Nasal delivery. The use of animal models to predict performance in man

Journal of Drug Targeting

Volumn 3, Issue 6, 1996, Pages 427-442

  Illum, Lisbeth ^a  

^a Albert Einstein Centre   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ANATOMY; ANIMAL MODEL; DOG; DRUG ABSORPTION; DRUG METABOLISM; GUINEA PIG; HUMAN; INTRANASAL DRUG ADMINISTRATION; MONKEY; MUCOCILIARY CLEARANCE; NONHUMAN; PHYSIOLOGY; PRIORITY JOURNAL; RABBIT; RAT; REVIEW; SHEEP;

EID: 0029760056     PISSN: 1061186X     EISSN: None     Source Type: Journal    
DOI: 10.3109/10611869609015963     Document Type: Review

References (107)

1. Altszuler, N. and Hampshire, J., 1981, Intranasal instillation of oxytocin increases insulin and glucagon secretion, Proc. Soc. Exptal. Biol. Med., 168: 123-124.
2. Andersen, I., Camner, P., Jensen, P.L., Philipson, K. and Proctor, D.F., 1974, Nasal clearance in monozygotic twins, Am. Rev. Respir. Dis., 110: 301-305.
3. 6] LHRH, in rhesus monkeys I, J. Pharm. Sci., 73: 684-685.
4. Asakura, K., Shirasaki, H., Narita, S., Kojima, T. and Kataura, A., 1992, Study on the dye leakage response of the nasal mucosa following topical capsaicin challenge in guinea pigs, Acta Otolaryngol. (Stockh.), 112: 545-551.
5. Audus, L.K. and Tavakoli-Saberi, M.R., 1992, Aminopeptidases of newborn bovine nasal turbinate epithelial cell cultures, Int. J. Pharm., 76: 247-255.
6. Baldwin, P.A., Klingbeil, C.K., Grimm, C.J. and Longenecker, J.P., 1990, The effect of sodium tauro-24,25-dihydrofusidate on the nasal absorption of human growth hormone in three animal models, Pharm Res., 7: 547-552.
7. Baturina, E.Y., Sarycheva, N.Y., Deigin, Y.I., Yarova, E.P., Kamenskii, A.A. and Asharin, I.P., (1988), Paradoxical correlations of the effectiveness of intranasal and intraperitoneal administration of dermorphins in rats, Bull. Exp. Biol. Med., 105: 177-179.
8. Bjork, E. and Edman, P., 1988, Degradable starch microspheres as a nasal delivery system for insulin, Int. J. Pharm. 47: 233-238.
9. Bond, S.W., Hardy, J.G. and Wilson, C.G., 1984, Deposition and clearance of nasal sprays, Proc. 2nd Int. Congress of Biopharmaceutics and Pharmacokinetics, Salamanca, pp 93-98.
10. Brittebo, E.B., 1982, Metabolism of progesterone by nasal mucosa in rats and mice, Acta Pharmacol. Toxicol., 51: 441-445.
11. Brittebo, E.B., 1985, Localisation of oestradiol in the rat nasal mucosa, Acta Pharmacol. Toxicol., 57: 285-290.
12. Brittebo, E.B. and Rafter, J.J., 1984, Steroid metabolism by rat nasal mucosa Studies on progesterone and testosterone, J. Steroid. Biochem., 20: 1147-1151.
13. Chung, F.Y. and Donovan, M.D., 1993, Proteolytic activity in nasal secretions, Proceed. Int. Symp. Control. Rel. Bioact. Mater., 20: 448-149.
14. Corbo, D.C., Huang, Y.C. and Chien, Y.W., 1988, Nasal delivery of progestational steroids in ovariectomised rabbits. I. Progesterone comparison of pharmacokinetics with intravenous and oral administration, Int. J. Pharm. 46: 133-140.
15. Critchley, H., Davis, S.S., Farraj, N.F. and Illum, L., 1994, Nasal absorption of desmopressin in rats and sheep. Effect of a bioadhesive microsphere delivery system, J. Pharm. Pharmacol., 46: 651-656.
16. Cuddihy, R.G., Brownstein, D.G., Raabe, O.G. and Kanapilly, G.M., 1973, Respiratory tract deposition of inhaled polydisperse aerosols in beagle dogs, J. Aerosol Sci., 4: 35-45.
