Systemic drug delivery via the buccal mucosal route

Pharmaceutical Technology North America

Volumn 25, Issue 6, 2001, Pages 70-81

  Shojaei, Amir H ^a   Chang, Richard K ^a   Guo, Xiaodi ^a   Burnside, Beth A ^a   Couch, Richard A ^a  

^a Shire Laboratories Inc   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 0039739976     PISSN: 15342131     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (100)

1. B.J. Aungst, "Comparison of Nasal, Rectal, Buccal, Sublingual and Intramuscular Insulin Efficacy and the Effects of a Bile Salt Absorption Promoter," J. Pharmacol. Exp. Ther. 244 (1), 23-27 (1988).
2. Z. Shao and A.K. Mitra, "Nasal Membrane and Intracellular Protein and Enzyme Release by Bile Salts and Bile Salt-Fatty Acid Mixed Micelles: Correlation with Facilitated Drug Transport," Pharm. Res. 9 (9) (1992).
3. A.P. Soyani and Y.W. Chien, "Systemic Delivery of Peptides and Proteins across Absorptive Mucosae," Crit. Rev. Ther. Drug Carrier Sys. 13 (1-2), 85-184 (1996).
4. T. Shimamoto, "Pharmaceutical Aspects. Nasal and Depot Formulations of Leuprolide," J. Androl. 8 (1), S14-S16 (1987).
5. R. Dal Negra et al., "Calcitonin Nasal Spray in Patients with Chronic Asthma: a Double-blind Crossover Study vs Placebo," Int. J. Clin. Pharmacol. Ther. Toxicol. 29 (4), 144-146 (1991).
6. J. Streisand et al., "Absorption and Bioavailability of Oral TransMucosal Fentanyl Citrate," Anesthesiology 75, 223-229 (1991).
7. C.A. Squier, "The Permeability of Oral Mucosa," Crit. Rev. Oral Biol. Med. 2 (1), 13-32 (1991).
8. D. Harris and J.R. Robinson, "Drug Delivery via the Mucous Membranes of the Oral Cavity," J. Pharm. Sci. 81 (1), 1-10 (1992).
9. M. Ishida et al., "Mucosal Dosage Form of Lidocaine for Toothache Using Hydroxypropyl Cellulose and Carbopol," Chem. Pharm. Bull. 30, 980-984 (1982).
10. A.E.M. Collins et al., "Evaluation of a Controlled Release Compact Containing Tetracycline Hydrochloride Bonded to Tooth for the Treatment of Periodontal Disease," Int. J. Pharm. 51, 103-114 (1989).
11. R. Elkayam et al., "Sustained Release Device Containing minocycline for Local Treatment of Periodontal Disease," J. Controlled Release 7, 231-236 (1988).
12. L. Samaranayake and M. Ferguson, "Delivery of Antifungal Agents to the Oral Cavity," Adv. Drug Del. Dev. 13, 161-179 (1994).
13. T. Nagai, "Adhesive Topical Drug Delivery System," J. Controlled Release 2, 121-134 (1985).
14. T. Nagai and Y. Machida, "Mucosal Adhesive Dosage Forms," Pharm. Int. 196-200 (August, 1985).
15. R.B. Gandhi and J.R. Robinson, "Oral Cavity as a Site for Bioadhesive Drug Delivery," Adv. Drug Del. Rev. 13, 43-74 (1994).
16. M.E. Dowty et al., "Transport of Thyrotropin Releasing Hormone in Rabbit Buccal Mucosa In Vitro," Pharm. Res. 9 (9), 1113-1122 (1992).
17. L.A. Tabak et al., Role of Salivary Mucins in the Protection of the Oral Cavity," J. Oral Pathol. 11, 1-17 (1982).
18. M.R. Tavakoli-Saberi and K.L. Audus, "Cultured Buccal Epithelium: an In Vitro Model Derived from the Hamster Pouch for Studying Drug Transport and Metabolism," Pharm. Res. 6, 160-162 (1989).
19. M.R. Tavakoli-Saberi et al., "Aminopeptidase Activity in Human Buccal Epithelium and Primary Cultures of Hamster Buccal Epithelium," Pharm. Res. 6, S-197 (1989).
20. H.R. Leipold and E. Quadros, "Nicotine Permeation through Buccal Cultures," Proc. Int. Symp. Contr. Rel. Bioact. Mater. 20, 242-243 (1993).
