Drug – bio-affecting and body treating compositions – Radionuclide or intended radionuclide containing; adjuvant... – In an organic compound
Patent
1997-12-24
2000-02-15
Clardy, S. Mark
Drug, bio-affecting and body treating compositions
Radionuclide or intended radionuclide containing; adjuvant...
In an organic compound
530300, 530331, 424 111, 424 165, 424 91, A61K 5100, A61M 3614
Patent
active
060249382
ABSTRACT:
A lyophilized imaging agent formulation and methods for making same are disclosed, such formulations comprise a targeting molecule such as antibody or chemotactic peptide, a linker such as diethylenetriaminepentaacetic acid (DTPA) or succinimidyl 6-hydrazinium nicotinate hydrochloride (SHNH), drying protectant such as mannitol, maltose or tricine, and excipient such as polysorbate 80, in citrate buffer. The formulations of the invention are lyophilized and may be stored stably for extended periods of time. Following reconstitution with diluent, the formulations are administered to a subject for scintigraphic imaging or therapeutic use. Also contemplated is a kit comprising a two-vial system wherein a first vial comprises a lyophilized formulation of imaging agent in the form of a lyophilized cake, and a second vial comprises a pharmaceutically acceptable carrier or diluent.
REFERENCES:
patent: 4926869 (1990-05-01), Rubin et al.
patent: 5350837 (1994-09-01), Bridger et al.
patent: 5670133 (1997-09-01), Zamora
patent: 5700444 (1997-12-01), Zamora et al.
patent: 5759515 (1998-06-01), Rhodes et al.
patent: 5792444 (1998-08-01), Fischman et al.
patent: 5807538 (1998-09-01), Dean et al.
Tschopp, J., "Kinetics of Activation of the First Component of Complement (C1) by IgG Oligomers," Mol. Immunol. 19(5):651-657 (1982).
Vandenberg, E., et al., "Protein Immobilization to 3-Aminopropyl Triethoxy Silane/Glutaraldehyde Surfaces: Characterization by Detergent Washing, " J. Colloid & Interface Sci. 143(2):327-335 (1991).
Vnek, J., et al., "Association of Normal Serum Protein Antigens With Chimpanzee Hepatitis B Surface Antigen Particles," J. Med. Virol. 2:319-333 (1978).
Zav'yalov, V.P., et al., "Temperature and pH Dependent Changes of Immunoglobulin G Structure," Biochim. Biophys. Acta 386:155-167 (1975).
The Merck Index, 10.sup.th Ed., Windhulz, M., et al., eds., Merck & Co., Inc., pub., Rahway, N.J., p. 1095 (No. 7455) (1983).
Rubin, R.H., et al., ".sup.111 In-Labeled Nonspecific Immunoglobulin Scanning in the Detection of Focal Infection," N. Engl. J. Med. 321(14):935-940 (1989).
Schwartz, D.A., et al., "Preparation of Hydrazino-Modified Proteins and Their Use for the Synthesis of .sup.99m Tc-Protein Conjugates," Bioconjugate Chem. 2(5):333-336 (1991).
Shapshak, P., et al., "Quantitation of Human Immunoglobulin G and Albumin in Electroimmunodiffusion Gels Containing Ionic and Nonionic Detergents, " Anal. Biochem. 132:305-311 (1983).
Prince, A.M., et al., "A New Hepatitis B Vaccine Containing HBeAg in Addition to HBsAg," Develop. Biol. Standard. 54:13-22 (1983).
Prince, A.M., et al., "An Affordable Multideterminant Plasma-Derived Hepatitis B Virus Vaccine, " IARC Scientific Publications 63:355-372 (1984).
Rosenqvist, E., et al., "Thermal Properties of Human IgG," Mol. Immun. 24(5):495-501 (1987).
Nolte, F.S., and Kapral, F.A., "Immunogenicity of Staphylococcus aureus Delta-Toxin," Infection and Immunity 31(3):1251-1260 (1981).
Oreskes, I., and Mandel, D., "Size Fractionation of Thermal Aggregates of Immunoglobulin G," Anal. Biochem. 134:199-204 (1983).
