Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Particulate form
Reexamination Certificate
2011-06-21
2011-06-21
Eyler, Yvonne L (Department: 1619)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Particulate form
C424S468000, C514S102000
Reexamination Certificate
active
07964219
ABSTRACT:
The present invention provides compositions and methods for the controlled release delivery of one or more biologically active compounds to a subject. Specifically, the invention provides for a pharmaceutical composition for the controlled release delivery of biologically active compounds to a subject comprising: a) a complex of a biologically active compound having at least one basic functional group and a polyanion derived from hexahydroxycyclohexane having at least two negatively charged functional groups; and b) a pharmaceutically acceptable carrier comprising a biodegradable, water-insoluble polymer. By complexing a biologically active compound with a polyanion, the tight, stable complex may be incorporated into a long-acting dosage system having a more desired drug release curve over time than that is found in the prior art. The invention also provides the methods of making such compositions and the methods of use thereof.
REFERENCES:
patent: 4578384 (1986-03-01), Hollinger
patent: 4675189 (1987-06-01), Kent et al.
patent: 4728721 (1988-03-01), Yamamoto et al.
patent: 4767628 (1988-08-01), Hutchinson
patent: 4938763 (1990-07-01), Dunn et al.
patent: 5059591 (1991-10-01), Janoff et al.
patent: 5077049 (1991-12-01), Dunn et al.
patent: 5225205 (1993-07-01), Orsolini
patent: 5278201 (1994-01-01), Dunn et al.
patent: 5278202 (1994-01-01), Dunn et al.
patent: 5410016 (1995-04-01), Hubbell et al.
patent: 5480656 (1996-01-01), Okada et al.
patent: 5501863 (1996-03-01), Rössling et al.
patent: 5529914 (1996-06-01), Hubbell et al.
patent: 5538739 (1996-07-01), Bodmer et al.
patent: 5595760 (1997-01-01), Cherif-Cheikh
patent: 5614510 (1997-03-01), Persson
patent: 5654010 (1997-08-01), Johnson et al.
patent: 5698213 (1997-12-01), Jamiolkowski et al.
patent: 5739176 (1998-04-01), Dunn et al.
patent: 6312679 (2001-11-01), Tomalia et al.
patent: 6410044 (2002-06-01), Chudzik et al.
patent: 6528080 (2003-03-01), Dunn et al.
patent: 6589548 (2003-07-01), Oh et al.
patent: 6592899 (2003-07-01), Fowers et al.
patent: 2004/0228833 (2004-11-01), Costantino et al.
patent: 0058481 (1982-08-01), None
patent: 04026630 (1992-01-01), None
patent: WO 93/16687 (1993-09-01), None
patent: WO 93/17668 (1993-09-01), None
patent: WO/96/21440 (1996-07-01), None
patent: WO/02/10177 (2002-02-01), None
patent: WO/2004/045633 (2004-06-01), None
Jeong, et al, New Biodegradable Polymers for Injectable Drug Delivery Systems, 1999, Journal of Controlled Release, Elsevier, vol. 62, pp. 109-114.
Evidentiary reference taken from http://www.sigmaaldrich.com/catalog/search/ProductDetail/SIGMA/P9763.
Journal of Molecular Biology, 1H-NMR Assignment and Solution Structure of Human Acidic Fibroblast Growth Factor Activated by Inositol Hexaphosphate, by Pineda-Lucena et al, vol. 242, issue 1, pp. 81-98 (abstract only).
Myo-inositol product information taken from http://chemicalland21.com/lifescience/foco/INOSITIOL.htm.
Lin et al “Accelerated Degradation of Poly(∈-caprolactone) by Organic Amines,” Pharmaceutical Research, vol. 11, No. 7, 1994.
Jeong et al “New biodegradable polymers for injectable drug delivery Systems,” Journal of Controlled Release 62 (1999) 109-114.
Lin et al “Accelerated Degradation of Poly((-caprolactone) by Organic Amines,” Pharmaceutical Research, vol. 11, No. 7, 1994.
A. Lucke et al., Peptide Acylation by Poly(α-Hydroxy Esters),Pharm. Research, vol. 19, No. 2, Feb. 2002.
W. Lin et al., Accelerated Degradation of Poly(∈-caprolactone) by Organic Amines,Pharm. Research, vol. 11, No. 7, (1994).
M. Krishnan et al., FTIR-ATR spectroscopy for monitoring plyanhydride/anhydride-amine reactions,J. Controlled Release69 (2000) p. 273-281.
D. Hee Na et al., Monitoring of peptide acylation inside degrading PLGA microspheres by capillary electrophoresis and MALDI-TOF mass spectrometry,J. Controlled Release92 (2003) p. 291-299.
A. Lucke et al., Peptide Acylation by Poly (α-Hydroxy Esters),Pharm. Researchvol. 19 No. 2, Feb. 2002.
V. Sinha et al., Biodegradable microspheres for protein delivery,J. Controlled Release, 90 (2003) p. 261-280.
S. Schwendeman, Recent Advances in the Stabilization of Proteins Encapsulated in Injectable PLGA Delivery Systems,Critical Reviews in Therapeutic Drug Carrier Systems, 19(1): 73-98 (2002).
A. Domb et al., Chemical Interactions Between Drugs Containing Reactive Amines with Hydrolyzable Insoluble Biopolymers in Aqueous Solutions,Pharm. Researchvol. 11, No. 6 (1994).
D. Birnbaum et al., Molecular weight distribution changes during degradation and release of PLGA nanoparticles containing epirubicin HCI,J. Biomater. Sci. Polymer Edn., vol. 14 No. 1, pp. 87-102 (2003).
Lin et al., Accelerated degradation of poly(epsilon-caprolactone by organic amines,Pharm. Res. 1994.
Chien Benjamin
Li Yuhua
Cohen Pontani Lieberman & Pavane LLP
Eyler Yvonne L
QPS, LLC
Ziska Suzanne
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