2006.01) gentenstrasse 16, 80538 Mϋnchen (DE). A61K 9/28 (2006.01) (81) Designated States (unless otherwise indicated, for every (21) International Application Number: kind of national protection available): AE, AG, AL, AM, PCT/EP2007/007243 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: 16 August 2007 (16.08.2007) ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, KR, KZ, LA, LC, LK, (25) Filing Language: English LR, LS, LT, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PG, PH, PL, (26) Publication Language: English PT, RO, RS, RU, SC, SD, SE, SG, SK, SL, SM, SV, SY, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, (30) Priority Data: ZM, ZW 06017263.2 18 August 2006 (18.08.2006) EP 11/516,573 7 September 2006 (07.09.2006) US (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, (71) Applicant (for all designated States except US): LOSAN GM, KE, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM, PHARMA GMBH [DE/DE]; Otto-Hahn-Strasse 13, ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), 79395 Neuenburg (DE). European (AT,BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HU, IE, IS, IT, LT,LU, LV,MC, MT, NL, PL, (72) Inventors; and PT, RO, SE, SI, SK, TR), OAPI (BF, BJ, CF, CG, CI, CM, (75) Inventors/Applicants (for US only): GRUBER, Peter GA, GN, GQ, GW, ML, MR, NE, SN, TD, TG). [DE/DE]; Bachelhurst 13b, 79249 Merzhausen (DE). KRAAHS, Peter [DE/DE]; Toni-Schmid-Str. 11a, 81825 Published: Mϋnchen (DE). — with international search report (54) Title: PHARMACEUTICAL COMPOSITIONS EASY TO SWALLOW, NOT CAUSING ANY UNPLEAS ANT ORAL SEN- SATION AND COMPRISING PARTICLES WITH AN ACTIVE PRINCIPLE (57) Abstract: The present invention relates to a pharmaceutical composition for direct oral administration which is very easy to swallow especially for young children, comprising at least one pharmaceutically active compound. The pharmaceutical composition is present in the form of one or more particles. The particles comprise a core containing the active ingredient which has been provided with one or more coatings. The pharmaceutical composition is preferably administered in combination with a powder and/or granules which, when applied to the tongue, spontaneously generate additional saliva. With the extra saliva, the coated particles form a soft, smooth, but mechanically stable surface perceived as pleasant in the mouth within seconds so that they may be swallowed easily and practically in the right quantity with the extra saliva formed. PHARMACEUTICAL COMPOSITIONS EASY TO SWALLOW, NOT CAUSING ANY UNPLEASANT ORAL SENSATION AND COMPRISING PARTICLES WITH AN ACTIVE PRINCIPLE Field of the Invention: The present invention relates to a pharmaceutical composition for direct oral administration which is very easy to swallow especially for young children and which comprises at least one pharmaceutically active compound. The pharmaceutical composition is present in the form of one or more particles. The particles consist of a core containing the active ingredient which has been provided with one or more coatings. The pharmaceutical composition is preferably administered in combination with a powder and/or granules which, when applied to the tongue, spontaneously generate saliva. Within seconds, the coated particles form a soft, smooth, but mechanically stable surface with the saliva, which is perceived as pleasant in the mouth so that they may be swallowed easily and practically in the right quantity. Background of the Invention: The oral ingestion of solid medicament forms (especially of tablets and capsules) is accompanied by numerous problems for children and older people. Children must be 6 to 8 years old before they can reliably swallow solid medicament forms, there being major restrictions concerning the size of the medicament forms. Older people often suffer from swallowing disorders, too, which are caused by a decrease in saliva formation in old age so that the solid medicament forms may be swallowed only with difficulty. They react with reluctance to the regular ingestion often necessary over many years which frequently leads to irregular compliance. In an attempt to solve these problems, numerous alternatives have been offered in the market place. However, tablets for chewing or sucking and orodispersible tablets are not a genuine alternative either, especially for young children. Due to dental problems, older people often have an aversion against chewable tablets, too, and sucking tablets or orodispersible tablets are not convincing either due to reduced salivation. In addition, an expensive and complicated step is necessary to first convert the active ingredients which often have a bitter taste into small saliva-resistant particles before they are