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(12) Patent Application Publication (10) Pub. No.: US 2003/0108602 A1 Chu Et Al

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(12) Patent Application Publication (10) Pub. No.: US 2003/0108602 A1 Chu Et Al US 2003O1086O2A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2003/0108602 A1 Chu et al. (43) Pub. Date: Jun. 12, 2003 (54) TABLETS AND METHODS FOR MODIFIED (22) Filed: Jul. 8, 2002 RELEASE OF HYDROPHILIC AND OTHER ACTIVE AGENTS Related U.S. Application Data (75) Inventors: James Shunnan Chu, Palo Alto, CA (63) Continuation of application No. 09/599,102, filed on (US); Yisong Yang, Sunnyvale, CA May 19, 2000, now Pat. No. 6,419,954. (US); Joseph A. Fix, Half Moon Bay, CA (US) Publication Classification Correspondence Address: (51) Int. Cl. ............................................... A61K 9/20 TOWNSEND AND TOWNSEND AND CREW, (52) U.S. Cl. .............................................................. 424/465 LLP TWO EMBARCADERO CENTER EIGHTH FLOOR (57) ABSTRACT SAN FRANCISCO, CA 94111-3834 (US) (73) Assignee: Yamanouchi Pharma Technologies, The invention provides a tablet and methods for making the Inc., Palo Alto, CA (US) tablet comprising a gel-forming material and at least one particle comprising an active agent in contact with a coating (21) Appl. No.: 10/191,979 material to modify release of the active agent. Patent Application Publication Jun. 12, 2003 Sheet 1 of 11 US 2003/0108602 A1 (O) N 3(O) 2(O) A/G /A Patent Application Publication Jun. 12, 2003. Sheet 2 of 11 US 2003/0108602 A1 O / O2 OOO OO O Q(SO39 O KC O () i88. OOO OO Okk (ki (k) <k. SJS19O OO <! o O OSS) O O 33 kg) O<< 3k 32 "ooO O & : A/6, 2O Patent Application Publication Jun. 12, 2003 Sheet 3 of 11 US 2003/0108602 A1 Active POWCer (Cevimeline HCI) Formulation Parameters -Pretreatment of Active -Binder: Solid or Solution Binder -% Content of Binder (HPC or PEO/PEG) -Amount of Water Process Parameters -Equipment Selection -Spray Technique Pelletization -Product Temperature (Granulation) -Drying Procedure Process -Milling Technique -High Shear G -Fluid-Bed G In-Process Tests -Yield Active Pellet/Granules -Physical Characteristics -ASSay FIG. 3. Patent Application Publication Jun. 12, 2003 Sheet 4 of 11 US 2003/0108602 A1 Active Crystal Active Pellet -Made Using HPC -Made Using PEO/PEG Formulation for Coating Suspension Wurster Process - Coating Amount (Particle Coating) - Dilution With GPCG-1 - PlastCizers/Other Additives Using Polymeric Coating Agents Process Parameters - Surelease (ECAC. Dispersion) - Airflow - Eudragit RS/NE (Polyacrylic D.) - Product Temperature - Kollicoat SR (PVA Aq. Dispersion) - Atomization Pressure - Spray Rate - Plate/Nozzle Size Coating Product - Yield Coated Active Bead - Physical Characteristics - Assay/Dissolution Test FIG. 4. Patent Application Publication Jun. 12, 2003 Sheet 5 of 11 US 2003/0108602A1 OCAS Matrix Components Active Powder (PEO/PEG) (Cevimeline HCI) Granulation Process Process Parameters -With or w/o Coated Drug - High Shear Granulation - Roller Compaction -Equipment - Fluid-Bed Granulation -Wet or Dry Process -Product Temperature -Spray Technique -Drying/Milling Technique Process Parameters Final Blend -Physical Data of PEO/PEG Granules or Final Blends (Coated Drug + PEO/PEG) -Assay of Coated Beads -Blending Procedure Process Parameters -Tablet Weight/Shape Compression -Compression Force Final Matrix Tablet Final Product -Physical Characteristics Surelease or Kollicoat Coated -Dissolution (Release) Test Beads in OCAS Matrix -Content Uniformity FIG. 5. Patent Application Publication Jun. 12, 2003 Sheet 6 of 11 US 2003/0108602 A1 7OO 65O 6OO 55O 5 OO O 2O 4O 6O 8O Coating Amount (%) A/6 6. Patent Application Publication Jun. 12, 2003 Sheet 7 of 11 US 2003/0108602 A1 OO O 2 4. 6 8 O 2 TIME (hr) 0- 20% Cooted -- 3O%. Cooted -A- 4O% COOted ->{- 50%. Cooted -ek- 7O% coated A/6 Z. Patent Application Publication Jun. 12, 2003 Sheet 8 of 11 US 2003/0108602 A1 OO 4O mm Round/ConCOve/5KP O 6 2 8 24 3O TIME (HOUR) A/G 3. Patent Application Publication Jun. 12, 2003 Sheet 9 of 11 US 2003/0108602A1 2O OO 8O O 4. 8 2 16 2O 24, 28 Time (hour) A/6 9. Patent Application Publication Jun. 12, 2003 Sheet 10 of 11 US 2003/0108602 A1 O 6 2 8 24 3O TIME (HOUR) -0- 1.1 mm Round/Concave/3.5 KP, n= 6 -o- 8.7 x 8.9 mm Oval/2-3 KP, n = 3 A/6 /O. Patent Application Publication Jun. 12, 2003 Sheet 11 of 11 US 2003/0108602 A1 O N) - CN MO O N) (A) (/) (f) 555 E at E 2 ais 2d - - - O 3. 