Pharmaceutical development of a parenteral lyophilized formulation of the investigational antitumor neuropeptide antagonist [Arg6, D-Trp7.9, MePhe8]-Substance P {6-11}

Investigational New Drugs

Volumn 16, Issue 2, 1998, Pages 99-111

  Jonkman de Vries, J D ^a   Rosing, H ^a   Talsma, H ^b   Henrar, R E C ^c   Kettenes van Den Bosch, J J ^b   Bult, A ^b   Beijnen, J H ^a,b  

^a SLOTERVAART HOSPITAL   (Netherlands)

^b UTRECHT UNIVERSITY   (Netherlands)

^c VU UNIVERSITY MEDICAL CENTER   (Netherlands)

Author keywords

Analytical characterization; Antagonist G ( Arg6, D Trp7,9, MePhe8 substance P 6 11 ); Oxidative degradation products; Parenteral formulation; Stability

Indexed keywords

ANTINEOPLASTIC AGENT; NEUROPEPTIDE; SUBSTANCE P DERIVATIVE;

ARTICLE; DIFFERENTIAL SCANNING CALORIMETRY; DRUG FORMULATION; DRUG SOLUBILITY; FREEZE DRYING; PRIORITY JOURNAL; QUALITY CONTROL;

AMINO ACID SEQUENCE; ANTINEOPLASTIC AGENTS; CHEMISTRY, PHARMACEUTICAL; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DRUG STABILITY; FREEZE DRYING; INFUSIONS, PARENTERAL; MAGNETIC RESONANCE SPECTROSCOPY; MOLECULAR STRUCTURE; NEUROPEPTIDES; OXIDATION-REDUCTION; PEPTIDE FRAGMENTS; SUBSTANCE P;

EID: 0031761374     PISSN: 01676997     EISSN: None     Source Type: Journal    
DOI: 10.1023/A:1006041024109     Document Type: Article

References (21)

1. 11]-Substance P, a potent bombesin antagonist in murine Swiss 3T3 cells, inhibits the growth of human small cell lung cancer cells in vitro. Proc Natl Acad Sci USA 85: 1859-1863, 1988
2. Woll PJ, Rozengurt E: A neuropeptide antagonist that inhibits the growth of small cell lung cancer in vitro. Cancer Res 50: 3968-3973, 1990
3. 11]-Substance P inhibits the growth of human small cell lung cancer xenografts in vivo. Eur J Cancer 29A: 1450-1453, 1993
4. Sethi T, Langdon S, Smyth J, Rozengurt E: Growth of small cell lung cancer cells: stimulation by multiple neuropeptides and inhibition by broad spectrum antagonists in vitro and in vivo. Cancer Res 52: 2737s-2742s, 1992
5. Langdon S, Sethi T, Ritchie A, Muir M, Smyth J, Rozengurt E: Broad spectrum neuropeptide antagonists inhibit the growth of small cell lung cancer in vivo. Cancer Res 52: 4554-4557, 1992
6. Manning MC, Patel K, Borchardt RT: Stability of protein pharmaceuticals. Pharm Res 6: 903-918, 1989
7. Oliyai C, Schoneich C, Wilson GS, Borchardt RT: In Topics in pharmaceutical sciences 1991, (eds) D.J.A. Crommelin and K.K. Mihda, Medpharm Scientific Publishers, Stuttgart, pp. 23-46, 1992
8. Brot N, Weissbach H: Biochemistry and physiological role of methionine sulfoxide residues in proteins. Arch Biochem Biophys 223: 271-281, 1983
9. Whitaker JR, Feeney RE: Chemical and physical modification of proteins by the hydroxide ion. CRC Crit Rev Food Sci Nutr 19: 173-212, 1983
10. 8]-Substance P 6-11 characterized by high-performance liquid chromatography. J Pharm Biomed Anal 12: 811-819, 1994
11. 8]-Substance P {6-11}: a comparative study. Anal Biochem 220: 98-102, 1994
12. 8]-Substance P {6-11} in aqueous solution. Anal Biochem 227: 334-341, 1995
13. Davignon JP, Slack JA, Beijnen JH, Vezin WR, Schoemaker TJ: EORTC/CRC/NCI guidelines for the formulation of investigational cytotoxic drugs. Eur J Cancer Clin Oncol 24: 1535-1538, 1988
14. Martin AN, Swarbrick J, Cammarata A: In Physical Pharmacy, Lea & Febiger, Philadelphia, pp. 189-235, 1969
15. Roepstorff P, Fohlman J: Proposal for a common nomenclature for sequence ions in mass spectra of peptides. Biomed Mass Spectrom 11: 601, 1984
16. 8]-Substance 6 {6-11}. Anal Chem 67: 4431-4436, 1995
17. Pecsok RL, Shields LD, Cairns T, McWilliam IG: In Modern Methods of Chemical Analysis, 2nd edition, John Wiley & Sons, New York, USA, pp. 174-175, 1976
18. Hsu CC, Ward CA, Pearlman R, Nguyen HM, Yeung DA, Curley JG: Determination of optimum residual moisture in lyophilized protein pharmaceuticals. Develop Biol Standard 74: 255-271, 1991
19. Vemuri S, Yu CD, Roosdorp N: Effect of cryoprotectants on freezing, lyophilization and storage of lyophilized recombinant alpha-antitrypsin formulations. PDA J Pharm Sci Technol 48: 241-246, 1994
20. Baffi RA, Garnick RL: Quality control issues in the analysis of lyophilized proteins. Develop Biol Standard 74: 181-184, 1991
21. Anonymous: Draft guideline for validation of the limulus amoebocyte lysate test as an end product endotoxin test for human and animal parenteral drugs and medical devices. Washington DC: Food and Drug Administration: 33-34, 1983