Stable and preserved erythropoietin compositions

Details Stable and preserved erythropoietin compositions Stable and preserved erythropoietin compositions

1995-05-24

1997-08-26

Cook, Rebecca

Drug, bio-affecting and body treating compositions

Designated organic active ingredient containing

Peptide containing doai

A61K 3822

Patent

active

056611250

ABSTRACT:
The invention is to stable compositions of erythropoietin that contain an antimicrobial preservative thereby providing a multi-dose formulation. Preservatives useful in the pharmaceutical compositions of the present invention include benzyl alcohol, parabens, phenol and mixtures thereof. Other additives, including buffers may be included in the composition.

REFERENCES:
patent: 4806524 (1989-02-01), Kawaguchi et al.
patent: 4879272 (1989-11-01), Shimoda et al.
patent: 4992419 (1991-02-01), Woog et al.
patent: 5322837 (1994-06-01), Hewick et al.
patent: 5354934 (1994-10-01), Pitt et al.
patent: 5376632 (1994-12-01), Konings et al.
Aalto, et al, "p-Hydroxybenzoic Acid Esters as Preservatives; I. Uses, Antibacterial and Antifungal Studies, Properties and Determination," Journal of American Pharm. Assoc., 8(16):449-457 (1953).
Akers, M., "Considerations in Selecting Antimicrobial Preservative Agents for Parenteral Product Development," Pharm Tech, pp. 36-46 (May) (1984).
Aldrete, et al "Allergy to Local Anesthetics," JAMA, 207(2):356-357 (1969).
Alegnani, W., "A Rapid Test for Evaluating the Preserving Properties of Multidose Injectables," Inter. Symp. on Preserv., Devel. Biol. Standard, 24:91-97 (1974).
Ashford, et al, "A Study of the Effectiveness of Vaccines. Antimicrobial Agents in Biological Parenteral Products," Intern Symp. on Preserv., Devel. Biol. Standard, 24:29-38 (1973).
Behme et al, "Incompatibility of Ifosfamide with Beyzyl-Alcohol Preserved Bacteriostatic Water for Injection," Am. J. Hosp. Pharm, pp. 627-628 (1988).
Davisson, et al., "The Preservation of Polcomyelitis Vaccine With Stabilized Merthcolate," J. Lab. Clin. Med., 4/(1):8-19 (1956).
Decker, et al., "Frequency of Preservative Use in Cosmetic Formulas as Disclosed to FDA-1987," Cosmetics & Toiletries, 102:21-24 (1987).
Geigert, J., "Overview of the Stability and Handling of Recombinant Protein Drugs," Journal of Parenteral Science & Tech., 43(5):220-224 (1989).
Gershanik, et al., "The Gasping Syndrome and Benzyl Alcohol Poisoning," N.E. Journal of Med., pp. 1384-1388 (Nov. 1982).
Gershenfeld, et al., "Preservatives for Preparations Containing Gelatin," Am. J. Pharm, 111:277-287 (1939).
Gottfried, N.S., "Alkyl p-Hydroxybenzoate Esters as Pharmaceutical Preservatives," Am. J. Hosp. Pharm., 19:310-314 (1962).
Happel, J., "Antimicrobial Preservatives in Pharmaceuticals," Disinfection Steriliz. and Preservation, pp. 579-588 (1972).
Jaconia, D., "Preservatives in Pharmaceutical Products," Quality Control in Pharm. Industry, 1:101-128 (1972).
Kimura, et al., "Parenteral Toxicity Studies With Benzyl Alcohol," Toxicology and Applied Pharm., 18:60-68 (1971).
Kostenbauder, "Physical Factors influencing the Activity of Antimicrobial Agents," Disinfection, Sterilization, Preservation, pp. 811-828 (1983).
Lachman, L., "Instability of Antimicrobial Preservatives," Meeting of Parenter, Drug Assn., pp. 127-144 (Jun. 1967).
McDavid, J., "Characteristics of Parabens as Preservatives," Intern Sympos. on Preserv., Develop Biol. Standard, 24:49-55 (1973).
Miyake, et al., "Purification of Human Erythropoietin," Journal of Biol. Chemistry, 252(15):5558-5564 (1977).
Nagel. et al., "Paraben Allergy," JAMA, 237(15):1594-1595 (1977).
Perlman, et al., "Formula and Strategy for Recombinant Proteins: HGH and PA", Genentech Inc., pp. 23-30 (1988).
Russell, D., "The Inclusion of Antimicrobial Agents in Pharmaceutical Products," Adv. Appl. Micro., 9:1-38 (1967).
Russell, D., "Principals of Antimicrobial Activity," Disinfection, Sterilization, Preservation, pp. 717-750 (1983).
Shmunes, E., "Allergic Dermatitis to Benzyl Alcohol in Injectable Solution," Arch Dermatol, 120:1200-1201 (1984).
Strickland, et al., "Occurrence of Sulfate on the N-Linked Oligosaccharides of Human Erythropoletin," Journal of Cell Bioch. Suppl., 16(d):167 (1992).
Wallhausser, K., "Antimicrobial Preservatives in Europe: Experience With Preservatives Used in Pharmaceuticals and Cosmetics," International Symp. on Preserv. in Biol. Products, Devel. Biol. Standard, 24:9-28 (1973).
Yu-Chang, et al., "Review of Excipients and pH's for Parenteral Products Used in the United States" Journal of Parenteral Durg Assoc., 34(6):452-462 (1980).
Remington's Pharmaceutical Science, 1975, p. 1466.

Affiliated with

Also associated with

Rating

Stable and preserved erythropoietin compositions does not yet have a rating. At this time, there are no reviews or comments for this patent.

If you have personal experience with Stable and preserved erythropoietin compositions, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Stable and preserved erythropoietin compositions will most certainly appreciate the feedback.

Rate now

Comments { 0 }

Profile ID: LFUS-PAI-O-1988553