17. Dahl, A.R., 1986, Possible consequences of cytochrome P-450 dependent monooxygenases in nasal tissues, in: Toxicology of the nasal passages (G.S. Barrow, ed.), Hemisphere, Washington, pp 263-273.
18. Deurloo, M.J.M., Hermens, A.J.J., Romeyn, S.G., Verhoef, J.C. and Merkus, F.W.H.M., 1989, Absorption enhancement of intranasally administered insulin by sodium taurodihydrofusidate (STDHF) in rabbits and rats, Pharm. Res., 6: 853-856.
19. Dorato, M.A., 1994, Toxicological evaluation of intranasal peptide and protein drugs, in: Drug permeation enhancement; theory and applications (D.S. Hsieh, ed), Marcel Dekker, Inc., New York, pp 345-381.
20. 3H]leucine enkephalin, J.Pharm. Sci., 79: 768-770.
21. Farraj, N.F., Johansen, B.R., Davis, S.S. and Illum, L., 1990, Nasal administration of insulin using bioadhesive microspheres as a delivery system, J. Control. Rel. 13: 253-261.
22. Fisher, A.N., Brown, K., Davis, S.S., Parr, G.D. and Smith, D.A., 1985, The nasal absorption of sodium cromoglycate in the albino rat, J. Pharm. Pharmacol., 37: 38-41.
23. Fisher, A.N., Farraj, N.F., O'Hagan, D.T., Jabbal-Gill, I., Johansen, B.R., Davis, S.S. and Illum, L., 1991, Effect of L-α-lysophosphatidylcholine on the nasal absorption of human growth hormone in three animal species, Int. J. Pharm., 74: 147-156.
24. Gibson, R.E. and Olanoff, L., 1987, Physicochemical determinants of nasal absorption, J. Control. Rel. 6: 361-366.
25. Gizurarson, S., Tamura, S., Kurata, T., Hasiguchi, K. and Ogawa, H., 1991, The effect of cholera toxin and cholera toxin B subunit on the nasal mucosal membrane, Vaccine, 9: 825-832.
26. Gopinath, P.G., Gopinath, G. and Kumar, T.C.A., 1978, Target site of intranasally sprayed substances and their transport across the nasal mucosa: A new insight into the intranasal route of drug delivery, Curr. Ther. Res., 23: 596-607.
27. 99mTcDTPA from guinea pig nasal, tracheobronchial, and bronchoalveolar airways, Thorax, 45:841-845.
28. Hamaguchi, Y., Ohi, M., Ukai, K., Sakakura, Y. and Miyoshi, Y., 1986. Proteolytic activity and serum protease inhibitors in nasal secretions from adult patients with common colds, Rhinology, 24: 125-132.
29. Hermens, W.A.J.J., Deurloo, M.J.M., Romeyn, S.G., Verhoef, J.C. and Merkus, F.W.H.M., 1990, Nasal absorption enhancement of 17β-oestradiol by dimethyl-β-cyclodextrin in rabbits and rats, Pharm. Res., 7: 144-146.
30. Hilding, A.C., 1932, Experimental surgery of the nose and sinuses: I. Changes in the morphology of the epithelium following variations in ventilation, Arch. Otolaryng., 16: 9-18.
31. Hilger, P.A., 1989, Diseases of the nose, in: Fundamentals of otolaryngology (G.L. Adams, L.R. Boies, P.A. Hilger, eds.), W.B. Saunders Company, London, pp. 206-248.
32. Hirai, S., Ikenaga, T. and Matsuzawa, T., 1978, Nasal absorption of insulin in dogs, Diabetes, 27: 296-299.
33. Hirai, S., Yashiki, T., Matsuzawa, T. and Mima, H., 1981a, Absorption of drugs from the nasal cavity of rats, Int. J. Pharm., 7: 317-325.
34. Hirai, S., Yashiki, T. and Mima, H., 1981b, Effect of surfactant on the nasal absorption of insulin in rats, Int. J. Pharm., 9: 165-172.
35. Hirai, S., Yashiki, T. and Mima, H., 1981c, Mechanisms for the enhancement of nasal absorption of insulin by surfactants, Int. J. Pharm. 9: 173-184.
