Feeding liquid, non-ionic surfactant and cyclodextrin affect the properties of insulin-loaded poly(lactide-co-glycolide) microspheres prepared by spray-drying

Journal of Controlled Release

Volumn 86, Issue 2-3, 2003, Pages 267-278

  Quaglia, Fabiana ^a   De Rosa, Giuseppe ^a,b   Granata, Elena ^a   Ungaro, Francesca ^a   Fattal, Elias ^b   La Rotonda, Maria Immacolata ^a  

^a UNIVERSITY OF NAPLES FEDERICO II   (Italy)

^b UNIV PARIS SUD   (France)

Author keywords

Hydroxypropyl cyclodextrin; Insulin; Microspheres; Non ionic surfactants; Spray drying; Stability

Indexed keywords

2 HYDROXYPROPYL BETA CYCLODEXTRIN; ACETIC ACID; BOVINE INSULIN; MICROSPHERE; POLOXAMER; POLYGLACTIN; POLYSORBATE 20; SURFACTANT;

ARTICLE; CIRCULAR DICHROISM; CONTROLLED DRUG RELEASE; DISPERSION; DRUG CONFORMATION; DRUG FORMULATION; DRUG STABILITY; EMULSION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; MICROENCAPSULATION; PARTICLE SIZE; PRIORITY JOURNAL; SPRAY DRYING; TURBIDIMETRY;

EID: 0037449483     PISSN: 01683659     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0168-3659(02)00414-5     Document Type: Article

References (35)