processed into chewable tablets, sucking tablets or orodispersible tablets, the masking of the taste often being more or less destroyed by the subsequent necessary compression to tablets with the result that the bitter taste often leads to an aversion against this medicament form. The processing of release-controlled enteric-coated or retarded particles into the above medicament forms is even more problematic. Again, the subsequent compaction causes at least partial destruction of the coating layer. As a result, formulators attempt to protect the saliva-resistant particles by a large amount of adjuvants which are easily compressed. This, in turn, raises the cost of preparing these tablets and increases the tablet size unnecessarily. Therefore, there are granules and powders on the market which usually must be converted into a suspension with a certain amount of water before ingestion. In most cases, such suspensions require preservation, must be kept in the refrigerator and generally entail high production costs. Often mistakes are made when the suspension is prepared. By foaming or insufficient agitation before application, problematic dosing errors may occur, and especially older people have problems with this dosage form. With young children or adults with swallowing disorders, a syrup is often chosen as an alternative. In many cases, however, problems occur because the active ingredient is very bitter. Syrups must always be protected by preservatives which have an inherent allergy risk. In many active ingredients, stability problems occur when they are processed into an aqueous syrup. US-A-4,882,169 proposes coated pellets having a diameter of 0.2 to 3 mm which allegedly form a homogeneous dispersion in water. The particles contain at least one pharmaceutically active substance, optionally one or more release-controlling or taste-masking coatings and one swellable outer layer. The latter contains a swellable polymer, preferably guar, and a binder. Together with guar granules and flavouring agents, the coated pellets are bagged into sachets from which they are taken and dispersed in water. US-A-5,288,500 proposes to combine a plurality of particles containing the active ingredient having a diameter of 0.05 to 7 mm with a gelling or swelling agent. The latter may be present in admixture with the particles containing the active ingredient, be contained on a coating, be added to the particles containing the active ingredient before admixing with an aqueous carrier or be dispersed in an aqueous carrier to which the particles containing the active ingredient are admixed. The proposed formulation is dispersed in an aqueous carrier. In particular, hydrophilic polymers forming colloidal dispersions, sols or suspensions in an aqueous environment are indicated as gelling or swelling agents for the formulations proposed in US-A-5,288,500. The polymers are used in an amount sufficient to ensure that dispersal in an aqueous carrier is not impaired. If desired, the viscosity in the immediate vicinity of the dispersed particles may be influenced by the formation of salt, chelation, changes of polarity and such like. The components of the formulation may be kept separate until they are processed or bagged into sachets or processed to tablets or capsules. The formulations described in US-A-4,882,169 and US-A-5,228,500 are ingested together with an aqueous carrier wherein they must be dispersed before administration. In this process, the formulations disintegrate into individual particles so that quantitative ingestion is not guaranteed as a rule. This is because, in general, drinking a particle suspension or dispersion is a real problem, for after the solution has been drunk a residue of the particles is usually left on the bottom of the vessel and can be brought into the mouth with difficulty only. It is not at all sure either whether the patient will even try to do this. Sedimentation of the particles may be prevented partially only by drinking the particle suspension very quickly after stirring. Such a medicament form which requires fast drinking is particularly unsuitable for young children and older patients. Formulations according to the two cited patents have the disadvantage that quantitative ingestion in the prescribed dose is generally not guaranteed and that they must be predispersed in an aqueous carrier first, i.e. clean drinking water and a suitable vessel must be available which renders ingestion difficult, especially when travelling. An improved agent is disclosed in WO 98/06385. The printed publication describes a pharmaceutical composition in the form of particles which may be ingested directly even without liquid.
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