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(12) Patent Application Publication (10) Pub. No.: US 2009/0004248 A1 Bunick Et Al

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(12) Patent Application Publication (10) Pub. No.: US 2009/0004248 A1 Bunick Et Al US 20090004248A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2009/0004248 A1 Bunick et al. (43) Pub. Date: Jan. 1, 2009 (54) DUAL PORTION DOSAGE LOZENGE FORM Related U.S. Application Data (60) Provisional application No. 60/947,004, filed on Jun. (76) Inventors: Frank Bunick, Randolph, NJ (US); 29, 2007. Joseph Luber, Quakertown, PA Publication Classification (US); Stephan G. Wiet, Morristown, NJ (US); Gerard P. (51) Int. Cl. McNally, Berwyn, PA (US); David A69/20 (2006.01) Wynn, Huntingdon Valley, PA (US) A6IR 9/28 (2006.01) A63L/485 (2006.01) (52) U.S. Cl. ......................................... 424/440: 514/289 Correspondence Address: PHILIP S. JOHNSON (57) ABSTRACT JOHNSON & JOHNSON The present invention relates to a dosage form including both ONE JOHNSON & JOHNSON PLAZA a disintegrative tablet portion and a hard candy portion, NEW BRUNSWICK, NJ 08933-7003 (US) wherein: (i) the disintegrative tablet portion comprises at least one pharmaceutically active agent, and (ii) the hard candy portion covers at least 20% of the surface of the disintegrative (21) Appl. No.: 12/143,916 tablet portion, and wherein the disintegration time of the hard candy portion is at least ten times longer than the disintegra (22) Filed: Jun. 23, 2008 tion time of the disintegrative tablet portion. US 2009/0004248 A1 Jan. 1, 2009 DUAL PORTION DOSAGE LOZENGE FORM rated by reference. As used herein, all percentages are by weight unless otherwise specified. CROSS REFERENCE TO RELATED APPLICATION Disintegrative Tablet Portion 0008. The dosage form of the present invention includes a 0001. This application claims priority to prior U.S. provi disintegrative tablet portion. The disintegrative tablet portion sional patent application 60/947,004 filed on Jun. 29, 2007, includes one or more pharmaceutically active agents and which is hereby incorporated in its entirety. optionally includes one or more compressible excipients, water-swellable excipients, effervescent couples, and other FIELD OF THE INVENTION ingredients. 0009. In one embodiment, the disintegrative tablet portion 0002 The present invention relates to a dosage form has a hardness of less than about 15 kp/cm, such as less than including both a disintegrative tablet portion and a hard candy 10 kp/cm, such as less than 5 kp/cm. In one embodiment portion, and the use thereof. Sufficient amount of energy is applied to the disintegrative tablet portion for a sufficient amount of time to decrease its BACKGROUND OF THE INVENTION hardness. In one embodiment, energy is applied to the disin tegrative tablet portion in the form of heat or electromagnetic 0003 Pharmaceuticals intended for oral administration are typically provided in Solid form as tablets, capsules, pills, radiation, such as microwaves. Depending on the composi lozenges, or granules. Rapidly disintegrative tablets are often tion of the disintegrative tablet portion, in one embodiment, employed in the administration of pharmaceuticals where it is heating may be performed at a temperature generally in the impractical to provide a tablet for Swallowing whole, for range of ambient temperature to 100° C. or beyond for a time instance with pediatric patients. Several workers in the field sufficient to achieve a softening effect. have explored rapidly disintegrative tablets (e.g., U.S. Pat. 0010. In one embodiment, the disintegrative tablet portion Nos. 6,106,861 and 6,024,981 and PCT Application No. WO has a friability of less than about 2% (such as less than about 99/47126). 1%, such as less than about 0.5%) prior to the application of 0004. Applicants invention relates to a dual portion dosage energy to the disintegrative tablet portion, which is the second form that combines the use of a rapidly disintegrative tablet step of the process. A discussion of disintegrative tablet por containing a pharmaceutically active agent with a slower tion friability is presented in USP 23 (1995) 1216, p. 1981. disintegrative hard candy portion (e.g., a lozenge). The dos 0011. In one embodiment the disintegrative tablet portion age form, thus, provides both the benefit of the fast delivery of is designed to dissolve in the mouth when placed on the pharmaceutically active agent contained within the rapidly tongue in less than about 60 seconds, e.g. less than about 45 disintegrative tablet portion with the benefit of slower degrad seconds, e.g. less than about 30 seconds, e.g. less than about ing hard candy portion, which may contain a second pharma 15 seconds. ceutically active agent. Compressible Excipient SUMMARY OF THE INVENTION 0012. In one embodiment, the disintegrative tablet portion includes one or more compressible