Properties and formulation of oral drug delivery systems of protein and peptides

Indian Journal of Pharmaceutical Sciences

Volumn 69, Issue 6, 2007, Pages 741-747

  Semalty, A ^a   Semalty, Mona ^a   Singh, R ^a   Saraf, S ^b   Saraf, Shubhini ^c  

^a H N B GARHWAL UNIVERSITY   (India)

^b NIEC   (India)

^c Faculty of Pharmacy BBDNITM   (India)

Author keywords

Oral insulin; Oral protein delivery; Protein and peptide

Indexed keywords

ALPHA INTERFERON; AMMONIUM SULFATE; APROTININ; BESTATIN; CALCITONIN; CAMOSTAT MESILATE; CETRIMIDE; CITRATE SODIUM; CYCLODEXTRIN DERIVATIVE; DODECYL SULFATE SODIUM; EDETIC ACID; GLUCAGON; GONADORELIN; HUMAN GROWTH HORMONE; INSULIN; LEUCINE ENKEPHALIN; METENKEPHALIN; PEPTIDE; POLYSORBATE; POTASSIUM DIHYDROGEN PHOSPHATE; PROTIRELIN; RECOMBINANT HUMAN INSULIN; SUBSTANCE P; SUCROSE; TETRAGASTRIN; TREHALOSE; TYROTHRICIN; UNINDEXED DRUG; VASOPRESSIN; ZINC;

AMINO TERMINAL SEQUENCE; CARBOXY TERMINAL SEQUENCE; DRUG ABSORPTION; DRUG DELIVERY SYSTEM; DRUG FORMULATION; GASTROINTESTINAL TRACT; HUMAN; HYDROGEN BOND; HYDROPHILICITY; HYDROPHOBICITY; IMMUNOGENICITY; INTESTINE MUCOSA; PHYSICAL CHEMISTRY; PROTEIN FOLDING; REVIEW; STEREOCHEMISTRY;

EID: 40749145377     PISSN: 0250474X     EISSN: None     Source Type: Journal    
DOI: 10.4103/0250-474X.39426     Document Type: Review

References (84)

