Porcine insulin biodegradable polyester microspheres: Stability and in vitro release characteristics

Pharmaceutical Development and Technology

Volumn 5, Issue 1, 2000, Pages 1-9

  Shao, Pushpa G ^a   Bailey, Leonard C ^b  

^a PFIZER INC   (United States)

^b RUTGERS UNIVERSITY   (United States)

Author keywords

Insulin; PLGA; Poly(D,L lactide co glycolide); Polymer; Stability

Indexed keywords

INSULIN; MICROSPHERE; PIG INSULIN; POLYGLACTIN; POLYLACTIC ACID; POLYMER;

ARTICLE; DRUG DEGRADATION; DRUG FORMULATION; DRUG STABILITY; EMULSION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; MICROSCOPY; NONHUMAN; PRIORITY JOURNAL;

ANIMALS; BIOCOMPATIBLE MATERIALS; BROMPHENOL BLUE; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DRUG STABILITY; HEAT; HUMIDITY; HYDROGEN-ION CONCENTRATION; INDICATORS AND REAGENTS; INSULIN; LACTIC ACID; MICROSPHERES; POLYESTERS; POLYGLYCOLIC ACID; POLYMERS; SWINE;

EID: 0033979387     PISSN: 10837450     EISSN: None     Source Type: Journal    
DOI: 10.1081/PDT-100100513     Document Type: Article

References (20)

1. R. Langer, New methods of drug delivery, Science, 249, 1527-1533 (1990).
2. Y. W. Chien, Human insulin: Basic sciences to therapeutic uses, Drug Dev. Ind. Pharm., 22(8), 753-789 (1996).
3. B. J. A. Furr and F. G. Hutchinson, A biodegradable delivery system for peptide: Preclinical experience with the gonadotropin releasing hormone agonist Zoladex®. J. Controlled Release, 21, 117-128 (1992).
4. D. D. Lewis, Controlled release of bioactive agents from lactide/glycolide polymer, in Biodegradable Polymers as Drug Delivery Systems (M. Chasin and R. Langer, eds.), Marcel Dekker, New York, 1990, pp. 1-41.
5. Y. Ogawa, H. Okada, M. Yamamoto, and T. Shinamoto, In vivo release profiles of leuprolide acetate from micro-capsules prepared with polylactic acids or copoly(lactic/ glycolic) acids and in vivo degradation of these polymers, Chem. Pharm. Bull., 36, 2576-2588 (1988).
6. S. Cohen, T. Yoshioka, M. Lucarelli, L. H. Hwang, and R. Langer, Controlled delivery systems for proteins based on poly(lactic/glycolic) microsphere, Pharm. Res., 8, 713-720 (1991).
7. M. J. Alonso, S. Cohen, T. G. Park, R. K. Gupta, G. R. Siber, and R. Langer, Determinants of release rate of tetanus vaccine from polyester microspheres, Pharm. Res., 10, 945-953 (1993).
8. W. Lu and T. G. Park, Protein release from Poly(lactic-co-glycolic acid) microspheres: Protein stability problems, J. Pharm. Sci. Technol., 49(1), 13-19 (1995).
9. R. E. Johnson, L. A. Lanaski, V. Gupta, M. J. Griffin, H. T. Gaud, T. E. Needham, and H. Zia, Stability of atrio-peptin III in poly(D,L-lactide-co-glycolide) microspheres, J. Controlled Release, 17, 61-68 (1991).
10. J. L. Cleland, A. Mac, B. Boyd, J. Yang, E. T. Duenas, D. Yeung, D. Brooks, C. Hsu, H. Chu, V. Mukku, and A. J. S. Jones, The stability of Recombinant Human Growth Hormone in Poly(lactic-co-glycolic acid) (PLGA) microspheres, Pharm. Res., 14(4), 420-425 (1997).
11. I. Soriano, C. Evora, and M. Llabres, Preparation and evaluation of insulin-loaded poly(DL-lactide) microspheres using an experimental design, Int. J. Pharm., 142, 135-142 (1996).
12. A. K. Kwong, S. Chou, A. M. Sun, M. V. Sefton, and M. F. A. Goosen, In vitro and in vivo release of insulin from Poly(Lactic acid) microbeads and pellets, J Controlled Release, 4, 47-62 (1986).
13. J. F. Young, Humidity control in the laboratory using salt solutions - a review, J. Appl. Chem., 17, 241-245 (1967).
14. F. Sundby, Separation and characterization of acid-induced insulin transformation products by paper electrophoresis in 7 M urea. J. Biol. Chem., 237(11), 3406-3411 (1962).
15. J. Brange and L. Langkjaer, Insulin structure and stability, in Stability and Characterization of Protein and Peptide Drugs: Case Histories (Y. J. Wang and R. Pearlman, eds.), Plenum Press, New York, 1993, pp. 315-350.
16. Official Monograph for Insulin Human, in United States Pharmacoepia, 23rd ed., The United States Pharmacopeial Convention, Rockville, MD, 1995, pp. 809-810.
17. J. Brange, Chemical stability of insulin. 4. Mechanisms and kinetics of chemical transformations in pharmaceutical formulation, Acta Pharm. Nord. 4(4), 209-222(1992).
18. R. T. Darrington and B. D. Anderson, Effects of insulin concentration and self-association on the partitioning of its A-21 cyclic anhydride intermediate to Desamido insulin and covalent dimer, Pharm. Res., 12(7), 1077-1084 (1995).
19. R. G. Strickley and B. D. Anderson, Solid-state stability of human insulin II. Effect of water on reactive intermediate partitioning in lyophiles from pH 2-5 solutions: Stabilization against covalent dimer formation, J. Pharm. Sci., 86(6), 645-653 (1997).
20. R. T. Darrington and B. D. Anderson, Evidence for a common intermediate in insulin deamidation and covalent dimer formation: Effects of pH and aniline trapping in dilute acidic solutions, J. Pharm. Sci., 84, 275-282 (1995).