21. J. Jacobsen et al., "TR146 Cells Grown on Filters as a Model for Human Buccal Epithelium: I. Morphology, Growth Properties, and Permeability," Int. J. Pharm. 125, 165-184 (1995).
22. J. Jacobsen et al., "TR146 Cells as a Model for Human Buccal Epithelium: II. Optimisation and Use of a Cellular Sensitivity MTS/PMS assay," Int. J. Pharm. 141, 217-225 (1996).
23. J. Jacobsen et al., "Filter-Grown TR146 Cells as an In Vitro Model of Human Buccal Epithelial Permeability," Eur. J. Oral Sci. 107, 138-146 (1999).
24. H.M. Nielsen and M.R. Rassing, "TR146 Cells Grown on Filters as a Model of Human Buccal Epithelium: III. Permeability Enhancement by Different pH Values, Different Osmolality Values, and Bile Salts," Int. J. Pharm. 185, 215-225 (1999).
25. H.M. Nielsen et al., "TR146 Cells Grown on Filters as a Model of Human Buccal Epithelium: Permeability of Fluorescein Isothiocyanate-Labelled DexTrans in the Presence of Sodium Glycocholate." J. Controlled Release 60, 223-233 (1999).
26. A.H. Beckett and E.J. Triggs, "Buccal Absorption of Basic Drugs and Its Application as an In Vivo Model of Passive Drug Transfer through Lipid Membranes," J. Pharm. Pharmacol. 19 (Suppl.), 31S-41S (1967).
27. W. Schurmann and P. Turner, "Membrane Model of the Human Oral Mucosa as Derived from Buccal Absorption Performance and Physicochemical Properties of the Beta-Blocking Drugs Atenolol and Propranolol," J. Pharm. Pharmacol. 30, 137-147 (1978).
28. I.G. Tucker, "A Method to Study the Kinetics of Oral Mucosal Drug Absorption from Solutions," J. Pharm. Pharmacol. 40, 679-683 (1988).
29. C.L. Barsuhn et al., "Human Buccal Absorption of Flubriprofen," Clin. Pharmacol Ther. 44, 225-231 (1988).
30. I. Gonzalez-Younes et al., "Absorption of Flubriprofen through Human Buccal Mucosa," J. Pharm. Sci. 80, 820-823 (1991).
31. L. Benes et al., "Plasma Melatonin (M) and Sulfatoxymelatonin (aMT6s) Kinetics after Transmucosal Administration to Humans," in Melatonin and the Pineal Gland - From Basic Science to Clinical Application, Y. Touitou et al., Eds. (Elsevier Science Publishers B.V., Amsterdam, 1993), pp. 347-350.
32. R.L. McQuinn et al., "Sustained Oral Mucosal Delivery in Human Volunteers of Buprenorphine from Thin Non-eroding Mucoadhesive Polymeric Disks," J. Controlled Release 34, 243-250 (1995).
33. L. Benes et al., "Transmucosal, Oral Controlled-Release, Transdermal Drug Administration in Human Subjects: A Crossover Study with Melatonin," J. Pharm. Sci. 86 (10), 1115-1119 (1997).
34. M.M. Veillard et al., "Preliminary Studies of Oral Mucosal Delivery of Peptide Drugs," J. Controlled Release 6, 123-131 (1987).
35. H. Yamahara and V.H. Lee, "Drug Metabolism in the Oral Cavity," Adv. Drug Del. Rev. 12, 25-39 (1993).
36. B.J. Aungst and N.J. Rogers, "Comparison of the Effects of Various Transmucosal Absorption Promoters on Buccal Insulin Delivery," Int. J. Pharm. 53, 227-235 (1989).
37. I.A. Siegel and H.P. Gordon, "Surfactant-Induced Increase of Permeability of Rat Oral Mucosa to Non-electolytes In Vivo," Arch. Oral Biol. 30 (1), 43-47 (1985).
38. Y. Kurosaki et al., "Enhanced Permeability of Keratinized Oral Mucosa to Salicylic Acid with 1-Dodecylacycloheptan-2-one(Azone). In Vitro Studies in Hamster Cheek Pouch," Int. J. Pharm. 49, 47-55 (1989).
39. Y. Kurosaki et al., "Effects of Surfactants on the Absorption of Salicylic Acid from Hamster Cheek Pouch as a Model of Keratinized Oral Mucosa," Int. J. Pharm. 47, 13-19 (1988).
40. M. Tanaka et al., "Absorption of Salicylic through the Oral Mucous Membrane of Hamster Cheek Pouch," Chem. Pharm. Bull. 28 (4), 1056-1061 (1980).