excipients. What is meant 0005. The present invention relates to a dosage form by a compressible excipient is an ingredient that can be com including both a disintegrative tablet portion and a hard candy pressed into a tablet shape without the addition of other bind portion, wherein: (i) the disintegrative tablet portion includes ing agents. In one embodiment, the compressible excipient in at least one pharmaceutically active agent, and (ii) the hard the form of a hydrate, and may be selected from organic candy portion covers at least 20% of the surface of the disin compounds Such as dextrose monohydrate, maltodextrin, lac tegrative tablet portion, and wherein the disintegration time of tose monohydrate, and dextrin, as well as inorganic com the hard candy portion is at least five times (such as at least ten pounds including dibasic calcium phosphate dihydrate, diba times) longer than the disintegration time of the disintegrative sic sodium phosphate dihydrate, dibasic sodium phosphate tablet portion. Other features and advantages of the present heptahydrate, dibasic sodium phosphate dodecahydrate, invention will be apparent from the detailed description of the monobasic sodium phosphate monohydrate, and monobasic invention and from the claims. Sodium phosphate dihydrate. In one embodiment, the disin tegrative tablet portion includes a compressible excipient DETAILED DESCRIPTION OF THE INVENTION selected from the group consisting of isomalt, dextrose mono hydrate, maltodextrin, lactose monohydrate, dextrin, manni 0006. It is believed that one skilled in the art can, based tol, lactitol, Sorbitol. Xylitol, erythritol. Sucrose, and lactose. upon the description herein, utilize the present invention to its 0013. In one embodiment, the compressible excipient(s) fullest extent. The following specific embodiments can be are in the form of particles having an average particle diam construed as merely illustrative, and not limitative of the eter of from about 50 to about 500 microns, such as from remainder of the disclosure in any way whatsoever. about 75 to about 400 microns. 0007. Unless defined otherwise, all technical and scien 0014. In one embodiment, the disintegrative tablet portion tific terms used herein have the same meaning as commonly includes from about 5 to about 90 percent, such as from about understood by one of ordinary skill in the art to which the 15 to about 75 percent, by weight of one or more compress invention belongs. Also, all publications, patent applications, ible excipients. In one embodiment, the disintegrative tablet patents, and other references mentioned herein are incorpo portion includes at least 40 percent by weight of the one or US 2009/0004248 A1 Jan. 1, 2009 more compressible excipients, based on the total weight of production include direct compression (“dry blending'), dry the disintegrative tablet portion. granulation followed by compression, and wet granulation followed by drying and compression. Other methods include Water-Swellable Excipient the use of compacting roller technology Such as a chilsonator 0015. In one embodiment, the disintegrative tablet portion or drop roller, or molding, casting, or extrusion technologies. further includes one or more water-swellable excipients. All of these methods are well known in the art, and are What is meant be water swellable excipient is a material that described in detail in, for example, Lachman, et al. The is designed to Swell or wick liquid upon contact with a liquid Theory and Practice of Industrial Pharmacy, Chapter 11, (3rd medium and to aid in the disintegration of the compressed Ed. 1986). tablet. The water-swellable excipient may be selected from 0022. In one embodiment, the disintegrative tablet por Superdisintegrants such as crospovidone, croScarmellose, tions are formed by the direct compression method, which Sodium starch glycolate, cellulose compounds such as micro involves directly compacting a blend of the pharmaceutically crystalline cellulose, starches, alginic acid and inorganic active agent, the compressible excipient, the water-swellable clays Such as bentonite, attapulgite, and magnesium alumi excipient, and any other appropriate optional ingredients. num silicate. In one embodiment, the a water-swellable After blending, a pre-determined volume of particles is filled excipient is at least partially hydrated and selected from the into a die cavity of a rotary tablet press, which continuously group consisting of sodium starch glycolate, crospovidone, rotates as part of a “die table' from the filling position to a croScarmellose, microcrystalline cellulose, starches, hydrox compaction position. The particles are compacted between an ypropyl cellulose, and alginic acid. upper punch and a lower punch to an ejection position, at 0016. In one embodiment, the amount of water-swellable which the resulting disintegrative
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