36. Hochstrasser, K., 1983, Proteinases and their inhibitors in human nasal mucus, Rhinology, 21: 217-222.
37. Holbrook, P.A. and Irwin, W.J., 1992, Hydrolysis of peptides in sheep nasal mucosa, J. Control. Rel. 21: 209.
38. Holbrook, P.A., Irwin, W.J., Livingstone, C.R. and Dey, M., 1991, A study of the proteolytic activity in sheep nasal mucosa. Proceed. Int. Symp. Control. Rel. Bioact Mater., 18: 285-286.
39. Huang, C.H., Kimura, R., Bawarshi-Nassar, R. and Hussain, A., 1985, Mechanism of nasal absorption of drugs. I: Physicochemical parameters influencing the rate of in situ nasal absorption of drugs in rats, J. Pharm. Sci., 74: 608-611.
40. Hussain, A.A., Bawarshi-Nassar, R. and Huang, C.H., 1985a, Physicochemical considerations in intranasal drug administrations, in: Transnasal systemic medications (Y.W. Chien, ed.), Elsevier, Amsterdam, pp. 121-137.
41. Hussain, A., Faraj, J., Aramaki, Y. and Truelove, J.E., 1985b, Hydrolysis of leucine enkephalin in the nasal cavity of the rat-A possible factor in the low bioavailability of nasally administered peptides, Biochem. Biophys. Res. Com., 133: 923-928.
42. Hussain, A., Foster, T., Hirai., S., Kashihara, T., Batenhorst, R. and Jones, M., 1980a, Nasal absorption of propranolol in humans, J. Pharm. Sci., 69: 1240-1242.
43. Hussain, A.A., Hirai, S. and Bawarshi, R., 1981, Nasal absorption of natural contraceptive steroids in rats-progesterone absorption, J. Pharm. Sci., 70: 466-467.
44. Hussain, A.A., Hirai, S. and Bawarshi, R., 1980b, Nasal absorption of propranolol from different dosage forms by rats and dogs, J. Pharm. Sci., 69: 1411-1413.
45. Hussain, A.A., Iseki, K., Kagoshima, M. and Dittert, L.W., 1990a, Hydrolysis of peptides in the nasal cavity of humans, J. Pharm. Sci., 79: 947-948.
46. Hussain, M.A., and Aungst, B.J., 1994, Nasal mucosal metabolism of an LH-RH fragment and inhibition with boroleucine, Int. J. Pharm., 105: 7-10.
47. Hussain, M.A., Koval, C.A., Shenvi, A.B. and Aungst, B.J., 1990b, Recovery of nasal mucosa from the effects of aminopeptidase inhibitors, J. Pharm. Sci., 79: 398-400.
48. Igawa, T., Maitani, Y., Machida, Y. and Nagai, T., 1990, Intranasal administration of human fibroblast interferon in mice, rats, rabbits and dogs, Chem. Pharm. Bull. 38: 549-551.
49. Ikeda, K., Murata, K., Kobayashi, M. and Noda, K., 1992, Enhancement of bioavailability of dopamine via nasal route in beagle dogs, Chem. Pharm. Bull., 40: 2155-2158.
50. Illum, L., Farraj, N.F. and Davis, S.S., 1994, Chitosan as a novel nasal delivery system for peptide drugs, Pharm. Res. 11: 1186-1189.
51. Illum, L., Farraj, N.F., Critchley, H. and Davis, S.S., 1988, Nasal administration of gentamicin using a novel microsphere delivery system, Int. J. Pharm., 46: 261-265.
52. Illum, L., Farraj, N.F., Davis, S.S., Johansen, B.R. and O'Hagan, D.T., 1990, Investigation of nasal absorption of biosynthetic human growth hormone in sheep - use of bioadhesive microsphere delivery system, Int, J. Pharm., 63: 207-211.
53. Ingelstedt, S., 1956, Studies on the conditioning of air in the respiratory tract, Acta Otolaryng. (Stockh.) suppl 131.
54. Juto, P., Settergren, B. and Mincheva-Nilsson, L., 1989, Serum IgG and IgM responses in mumps infection as measured by ELISA using a guinea pig capture antibody raised by intranasal immunization, J. Infect. Dis., 159: 998-999.
