Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Radical -xh acid – or anhydride – acid halide or salt thereof...
Reexamination Certificate
2007-08-21
2007-08-21
Badio, Barbara P. (Department: 1617)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Radical -xh acid, or anhydride, acid halide or salt thereof...
C514S252120, C562S460000, C544S358000
Reexamination Certificate
active
10880851
ABSTRACT:
In one aspect, the present invention relates to a formulation in the form of molecular dispersion comprising i) fenofibric acid, a physiologically acceptable salt or derivative thereof and optionally other active substances, ii) a binder component comprising at least one enteric binder, and optionally iii) other physiologically acceptable excipients.In a second aspect, the present invention relates to novel salts of fenofibric acid that are photostable when compared to other salts of fenofibric acid.
REFERENCES:
patent: 2799241 (1957-07-01), Wurster
patent: 3133132 (1964-05-01), Loeb et al.
patent: 3173876 (1965-03-01), Zobrist
patent: 3276588 (1966-10-01), Rosaen
patent: 3541005 (1970-11-01), Strathmann et al.
patent: 3541006 (1970-11-01), Bixler et al.
patent: 3546142 (1970-12-01), Michaels et al.
patent: 3845770 (1974-11-01), Theeuwes et al.
patent: 3907792 (1975-09-01), Mieville
patent: 3914286 (1975-10-01), Mieville
patent: 3916899 (1975-11-01), Theeuwes et al.
patent: 4058552 (1977-11-01), Mieville
patent: 4072705 (1978-02-01), Mieville
patent: 4088864 (1978-05-01), Theeuwes et al.
patent: 4160020 (1979-07-01), Ayer
patent: 4179515 (1979-12-01), Mieville
patent: 4200098 (1980-04-01), Ayer et al.
patent: 4233298 (1980-11-01), Mieville
patent: 4235896 (1980-11-01), Mieville
patent: 4340585 (1982-07-01), Borzatta et al.
patent: 4372954 (1983-02-01), Moreau et al.
patent: 4574080 (1986-03-01), Roswall et al.
patent: 4800079 (1989-01-01), Boyer
patent: 4803081 (1989-02-01), Falk et al.
patent: 4859703 (1989-08-01), Krause
patent: 4895726 (1990-01-01), Curtet et al.
patent: 5179097 (1993-01-01), Angres
patent: 5286497 (1994-02-01), Hendrickson et al.
patent: 5573776 (1996-11-01), Harrison et al.
patent: 5737320 (1998-04-01), Madonna
patent: 6074670 (2000-06-01), Stamm et al.
patent: 6277405 (2001-08-01), Stamm et al.
patent: 6284803 (2001-09-01), Kothrade et al.
patent: 6514531 (2003-02-01), Alaux et al.
patent: 2001/0006662 (2001-07-01), Krill et al.
patent: 2003/0077297 (2003-04-01), Chen et al.
patent: 2005/0008704 (2005-01-01), Ray et al.
patent: 2005/0101561 (2005-05-01), Tunac et al.
patent: 2005/0148594 (2005-07-01), Cink et al.
“Guidline for the photostability testing of new drug substances and prodrugs,” International Conference on Harmonization. Federal Register 65(95):27115-22 (1997).
Photochemical Reactions. In Stephen R. Byrn, Ralph R. Pfieffer and Joseph G. Stowell ed. Solid-State Chemistry of Drugs, 2ndedition, SSCI, Inc., West Lafayette, Indiana, 1999. pp. 391-416.
USP vol. 25, chapter 776, published by the United States Pharmacopeia (2002).
Albini, et al., “Photochemistry of drug,” In Nalwa, Hari Singh.ed. Handbook of Photochemistry and Photobiology, American Scientific Publishers, Stevenson Ranch, Calif, 147-193 (2003). (CODEN: 69ENDV Conference; General Review written in English. CAN 140:344560 AN 2003:744654 CAPLUS).
Albini, et al., “Photochemistry of drugs: and overview and practical problems,” Special Publication—Royal Society of Chemistry, 225 (Drugs: Photochemistry and Photostability), 1-73 (1998). (CODEN: SROCDO ISSN: 0260-6291. General Review written in English. CAN 130:57040 AN 1998:637767 CAPLUS).
Cohen, et al., “Structure-sensitive reactions of organic crystals,” Proc. Intern. Symp. Reactivity solids, 4thAmsterdam, 1961, vol. date 1960, 556-562.
El-Shafei, et al., “Semi-empirical molecular orbital methods in the design of organic colorants,” AATCC Review (2001), 1(12), 23-26. CODEN: ARAEBW ISSN: 1532-8813. Journal written in English. CAN 137:34449 AN 2002:38338 CAPLUS.
Greenhill, J. V. (Department Chemistry, University Florida, Gainesville, FL, USA). “Is the photodecomposition of drugs predictable?” In Toennesen, Hanne Hjorth ed: Photostability of Drugs and Drug Formulations, [International Meeting on Photostability of Drugs], 1st, Oslo, Jun. 1995 (1996), Meeting Date 1995, 83-110. Publisher: Taylor & Francis, London, UK CODEN: 63MKAH Conference; General Review written in English. CAN 125:284474 AN 1996:647343 CAPLUS.
Harris, et al., “Probing polymorphism and reactivity in the organic solid state using carbon-13 NMR spectroscopy: studies ofp-Formyl-trans-cinnamic acid.” J. of Solid State Chemistry. 94(1):197-205 (1991).
Liu, et al., “Inclusion of acitretin into cyclodextrins: Phase solubility, photostability, and physicochemical characterization,” Department of Pharmacy, National University of Singapore, Singapore. Journal of Pharmaceutical Sciences, 92(12): 2449-2457 (2003).
Matsuda et al., “Physicochemical characterization of furosemide modifications,” International J. Pharmaceutics, 60(1):11-26 (1990).
Matsuda, et al., “Pharmaceutical evaluation fo carbamazepine modifications: comparative study for photostability of carbarmazepine polymorphs by using Fourier-transformed reflection-absorption infrared spectroscopy and colorimetric measurement.” J. of Pharmacy and Pharmacology, 46(3): 162-167 (1994).
Najanishi, et al., “Preparation of p-phenylenediacrylic acid salts and their photoreaction in the solid state.” Kenkyu Hokoku—Sen'I Kobunshi Zairyo Kenkyusho, 133:39-43 (1982) English Abstract Only.
Nord, K., Andersen, H., Tonnesen, H.H.Photoreactivity of biologically active compounds. XII. Photostability of polymorphic modifications of chloroquine diphosphate. Drug Stability, 1(4):243-248, 1997.
Price, S.L., “The computational predication of pharmaceutical crystal structures and polymorphism,” Advanced Drug Delivery Reviews, 56:301-319 (2004).
Tonnesen, H.H, et al., “Photoreactivity of biologically active compounds. XIII. Photostability of mefloquine hydrochlorice in the solid state”, Drug Stability, 1(4), 249-253, 1997.
Cink Russell Drew
Gao Yi
Long Michelle A.
Morris John B.
Paterson, Jr. Joseph B.
Abbott Laboratories
Badio Barbara P.
Steele Gregory W.
LandOfFree
Salts of fenofibric acid and pharmaceutical formulations... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Salts of fenofibric acid and pharmaceutical formulations..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Salts of fenofibric acid and pharmaceutical formulations... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3837903