Microparticle compositions and methods for the manufacture...

Details Microparticle compositions and methods for the manufacture... Microparticle compositions and methods for the manufacture...

2004-02-10

2010-12-07

Fubara, Blessing M (Department: 1618)

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Particulate form

C424S484000, C424S486000

Reexamination Certificate

active

07846479

ABSTRACT:
Microparticles with adsorbed complexes of macromolecule and detergent, methods of making such microparticles, and uses thereof, are disclosed. The microparticles comprise a polymer, such as a poly(α-hydroxy acid), a polyhydroxy butyric acid, a polycaprolactone, a polyorthoester, a polyanhydride, and the like, and are formed using cationic, anionic, or nonionic detergents. The surfaces of the microparticles have adsorbed thereon a complex of biologically active macromolecules, such as nucleic acids, polypeptides, antigens, and adjuvants, and a detergent. Preferred polymers are poly(D,L-lactide-co-glycolides), more preferably those having a lactide/glycolide molar ratio ranging from 40:60 to 60:40 and having a molecular weight ranging from 30,000 Daltons to 70,000 Daltons. Preferred macromolecules are bacterial and viral antigens (such as HIV antigens, meningitis B antigens, streptococcus B antigens, and Influenza A hemagglutinin antigens) as well as polynucleotides that encode for such antigens.