1. Dence JE. Steroids and Peptide: Selected Chemical Aspects for Biology, Biochemistry and Medicine. New York: John Willey and Sons; 1980, p. 89.
2. Hey DH, John DI. Amino acids Peptides and Related Compounds, In; Organic Chemistry. Baltimore: University Park Press; 1978, p. 5.
3. Matthews DM. Intestinal absorption of peptides. Physiol Res 1975;55:537-607.
4. Walker WA, Isselbacher KJ. Uptake and transport of macromolecules by the intestine: Possible role in clinical disorders. Gastroenterology 1974;67:59-70.
5. Klostermeyer H, Humble RE. Chemistry and biochemistry of insulin. Agnew Chem Intern 1966;5:807-11.
6. Nair M, Chein YW. Development of anticandidal delivery systems: II. Int J Pharm 1993;89:41.
7. Lesch CA, Squier CA, Crutchley A, Willams DM, Speight P. the permeability of human oral mucosa and skin to water. J Dent Res 1989;68:1345.
8. Rathbone MJ, Drummond BK, Tucker IG. Oral cavity as a site for systemic drug delivery. Adv Drug Del Rev 1994;13:1-22.
9. Chein YW, Su KS, Chang SF. editors, Nasal Systemic Drug Delivery. New York: Marcel Dekker Inc; 1989.
10. Su KS. Intranasal delivery of peptides and proteins. Pharm Int 1986;7:8-11.
11. Van de Donk HJ, Van der Heuvel AG, Zuidema J, Merkus FW. The effects of nasal drops and their additives on human mucociliary clearance. Rhinology 1982;20:127-37.
12. De Boer AG, Breimer DD, Mattie H, Pronk J, Gubbens-Stibbe JM. Rectal absorption of drugs. Clin Pharmacol Ther 1979;1:441.
13. Clark AR, Shire SJ. Protein formulation and delivery. In: McNally EJ, editors. Drugs and the Pharmaceutical Science. Vol. 99. New York: Marcel Dekker; 2000. p. 201-12.
14. Siegel IA. Permeability of the rat oral mucosa to organic solutes measured in vivo. Arch Oral Biol 1984;29:13-6.
15. McMartin C, Hutchinson LE, Hyde R, Peters GE. Analysis of structural requirements for the absorption of drugs and macromolecules from the nasal cavity. J Pharm Sci 1987;76:535-40.
16. Maitani Y, Machida Y, Nagai T. Influence of molecular weight and charge on nasal absorption of dextran and DEAE-dextran in rabbits. Int J Pharm 1989;49:23-7.
17. Donovan MD, Flynn GL, Amidon GL. Absorption of polyethylene glycols 600 through 2000: The molecular weight dependence of gastrointestinal and nasal absorption. Pharm Res 1990;7:863-8.
18. Green PG, Hinz RS, Kim A, Szoka FC, Guy RH. Iontophoretic delivery of a series of tripeptides across the skin in vitro. Pharm Res 1991;8:1121-7.
19. Delie F, Letourneux Y, Nisato D, Puisieux F, Couvreur P. Oral administration of peptides: Study of a glycerolipidic prodrug. Int J Pharm 1995;115:45-52.
20. Burnham NL. Polymers for delivering peptides and proteins. Am J Hosp Pharm 1999;51:210-8.
21. Palm K, Luthman K, Ungell AL, Strandlund G, Artursson P. Correlation of drug absorption with molecular surface properties. J Pharm Sci 1996;85:32-9.
22. Ho NFH, Day JS, Barsuhn CL, Burton PS, Raub TJ. Biophysical model approaches to mechanistic transepithelial studies of peptides. J Control Release 1990;11:3-24.
23. Merkle HP, Wolany GJ. Intraoral peptide absorption. In: Audus KL, Raub TJ, editors. Biological barriers to protein delivery. New York/London: Plenum; 1993. p. 131-60.
24. Burnham N. Polymers for delivering peptides and proteins. Am J Hosp Pharm 1994;51:210-8.
25. Reddy IK, Madan PL. Controlled/sustained release: Proteins and peptides. Pharm Times 1992;58:132.
26. Siegel IA, Izutsu KT, Watson E. Mechanisms of nonelectrolyte penetration across dog and rabbit oral mucosa in vitro. Arch Oral Biol 1981;26:357-61.
27. Corbo DC, Huang YC, Chein, YW. Nasal delivery of progestational steroid in ovariectomized rabbits, II: Effect of penetrant hydrophilicity. Int J Pharm 1989;50:253-60.
28. Huang CH, Kimura R, Bwarshi-Nassar R. Mechanism of nasal absorption of drugs, II: Absorption of l-tyrosine and the effect of structural modiÆcation on its absorption. J Pharm Sci 1985;74:1298-301.
29. Hirai S, Yashiki T, Matsuzawa T, Mima H. Absorption of drugs from the nasal mucosa of rat. Int J Pharm 1981;7:317-25.