41. C.K. Oh and W.A. Ritschel, "Biopharmaceutic Aspects of Buccal Absorption of Insulin," Meth. Find Exp. Clin. Pharmacol. 12 (3), 205-212 (1990).
42. I.A. Siegel et al., "Mechanisms of Non-electrolyte Penetration across Dog and Rabbit Oral Mucosa In Vitro," Arch. Oral Biol. 26, 357-361 (1981).
43. M.E. Dowty et al., "Enzyme Characterization Studies on the Rate-Limiting Barrier in Rabbit Buccal Mucosa," Int. J. Pharm. 88, 293-302 (1992).
44. C.A. Squier and P.W. Wertz, "Structure and Function of the Oral Mucosa and Implications for Drug Delivery," in Oral Mucosal Drug Delivery, M.J. Rathbone, Ed. (Marcel Dekker, New York, Vol. 74, 1996), pp. 1-26.
45. M. Mehta et al., "In Vitro Penetration of Tritium-Labelled Water (THO) and [3H]PbTx-3 (a red tide toxin) through Monkey Buccal Mucosa and Skin," Toxicol. Lett. 55, 185-194 (1991).
46. V. Kataja and A. Yap, "Combination of Cisplatin and Interferon-α2a (Roferon-A) in Patients with Non-Small Cell Lung Cancer (NSCLC). An Open Phase II Multicenter Study," Eur. J. Cancer 31A, 35-40 (1995).
47. M. Ishida et al., "New Mucosal Dosage Form of Insulin," Chem. Pharm. Bull. 29 (3), 810-816 (1981).
48. A.J. Hoogstraate et al., "Buccal Delivery of Fluorescein Isothiocyanate-Dextran 4400 and the Peptide Drug Buserelin with Glycodeoxycholate as an Absorption Enhancer in Pigs," J. Controlled Release 41, 77-84 (1996).
49. C.A. Lesch et al., "The Permeability of Human Oral Mucosa and Skin to Water," J. Dent. Res. 68, 1345-1349 (1989).
50. A.J. Hoogstraate et al., "Effects of Bile Salts on Transport Rates and Routes of FTIC-Labelled Compounds across Porcine Buccal Epithelium In Vitro. J. Controlled Release 40, 211-221 (1996).
51. E. Quadros et al., "Buccal and Colonic Absorption of CGS 16617, A Novel ACE Inhibitor," J. Controlled Release 19, 77-86 (1991).
52. C.A. Squier and B.K. Hall, "The Permeability of Skin and Oral Mucosa to Water and Horseradish Peroxidase as Related to the Thickness of the Permeability Barrier," J. Invest. Dermatol. 84 (176-179) (1985).
53. A.J. Hoogstraate et al., "Diffusion Rates and Transport Pathways of FITC-Labelled Model Compounds through Buccal Epithelium," Proc. Int. Symp. Contr. Rel. Bioact. Mater. 20, 234-235 (1993).
54. A.J. Hoogstraate et al. "Diffusion Rates and Transport Pathways of FITC-Labelled Model Compounds through Buccal Epithelium," Pharm. Res. 9, S-188 (1992).
55. C.A. Squier et al., "Lipid Content and Water Permeability of Skin and Oral Mucosa," J. Invest. Dermatol. 96 (1), 123-126 (1991).
56. P. Collins et al., "Comparative Study of Porcine Oral Epithelium. J. Dent. Res. 60(A), 543 (1981).
57. A.H. Shojaei and X. Li, "In Vitro Permeation of Acyclovir through Porcine Buccal Mucosa," Proc. Int. Symp. Contr. Rel. Bioact. Mater. (Vol. 23) (Controlled Release Society, 1996) pp. 507-508.
58. A.H. Shojaei and X. Li, "Determination of Transport Route of Acyclovir across Buccal Mucosa," in Proc. Int. Symp. Contr. Rel. Bioact. Mater. (Vol. 24) (Controlled Release Society, 1997) pp. 427-428.
59. A.M. Manganaro and P.W. Wertz, "The Effects of Permeabilizers on the In Vitro Penetration of Propranolol through Porcine Buccal Epithelium. Mil. Med. 161 (11), 669-672 (1996).
60. R. Gandhi and J. Robinson, "Mechanisms of Penetration Enhancement for TransBuccal Delivery of Salicylic Acid," Int. J. Pharm. 85, 129-140 (1992).
61. G.J.M. Wolany et al., "Buccal Absorption of Sandostatin (octreotide) in Conscious Beagle Dogs," Proc. Int. Symp. Contr. Rel. Bioact. Mat. 17, 224-225 (1990).
