Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Particulate form
Reexamination Certificate
2003-02-26
2008-09-23
Woodward, M P (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Particulate form
C424S408000, C424S439000, C424S451000, C424S457000, C424S458000, C424S465000, C424S469000
Reexamination Certificate
active
07427413
ABSTRACT:
The present invention provides storage stable, shaped particles of allotropic organic compounds. The particles of the present invention can be shaped according to the desired application. Preferred shapes of such particles are microspheres, particularly those having diameters of about 1 to about 1,000 microns. The stable shaped particles of the present invention are particularly well-suited to the fabrication of pharmaceutical formulations, particularly where sustained release and uniform bioavailability are desired. The storage stable particles are formed by a solid state crystallization of allotropic organic compounds. The solid state crystallization process of the present invention affords a means for achieving a storage stable crystalline form of said allotropic compound without loss or deterioration of the original particle dimensions.
REFERENCES:
patent: 2447362 (1948-08-01), Pessel
patent: 3800038 (1974-03-01), Rudel
patent: 4230621 (1980-10-01), Bernstein et al.
patent: 4347234 (1982-08-01), Wahlig et al.
patent: 4447426 (1984-05-01), Wang et al.
patent: 4521431 (1985-06-01), Crookes et al.
patent: 4584366 (1986-04-01), Gerking et al.
patent: 4810566 (1989-03-01), Kawakami et al.
patent: 4897307 (1990-01-01), Beck et al.
patent: 4919899 (1990-04-01), Herrmann et al.
patent: 4948871 (1990-08-01), Fukuoka et al.
patent: 4996222 (1991-02-01), Carlin et al.
patent: 5069910 (1991-12-01), Kovacic et al.
patent: 5290913 (1994-03-01), McAllister et al.
patent: 5360478 (1994-11-01), Krukonis et al.
patent: 5391810 (1995-02-01), Abe et al.
patent: 5409505 (1995-04-01), Morita et al.
patent: 5512303 (1996-04-01), Garza Flores et al.
patent: 5558678 (1996-09-01), Weger
patent: 5633014 (1997-05-01), Garza Flores et al.
patent: 5643604 (1997-07-01), Uribe et al.
patent: 5817634 (1998-10-01), Meezan et al.
patent: 5849651 (1998-12-01), Takayama et al.
patent: 5858410 (1999-01-01), Muller et al.
patent: 5874063 (1999-02-01), Briggner et al.
patent: 6528094 (2003-03-01), Savoir et al.
patent: 6537580 (2003-03-01), Savoir et al.
patent: 6663895 (2003-12-01), Savoir et al.
patent: 6737081 (2004-05-01), Savoir et al.
patent: 860515 (1961-02-01), None
patent: 0054868 (1982-02-01), None
patent: 0 364 944 (1990-04-01), None
patent: 0 364 944 (1990-04-01), None
patent: 57099562 (1992-06-01), None
patent: 0 508 969 (1992-10-01), None
patent: 0 508 969 (1992-10-01), None
patent: 0 531 845 (1993-03-01), None
patent: 0 531 845 (1993-03-01), None
patent: 57 099562 (1982-06-01), None
patent: 0143832 (1983-08-01), None
patent: 09 557558 (1997-09-01), None
patent: WO91 19484 (1991-12-01), None
patent: WO 91/19484 (1991-12-01), None
patent: WO99 43304 (1999-02-01), None
Extended European Search Report issued in EP 06 02 2834.3 on Feb. 23, 2007.
Mueller et al., “Melting Behavior, Mechanical Properties and Fracture of Crystallized Polycarbonates”LatinAmerican Journal of Metallurgy and Materials, 50:130-141, 1985, No. 2, Departamento de Ciencia de Materials, Universidad Simón Bolívar, Apartado 80659, Caracas 1080, Venezuela.
Matsuda et al., “Physicochemical Characterization of Spray-Dried Phenylbutazone Polymorphs”Journal of Pharmaceutical Sciences, 73:173-179, 1984, No. 2, American Pharmaceutical Association, Easton, PA.
Hancock et al., “Characteristics and Significance of the Amorphous State in Pharmaceutical Systems”,Journal of Pharmaceutical Sciences, 86:1-12, 1997, No. 1, American Pharmaceutical Association, Easton, PA.
Tang et al., “Effect of solvent vapor on optical properties of Pr4VOPc in polymethylmethacrylate”,J. Appl. Phys., 78:5884-5887, 1995, No. 10, American Institute of Physics, Melville, NY.