3s CN O O O }k O - Q 2 d S2 Aar S to S O to O O C O O Ow O 3 O O O & O S O OO CO Q OAOSSO % US 2003/0108602 A1 Jun. 12, 2003 TABLETS AND METHODS FOR MODIFIED delayed and/or pulsatile release of an active agent. The RELEASE OF HYDROPHILIC AND OTHER present invention fulfills these and other needs. ACTIVE AGENTS SUMMARY OF THE INVENTION CROSS-REFERENCES TO RELATED APPLICATIONS 0006 The present invention provides, for the first time, a tablet and methods for making the tablet that comprises a 0001. Not Applicable. gel-forming material and at least one particle comprising an active agent in contact with a coating material to modify STATEMENT AS TO RIGHTS TO INVENTIONS release of the active agent from the tablet. These particles MADE UNDER FEDERALLY SPONSORED that comprise the active agent and the coating material are RESEARCH AND DEVELOPMENT also referred to as “active agent-containing particle', 0002) Not Applicable. “coated particle' or “coated bead.” The gel-forming material forms a matrix (a 'gel-forming matrix”) for the active BACKGROUND OF THE INVENTION agent-containing particles. The active agent-containing par ticle is formulated with a coating material So that it can 0003) A variety of hydrogel-type preparations have been modify or control the release of the active agent by, for developed to effect the Sustained release of orally ingested example, Slowing or inhibiting the passage of the active drugs. For example, Japanese patent application JP-A-62 agent out of the tablet and into the digestive System. These 120315 discloses a preparation obtained by compression tablets are also referred to as OCASTM (oral controlled molding a drug, a hydrogel-forming water-Soluble polymer absorption System) matrix tablets herein. and an enteric coating. JP-A-63-215620 discloses a hydro gel-type preparation with a core having a drug and a 0007. In some embodiments of the invention, the release water-Soluble polymer and an outer layer with a water of the active agent from the tablet can be modified and soluble polymer as a base. JP-B-40-2053 discloses a sus controlled by the combination of two systems: 1) the gel tained-release preparation having a mixture of a drug and a forming matrix; and 2) the coating material in contact with high polymer of ethylene oxide and, as an optional compo the active agent. In the digestive System, the gel-forming nent, a hydrophilic Substance. However, all of these prepa matrix absorbs water to undergo Substantially complete rations are designed to release a drug continuously while the gelation during its stay in the upper digestive tract and administered preparation is still retained in the upper diges moves down into the lower digestive tract undergoing con tive tract, typically in the Stomach and Small intestine. They Stant erosion, continuously releasing the active agent-con were not intended to provide for a release of a drug in the taining particles from the tablet. This erosion of the gel lower digestive tract including the colon, where little water forming matrix can control the release of the active agent is available. containing particles from the tablet. In addition to the gel-forming matrix, the coating material that is on or around 0004 Hydrophilic gel-forming preparations have been the active agent provides another level of control in releas further developed So that they can provide a Sustained ing the active agent from the tablet. For example, the coating release of orally ingested drugs throughout the digestive material can modify or control the rate of diffusion of the System, including in the lower digestive tract. For example, active agent through the gel matrix and out of the tablet. EP 0 661 045 describes a preparation adapted to absorb Moreover, Since the coating material provides a physical water into its core to undergo Substantially complete gela and/or chemical barrier for the active agent, any type of tion during its stay in the upper digestive tract. AS the tablet active agents can be included in the tablets of the present moves down the digestive System in the form of a gel to the invention. The Selection of the active agent is not restricted lower digestive tract, the preparation Swells and the gelled to those which are released from the tablet in a favorable outer Surface of the tablet erodes gradually releasing the drug. This type of oral tablet is capable of providing a C. Sustained release of the drug throughout the digestive tract, 0008. In one aspect, the invention is particularly useful including in the colon. for an active agent that is hydrophilic. In the case of water insoluble or less hydrophilic active agents, the erosion of the 0005 While the gel-forming preparations, such as those gel-forming matrix of the tablet precedes the diffusion of the described in the EPO 661 045, have many applications, they active agent through the Swollengel layer of the tablet. Thus, may not be Suitable for certain types of active agents, the active agent release rate limiting Step is typically the particularly when the active agents are unstable in the erosion of the gel-forming matrix. Therefore, with these gel-forming preparations or may be released in a manner active agents, the gel-forming matrix alone can provide that is not desirable.
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