55. Kalubi, B., Takeda, N., Irifune, M., Ogino, S., Abe, Y., Su-Ling, H., Yamano, M., Matsunaga, T. and Tohyama, M., 1992, Nasal mucosal sensitisation with toluene diisocyanate (TDI) increases preprotachykinin A (PPTA) and preproCGRP mRNAs in guinea pig trigeminal ganglion neurones, Brain Res., 576: 287-296.
56. Kashi, S.D. and Lee, V.H.L., 1986, Enkephalin hydrolysis in homogenates of various absorptive mucosae of the albino rabbit: similarities in rates and involvement of aminopeptidases, Life Sci., 38: 2019-2028.
57. Kelemen, G., 1955, The nasal and paranasal cavities of the rabbit in experimental work, Arch. Otolaryngol., 61: 497-512.
58. Kublik, H. and Muller, B.W., 1994, Nasal absorption enhancement of 17β-oestradiol with bioadhesive microparticles in sheep, Eur. J. Pharm. Biopharm., 40 (Suppl.): 58S.
59. Kublik, H., Schreier, H. and Muller, B.W., 1994, Nasal absorption enhancement of 17β-oestradiol with different cyclodextrins in sheep, Eur. J. Pharm. Biopharm., 40 (Suppl.): 55S.
60. Kumar, T.C.A., David, G.F.X., Sankaranarayanan, A., Puri, V. and Sundram, K.R., 1982, Pharmacokinetics of progesterone after its administration to ovariectomized rhesus monkey by injection, infusion, or nasal spraying, Proc. Natl. Acad. Sci. USA, 79: 4185-4189.
61. Larsen, C., Niebuhr Jorgensen, M., Tommerup, B., Mygind, N., Dagrosa, E.E., Grigoleit, H.-G. and Malerczyk, V, 1987, Influence of experimental rhinitis on the gonadotropin response to intranasal administration of buserelin, Eur. J. Clin. Pharmacol, 33: 155-159.
62. Lee, S.W., Hardy, J.G., Wilson, C.G. and Smelt, G.J.C., 1984, Nasal sprays and polyps, Nucl. Med. Commun., 5: 697-703.
63. Lee, V.H.L., 1988, Enzymatic barriers to peptide and protein absorption, CRC Crit Rev. Ther. Drug Carrier Sys., 5: 69-97.
64. Lee, V.H.L., Kashi, S.D., Patel, R.M., Hayakawa, E. and Inagaki, K., 1987, Mucosal peptide and protein delivery: proteolytic activities in mucosal homogenates, Proc. Int. Symp. Control. Rel. Bioact. Mater., 14: 23-24.
65. Lee, W.A., Narog, B.A., Patapoff, T.W. and Wand, Y.J., 1991, Intranasal bioavailability of insulin powder formulations: Effect of permeation enhancer-to-protein ratio, J. Pharm. Sci., 80: 725-729.
66. Longenecker, J.P., 1986, Nazlin® - transnasal systemic delivery of insulin, in: Delivery systems for peptide drugs (S.S. Davis, L. Illum and E. Tomlinson, eds.), Plenum Press, New York, pp. 211-220.
67. Longenecker, J.P., Moses, A.C., Flier, J.S., Silver, R.D., Carey, M.C. and Dubovi, E.J., 1987, Effects of sodium taurodihydrofusidate on nasal absorption of insulin in sheep, J. Pharm. Sci., 76: 351-355.
68. Lung, M.A. and Wang, J.C.C., 1989, An anatomical investigation of the nasal venous vascular bed in the dog, J. Anat., 166: 113-119.
69. Lupo, C., Lodi, L., Canonaco, M., Valenti, A. and Dessi-Fulgheri, F., 1986, Testosterone metabolism in the olfactory epithelium of intact and castrated male rats, Neurosci. Lett., 69: 259-262.
70. Maitani, Y., Igawa, T., Machida, Y. and Nagai, T., 1986, Intranasal administration of β-interferon in rabbits, Drug Design and Deliv., 1: 65-70.