Oyen, W.J.G., et al., "Scintigraphic Detection of Bone and Joint Infections with Indium-111-Labeled Nonspecific Polyclonal Human Immunoglobulin G," J. Nucl. Med. 31(4):403-412 (1990).
Merrifield, R.B., "Solid Phase Peptide Synthesis. I. The Synthesis of a Tetrapeptide," J. Am. Chem. Soc. 85:2149-2154 (1963).
Morse, J.H., "The Aggregation of .gamma.-Myeloma Proteins," J. Immunol. 95(4):722-729 (1965).
Mumenthaler, M., et al., "Feasibility Study on Spray-Drying Protein Pharmaceuticals: Recombinant Human Growth Hormone and Tissue-Type Plasminogen Activator," Pharmaceutical Research 11(1):12-20 (Jan. 1994).
Manning, M.C., et al., "Stability of Protein Pharmaceuticals," Pharm. Res. 6(11):903-918 (1989).
McCarthy, D., et al., "Instrinsically Stable IgG Aggregates," J. Immunol. Methods 41:63-74 (1981).
McCarthy, D., et al., "A Simple Procedure for Assessing the Stability of Heat-Aggregated IgG Preparations," J. Immunol. Methods 41:75-79 (1981).
J.o slashed.ssang, T., et al., "Heat aggregation kinetics of human IgG," J. Chem. Phys. 82(1):574-589 (1985).
Lee, C.-l., et al., "A Solid-Phase Fluorescent Immunoassay for Human Prostatic Acid Phosphatase," Cancer Research 38:2871-2878 (1978).
Lougheed, W.D., et al., "Physical Stability of Insulin Formulations," Diabetes 32:424-432 (1983).
Hnatowich, D.J., et al., "The Preparation and Labeling of DTPA-Coupled Albumin," Int. J. Appl. Radiat. Isot. 33:327-332 (1982).
Humm, J.L., and Cobb, L.M., "Nonuniformity of Tumor Dose in Radioimmunotherapy," J. Nucl. Med. 31(1):75-83 (1990).
James, K., et al., "Structural Changes Occurring in 7S .gamma.-Globulins," Nature 202:563-566 (1964).
Datz, F.L., et al., "The Efficacy of Indium-111-Polyclonal IgG for the Detection of Infection and Inflammation," J. Nucl. Med. 35(1):74-83 (Jan. 1994).
Everse, J., and Stolzenbach, F.E., "Lyophilization," Methods in Enzymology XXII:33-39 (1971).
Fischman, A.J., et al., "Imaging Focal Sites of Bacterial Infection in Rats with Indium-111-Labeled Chemotactic Peptide Analogs," J. Nucl. Med. 32(3):483-491 (1991).
Burgess, D.J., et al., "A Novel Method of Determination of Protein Stability," Journal of Parenteral Science & Technology 46(5):150-155 (1992).
Burnouf, T., et al., "A Highly Purified Factor VIII:c Concentrate Prepared from Cryoprecipitate by Ion-Exchange Chromatography," Vox Sanguinis 60:8-15 (1991).
Chawla, A.S., et al., "Aggregation of Insulin, Containing Surfactants, in Contact with Different Materials," Diabetes 34:420-424 (1985).
Abrams, M.J., et al., "Technetium-99m-Human Polyclonal IgG Radiolabeled via the Hydrazino Nicotinamide Derivative for Imaging Focal Sites of infection in Rats," J. Nucl. Med. 31(12):2022-2028 (1990).
Borrebaeck, C.A.K., "Strategy for the production of human monoclonal antibodies using in vitro activated B cells," J. Immunol. Meth. 123:157-165 (1989).
Bryant, R.L., and Barnett, J.B., "Adjuvant Properties of Retinol on IgE Production in Mice," Int. Archs. Allergy Appl. Immunol. 59:69-74 (1979).
Bornstein Michael
Corbo Diane C.
Larsen Scott K.
Link Mary Jean M.
Solomon Howard F.
Clardy S. Mark
Johnson-Matthey Inc.
Jones Dameron
Ortho Pharmaceutical Corporation
LandOfFree
Lyophilized imaging agent formulation comprising a chemotactic p does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Lyophilized imaging agent formulation comprising a chemotactic p, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Lyophilized imaging agent formulation comprising a chemotactic p will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-1903448