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(12) United States Patent (10) Patent No.: US 8.440,170 B2 Stroppolo Et Al

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(12) United States Patent (10) Patent No.: US 8.440,170 B2 Stroppolo Et Al USOO844.017OB2 (12) United States Patent (10) Patent No.: US 8.440,170 B2 Stroppolo et al. (45) Date of Patent: May 14, 2013 (54) ORALLY DISINTEGRATING TABLETS WITH (51) Int. Cl. SPECKLED APPEARANCE 469/44 (2006.01) A614.9/00 (2006.01) (75) Inventors: Federico Stroppolo, Mezzovico (CH): (52) U.S. Cl. Shahbaz Ardalan, Mezzovico (CH) USPC ......................................... 424/10.2: 424/10.3 (73) Assignee: Alpex Pharma SA, Mezzovico (CH) (58) Field of Classification Search ................. 19. (*) Notice: Subject to any disclaimer, the term of this See application file for complete search history. patent is extended or adjusted under 35 (56) U.S.C. 154(b) by 43 days. Refeeees Citede U.S. PATENT DOCUMENTS (21) Appl. No.: 12/811,737 3,555,144. A * 1/1971 Pazar et al. .................. 424,103 1-1. 2003/0180357 A1* 9, 2003 Martino et al. ............... 424/465 (22) PCT Filed: Jan. 30, 2009 2004/0213855 A1 * 10, 2004 Pettersson et al. ............ 424/489 (86). PCT No.: PCT/EP2009/051055 * cited by examiner E. Jul. 6, 2010 Primary Examiner — Fereydoun G Sajjadi (2), (4) Date: ul. O, Assistant Examiner — Genevieve S Alley (87) PCT Pub. No.: WO2O09/098169 (74) Attorney, Agent, or Firm — Rothwell, Figg, Ernst & Manbeck, P.C. PCT Pub. Date: Aug. 13, 2009 (57) ABSTRACT (65)65 PriorO PublicationDO Dat Orally disintegrating tablets containing colored granules of a US 2010/0278754 A1 Nov. 4, 2010 water-soluble Sugar which give them a speckled appearance are described. The orally disintegrating tablets with speckled Related U.S. Application Data appearance are readily and easy identifiable by physicians, nurses and patients. (60) Provisional application No. 61/026,249, filed on Feb. 5, 2008. 9 Claims, No Drawings US 8,440,170 B2 1. 2 ORALLY DISINTEGRATING TABLETS WITH users. For example, blue spots on a white or yellow tablet SPECKLED APPEARANCE Surface are easily visible, making Such tablets more identifi able than white or monocolored tablets. CROSS REFERENCE TO RELATED Solid or semisolid forms with speckled appearance are APPLICATION very common among cosmetic and laundry products, such as tooth pastes or Soaps. This application is a 35 U.S.C. 371 National Phase Entry They are prepared by incorporating colored beads of a Application from PCT/EP2009/051055, filed Jan. 30, 2009, different material into the composition. which claims the benefit of U.S. Provisional 61/026,249 filed In case of ODT, the colored beads must be soluble and Feb. 5, 2008, the disclosures of which are incorporated herein 10 in their entirety by reference. dissolve as fast as the tablets to avoid an unpleasant grinding The present invention generally relates to the identification sensation when the tablet disintegrates in the oral cavity. of orally disintegrating tablets. More particularly, the inven Moreover, the colored beads must be stable, i.e. they must not tion relates to orally disintegrating tablets with speckled release the color during storage, and should give minimal appearance for their easy identification by physicians, nurses 15 coloration of the oral cavity after disintegration of the tablet. and patients. The present invention relates to orally disintegrating tab Solid pharmaceutical dosage forms for oral administration lets containing colored granules which give a speckled are usually in pill, tablet or capsule form. These dosage forms appearance to the tablets for their readily and easy identifica are available in a limited variety of shapes, size, and colors, tion by physicians, nurses and patients. and many of them are very similar to each other in their The orally disintegrating tablets of the invention contains outward appearance. colored granules of a water-soluble Sugar. Frequently, users confuse such dosage forms, particularly The present invention relates to orally disintegrating tab if they are elderly or have limited vision. The consequences of lets (ODT) with speckled appearance which make them taking the wrong medication can be life-threatening. For this readily identifiable by users. reason Health Authorities require that each dosage form and 25 The ODT with speckled appearance are prepared by mix strength must be clearly identified simply by individual visual ing Soluble colored granules to the pharmaceutically accept inspection. able carrier. Identification of tablets is usually made by using different The term “colored granules” as used herein after means shapes, sizes, or colors, or by color coating, printing or granules of a color different from the color of the tablet. embossing them. Very often a double identification is 30 required such as embossing and coloring, or coating and Colored granules are, for example, blue or yellow granules in printing, etc. a white tablet, blue or white granules in a yellow tablet, Also correct intake of drugs is important for their effective yellow or white granules in a blue tablet, dark bluegranules in CSS. a light blue tablet, blue granules