Comparison of nasal insulin powders prepared by supercritical fluid and freeze-drying techniques

Particulate Science and Technology

Volumn 15, Issue 3-4, 1997, Pages 273-301

  Zia, Hossein ^a   Dondeti, Polireddy ^a   Needham, Thomas E ^a  

^a UNIVERSITY OF RHODE ISLAND   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CARBOPOL 974P; CHITOSAN; DRUG CARRIER; GLYCYRRHIZIC ACID DERIVATIVE; INSULIN; MACROGOL; POLYACRYLIC ACID; POLYVOX; UNCLASSIFIED DRUG;

ANIMAL EXPERIMENT; ARTICLE; CONTROLLED STUDY; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG DISTRIBUTION; DRY POWDER; FREEZE DRYING; HUMAN; INTRANASAL DRUG ADMINISTRATION; PHARMACEUTICAL ENGINEERING; PRIORITY JOURNAL; RABBIT; SCANNING ELECTRON MICROSCOPY; SUPERCRITICAL FLUID EXTRACTION;

EID: 0031391648     PISSN: 02726351     EISSN: 15480046     Source Type: Journal    
DOI: 10.1080/02726359708906772     Document Type: Article

References (52)

1. Y. W. Chien, K.S.E. Su, and S.F. Chang (Ed.), Nasal Systemic Drug Delivery, Dekker, New York, 1989
2. H. Zia, P. Dondeti, and T.E. Needham, Nasal drug delivery. Clin. Res. Reg. Aff., vol. 10, pp 99–135, 1993.
3. D. Provasi, A. Minutello, A De Ascentiis, P.L. Catellani, and P. Colombo, Nasal powders, an animal model for formulation studies, in D. Duchene (Ed,) ßuccal and Nasal Administration as an Alternative to Parenteral Administration. Editions de Sante, Paris pp 282–286, 1992.
4. N.G.M. Schipper, S.G. Romeijn, J.C. Verhoef, and F.W.H.M. Merlcus, Nasal insulin delivery with dimethyl-ß-cyclodextrin as an absorption enhancer in rabbits: Powder more effective than liquid formulations. Pharm. Res, vol. 10, pp 682–686, 1993.
5. A.P. MacKenzie, ‘Freeze-drying of aqueous solutions containing peptides and proteins’ln D. Marshak D. and D. Liu (Eds.), Therapeutic Peptides and Proteins: Formulation, Delivery, and Targeting, Communications in Molecular Biology, Cold Spring HBibor Laboratory, pp 17–21, 1989.
6. M.J. Pikal, Freeze-drying of proteins, Part I: Process Design. BioPharm, vol.3(8), ppl8-27, 1990.
7. M.J. Pikal, Freeze-drying of proteins, Part IT: Formulation selection. BioPharm, vol. 3(9), pp26-30, 1990.
8. M.J. Pikal, K. Dellerman, and M. L. Roy, Formulation and stability of ffeeze-dried proteins: Effects of moisture and oxygen on the stability of ffeeze-dried formulations of human growth hormone. Dev. Biol. Standard, vol 74, pp21-38, 1991.
9. C.C. Hsu, C A. Ward, R. Pearlman, H.M. Nguyen, D A. Yeung, and J.G. Curley, Determining the optimum residual moisture in lyophilized protein pharmaceuticals. Dev. Biol. Standard, vol.74, pp255-271, 1991.
10. M.J. Hageman, ‘Water sorption and solid-state stability of proteins’ in T. J. Ahem, and M.C. Manning, (Eds.), Stability of Protein Pharmaceuticals, Part A: Chemical and Physical Pathways of Protein Degradation, Plenum Press, New York, pp273-309, 1992.
11. Cleland, M.F. Powell, and S.J. Shire, The development of stable protein formulations: A close look at protein aggregation, deamidation, and oxidation. Crit. Rev. Ther. Drug Carrier Systems, vol. 10(4), pp307-377, 1993.
12. K.W. Hutchenson and N. R. Foster (Eds.), Innovations in Supercritical Fluids Science and Technology, ACS Symposium Series 608, American Chemical Society, Washington, DC, 1995.