71. Maitani, Y., Uchida, N., Taniguchi, M., Yamazaki, S., Hara, M., Yakayama, K., Machida, Y. and Nagai, T., 1990, The inactivation process of fibroblast interferon-β in the preparation stage and in the rabbit nasal absorption of mixed and freeze dried powder dosage forms, Int. J. Pharm., 64: 139-146.
72. Manzoni, C., Monti, C. and Valente, M., 1989, Bioavailability of elcatonin (ASU1,7 - eel calcitonin) after intranasal administration to rats and dogs, Pharmacol. Res., 21: 105-106.
73. Martin, M.E.D., Dewar, J.B. and Newman, J.F.E., 1988, Polymerized serum albumin beads possessing slow release properties for use in vaccines, Vaccine, 6: 33-38.
74. Masuda, H., 1983, Electron microscopic studies on the permeability of the nasal respiratory epithelium of the guinea pig, Otologia Fukuoka, 29: 389-401.
75. May, N.D.S., 1964, The anatomy of the sheep, University of Queensland Press, Brisbane, Queensland, Australia.
76. Mayor, S. and Illum, L., 1994, An investigation of the effect of anaesthetics on the nasal absorption of insulin in rats, Proceed. Intern. Symp. Control Rel. Bioact Mater., 21: 334-335.
77. Merkus, F.W.H.M., Verhoef, J.C., Romeijn, S.G. and Schipper, N.G.M, 1991, Interspecies differences in the nasal absorption of insulin, Pharm. Res., 8: 1343.
78. Morimoto, K., Yamaguchi, H., Iwakura, Y, Miyazaki, M., Nakatani, E., Iwamoto, T., Ohashi, Y. and Nakai, Y., 1991, Effects of proteolytic enzyme inhibitors on the nasal absorption of vasopressin and an analogue, Pharm. Res., 8: 1175-1179.
79. Mygind, N., 1978, Nasal Allergy, Blackwell Scientific Publications, Oxford.
80. Nagai, T. and Machida, Y., 1985, Mucosal adhesive dosage forms, Pharm. Int., 6: 196-200.
81. Nagai, T., Nishimoto, Y., Nambu, N., Suzuki, Y. and Sekine, K., 1984, Powder dosage form of insulin for nasal administration, J. Control. Rel., 1: 15-22.
82. Nolte, M.S., Taboga, C., Salamon, E., Moses, A., Longenecker, J., Flier, J. and Karam, J.H., 1989, Biological activity of nasally administered insulin in normal subjects, Horm Metabol. Res., 22: 170-174.
83. Nugmanova, Z.S., Nugmanova, D.D., Beklemishew, N.D. and Andreeva, N.A., 1989, Immunocompetent cells in the local and systemic immunity organs of intact and sensitized guinea pig in the course of specific intranasal immunotherapy, Zh. Mikrobiol. Epidemil. Immunobiol., N2: 92-96.
84. O'Hagan, D.T. and Illum, L., 1990, Absorption of peptides and proteins from the respiratory tract and the potential for development of locally administered vaccine, CRC Crit. Rev. Ther. Drug Carrier Sys., 7: 35-97.
85. Okada, H., Yamazaki, I., Ogawa, Y., Hirai, S., Yashiki, T. and Mima H., 1982, Vaginal absorption of a potential luteinizing hormone releasing hormone analogue (leuprolide) in rats I: Absorption by various routes and absorption enhancement, J. Pharm. Sci., 71: 1367-1371.
86. Park, J.F., Clarke, W.J. and Bair, W.J., 1970, Respiratory system, in: The beagle as an experimental animal (A.C. Andersen and L.S. Good, eds.), Iowa State University Press, Ames, Iowa, pp. 285-293.
87. Patrick, G. and Stirling, C., 1977, Measurement of mucociliary clearance from the trachea of conscious and anaesthetised rats, J. Appl. Physiol., 42: 451-455.
88. Phalen, R.F., 1984, Inhalation studies: Foundations and Techniques, CRC Press, Inc., Boca Raton.
89. Phillpotts, R.J., Davies, H.W., Willman, J., Tyrrell, D.A.J. and Higgins, P.G., 1984, Pharmacokinetics of intranasally applied medication during a cold, Antiviral Res., 4: 71-74.
