Evaluation of polyanhydride microspheres for basal insulin delivery: Effect of copolymer composition and zinc salt on encapsulation, in vitro release, stability, in vivo absorption and bioactivity in diabetic rats

Journal of Pharmaceutical Sciences

Volumn 98, Issue 11, 2009, Pages 4237-4250

  Manoharan, Chandrasekar ^a   Singh, Jagdish ^a  

^a NORTH DAKOTA STATE UNIVERSITY   (United States)

Author keywords

Controlled release; Insulin; Microspheres; Polyanhydrides; Stability

Indexed keywords

COPOLYMER; INCELLIGENT SG; INSULIN; MICROSPHERE; POLY 1,3 BIS (P CARBOXYPHENOXY) PROPANE CO SEBACIC ACID; POLYANHYDRIDE; SOLVENT; UNCLASSIFIED DRUG; ZINC DERIVATIVE;

ANIMAL EXPERIMENT; ANIMAL MODEL; ARTICLE; CONTROLLED STUDY; DIMERIZATION; DRUG ABSORPTION; DRUG ACTIVITY; DRUG DELIVERY SYSTEM; DRUG RELEASE; DRUG STABILITY; EMULSION; ENCAPSULATION; EVAPORATION; IN VITRO STUDY; IN VIVO STUDY; KINETICS; MALE; NONHUMAN; PARTICLE SIZE; PROTEIN ANALYSIS; RAT; STREPTOZOCIN DIABETES; TECHNIQUE;

EID: 70349633416     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.21741     Document Type: Article

References (35)

