Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Patent
1997-09-30
1999-10-12
Harrison, Robert H.
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Tablets, lozenges, or pills
424451, 424452, 424457, 424464, 424469, 424470, 424484, 424485, 424486, 424487, 424488, 424489, A61K 914, A61K 916, A61K 926, A61K 948
Patent
active
059651636
ABSTRACT:
A process for the manufacture of particles comprises mechanically working a mixture of a drug and a hydrophobic and/or hydrophilic fusible carrier in a high speed mixture so as to form agglomerates, breaking the agglomerates to give controlled release particles and optionally continuing the mechanical working with the optional addition of a low percentage of the carrier or diluent.
REFERENCES:
patent: 2738303 (1956-03-01), Blythe et al.
patent: 3065143 (1962-11-01), Christenson et al.
patent: 3652589 (1972-03-01), Flick et al.
patent: 3830934 (1974-08-01), Flick et al.
patent: 3845770 (1974-11-01), Theeuwes et al.
patent: 3950508 (1976-04-01), Mony et al.
patent: 3965256 (1976-06-01), Leslie
patent: 3974157 (1976-08-01), Shetty et al.
patent: 4013784 (1977-03-01), Speiser
patent: 4076798 (1978-02-01), Casey et al.
patent: 4132753 (1979-01-01), Blichare et al.
patent: 4259314 (1981-03-01), Lowey
patent: 4310483 (1982-01-01), Dorfel et al.
patent: 4343789 (1982-08-01), Kawata et al.
patent: 4366172 (1982-12-01), Lednicer
patent: 4380534 (1983-04-01), Fukui et al.
patent: 4389393 (1983-06-01), Schor et al.
patent: 4421736 (1983-12-01), Walters et al.
patent: 4483847 (1984-11-01), Augart
patent: 4533562 (1985-08-01), Ikegami et al.
patent: 4613619 (1986-09-01), Sleigh et al.
patent: 4621114 (1986-11-01), Watanabe
patent: 4801458 (1989-01-01), Hidaka et al.
patent: 4801460 (1989-01-01), Goertz et al.
patent: 4828836 (1989-05-01), Elger et al.
patent: 4834984 (1989-05-01), Goldie et al.
patent: 4834985 (1989-05-01), Elger et al.
patent: 4844907 (1989-07-01), Elger et al.
patent: 4844909 (1989-07-01), Goldie et al.
patent: 4861598 (1989-08-01), Oshlack
patent: 4880830 (1989-11-01), Rhodes
patent: 4894234 (1990-01-01), Sharma et al.
patent: 4917899 (1990-04-01), Geoghegan et al.
patent: 4925675 (1990-05-01), Glannnini et al.
patent: 4935246 (1990-06-01), Ahrens
patent: 4967486 (1990-11-01), Doelling
patent: 4970075 (1990-11-01), Oshlack
patent: 4987136 (1991-01-01), Kreek et al.
patent: 4990341 (1991-02-01), Goldie et al.
patent: 5007790 (1991-04-01), Shell
patent: 5023089 (1991-06-01), Sakamoto et al.
patent: 5026560 (1991-06-01), Makino et al.
patent: 5030400 (1991-07-01), Danielson et al.
patent: 5073379 (1991-12-01), Klimesh et al.
patent: 5126145 (1992-06-01), Evenstad
patent: 5132142 (1992-07-01), Jones et al.
patent: 5133974 (1992-07-01), Paradissis et al.
patent: 5162117 (1992-11-01), Stupak et al.
patent: 5167964 (1992-12-01), Muhammed et al.
patent: 5169645 (1992-12-01), Shukla et al.
patent: 5178868 (1993-01-01), Malmqvist-Granlund et al.
patent: 5196203 (1993-03-01), Boehm
patent: 5202128 (1993-04-01), Morella et al.
patent: 5204119 (1993-04-01), Shiobara et al.
patent: 5266331 (1993-11-01), Oshlack et al.
patent: 5271934 (1993-12-01), Goldenberg et al.
patent: 5273760 (1993-12-01), Oshlack et al.
patent: 5286493 (1994-02-01), Oshlack et al.
patent: 5292461 (1994-03-01), Juch et al.
patent: 5300300 (1994-04-01), Egidio et al.
patent: 5330766 (1994-07-01), Morella et al.
patent: 5395626 (1995-03-01), Kotwal et al.
patent: 5403593 (1995-04-01), Royce
patent: 5443846 (1995-08-01), Yoshioka et al.
patent: 5453283 (1995-09-01), Munch et al.
patent: 5472710 (1995-12-01), Klokkers-Bethke et al.
patent: 5500227 (1996-03-01), Oshlack et al.
patent: 5549912 (1996-08-01), Oshlack
patent: 5580578 (1996-12-01), Oshlack et al.
patent: 5591452 (1997-01-01), Miller et al.
patent: 5639476 (1997-06-01), Oshlack et al.
patent: 5807583 (1998-09-01), Kristensen et al.
patent: 5843480 (1998-12-01), Miller et al.
patent: 5849240 (1998-12-01), Miller et al.
McTaggart, C.M., et al., "The Evaluation of Formulation and Processing Conditions of a Melt Granulation Process", Int. J. Pharm., vol. 19, No. 2, Issued 1984, pp. 139-148.
El-Shanawany, S., "Sustained Release of Nitrofurantoin From Inert Wax Matrixes", J. Controlled Release, vol. 26, No. 1, Issued 1993, pp. 11-19.
R. Kinget et al., "Preparation and Properties of Granulates Containing Solid Dispersions", Acta Phar. Tech., vol. 31, No. 2, 1985, pp. 57-62.