62. S. Nakane et al., "Oramucosal Delivery of LHRH: Pharmacokinetic Studies of Controlled and Enhanced Transmucosal Permeation," Pharm. Dev. Technol. 20 (3), 251-259 (1996).
63. A. Steward et al., "The Effect of Enhancers on the Buccal Absorption of Hybrid (BDBB) Alpha-Interferon," Int. J. Pharm. 104, 145-149 (1994).
64. S. Senel et al., "Enhancement of In Vitro Permeability of Porcine Buccal Mucosa by Bile Salts: Kinetic and Histological Studies," J. Contr. Rel. 32, 45-56 (1994).
65. B.J. Aungst and N.J. Rogers, "Site Dependence of Absorption-Promoting Actions of Laureth-9, Na Salicylate, Na2EDTA, and Aprotinin on Rectal, Nasal, and Buccal Insulin Delivery," Pharm. Res. 5 (5), 305-308 (1988).
66. J. Zhang et al., "An In Vivo Dog Model for Studying Recovery Kinetics of the Buccal Mucosa Permeation Barrier after Exposure to Permeation Enhancers: Apparent Evidence of Effective Enhancement without Tissue Damage," Int. J. Pharm. 101, 15-22 (1994).
67. B.J. Aungst, "Site Dependence and Structure-Effect Relationships for Alkylglycosides as TransMucosal Absorption Promoters for Insulin," Int. J. Pharm. 105, 219-225 (1994).
68. N.A. Peppas and P.A. Buri, "Surface, Interfacial and Molecular Aspects of Polymer Bioadhesion on Soft Tissues," J. Contr. Rel. 2, 257-275 (1985).
69. H.S. Ch'ng et al., "Bioadhesive Polymers as Platforms for Oral Controlled Drug Delivery II: Synthesis and Evaluation of Some Swelling, Water-Insoluble Bioadhesive Polymers," J. Pharm. Sci. 74 (4), 399-405 (1985).
70. R.E. Gandhi and J.R. Robinson, "Bioadhesion in Drug Delivery," Indian J. Pharm. Sci. 50 (May/June), 145-152 (1988).
71. S.S. Leung and J.R. Robinson, "Polymer Structure Features Contributing to Mucoadhesion: II," J. Contr. Rel. 12, 187-194 (1990).
72. Y.D. Sanzgiri et al., "Evaluation of Mucoadhesive Properties of Hyaluronic Acid Benzyl Esters," Int. J. Pharm. 107, 91-97 (1994).
73. C.M. Lehr et al., "In Vitro Evaluation of Mucoadhesive Properties of Chitosan and Some Other Natural Polymers," Int. J. Pharm. 78, 43-48 (1992).
74. K. Park and J.R. Robinson, "Bioadhesive Polymers as Platforms for Oral Controlled Drug Delivery: Method to Study Bioadhesion," Int. J. Pharm. 19, 107-127 (1984).
75. T. Nagai and Y. Machida, "Buccal Delivery Systems Using Hydrogels," Adv. Drug Del. Rev. 11, 179-191 (1993).
76. S. Anlar et al., "Formulation and In Vitro-In Vivo Evaluation of Buccoadhesive Morphine Sulfate Tablets," Pharm. Res. 11 (2), 231-236 (1994).
77. R. Anders and H. Merkle, "Evaluation of Laminated Mucoadhesive Patches for Buccal Drug Delivery," Int. J. Pharm. 49, 231-240 (1989).
78. J.-H. Guo, "Investigating the Surface Properties and Bioadhesion of Buccal Patches," J. Pharm. Pharmacol. 46, 647-650 (1994).
79. R. Anders et al., "Buccal Absorption of Protirelin: An Effective Way to Stimulate Thyrotropin and Prolactin," J. Pharm. Sci. 72, 1481-1483 (1983).
80. A.H. Shojaei and X. Li, "Novel Copolymers of Acrylic Acid and Polyethylene Glycol Monomethylether Monomethacrylate for Buccal Mucoadhesion: Preparation and Surface Characterization," Pharm. Res. 12 (S1) (9), S210 (1995).
81. X. Li and A.H. Shojaei, "Novel Copolymers of Acrylic Acid and Polyethylene Glycol Monomethylether Monomethacrylate for Buccoadhesion: In Vitro Assessment of Buccoadhesion and Analysis of Surface Free Energy," Proc. Int. Symp. Contr. Rel. Bioact. Mater. 23, 165-166 (1996).