1. Leahy JL. 2002. Intensive insulin therapy in type 1 diabetes mellitus. In: Leahy JL, Cefalu WT, editors. Insulin therapy. New York: Marcel Dekker, Inc. pp. 87-112.
2. White J, Campbell RD. 1996. Diabetes mellitus. In: Herfindal ET, Gourly DR, editors. Textbook of therapeutics: Drug and disease management. Baltimore: Williams & Wilkins. pp. 357-386.
3. Kang F, Singh J. 2005. Preparation, in vitro release, in vivo absorption and biocompatibility studies of insulin-loaded microspheres in rabbits. AAPS PharmSciTech 6:E487-E494. (Pubitemid 41631767)
4. Riddle MC. 2004. Timely initiation of basal insulin. Am J Med 116:S3-S9.
5. Shao PG, Bailey LC. 2000. Porcine insulin biodegradable polyester microspheres: Stability and in vitro release characteristics. Pharm Dev Technol 5:1-9.
6. Quaglia F, Rosa GD, Granata E, Ungaro F, Fattal E, La Rotonda MI. 2003. Feeding liquid, non-ionic surfactant and cyclodextrin affect the properties of insulin-loaded poly (lactide-co-glycolide) microspheres prepared by spray-drying. J Control Release 86:267-278. (Pubitemid 36084275)
7. Rosa GD, Iommelli R, La Rotonda MI, Miro A, Quaglia F. 2000. Influence of the co-encapsulation of different non-ionic surfactants on the properties of PLGA insulin-loaded microspheres. J Control Release 69:283-295. (Pubitemid 30813449)
8. Tamada J, Langer R. 1992. The development of polyanhydrides for drug delivery applications. J Biomater Sci Polym Ed 3:315-353.
9. Tabata Y, Gutta S, Langer R. 1993. Controlled delivery systems for proteins using polyanhydride microspheres. Pharm Res 10:487-496. (Pubitemid 23113038)
10. Chiba M, Hanes J, Langer R. 1997. Controlled protein delivery from biodegradable tyrosine-containing poly(anhydride-co-imide) microspheres. Biomaterials 18:893-901. (Pubitemid 27270214)
11. Furtado S, Abramson D, Simhkay L, Wobbekind D, Mathiowitz E. 2006. Subcutaneous delivery of insulin loaded poly(fumaric-co-sebacic anhydride) microspheres to type 1 diabetic rats. Eur J Pharm Biopharm 63:229-236. (Pubitemid 43776221)
12. Torres MP, Determan AS, Anderson GL, Mallapragada SK, Narasimhan B. 2007. Amphiphilic polyanhydrides for protein stabilization and release. Biomaterials 28:108-116. (Pubitemid 44427910)
13. Determan AS, Trewyn BG, Lin S, Nilsen-Hamilton M, Narasimhan B. 2004. Encapsulation, stabilization, and release of BSA-FITC from polyanhydride microspheres. J Control Release 100:97-109. (Pubitemid 39445989)
14. Kumar N, Langer RS, Domb AJ. 2002. Polyanhydrides: An overview. Adv Drug Deliv Rev 54:889-910.
15. Katti DS, Lakshmi S, Langer R, Laurencin CT. 2002. Toxicity, biodegradation and elimination of polyanhydrides. Adv Drug Deliv Rev 54:933-961.
16. Domb AJ, Rock M, Schwartz J, Perkin C, Yipchuk G, Broxup B, Villemure JG. 1994. Metabolic disposition and elimination studies of a radiolabelled biodegradable polymeric implant in the rat brain. Biomaterials 15:681-688. (Pubitemid 24230608)
17. Domb AJ, Rock M, Perkin C, Yipchuck G, Broxup B, Villemure JG. 1995. Excretion of a radiolabelled anticancer biodegradable polymeric implant from the rabbit brain. Biomaterials 16:1069-1072.
18. Brem H, Kader A, Epstein JI, Tamargo RJ, Domb A, Langer R, Leong KW. 1989. Biocompatibility of a biodegradable, controlled-release polymer in the rabbit brain. Sel Cancer Ther 5:55-65. (Pubitemid 19197883)
19. Laurencin CT, Domb A, Morris C, Brown V, Chasin M, McConnel R, Lange N, Langer R. 1990. Poly(anhydride) administration in high doses in vivo: Studies of biocompatibility and toxicology. J Biomed Mater Res 24:1463-1481. (Pubitemid 20359834)
20. Tamargo RJ, Epstein JI, Reinhard CS, Chasin M, Brem H. 1989. Brain biocompatibility of a biodegradable, controlled-release polymer in rats. J Biomed Mater Res 23:253-266. (Pubitemid 19042070)
21. Ron E, Turek T, Mathiowitz E, Chasin M, Hageman M, Langer R. 1993. Controlled release of polypeptides from polyanhydrides. Proc Natl Acad Sci USA 90:4176-4180.
22. Mathiowitz E, Langer R. 1987. Polyanhydride microspheres as drug carriers I. Hot-melt microencapsulation. J Control Release 5:13-22. (Pubitemid 17106642)
23. Perez C, Castellanos IJ, Costantino HR, Al-Azzam W, Griebenow K. 2002. Recent trends in stabilizing protein structure upon encapsulation and release from bioerodible polymers. J Pharm Pharmacol 54:301-313. (Pubitemid 34232331)
24. van de Weert M, Hennink WE, Jiskoot W. 2000. Protein instability in poly(lactic-co-glycolic acid) microparticles. Pharm Res 17:1159-1167.
25. Manoharan C, Singh J. 2009. Insulin loaded PLGA microspheres: Effect of zinc salts on encapsulation, release, and stability. J Pharm Sci 98:529-542.
26. Shen E, Kipper MJ, Dziadul B, Lim MK, Narasimhan B. 2002. Mechanistic relationships between polymer microstructure and drug release kinetics in bioerodible polyanhydrides. J Control Release 82:115-125. (Pubitemid 34775053)
27. Conix A. 1966. Poly[1,3-bis-(p-carboxyphenoxy)-propane anhydride]. Macromol Synth 2:95-99.
28. Smith PK, Krohn RI, Hermanson GT, Mallia AK, Gartner FH, Provenzano MD, Fujimoto EK, Goeke NM, Olson BJ, Klenk DC. 1985. Measurement of protein using bicinchoninic acid. Anal Biochem 150:76-85.
29. Vasheghani-Farahani E, Khorram M. 2002. Hydrophilic drug release from bioerodible polyanhydride microspheres. J Appl Polym Sci 83:1457-1464. (Pubitemid 34061227)
30. Berkland C, Kipper MJ, Narasimhan B, Kim KK, Pack DW. 2004. Microsphere size, precipitation kinetics and drug distribution control drug release from biodegradable polyanhydride microspheres. J Control Release 94:129-141. (Pubitemid 37542383)
31. Tamada JA, Langer R. 1993. Erosion kinetics of hydrolytically degradable polymers. Proc Natl Acad Sci USA 90:552-556. (Pubitemid 23028901)
32. Gopferich A, Langer R. 1993. The influence of microstructure and monomer properties on the erosion mechanism of a class of polyanhydrides. J Polym Sci Part A 31:2445-2458.
33. Kang F, Jiang G, Hinderliter A, DeLuca PP, Singh J. 2002. Lysozyme stability in primary emulsion for PLGA microsphere preparation: Effect of recovery methods and stabilizing excipients. Pharm Res 19:629-633. (Pubitemid 34553670)
34. Bartus RT, Tracy MA, Emerich DF, Zale SE. 1998. Sustained delivery of proteins for novel therapeutic agents. Science 281:1161-1162. (Pubitemid 28406281)
35. Galloway JA, Chance RE. 1994. Improving insulin therapy: Achievements and challenges. Horm Metab Res 26:591-598.