90. Pontiroli, A.E., Alberetto, M., Secchi, A., Dossi, G., Bosi, I. and Pozza, G., 1982, Insulin given intranasally induces hypoglycemia in normal and diabetic subjects, Br. Med. J., 284: 303-306.
91. Popp, J.A. and Monteiro-Riviere, N.A., 1985, Macroscopic, microscopic and ultrastructural anatomy of the nasal cavity, rat, in: Monographs on pathology of laboratory animals (T.C. Jones, U. Mohr and R.D. Hunt, eds.), Springer Verlag, pp. 3-10.
92. Proctor, D.F., Andersen, I. and Lundqvist, G., 1973, Clearance of inhaled particles from the human nose, Arch. Intern. Med., 131: 132-139.
93. Puri, C.P., Vajifdar, B.S., Nayak, V.G., Dhanasekaran, K., Pongubala, J.M.R., Hamied, Y.K. and Kumar, T.C.A., 1987, Pharmacokinetics of norethisterone following its oral administration and by spraying it nasally or sublingually to male bonnet monkeys, Contraception, 35: 381-388.
94. Rao, A.J., Moudal, N.R. and Li, C.H., 1986, β-endorphin: intranasal administration increases the serum prolactin level in monkey, Int. J. Peptide Protein Res., 28: 546-548.
95. Sakane, T., Akizuki, M., Yoshida, M., Yamashita, S., Nadai, T., Hashida, M. and Sezaki, H., 1991, Transport of cephalexin to the cerebrospinal fluid directly from the nasal cavity, J. Pharm. Pharmacol., 43: 449-451.
96. Sakane, T., Akizuki, M., Yoshida, M., Yamashita, S., Sezaki, H. and Nadai, T., 1994, Direct transport from the rat nasal cavity to the cerebrospinal fluid: the relation to the dissociation of the drug, J. Pharm. Pharmacol., 46: 378-379.
97. Sarkar, M.A., 1992, Drug metabolism in the nasal mucosa, Pharm. Res. 9: 1-9.
98. Schipper, N.G.M., Romeijn, S.G., Verhoef, J.C. and Merkus, F.W.H.M., 1993, Nasal insulin delivery with dimethyl-β-cyclodextrin as an absorption enhancer in rabbits: Powder more effective than liquid formulations, Pharm. Res., 10: 682-686.
99. Schreider, J.P., 1983, Nasal airway anatomy and inhalation deposition in experimental animals and people, in: Nasal tumors in animals and man, Volume III, Experimental nasal carcinogenesis, (G. Reznik and S.F. Stinson, eds.), CRC Press, Florida, pp. 1-26.
100. Shao, Z. and Mitra, A.K., 1994, Bile salt-fatty acid mixed micelles as nasal absorption promoters. III. Effects on nasal transport and enzymatic degradation of acyclovir prodrugs, Pharm. Res., 11: 243-250.
101. Stoksted, P., 1952, Rhinometric measurements for determination of the nasal cycle, Acta Oto-laryng. (Stockh.) suppl., 104: 159-176.
102. Stratford, R.E. and Lee, V.H.L., 1986, Aminopeptidase activity in homogenates of various absorptive mucosae in the albino rabbit: implications in peptide delivery, Int. J. Pharm. 30: 73-82.
103. Visor, G.C., Schuessler, B., Thompson, J. and Ling, T., 1987, Nasal absorption of the calcium antagonist nicardipine in rats and rhesus monkeys, Drug Devel. Ind. Pharm., 13: 1329-1343.
104. Vyas, S.P., Talwar, N., Karajgi, J.S. and Jain, N.K., 1993, An erythrocyte based bioadhesive system for nasal delivery of propranolol, J. Control. Rel., 23: 231-237.
105. Wagnar, J.E. and Manning, P.J., 1976, The biology of the guinea pig, Academic Press, New York.
106. Wolf, R.K., Allen, D.L., Hughes, A.B.L., Osier, M. and Dorato, 1993, Nasal clearance in rhesus monkeys, J. Aerosol Med., 6: 111-119.
107. Yamazaki, I., 1984, Relation between biological activities and blood levels of LHRH or its analogues by different routes of administration in rats, in: LHRH and its analogues (E. Labrie, A. Belanger and A. Dupont, eds.), Elsevier, Amsterdam, pp. 77-91.