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(12) Patent Application Publication (10) Pub. No.: US 2010/0260858 A1 Ruddy Et Al

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(12) Patent Application Publication (10) Pub. No.: US 2010/0260858 A1 Ruddy Et Al US 2010.0260858A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2010/0260858 A1 Ruddy et al. (43) Pub. Date: Oct. 14, 2010 (54) DRUG DELIVERY COMPOSITION (22) Filed: Apr. 8, 2010 Related U.S. Application Data (75) Inventors: Stephen B. Ruddy, Schwenksville, (60) Provisional application No. 61/168,040, filed on Apr. PA (US); Simon L. McGurk, 9, 2009. Collegeville, PA (US); Rakesh Patel, Bensalem, PA (US); John Publication Classification Bullock, West Chester, PA (US); (51) Int. Cl. Raj Kewalramani, Collegeville, PA A6IR 9/14 (2006.01) (US) A638/43 (2006.01) A 6LX 3/553 (2006.01) A63L/436 (2006.01) Correspondence Address: A63L/403 (2006.01) Fox Rothschild, LLP A6II 3/167 (2006.01) Elan Pharma International Limited A6IP 43/00 (2006.01) 997 Lenox Drive, Bldg. #3 (52) U.S. Cl. ......... 424/492; 424/490; 424/491; 424/494; Lawrenceville, NJ 08648 (US) 424/497; 424/94.1: 514/220; 514/291; 514/411; 514/616;977/773 (57) ABSTRACT (73) Assignee: ELAN PHARMA INTERNATIONAL LIMITED, A composition for delivery of a drug is disclosed. The com Athlone (IE) position has a semipermeable coating, particles of a medica ment having an effective average particle size of less than or about 2 Lum and at least one surface Stabilizer adsorbed on the (21) Appl. No.: 12/757,005 Surface of the medicament particles, and a solubilizing agent. Patent Application Publication Oct. 14, 2010 Sheet 1 of 7 US 2010/0260858A1 Patent Application Publication Oct. 14, 2010 Sheet 2 of 7 US 2010/0260858A1 Patent Application Publication Oct. 14, 2010 Sheet 3 of 7 US 2010/0260858A1 100 O - -- 0 20 40 60 80 100 120 140 Time (min) -0-Composition A - - Composition C Fig. 3 Patent Application Publication Oct. 14, 2010 Sheet 4 of 7 US 2010/0260858A1 s asso" --eit -- s: 3. ceaea-lae a lava 11aaaaa. 1. (). 3. 3. strocassemi- is sm. (1,3), 3: solinaecentation "saturation solutility a g g g g g g g g is s s Tirre trir Fig. 4 Patent Application Publication Oct. 14, 2010 Sheet 5 of 7 US 2010/0260858A1 O. O8 OOOS t OOO4 0.02 Time hrs Fig. 5 Patent Application Publication Oct. 14, 2010 Sheet 6 of 7 US 2010/0260858A1 6.0 row-oo-muar.m narror-manmaalaam-m-m-m--a orror-woo, time Tir FIG. 6 Patent Application Publication Oct. 14, 2010 Sheet 7 of 7 US 2010/0260858A1 3O ma-ma-am i O.25 : WR i? wit - was 8 aah A. As of Wah . .-saturation solubility 0.20 e--(4) O 20 30 O 50 SO O Tirre thrs Fig. 7 US 2010/0260858 A1 Oct. 14, 2010 DRUG DELIVERY COMPOSITION ticles have an effective average particle size of less than or about 2 Lum and a surface stabilizer adsorbed on the surface of CROSS-REFERENCE TO RELATED the medicament particles. APPLICATION 0008. In an embodiment, the medicament is a compound that has low native solubility in the fluid of the environment of 0001. This application claims benefit under 35 U.S.C. US S119(e) of U.S. Provisional Application No. 61/168,040, 0009. In another embodiment, the solubilizing agent is of filed Apr. 9, 2009, the disclosure of which is hereby incorpo a type and present in an amount Sufficient to dissolve the rated by reference herein, in its entirety. medicament particles within the composition prior to delivery of the medicament to the environment of use. BACKGROUND OF THE INVENTION 0010. In another embodiment, the solubilizing agent is a Surface-active agent or a pH-modulating agent. 0002 Some types of oral drug delivery compositions can 0011. In another embodiment, the semipermeable coating be described as extended-release, controlled-release, or Sus Substantially prevents the passage of medicament particles tained release compositions. These terms, however, have not out of the drug delivery composition, but allows passage of been used consistently in the art. A more consistent term to describe these compositions collectively is “modified-re dissolved medicament. lease' compositions. Modified-release compositions can be 0012. In another embodiment, the semipermeable coating defined as "compositions for which the drug release charac is a controlled-porosity microporous coating comprising a teristics of time course and/or location are chosen to accom poorly water-soluble or water-insoluble polymers and a plish therapeutic or convenience objectives not offered by water-soluble pore forming additives. conventional dosage forms.' 