30. Hansun LB, Christrup LL, Bundgaard H. Enhanced delivery of ketobemidone through porcine buccal mucosa in vitro via more lipophilic ester prodrugs. Int J Pharm 1992;88:237-42.
31. Hansun LB, Jorgenson A, Rasmussen SN, Christrup LL, Bundgaard H. Buccal absorption of ketobemidone and various ester prodrugs in the rat. Int J Pharm 1992;88:243-50.
32. Toniolo C, Bonora GM, Stavropoulos G, Cordopatis P, Theodoropoulos D. Self-association and solubility of peptides: Solvent-titration study of N-protected C-terminal sequences of substance P. Biopolymers 1986;25:281.
33. Touitou E. Enhancement of intestinal peptide absorption. J Control Release 1992;21:139-44.
34. Banga AK, Chein YW. Systemic delivery of therapeutic peptides and proteins. Int J Pharm 1988;48:15-50.
35. Conradi RA, Hilgers AR, Ho NF, Burton PS. The influence of peptide structure on transport across caco-2 cells. Pharm Res 1992;8:1453-60.
36. Conradi RA, Hilgers AR, Ho NF, Burton PS. The influence of peptide structure on transport across caco-2 cells, II: Peptide bond modification which results in improved permeability. Pharm Res 1992;9:435-9.
37. Burton PS, Conradi RA, Hilgers AR, Ho NFH, Maghiora LL. The relationship between peptide structure and transport across epithelial cell monolayers. J Control Release 1992;19:87-98.
38. Lee VH. Enzymatic barriers to peptide and protein absorption. Crit Rev Ther Drug Carrier Syst 1988;5:69-97.
39. Arakawa T. The stabilization of P-lactoglobulin by glycine and NaC1. Biopolymers 1989;28:1397.
40. Arakawa T, Kita Y, Carpenter JF. Protein-solvent interactions in pharmaceutical formulations. Pharm Res 1991;8 :285-91.
41. Charman SA, Mason KL, Charman WN. Techniques for assessing the effects of pharmaceutical excipients on aggregation of porcine growth hormone. Pharm Res 1993;10:954-62.
42. Tsai PK, Volkin DB, Dabora JM, Thompson KC, Bruner MW, Gress JO, Matuszewska B. Formulation design of acidic fibroblast growth factor. Pharm Res 1993;10:649-59.
43. Gonda I. Inhalation therapy with recombinant human deoxyribonuclease I. Adv Drug Deliv Rev 1996;19:37-46.
44. Johnson OL, Cleland JL, Lee HJ. A month-long effect from a single injection of microencapsulated human growth hormone. Nat Med 1996;2:795-9.
45. Izutsu KI, Yoshioko S, Kojima S. Physical stability and protein stability of freeze-dried cakes during storage at elevated temperatures. Pharm Res 1994;11:995-9.
46. Townsend MW, Byron PR, Deluca PP. Effects of. formulation additives on the degradation of freeze-dried ribonuclease A. Pharm Res 1990;7:1086-91.
47. Horbett TA. Stability of Protein Pharmaceuticals. Part A. In: Ahem TJ, Manning MC, editors. Chemical and Physical Pathways of Protein Degradation. New York: Plenum Press; 1992. p. 195.
48. Costantino HR, Langer R, Klibanov AM. Moisture-induced aggregation of lyophilized insulin. Pharm Res 1994;11:21-9.
49. Thurow H, Geisen K. Stabilisation of dissolved proteins against denaturation at hydrophobic interfaces. Diabetolgia 1984;27:212-8.
50. Mumenthaler M, Hsu CC, Pearlman R. Feasibility study on spray drying protein pharmaceuticals by improved optical methods. Pharm Res 1994;11:12-20.
51. Cleland JL, Jones AJ. Development of stable protein formulations for microencapsulation in biodegradable polymers: Proceedings of an International Symposium on Controlled Release of Bioactive Materials. Seattle: Controlled Release Society; 1995.
52. Gardener MLG. Intestinal assimilation of intact peptides and proteins from the diet: A neglected field? Biol Rev 1984;59:289-331.
53. Gardener MIG, Illingworth KM, Kelleher J, Wood D. Intestinal absorption of the intact peptide carnosine in man and comparison with intestinal permeability to lactulose. J Physiol 1991;439:411.
54. Gebert G. For enteral absorption intact β protein molecules. Algemin Medizin 1991;19:125.
55. Jain GK. Oral Protein Drug Delivery. In: Jain NK, editor. Advances in Controlled and Novel Drug Delivery. New Delhi: CBS Publishers; 2001. p. 232.
56. Wyvratt, MJ, Patchett AA. Recent developments in the design of angiotensin-converting enzyme inhibitors. Med Res Rev 1985;5:483-531.
