Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Particulate form
Reexamination Certificate
2011-01-11
2011-01-11
Saoud, Christine J (Department: 1646)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Particulate form
C424S490000, C424S070110, C424S085400, C514S021200
Reexamination Certificate
active
07867518
ABSTRACT:
The invention discloses a pharmaceutical composition for the controlled release of relatively toxic active compounds, in particular for bioactive proteins from the class of interferons. The composition comprises a biodegradable block copolymer constructed from poly(ethylene glycol) terephthalate (PEGT) and poly(butylene terephthalate) (PBT). The composition is provided in the form of injectable microparticles, of an injectable liquid which may have self-gelling properties, or of a solid implant. The invention further provides a pharmaceutical kit comprising the composition, methods for preparing the composition, and the pharmaceutical uses relating thereto.
REFERENCES:
patent: 5192743 (1993-03-01), Hsu et al.
patent: 5372808 (1994-12-01), Blatt et al.
patent: 5980948 (1999-11-01), Goedemoed et al.
patent: 6465425 (2002-10-01), Tracy et al.
patent: 2003/0031716 (2003-02-01), Tracy et al.
patent: 2003/0206928 (2003-11-01), Tormala et al.
patent: 0830859 (1998-03-01), None
patent: 0990440 (2000-04-01), None
patent: 1090928 (2001-04-01), None
patent: 1247522 (2002-10-01), None
patent: 2174409 (2001-10-01), None
patent: 2191012 (2002-10-01), None
patent: WO 9321858 (1993-11-01), None
patent: WO 9720047 (1997-06-01), None
patent: WO 9846212 (1998-10-01), None
patent: WO 03035030 (2003-05-01), None
patent: WO 03041689 (2003-05-01), None
patent: WO 03051336 (2003-06-01), None
Bezemer et al., “A Controlled Release System for Proteins Based on Poly(ether ester) Block-Copolymers: Polymer Network Characterization,” J. Control. Rel., vol. 62, No. 3, (1999), pp. 393-405.
Bezemer et al., “Amphiphilic Poly(ether ester amide) Multiblock Copolymers as Biodegradable Matrices for the Controlled Release of Proteins,” J. Biomed. Mater. Res., vol. 52, No. 1, (2000), pp. 8-17.
Bezemer et al., “Zero-Order Release of Lysozyme from Poly(ethylene glycol)/poly(butylenes terephthalate) Matrices,” J. Control. Rel., vol. 64, Nos. 1-3, (2000), pp. 179-192.
Bezemer et al., “Control of Protein Delivery from Amphiphilic Poly(ether ester) Multiblock Copolymers by Varying their Water Content using Emulsification Techniques,” J. Control. Rel., vol. 66, (2000), pp. 307-320.
Bezemer et al., “Microspheres for Protein Delivery Prepared from Amphiphilic Multiblock Copolymers, Part 1,” J. Control. Rel., vol. 67, (2000), pp. 233-248.
Bezemer et al., “Microspheres for Protein Delivery Prepared from Amphiphilic Multiblock Copolymers, Part 2,” J. Control. Rel., vol. 67, (2000), pp. 249-260.
Crommelin et al., “Interleukins and Interferons,” Pharmaceutical Biotechnology, Harwood Academic Publishers, (1997), pp. 219-222.
Hatefi et al., “Biodegradable Injectable in situ Forming Drug Delivery Systems,” J. Control. Rel., vol. 80, (2002), pp. 9-28.
Kontsek et al., “The Human Interferon System: Characterization and Classification after Discovery of Novel Members,” Acta Virol., vol. 47, (2003), pp. 201-215.
Mathiowitz et al., “Microencapsulation,” Encyclopedia of Controlled Drug Delivery, (ed. E. Mathiowitz), John Wiley & Sons, vol. 2, (1999), pp. 493-549.
Sohier et al., “A Novel Method to Obtain Protein Release from Porous Polymer Scaffolds: Emulsion Coating,” J. Control. Rel., vol. 87, Nos. 1-3, (2003), pp. 57-68.