82. A.H. Shojaei and X. Li, "Mechanisms of Buccal Mucoadhesion of Novel Copolymers of Acrylic Acid and Polyethylene Glycol Monomethylether Monomethacrylate," J. Contr. Rel. 47 (2), 151-161 (1997).
83. A.H. Shojaei et al., "TransBuccal Delivery of Acyclovir (I): In Vitro Determination of Routes of Buccal Transport," Pharm. Res. 15 (8), 1182-1188 (1998).
84. J.P. Cassidy et al., "Controlled Buccal Delivery of Buprenorphine," J. Contr. Rel. 25, 21-29 (1993).
85. G. De Grande et al., "Specialized Oral Mucosal Drug Delivery Systems: Patches, in Oral Mucosal Drug Delivery (Vol. 74), M.J. Rathbone, Ed. (Marcel Dekker, New York, 1996), pp. 285-318.
86. K. Yukimatsu et al., "Development of a Transmucosal Controlled-Release Device for Systemic of Antianginal Drugs Pharmacokinetics and Pharmacodynamics," Drug Dev. Ind. Pharm. 20 (4), 503-534 (1994).
87. Y. Nozaki et al., "Transmucosal Controlled Systemic Delivery of Isosorbide Dinitrate: In Vivo/In Vitro Correlation," J. Contr. Rel. 43, 105-114 (1997).
88. H.H. Alur et al., "Evaluation of a Novel, Natural Oligosaccharide Gum as a Sustained-Release and Mucoadhesive Component of Calcitonin Buccal Tablets," J. Pharm. Sci. 88 (12), 1313-1319 (1999).
89. Y. Kurosaki et al., "Enhancing Effect of 1-Dodecylazacycloheptan-2-one (Azone) on the Absorption of Salicyclic Acid from Keratinized Oral Mucosa and the Duration of Enhancement In Vivo," Int. J. Pharm. 51, 47-54 (1989).
90. I.A. Siegel and H.P. Gordon, "Effects of Surfactants on the Permeability of Canine Oral Mucosa In Vitro," Toxicol. Lett. 26, 153-157. (1985).
91. A. Coutel-Egros et al., "Combined Effects of pH, Cosolvent and Penetration Enhancers on the In Vitro Buccal Absorption of Propranolol through Excised Hamster Cheek Pouch," Int. J. Pharm. 84, 117-128 (1992).
92. A.H. Shojaei et al., "Transbuccal Permeation of a Nucleoside Analog, Dideoxycytidine: Effects of Menthol as a Permeation Enhancer," Int. J. Pharm. 192 (2), 139-146 (1999).
93. K. Satoh et al., "Factors Affecting the Bioadhesive Property of Tablets Consisting of Hydroxypropyl Cellulose and Carboxyvinyl Polymer," Chem. Pharm. Bull. 37, 1366-1368 (1989).
94. A. Gupta et al., "Interpolymer Complexation and Its Effect on Bioadhesion Strength and Dissolution Characteristics of Buccal Drug Delivery Systems," Drug Dev. Ind. Pharm. 20 (3), 315-325 (1994).
95. K. Watanabe et al., "Drug Release Behaviors from Hydrogel Prepared with Water Soluble Dietary Fibers," J. Pharm. Sci. Technol. Jpn. 51, 29-35 (1991).
96. T. Nguyen-Xuan et al., "Mucoadhesive Semisolid Formulations for Intraoral Use Containing Sucralfate," Eur. J. Pharm. Biopharm. 43 (2), 133-137 (1996).
97. M. Nair and Y.W. Chien, "Development of Anticandidal Delivery Systems: (II) Mucoadhesive Devices for Prolonged Drug Delivery in the Oral Cavity," Drug Dev. Ind. Pharm. 22 (3), 243-253 (1996).
98. B. Taylan et al., "Design and Evaluation of Sustained-Release and Buccal Adhesive Propranolol Hydrochloride Tablets," J. Contr. Rel. 38, 11-20 (1996).
99. J. Voorspoels et al., "Buccal Absorption of Progesterone in the Dog," Proc. Int. Symp. Contr. Rel. Bioact. Mater. 24, 185-186 (1997).
100. A.H. Shojaei, et al., "Evaluation of Poly(acrylic acid-co-ethylhexyl acrylate) Films for Mucoadhesive Transbuccal Drug Delivery: Factors Affecting the Force of Mucoadhesion," J. Contr. Rel. 67 (2/3), 223-232 (2000). PT