13. A. Juvekar, Study of a novel polymer loading process using near-critical carbon dioxide and a model drug. M S Thesis, University of Rhode Island, Kingston Rhode Island, 1994.
14. 1 Encapsulation and Controlled Release’, Royal Society of Chemistry, pp l17-130, 1993.
15. J.W. Tom, G. Lim, P.G. Debenedetti and R.K. Prud’homme, Applications of supercritical fluids in the controlled release of drugs. In E. Kiran and J. F. Brennecke (Eds.), ‘Supercritical Fluid Engineering Science-Fundamentals and Applications’, ACS Symposium Series 514, American Chemical Society, Washington, DC Chapter 19, 1993.
16. P.G. Debenedetti, J.W. Tom, S.D. Yeo, and G. Lim, Application of supercritical fluids for the production of sustained delivery devices. J. Controlled Release, vol.24, pp27-44, 1993.
17. S.D. Yeo, G. Lim, P.G. Debenedetti, and H. Bemstein, Formation of microparticulate protein powders using a supercritical fluid anti-solvent, Biotech. Bioeng., vol.41, pp341, 1993.
18. W.J. Schmitt, M.C. Salada, G.G. Shook, and S.M. Speaker III, Finely-divided powders by carrier solution injection into a near or supercritical fluid, AIChE Journal, vol.41(11), pp2476-2486, 1995.
19. R.G. Wissinger and M.E Paulaitis, Swelling and sorption in polymer-C02 mixtures at elevated pressures. J. Polymer Sci. Part B: Polymer Physics, vol.25, pp2497-2510, 1987.
20. R.G. Wissinger and M.E Paulaitis, Glass transitions in polymer/C02 mixtures at elevated pressures. J. Polymer Sci. Part B: Polymer Physics, vol,29, pp631-632, 1991.
21. M.D. Sefcik, Dilation of polycarbonate by carbon dioxide. J. Polymer Sci. Part B: Polymer Physics, vol.24, pp935-956, 1986.
22. M.D. Sefcik, Dilation and plasticization of polystyrene by carbon dioxide. J. Polymer Sci. Part B: Polymer Physics, vol.24, pp957-971, 1986.
23. T. Hirose, K. Mizoguchi, and Y. Kamiya, Y., Dilation of polyethylene by sorption of carbon dioxide. J. Polymer Sci. Part B: Polymer Physics, vol.24, pp2107-2115, 1986.
24. D.W. Matson, J.L. Fulton, R.C. Petersen, and R.D. Smith, Rapid expansion of supercritical fluid solutions: Solute formation of powders, thin films, and fibers. Ind. Eng. Chem. Res., vol.26, pp2298-2306, 1987.
25. M.E. Paulaitis, Solid solubilities in supercritical fluids at elevated pressures. Rev. Chem. Eng., vol.l, ppl79-188, 1983.
26. P. Dondeti, Development of a new non-surgicaJ perfusion technique to evaluate nasal drug delivery, M.S. Thesis, University of Rhode Island, Kingston, Rhode Island, 1991.
27. L.A. Luzzi, T.E. Needham, H. Zia, and P. Dondeti, lntranasal Administration of Larger Molecules Using the Infusion Polymer Loading Technology. U.S. Patent Application (pending) 1995
28. P. Dondeti, Optimization of nasal delivery of insulin, Ph.D. Dissertation, University of Rhode Island, Kingston, Rhode Island, 1994.
29. S. Hirai, T. Yashiki, and H. Mima, Mechanism for the Enhancement of the nasal Absorption oflnsulin By Surfactants. Int. J. Pharm., vol.9, ppl73-184, 1981.
30. S. Gizurarson, Animal models for intranasal drug delivery studies. Acta Pharm. Nord., vol.2(2), ppl05-122, 1990.
31. W.A. Ritschel, In vivo animal models for bioavailability assessment. S.T.P. Pharma, vol.3(2), ppl25-141, 1987.
32. R.H. Bell, and R.J. Hye, Animal models of diabetes mellitus: Physiology and pathology. J. Surg. Res., vol. 35, pp433-460, 1983.
33. F.W.H.M. Merkus, J.C. Verhoef, S.G. Romeijn, and N.G.M. Schipper, Interspecies differences in the nasal absorption of insulin. Pharm. Res., vol. 8(10), ppl343, 1991.