Sohier et al., “Release of Small Water-Soluble Drugs from Multiblock Copolymer Microspheres: A Feasibility Study,” Eur. J. Pharm. and Biopharm., vol. 55, No. 2, (2003), pp. 221-228.
Van De Weert et al., “Reversible Aggregation of Lysozyme in a Biodegradable Amphiphilic Multiblock Copolymer,” Eur. J. Pharm. and Biopharm., vol. 54, (2002), pp. 89-93.
Van Dijkhuizen-Radersma et al., “Control of Vitamin B12Release from Poly(ethylene glycol)poly(butylenes terephthalate) Multiblock Copolymers,” Biomaterials, vol. 23, No. 6, (2002), pp. 1527-1536.
Van Dijkhuizen-Radersma et al., “Biocompatibility and Degradation of Poly(ether-ester) Microspheres: in vitro and in vivo Evaluation,” Biomaterials, vol. 23, (2002), pp. 4719-4729.
Van Dijkhuizen-Radersma et al., “Stability Aspects of Salmon Calcitonin Entrapped in Poly(ether-ester) Sustained Release Systems,” Int. J. Pharm., vol. 248, Nos. 1-2, (2002), pp. 229-237.
Van Dijkhuizen-Radersma et al., “In vitro/in vivo Correlation for14C-Methylated Lysozyme Release from Poly(ether-ester) Microspheres,” Pharm. Res., vol. 21, No. 3, (2004), pp. 484-491.
Van Dijkhuizen-Radersma et al., “Biodegradable Poly(ether-ester) Multiblock Copolymers for Controlled Release Applications: An in vivo Evaluation,” J. Biomed. Mater. Res., vol. 71A, No. 1, (2004), pp. 118-127.
European Office Action, issued in EP07120539.7, dated Mar. 9, 2009.
RU Office Action, issued in 2007130090.
IL Office Action, issued in 184431.
Han et al., “Preparation and Evaluation of Poly(L-lactic acid) Microspheres Containing rhEGF for Chronic Gastric Ulcer Healing,” J. Control. Rel., vol. 75, (2001), pp. 259-269.
Khoobehi et al., “Clearance of Sodium Fluorescein Incorporated into Microspheres from the Vitreous after Intravitreal Injection,” Ophthalmic Surgery, vol. 22, No. 3, (Mar. 1991), pp. 175-180.
Li et al., “Kinetic and Thermodynamic Modeling of the Formation of Polymeric Microspheres using Solvent Extract/Evaporation Method,” J. Control. Rel., vol. 37, (1995), pp. 187-198.
Ruiz et al., “Aggregation of Recombinant Human Interferon Alpha 2b in Solution: Technical Note,” AAPS PharmSciTech, vol. 7, No. 4, Article 99, (2006), pp. E1-E5.
Van Dijkhuizen-Radersma et al., “Biodegradable Poly(ether-ester) Multiblock Copolymers for Controlled Release Applications,” 2003 Wiley Periodicals, Inc., pp. 1294-1304.
Zhou et al., “Study on Biodegradable Microspheres Containing Recombinant Interferon-α-2a,” Journal of Pharmacy and Pharmacology, vol. 54, (2002), pp. 1287-1292.
Mashkovskii, Drugs, Handbook for Physicians, Moscow, Novaya Volna, S.B. Divov publisher, 2001, vol. 2, pp. 322-324.
Dawson R. et al. Biochemist's Handbook, Moscow “Mir”, 1991, p. 350.
CN Office Action, issued in 200680007430.X.
U.S. Office Action, issued in U.S. Appl. No. 11/774,107, dated Sep. 22, 2009.
Li et al., “Clinical Application of Interferon,” Mudanjiang City Hospital, 157000. (2001).
Li et al., “Clinical Application of Interferon,” Mudanjiang City Hospital, 157000. (2001).
Bechet Anne Chantal
Bezemer Jeroen Mattijs
Stigter Martin
Van Dijkhuizen-Radersma Riemke
Biolex Therapeutics, Inc.
Brinks Hofer Gilson & Lione
Saoud Christine J
Seharaseyon Jegatheesan
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