and red granules in a white Conventional tablets are swallowed, usually with some 35 tablet, etc. water or other liquids, and the absorption of the active ingre The soluble colored granules are granular particles of a dient occurs in the gastro-intestinal tract. water-soluble Sugar Such as Sucrose or a polyalcohol. Specific Orally Disintegrating Tablets (ODT) dissolve in the oral examples of polyalcohols are Sorbitol, mannitol, Xylitol, fruc cavity by contact with saliva, do not require water for inges tose, etc. tion and could permit a buccal absorption of the active ingre 40 Preferably, the same polyalcohol already present in the dient. The advantageous properties of ODT overconventional pharmaceutically acceptable carrier of the ODT is used for tablets are making them always more and more popular for the preparation of the colored granules of the invention. drug administrations. Preferably, the ODT of the present invention contains col For their correct intake, it would be very helpful if ODT ored granules of mannitol. were more easily detectable and identifiable over conven 45 Even if water-soluble Sugars are excipients usually present tional tablets. in ODT, their use to prepare colored granules suitable for the In case of ODT physical identification methods are limited preparation of ODT with speckled appearance requires a because ODT tablets are characterized by a low hardness specific particle size. which allows their rapid dissolution when in contact with In fact, the particle size of the colored granules is critical. saliva (i.e. EU pharmacopoeia requires a disintegration time 50 Colored granules with too small particle size are not visible of not more than 3 minutes in water). and the resulting tablets have no speckled appearance. On the Coating is not usually used because it could delay Saliva other side, the use of colored granules with too large particle penetration in the tablets, so delaying their disintegration. size results in a tablet which appears uniformly colored and As a consequence, identification of ODT by printing is also therefore not readily identifiable over mono-colored tablets. unusual because this technique requires a Smooth and shining 55 The colored granules used in the ODT of the present inven tablet Surface. Such as a film- or a Sugar-coated tablet. tion have a particle size from about 10 um to about 1200 um, Embossing is possible but the dimension of characters is preferably from about 200 um to about 800 um, most prefer usually too small, due to the limited tablet surface, to be easily ably from about 300 um to about 500 um. read by elderly people or by people with a limited vision. The selection of the particle size of the colored granules of Colored ODT can be prepared but the limited number of 60 the ODT of the present invention depends on several factors. pharmaceutically acceptable colors make difficult to obtain Since the Sucrose or polyalcohol used for the colored granules an ODT easily identifiable over conventional colored tablets. is preferably one of the excipients already present in the ODT. One way to solve the problem would be to make ODT the particle size must be different from the particle size of the identifiable by using a particular colored pattern. already present excipient. ODT with speckled (spotted) appearance, i.e. with a bicol 65 The selection of the suitable particle size also depends on ored appearance characterized by the presence of spots of a the desired colored pattern. For example, the use of a little different color on their surface can be easily identified by quantity of large particles tends to produce an ODT with few US 8,440,170 B2 3 4 large colored spots on its Surface. Higher amount of Smaller roid; adrenocorticotropic hormones such as ACTH particles tends to produce less discrete colored spots on the cosintropin; alcohol deterrents such as calcium cianamide surface of the tablets. citrate, and disulfiram; aldose reductase inhibitors such as Then, the amount of colored granules suitable for each epalrestat, tolrestat, and Zopolrestat; aldosterone antagonists tablet, according to the present invention, can vary within a Such as canrenone, and spironolattone; anabolics Such as relatively large range depending on the particle size of the androisoxazole, androstenediol, methandriol, methenolon, granule. Preferably, the amount of colored granules ranges methyltrienolone, and nandrolone; narcotic analgesics Such between about 0.1% w/w and about 50% w/w, still more as alfentanil, buprenorphine, codeine and its derivatives, fen preferably between about 1% w/w and about 30% w/w. tanil, meperidine, methadone, morphine and its derivatives, Preferably the colored granules useful for the ODT with 10 pentazocine, phenazocine, propiram, propoxiphene, and speckled appearance of the present invention are prepared by Sufentanil; non narcotic analgesics such as aceclofenac, granulation of the water-soluble Sugar with an aqueous Sus acetaminophen, acetylsalicylic acid, alclofenac, alminopro pension or solution of the coloring agentina Suitable fluidbed fen, antypirine, benorilate, benoxoprofen, bromfenac, buce granulator.
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