1. Crotts G., Park T.G. Protein delivery from poly(lactic-co-glycolic acid) biodegradable microspheres: release kinetics and stability issues. J. Microencapsul. 15:1998;699-713.
2. Kissel T., Koneberg R. Injectable biodegradable microspheres for vaccine delivery. Cohen S., Bernstein H. Microparticulate Systems For the Delivery of Proteins and Vaccines. 1996;51-58 Marcel Dekker, New York.
3. van de Weert M., Hennink W.E., Jiskoot W. Protein instability in poly(lactic-co-glycolic acid) microparticles. Pharm. Res. 17:2000;1159-1167.
4. Schwendeman S.P., Cardamone M., Kibanov A., Langer R. Stability of proteins and their delivery from biodegradable polymer microspheres. Cohen S., Bernstein H. Microparticulate Systems For the Delivery of Proteins and Vaccines. 1996;1-49 Marcel Dekker, New York.
5. O'Hara P., Hickey A.J. Respirable PLGA microspheres containing rifampicin for the treatment of tuberculosis: manufacture and characterization. Pharm. Res. 17:2000;955-961.
6. Bittner B., Morlock M., Koll H., Winter G., Kissel T. Recombinant human erythropoietin (rhEPO) loaded poly(lactide-co-glycolide) microspheres: influence of the encapsulation technique and polymer purity on microsphere characteristics. Eur. J. Pharm. Biopharm. 45:1998;295-305.
7. Giunchedi P., Alpar H.O., Conte U. PDLLA microspheres containing steroids: spray-drying, o/w and w/o/w emulsifications as preparation methods. J. Microencapsul. 15:1998;185-195.
8. Witschi C., Doelker E. Peptide degradation during preparation and in vitro release testing of poly(L-lactic acid) and poly(D,L-lactic-co-glycolic acid) microparticles. Int. J. Pharm. 171:1998;1-18.
9. Ip A.Y., Arakawa T., Silvers H., Ransone C.M., Niven R.W. Stability of recombinant consensus interferon to air-jet and ultrasonic nebulization. J. Pharm. Sci. 84:1995;1210-1214.
10. Broadhead J., Rouan S.K., Hau I., Rhodes C.T. The effect of process and formulation variables on the properties of spray-dried beta-galactosidase. J. Pharm. Pharmacol. 46:1994;458-467.
11. Maa Y.F., Nguyen P.A., Hsu S.W. Spray-drying of air-liquid interface sensitive recombinant human growth hormone. J. Pharm. Sci. 87:1998;152-159.
12. Brange J., Langkjaer L. Chemical stability of insulin. 3. Influence of excipients, formulation and pH. Acta Pharm. Nord. 4:1992;149-158.
13. Oliva A., Fariña J., Llabrés M. Influence of temperature and shaking on stability of insulin preparations: degradation kinetics. Int. J. Pharm. 143:1996;163-170.
14. Brange J., Andersen L., Laursen E.D., Meyn G., Rasmussen E. Toward understanding insulin fibrillation. J. Pharm. Sci. 86:1997;517-525.
15. De Rosa G., Iommelli R., La Rotonda M.I., Miro A., Quaglia F. Influence of the co-encapsulation of different non-ionic surfactants on the properties of PLGA insulin-loaded microspheres. J. Control. Release. 69:2000;283-295.
16. Chawla A.T., Hinberg I., Johnson D. Aggregation of insulin, containing surfactant, in contact with different materials. Diabetes. 34:1985;420-424.
17. Irie T., Uekama K. Cyclodextrins in peptide and protein delivery. Adv. Drug Deliv. Rev. 36:1999;101-123.
18. Tokihiro K., Irie T., Uekama K. Varying effects of cyclodextrin derivatives on aggregation and thermal behavior of insulin in aqueous solution. Chem. Pharm. Bull. 45:1997;525-531.
19. Katakam M., Banga A.K. Aggregation of insulin and its prevention by carbohydrate excipients, PDA. J. Pharm. Sci. Technol. 49:1995;160-165.
20. Banga A.K., Mitra R. Minimization of shaking-induced formation of insoluble aggregates of insulin by cyclodextrins. J. Drug Target. 1:1993;341-345.
21. Oliva A., Fariña J.B., Labrés M. Development of two high-performance liquid chromatographic methods for the analysis and characterization of insulin and its degradation products in pharmaceutical preparations. J. Chromatogr. B. 749:2000;25-34.
22. Kwon Y.M., Baudys M., Knutson K., Kim S.W. In situ study of insulin aggregation induced by water-organic solvent interface. Pharm. Res. 18:2001;1754-1759.
23. Pocker Y., Biswas S.B. Conformational dynamics of insulin in solution. Circular dichroic studies. Biochemistry. 19:1980;5043-5049.
24. Brange J., Ribel U., Hansen J.F., Dodson G., Hansen M.T., Havelund S., Melberg S.G., Norris F., Norris K., Snel L. Monomeric insulins obtained by protein engineering and their medical implications. Nature. 333:1988;679-682.
25. Sato S., Ebert C.D., Kim S.W. Prevention of insulin self-association and surface adsorption. J. Pharm. Sci. 72:1983;228-232.
26. Kang S., Brange J., Burch A., Volund A., Owens D.R. Subcutaneous insulin absorption explained by insulin's physicochemical properties. Evidence from absorption studies of soluble human insulin and insulin analogues in humans. Diabetes Care. 14:1991;942-948.
27. Nielsen L., Frokjaer S., Brange J., Uversky V.N., Fink A.L. Probing the mechanism of insulin fibril formation with insulin mutants. Biochemistry. 40:2001;8397-8409.
28. Oliva A., Fariña J.B., Labrés M. Analysis of peptides and proteins: evaluation of purity, stability and structural characterization of insulin. Drug Dev. Ind. Pharm. 23:1997;915-927.
29. Ettinger M., Timasheff S.N., Optical activity of insulin I. On the nature of the circular dichroism bands. Biochemistry. 10:1971;824-831.
30. Melberg S.G., Johnson W.C. Changes in the secondary structure follow the dissociation of human insulin hexamers: a circular dichroism study. Proteins. 8:1990;280-286.
31. Blanco-Prieto M.J., Besseghir K., Zerbe O., Andris D., Orsolini P., Heimgartner F., Merkle H.P., Gander B. In vitro and in vivo evaluation of a somatostatin analogue released from PLGA microspheres. J. Control. Release. 67:2000;19-28.
32. Bittner B., Ronneberger B., Zange R., Volland C., Anderson J.M., Kissel T. Bovine serum albumin loaded poly(lactide-co-glycolide) microspheres: the influence of polymer purity on particle characteristics. J. Microencapsul. 15:1998;495-514.
33. Rojas J., Pinto-Alphandary H., Leo E., Pecquet S., Couvreur P., Gulik A., Fattal E. A polysorbate-based non-ionic surfactant can modulate loading and release of beta-lactoglobulin entrapped in multiphase poly(DL-lactide-co-glycolide) microspheres. Pharm. Res. 16:1999;255-260.
34. Blanco D., Alonso M.J. Protein encapsulation and release from poly(lactide-co-glycolide) microspheres: effect of the protein and polymer properties and of the co-encapsulation of surfactants. Eur. J. Pharm. Biopharm. 45:1998;285-294.
35. Quaglia F., Varricchio G., La Rotonda M.I., Larobina D., Mensitieri G. Modulation of drug release from hydrogels by using cyclodextrins: the case of nicardipine/β-cyclodextrin system in crosslinked polyethylenglycol. J. Control. Release. 71:2001;329-337.