34. M. Mishima, S. Okada, and M. Nakano, Promotion of nasal absorption of insulin by glycyrrhetinic acid derivatives. 1. J. Pharmacobio-Dyn., vol. 12, pp31-36, 1989.
35. P.M. Reardon, C.H.Gochoco, C.H., Audus, K.L., Wilson, G. and Smith, P.L., In vitro nasal transport across ovine mucosa: Effects of ammonium glycyrrhizinate on electrical properties and permeability of growth hormone releasing peptide, mannitol and lucifer yellow. Pharm. Res. vol.10, pp553-561, 1993.
36. P.M. Reardon, D.A. Wall, T.K. Hart, P.L. Smith, and C.H. Gochoco, Lack of effect of ammonium glycyrrhizinate on the morphology of ovine nasal mucosa in vitro. Pharm. Res., vol.10, ppl301-1307, 1993.
37. L. Ilium, H. Jorgensen, H. Bisgaard, O. Krogsgaard, and N. Rossing, Bioadhesive microspheres as a potential nasal drug delivery system. Int. J. Pharm., vol.39, pp l89-199, 1987.
38. W.A. Lee, Permeation enhancers for the nasal delivery of protein and peptide therapeutics. BioPharm. vol.3, pp22-25, 1990.
39. T. Nagai, Y. Nishimoto, N. Nambu, Y. Suzuki, and K. Sekine, Powder dosage form of insulin for nasal administration. J. Controlled Release, vol. 1, pp l5-22, 1984.
40. M. Morimoto, K. Morisaka, and A. Kama da, Enhancement of nasal absorption of insulin and calcitonin using polyacrylic acid gel. J. Pharm. Pharmacol., vol. 37, pp l34-136, 1985.
41. L. Ilium, N.F. Farraj, H. Critchley, and S.S. Davis, Nasal administration of gentamicin using a novel microsphere delivery system Int. J. Pharm., vol. 46, pp 261–265, 1988.
42. E. Bjork, and P. Edman, Degradable starch microspheres as a nasal delivery system for insulin. Int. J. Pharm., vol. 47, pp 233, 1988.
43. N.F. Farraj, B.R. Johansen, S.S. Davis, and L. Ilium, Nasal administration of insulin using bioadhesive microspheres as a delivery system. J. Controlled Release, vol. 13, pp 253–261, 1990.
44. L. Ilium, N.F. Farraj, S.S. Davis, B.R. Johansen, and D.T. O’Hagan, Investigation of the nasal absorption of biosynthetic human growth hormone in sheep -Use of a bioadhesive microsphere delivery system. Int. J. Pharm., vol.63, pp207, 1990
45. P. Edman, E. Bjork, and L. Ryden, Microspheres as a nasal delivery system for peptide drugs, J. Controlled Release, vol.21, pp l65-172, 1992
46. L. Ryden, and P. Edman. Effect of polymers and microspheres on nasal absorption of insulin in rats. Int. J. Pharm., vol.83, pp l-10, 1992.
47. P. E. Koochaki, Nasal pharmaceutical composition in powder form. European Patent Application EP 571671, 1993.
48. H. Critchley, S.S. Davis, N.F. Farraj, and L. Ilium, Nasal absorption of desmopressin in rats and sheep. Effect of a bioadhesive microsphere delivery system. J. Pharm. Pharmacol, vol. 46, pp 651–656, 1994.
49. E. Bjork, and P. Edman, Characterization of degradable starch microspheres as a nasal delivery system for drugs. Int. J. Pharm., vol.62, pp 187–192, 1990.
50. P. Dondeti, H. Zia, and T.E. Needham, Bioadhesive and formulation parameters affecting nasal absorption. Int. J. Pharm., vol.127, pp 115–133, 1996.
51. P. Couvreur, and F. Puisieux, Nano and microparticles for the delivery of polypeptides and proteins, Adv. Drug Del. Rev., vol. 10, pp 141–162, 1993
52. S.H.S. Leung, and J.R. Robinson, Bioadhesives in drug delivery. Polymer News, vol. 15, pp 333–342, 1990