M. J. Jozwiakowski et al., "Characterization of a Hot-Melt Fluid Bed Coating Process for Fine Granules", Pharm. Resear., vol. 7, No. 11, 1990, pp. 1119-1124.
B. Evrard et al., "Melt Granulation With a New Laboratory High-Shear Mixer", Laboratoire de Pharmacie Galenique, Institut de Pharmacie.
M. Niskanen et al., "Pelletization in a Centrifugal Granulator, Part I: Effects of Binder-Solution Concentration", Pharm. Tech. Int'l, Oct. 1990, pp. 22-38.
L. Lachman et al., "The Theory and Practice of Industrial Pharmacy", p. 315, Lea & Febiger, Phi. 1976.
FDA Guide to Inspections of Oral Solid Dosage Forms Pre/Post Approval Issues for Development and Validation, Jan. 1994.
T. Schaefer et al. "Melt Pelletization in a High Shear Mixer I Effects of Process variables and Binder", Acta Pharm. Nord. vol. 4, No. 3, pp. 133-140, 1992.
T. Schaefer et al. "Melt Pelletization in a High Shear Mixer II Power Consumption and Granule Growth", Acta Pharm. Nord. vol. 4, No. 3, pp. 141-148, 1992.
T. Schaefer, et al., "Melt Granulation in a Laboratory Scale High Shear Mixer", Drug Dev. and Indust. Phar., vol. 16, No. 8, pp. 1249-1277, 1990.
P. Flanders, et al., "The Controlled of Drug Releases From Conventional Melt Granulation Matrices", Drug Dev. and Industrial Pharm., vol. 13, No. 6, pp. 1001-1022, 1987.
Thomsen, L. Juul, "Matrix Pellets Prolonged Formulations Prepared by Melt Pelletization", Dept. of Pharm. Royal Danish School of Pharmacy, 1992.
Thomsen, L. Juul, et al., "Prolonged Release Matrix Pellets Prepared by Melt Pelletization I. Process Variables", Drug Development and Instrial Pharmacy, vol. 19, No. 15, pp. 1867-1887 (1993).
Thomsen, L. Juul, et al., "Prolonged Release Matrix Pellets Prepared by Melt Pelletization II. Hydrophobic Substances as Meltable Binders," Drug Development and Industrial Pharmacy, vol. 20, No. 7, pp. 1179-1197 (1994).
Thomsen, L. Juul, "Utilizing melt pelletization technique for the preparation of prolonged release products", Pelletization, (material elaborated by assistant prof. Lars Juul Thomsen, Department of Pharmaceutics, Royal Danish School of Pharmacy for the DIE course "Pelletization Technology", Nov. 1992, 106 pags plus 3 appendices.
Thomsen, L. Juul, "Prolonged Release Matrix Pellets Prepared by Melt Pelletization. Part IV: Drug Conent, Drug Particle Size, and Binder Composition", Pharmaceutical Technology Europa, pp. 19-22 (Oct. 1994).
G.M. Crass et al., "Sustained and Controlled Release Drug Delivery Systems", Modern Pharmaceutics, 2nd Edition, pp. 635-671, 1990.
N. Follonier et al., "Evaluation of Hot-Melt Extrusion as a New Technique for the Production of Polymer-Based Pellets for Sustained Release Capsules Containng High Loadings of Freely Soluble Drugs", Drug Dev. and Indus. Pharm., vol. 20, No. 8, pp. 1323-1339, 1994.
Sustained Release Medications, Noyes Data Corp., 1980.
M.A. Longer, "Sustained-Release Drug Delivery Systems", Remington's Pharm. Scie., 18th Edition, pp. 1676-1693, 1990.
M. Zahirul I. Khan, "Recent Trends and Progress in Sustained or Controlled Oral Delivery of Some Water Soluble Drugs: Morphine Salts, Diltiazem and Captopril", Drug Devl. and Indus. Pharm., vol. 21, No. 9, pp. 1037-1070, 1995.
J.P. Skelly, Scale-up of Immediate Release Oral Solid Dosage Forms, AAPS/FDA Workshop Committee, Pharmaceutical Technology, pp. 68-74, Apr. 1995.
SK Baveja et al., Int. J. Pharmaceutics, 41, (1988) pp. 55-62.
Formulating for Controlled Release with Methocel.RTM. Premium Cellulose Ethers, The Dow Chemical Company, 1989.
M S Vasquez et al., Drug Dev. & Ind. Pharmacy, 18(11&12), pp. 1355-1378 (1992).
L W S Cheong et al., Pharm. Res 9(11) pp. 1510-1514 (1992).
Pharmazeutische Stoffliste 6th Ed., 1985 p. 196.
Rote Liste 1993 Nos 05001 & 05008.
Haltbarkeits-Herstellungsdaten deutscher Arzneimittel p. 486.
Pharmazeutische Stoffliste 10. Auflage, p. 193, Nov. 1994.
Kuschinsky et al., Kurzes Lehrbuch der Pharmakologie und Toxikolgie, Georg Theime Verlag Stuttgart, New York 1987, pp. 270-273.
Rote Liste 1992, Entry No. 05020.
Derwent WPI C92-138727 Abstract JP 04/217 925
Challis Deborah
Heafield Joanne
Knott Trevor John
Leslie Stewart Thomas
Malkowska Sandra Therese Antoinette
Euro-Celtique S.A.
Harrison Robert H.
LandOfFree
Substained release compositions and a method of preparing pharma does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Substained release compositions and a method of preparing pharma, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Substained release compositions and a method of preparing pharma will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-649605