Frokjaer et al., “Application of differential scanning calorimetry to the determination of the solubility of a metastable drug”,Archiv for Pharmaci of . Chemi Scientific Ed.2:51-59, 1974, Kobenhavn: Danmarks Apotekerforening, Copenhagen, Denmark.
Giron, “Thermal analysis and calorimetric methods in the characterisation of polymorphs and solvates”,Thermochimica Acta248:1-59, 1995, Elsevier Science B.V., Oxford, U. K.
Kawashima, “Characterization of Polymorphs of Tranilast Anhydrate and Tranilast Monohydrate When Crystallized by Two Solvent Change Spherical Crystallization Techniques”,Journal of Pharmaceutical Sciences, 80:472-477, 1991, No. 5, American Pharmaceutical Association, Easton. PA.
Ibrahim et al., “Polymorphism of Phenylbutazone: Properties and Compressional Behavior of Crystals”,Journal of Pharamceutical Sciences, 66669-673, 1997, No. 5, American Pharmaceutical Association, Easton, PA.
Yu, “Inferring Thermodynamic Stability Relationship of Polymorphs from Melting Data”,Journal of Pharmaceutical Sciences, 84:966-974, No. 8, Aug. 1995, American Pharmaceutical Association, Easton. PA.
Salole, “The physicochemical properties of oestradiol”,Journal of Pharmaceutical&Biomedical Analysis, 5:635-648, No. 7, 1987, Pergammon Journals, Ltd., Gr. Britain.
Jerslev et al., “Organic solid-phase analysis”,Archiv for Pharmaci of Chemi. Scientific Edition, 9123-130, 1981, Kobenhavn: Danmarks Apotekerforening, Copenhagen, Denmark.
Frokjaer et al., “Dissolution behavior involving simultaneous phase changes of metastable drugs”,Archiv for Pharmaci of Chemi. Scientific Edition, 2:79-94, 1974, Kobenhavn: Danmarks Apotekerforening, Copenhagen, Denmark.
Forni et al., “Solid state transitions and cap availability in surface solid dispersions of chloramphenicol stearate polymorphs”,Drug Development and Industrial Pharmacy, 14:633-647, 1988, No. 5, Marcel Dekker, Inc., New York.
Thakkar et al., “Miscellar Solubilization of Testosterone III: Dissolution Behavior of Testosterone in Aqueous Solutions of Selected Surfactants”,Journal of Pharmaceutical Sciences, 58:68-71, 1969, No. 1, American Pharmaceutical Association, Easton. PA.
Haleblian, “Isolation and Characterization of Some Solid Phases of Fluprednisolone”,Journal of Pharmaceutical Sciences, 60:1485-1488, No. 10, Oct. 1971, American Pharmaceutical Association, Easton, PA.
Yang et al., “Polymorphism in Sulfonamides”,Journal of Pharmaceutical Sciences, 61:27-40, 1972, No. 1, American Pharmaceutical Association, Easton, PA.
Muramatsu et al., “Thermodynamic Relationship between alpha- and beta-Forms of Crystalline Progesterone”,Journal of Pharmaceutical Sciences, 68:175-176, 1979, No. 2, American Pharmaceutical Association, Easton, PA.
Pfeiffer et al., “Crystal Pseudopolymorphism of Cephaloglycin and Cephalexin”,Journal of Pharmaceutical Sciences, 59:1809-1814, 1970, No. 12, American Pharmaceutical Association, Eaton, PA.
JP 9227558 A (Abstract) (Database WPI, Week 9748, Derwent Publications Ltd., London GB; AN 97-516220 XP002107738) Sep. 2, 1997.
JP 57 0099562 A Jun. 21, 1982 Abstract) (Patent Abstracts of Japan, vol. 6, No. 186 (C-126) Sep. 22, 1982 (Abstract)).
JP 9557558 A (Abstract) (Database WPI, Week 9748, Derwent Publications Ltd., London, GB; AN 97-516220 XP002107738) Sep. 2, 1997.
Angeles Juan
De Gyves Aurelio
Gomez Abraham
Savoir John-Claude
Buchanan Ingersoll & Rooney P.C.
Mercier Melissa S
Skendi Finance Ltd.
Woodward M P
LandOfFree
Stable shaped particles of crystalline organic compounds does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Stable shaped particles of crystalline organic compounds, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Stable shaped particles of crystalline organic compounds will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3981101