0013. In another embodiment, the polymer of the con 0003. In general, modified-release compositions intended trolled-porosity microporous coating is selected from the for oral administration utilize drug delivery technologies to group consisting of cellulosic polymers such as ethylcellu release drug over a number of hours—constantly, intermit lose and cellulose acetate, methacrylates and phthalates, and tently, or after a lag time upon ingestion. Such effects can be the pore forming additive is selected from the group consist achieved, for example, through use of a drug release retardant ing of HPMC, PVP, and polyhydric alcohols such as manni contained within a matrix core or alternatively, a release tol. Xylitol and Sorbitol, and Sugars Such as Sucrose. modifying film coating that envelops a core. Examples of 0014. In an embodiment, the drug delivery composition is release-modifying film coatings include those responsive to in a dosage form of a capsule comprising multiparticlate changes in pH within the environment of the GI tract (e.g., beads, each bead comprises multiple layers, and, when enteric coatings), or microporous coatings that govern drug described starting at the center of the bead and moving radi release upon formation of concentration gradients or artifi ally outward, has a center comprising an inert core, a layer of cially created osmotic gradients. solubilizing agent, a layer of medicament particles having an 0004 Exemplary modified-release compositions incorpo effective average particle size of less than or about 2 um and rating a release-modifying film coating and/or an enteric a surface stabilizer adsorbed on the surface of the medicament coating include the Elan Pharma International Ltd., particles, and a semipermeable coating. SODAS(R) (Spheroidal Oral Drug Absorption System) multi 0015. According to an embodiment of the invention, the particulate drug delivery system as exemplified in U.S. Pat. composition comprises a multiparticulate pharmaceutical No. 6.228,398, herein incorporated by reference. dosage form comprising a plurality of beads. Each bead com 0005 Exemplary compositions utilizing an artificially prising an inert Substrate, a Surface-active agent layer dis created osmotic gradient to deliver active agents include the posed about the inert Substrate, and a semipermeable coating. Alza Corporation OROS(R) Push PullTM osmotic drug delivery Disposed between the Surface-active agent layer and the system which is described in U.S. Pat. Nos. 5,413.572; 5,324, semipermeable coating are medicament particles. The medi 280; and 6,419,952, each of which is incorporated by refer cament particles have an effective average particle size of less ence herein and each of which is directed to an osmotic than or about 2 um and a surface stabilizer adsorbed on the system for delivering a beneficial agent to an environment of surface of the particles. use. The osmotic system described therein comprises (a) an 0016. In another embodiment, the medicament is a com outside semipermeable wall, (b) a middle osmotically active pound of Class II or Class IV (identified by the BCS (Biop layer, (c) a capsule comprising a beneficial agent, and (d) a harmaceutical Classification System)), which includes, but is passageway for dispensing the beneficial agent from the not limited to, compounds such as tacrolimus, Sirolimus, osmotic system. Another osmotic dosage form is taught in fenofibrate, carvedilol, celecoxib, and naproxen. U.S. Pat. No. 4,971,790 (incorporated by reference herein), 0017. In another embodiment, the medicament is a weakly which is directed to a composition comprising a drug, a basic compound Such as clozapine. neutral hydrogel and an ionic hydrogel. 0018 Yet another embodiment of the invention comprises 0006. There is still, however, a need in the art to delivery a multiparticulate pharmaceutical dosage form comprising poorly water-soluble drugs exhibiting low native solubility in beads, each bead having a core of an inert Substrate, a layer of the fluid of the environment of use. medicament particles having an effective average particle size of less than or about 2 um and a Surface stabilizer SUMMARY OF THE INVENTION adsorbed on the Surface of the particles, and a semipermeable coating. Disposed between the medicament layer and the 0007. A drug delivery composition having a semiperme semipermeable coating is pH-modulating agent layer. able coating, particles of a medicament, and an agent that 0019. In another embodiment, the pH-modulating agent solubilizes the medicament is provided. The medicament par layer comprises one organic acid, possibly two or more. US 2010/0260858 A1 Oct. 14, 2010 0020. In another embodiment, the organic acid is selected nique intended to result in nanoparticulates. Examples of from the group consisting of adipic acid, ascorbic acid, citric Such techniques are described in more detail below. A nano acid, fumaric acid, gallic acid, glutaric acid, lactic acid, malic particle/nanoparticulate medicament is distinguished from a acid, maleic acid. Succinic acid, tartaric acid, and other non-nanoparticulate API, which typically does not have a organic acids Suitable for use in pharmaceutical preparations reduced particle size. for oral administration. 0032. According to an embodiment, non-nanoparticulate API is processed to reduce its particle size to a nanoparticu BRIEF DESCRIPTION OF THE DRAWINGS late medicament. In an embodiment, the size reduction pro cess is a milling process. The resulting milled nanoparticulate 0021.
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