REFERENCES:
patent: 3523907 (1970-08-01), Vrancken et al.
patent: 5538739 (1996-07-01), Bodmer et al.
patent: 5643605 (1997-07-01), Cleland et al.
patent: 5783567 (1998-07-01), Hedley et al.
patent: 5814482 (1998-09-01), Dubensky, Jr. et al.
patent: 5840970 (1998-11-01), Sumner et al.
patent: 5842723 (1998-12-01), Hartling et al.
patent: 5869103 (1999-02-01), Yeh et al.
patent: 5871747 (1999-02-01), Gengoux-Sedlik et al.
patent: 5928647 (1999-07-01), Rock
patent: 6015686 (2000-01-01), Dubensky, Jr. et al.
patent: 6086901 (2000-07-01), O'Hagan et al.
patent: 6395253 (2002-05-01), Levy et al.
patent: 6562346 (2003-05-01), Paliard et al.
patent: 2001/0046967 (2001-11-01), Van Nest
patent: 2002/0009466 (2002-01-01), Brayden
patent: WO 90/14837 (1990-12-01), None
patent: WO 94/15635 (1994-07-01), None
patent: WO 94/28879 (1994-12-01), None
patent: WO 95/24929 (1995-09-01), None
patent: WO-95/24929 (1995-09-01), None
patent: WO 96/20698 (1996-07-01), None
patent: WO 97/02810 (1997-01-01), None
patent: WO 97/38087 (1997-10-01), None
patent: WO 98/10750 (1998-03-01), None
patent: WO 98/33487 (1998-08-01), None
patent: WO 99/18226 (1999-04-01), None
patent: WO 00/06123 (2000-02-01), None
patent: WO 00/50006 (2000-08-01), None
patent: WO 01/81609 (2001-01-01), None
patent: WO 01/36599 (2001-05-01), None
Singh et al. (Cationic microparticles: A potent delivery system for DNA vaccines in PNAS, vol. 97, No. 2, Jan. 2000, pp. 811-816.
Kazzaz, J. et al., “Induction of Cytotoxic T-lymphocyte activity in mice with HIV p24 gag protein adsorbed to the surface of poly(lactide-co-glycolide) microparticles,” Proceed. Int'l Symp. Control. Rel. Bioact. Mater., 26 (1999), Controlled Release Society, pp. 104-105.
Coombes, A.G.A. et al., “Single Does, Polymeric, Microparticle-Based Vaccines: The Influence of Formulation Conditions on the Magnitude and Duration of the Immune Response to a Protein Antigen,” Vaccine, vol. 14, No. 15, 1996, pp. 1429-1438.
Duncan, J.D. et al., “Poly(lactide-co-glycolide) Microencapsulation of Vaccines for Mucosal Immunization,” Mucosal Vaccines, 1996, pp. 159-173.
Eldridge, J. et al., “New Advances in Vaccine Delivery Systems,” Seminars in Hemotology, vol. 30, No. 4, Suppl. 4, Oct. 1993, pp. 16-25.
Higgins, D. et al., “MF59 Adjuvant Enhances the Immunogenicity of Influenza Vaccine in Both Young and Old Mice,” Vaccine, vol. 14, No. 6, 1996, pp. 478-484.
Men, Y. et al., “Introduction of a Cytotoxic T Lymphocite Response by Immunization With a Malaria Specific CTL Peptide Entrapped in Biodegradable Polymer Microspheres,” Vaccine, vol. 15, No. 12/13, 1997, pp. 1405-1412.
Moore, A. et al., “Immunization With a Soluble Recombinant HIV Protein Entrapped in Biodegradable Microparticles Induces HIV-Specific CD8+ Cytotoxic T Lymphocites and CD4+ TH1 Cells,” Vaccine, vol. 13, No. 18, 1995, pp. 1741-1995.
Nakaoka, R. et al., “Enhanced Antibody Production Through Sustained Antigen Release From Biodegradable Granules,” Journal of Controlled Release, vol. 37 (1995), pp. 215-224.
O'Hagan, Derek et al., Biodegradable Microparticles for Oral Immunization, Vaccine, vol. 11, 1993, pp. 149-154.
O'Hagan, Derek et al., “Long-Term Antibody Responses in Mice Following Subcutaneous Immunization With Ovalbumin Entrapped in Biodegradable Microparticles,” Vaccine, vol. 11, 1993, pp. 1965-1969.
Sah, H. et al., “Continuous Release of Proteins From Biodegradable Microcapsules and in Vivo Evaluation of Their Potential as a Vaccine Adjuvant,” Journal of Controlled Release 35 (1995), pp. 137-144.
Vordermeier, H.M. et al., “Synthetic Delivery System for Tuberculosis Vaccines: Immunological Evaluation of the M. Tuberculosis 38 kDa Protein Entrapped in Biodegradable PLG Microparticles,” Vaccine, vol. 13, No. 16, 1995, pp. 1576-1582.
Powell, M. F. et al., “Vaccine Design: The Subunit and Adjuvant Approach,” Plenum Press, New York, 1995, p. 183.
Eldridge, J. et al., “Biodegradable and Biocompatible Poly(DL-Lactide-Co-Glycolide) Microspheres as an Adjuvant for Staphylococcal Enterotoxin B Toxoid Which Enhances the Level of Toxin-Neutralizing Antibodies,” Infection and Immunity, vol. 59, No. 9, Sep. 1991, pp. 2978-2986.
Singh, Manmohan et al., “The preparation and characterization of polymeric antigen delivery systems for oral administration,” Advanced Drug Delivery Reviews 34 (1998), pp. 285-304.
Denis-Mize, K.S. et al., “Plasmid DNA Adsorbed onto cationic microparticles mediates target gene expression and antigen presentation by dendritic cells,” Gene Therapy 2000, pp. 2105-2112.
Kazzaz, J. et al., “Novel anionic microparticles are a potent adjuvant for the induction of cytotoxic T lymphocytes against recombinant p55 from HIV-1,” Journal of Controlled Release 67 (2000), pp. 347-356.
Singh, Manmohan et al., “Cationic microparticles: A potent delivery system for DNA vaccines,” Proceedings of the National Academy of Science, Jan. 18, 2000, vol. 97, No. 2, pp. 811-816.
O'Hagan, Derek T., et al., “Long-term antibody responses in mice following subcutaneous immunization with ovalbumin entrapped in biodegradable microparticles,” Vaccine, vol. 11, Issue 9, 1993, pp. 965-969.
Hayley, Jeffery et al., “The preparation and Characterization of Poly(lactide-co-glycolide) Microparticles. II. The Entrapment of a Model Protein Using a (Water-in-Oil)-in-Water Emulsion Solvent Eaporation Technique,” Pharmaceutical Research, vol. 10, No. 3, 1993, pp. 362-368.
Ogawa, Yasuaki et al., “A New Technique to Efficiently Entrap Leuprolide Acetate Into Microcapsules of Polylactic Acid or Copoly (Lactic/Glycolic) Acid,” Chem. Pharm. Bull., vol. 36,1988, pp. 1095-1103.
Polo, John M. et al., “Stable alphavirus packaging cell lines for Sindbis virus-and Semliki Forest virus-derived vectors,” Proceedings of the National Academy of Science, vol. 96, Apr. 1999, pp. 4598-4603.
Chapman, Barbara S., “effect of intron A from human cytomegalovirus (Towne) immediate-early gene on heterologous expression in mammalian cells,” Nucleic Acids Research, vol. 19, No. 14, pp. 3979-3986.
Elias Fattal et al., “Biodegradable polyalkylcyanoacrylate nanoparticles for the delivery of oligonucleotides”,Journal of Controlled Release, 53, 1998, pp. 137-143.
Christine Chavany et al, “Polyalkylcyanoacrylate Nanoparticles as Polymeric Carriers for Antisense Oligonucleotides”,Pharm. Res., vol. 9, No. 4, 1992, pp. 441-449.

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