57. Brewster D, Waltham K. TRH degradation rates vary widely between different animal species. Biochem Pharmacol 1981;30:619-22.
58. Davis S, Abuchowski A, Park YK, Davis FF. Alteration of the circulating life and antigenic properties of bovine adenosine deaminase in mice by attachment of polyethylene glycol. Clin Exp Immunol 1981;46:649-52.
59. Christopher HP. Nobex Corporation: Crossing Barrier for Better. Drug Delivery 2003;3:12.
60. Jennewein HM, Waldeck F, Konz W. The absorption of tetragastrin from different sites in rats and dogs. Arzneimittelforschung 1974;24:1225-8.
61. Kidron M, Bar OJ, Berry EM, Ziv E. Alteration of the paracellular space of enterocytes with glucose to modulate the passive intestinal absorption of insulin. Life Sci 1982;31:2837.
62. Saffran M, Bedra C, Kumar GS, Neckers DC. Vasopressin: A model for the study of effects of additives on the oral and rectal administration of peptide drugs. J Pharm Sci 1988;77:33-8.
63. Takaori K, Burton J, Donowitz M. The transport of an intact oligopeptide across adult mammalian jejenum. Biochem Biophys Res Commun 1986;137:682-7.
64. 2EDTA and sodium glycocholate on intestinal absorption of insulin. Biol Pharm Bull 1993;16:68-72.
65. Lueben HL, Lehr CM, Rentel CO, Noach AB, Boer AG, Verhoel JC, et al. Bioadhesive polymers for the peroral delivery of peptide drugs. J Control Rel 1994;29:329-38.
66. Tozaki H, Nishioka J, Komoike J, Okada N, Fujita T, Muranishi S, et al. Enhanced absorption of insulin and (Asu(1,7)) eel-calcitonin using novel azopolymer-coated pellets for colon-specific drug delivery. J Pharm Sci 2001;90:89-97.
67. Vyas SP, Khar RK. Controlled Drug Delivery. New Delhi: Vallabh Prakashan; 2002. p. 524.
68. Hirai S, Yashiki T, Mima H. Absorption of drugs from the nasal mucosa of rat. Int J Pharm 1981;9:317-25.
69. Chen H, Langer R. Oral particulate delivery: Status and future trends. Adv Drug Deliv Rev 1998;34:339-50.
70. Saffran M, Kumar GS, Savariar C, Burnham JC, Williams F, Neckers DC. A new approach to the oral administration of insulin. Science 1986;233:1081.
71. Bernkop-Schnurch A, Scerbe-Saiko A. Synthesis and in vitro evaluation of chitosan-EDTA-protease-inhibitor conjugates which might be useful in oral delivery of peptides and proteins. Pharm Res 1998;15:263-9.
72. Leon-Bay A. Ho KK, Agarwal R, Baughman RA, Chaudhary K, DeMorin F, et al. 4-{4-[(2-Hydroxyben-zoyl)amino]phenyl}butyric acid as a novel oral delivery agent for recombinant human growth. hormone. J Med Chem 1996;39:2571-8.
73. Oppenheim RC, Stewart NF, Gordon L, Patel HM. The Production and Evaluation of Orally Administered Insulin Nanoparticles. Drug Develop Ind Pharm 1982;8:531-46.
74. Touitou E, Rubinstein AA. Targeted enteral delivery of insulin to rats. Int J Pharm 1986;30:95-99.
75. Lewis DH. Biodegradable Polymers as Drug Delivery System. In: Chasin M, Langer R, editors. Biopolymers. New York: Marcel Dekker; 1990. p. 8-24.
76. Tabata Y, Langer R. Polyanhydride. microspheres that display near-constant release of water-soluble model drug. compounds. Pharm Res 1993;10:391-9.
77. Gombotz WR, Healy MS, Brown LR. US Patent No. US5019400, 1991.
78. Hanson MA, Roun SK. Stability of Protein Pharmaceuticals. Part B. In: Ahern, TJ, Manning MC. editors. In Vivo Pathways of Degradation and Strategies for Protein Stabilization. New York: Plenum Press; 1992. p. 209.
79. News release. New delivery system to administer insulin orally. Pharm Tech 2003;27:17.
80. Morçöl T, Nagappan P, Nerenbaum L, Mitchell A, Bell SJ. Calcium phosphate-PEG-insulin-casein (CAPIC) particles as oral delivery systems for insulin. Int J Pharm 2004;277:91-7.
81. Johnson OL. Oral protein drug delivery In: McNally EJ, editors. Protein Formulation and Delivery. New York: Marcel Dekker; 2000. p. 251.
82. Kristy MW, Peppas NA. [Last accessed on 2005 Oct 28]. Available from: http://aiche.confex.com/aiche/2005/preliminaryprogram.
83. Peppas NA. Devices based on intelligent biopolymers for oral protein delivery. Int J Pharm 2004;277:11-7.
84. News Section, First human insulin inhalation powder approved by USFDA. Nat Med J India 2006;19:53.