Oral transmucosal drug delivery

Modified-Release Drug Delivery Technology, Second Edition

Volumn 1, Issue , 2008, Pages 53-73

  Pather, S Indiran ^a   Rathbone, Michael J ^b   Şenel, Sevda ^c  

^a California Northstate College of Pharmacy   (United States)

^b INTERAG   (New Zealand)

^c HACETTEPE UNIVERSITY   (Turkey)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 78650735150     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Chapter

References (51)

1. Ghosh TK, Pfister WR, eds. Drug Delivery to the Oral Cavity: Molecules to Market. Boca Raton, FL: CRC Press, 2005; Appendix 1:357-83.
2. The United States Patent and Trademark Office website. http://www.uspto. gov/patft/index.html
3. Food and Drug Administration. The Electronic Orange Book: Approved Drugs Products with Therapeutic Equivalence Evaluations, 2007. http://www.fda.gov/cder/ob/default.htm
4. Squier CA, Wertz PW. Structure and function of the oral mucosa and implications for drug delivery. In: Rathbone MJ, ed. Oral Mucosal Delivery. New York: Marcel Dekker, 1996.
5. Jasti BR, Abraham W. Oral transmucosal delivery of protein and peptide therapeutics. In: Ghosh TK, Pfister WR, eds. Drug Delivery to the Oral Cavity:Molecules to Market. Boca Raton, FL: CRC Press, 2005.
6. Hill MW. Cell renewal in oral epithelia. In: Meyer J, Squier CA, Gerson SJ, eds. The Structure and Function of Oral Mucosa, New York: Pergamon, 1984.
7. Bardow A, Moe D, Nyvad B, Nauntofte B. The buffer capacity and buffer systems of human whole saliva measured without loss of CO2. Arch Oral Biol 2000; 45(1): 1-12.
8. DeFelippis, MR. Overcoming the challenges of noninvasive protein and peptide delivery. Am Pharm Review 2003; 6(4): 21-30.
9. Li B, Robinson JR, Preclinical assessment of oral mucosal drug delivery systems. In: Ghosh TK, Pfister WR, eds. Drug Delivery to the Oral Cavity:Molecules to Market. Boca Raton, FL: CRC Press, 2005.
10. Alur HH, Beal JD, Pather SI, Mitra AK, Johnston TP. Evaluation of a novel, natural oligosaccharide gum as a sustained-release and mucoadhesive component of calcitonin buccal tablets. J Pharm Sci 1999; 88: 1313-9.
11. MonoSol Rx website. http://www.monosolrx.com/index.html
12. Dugger, HA III. Buccal, polar and non-polar spray or capsule. United States Patent 6,998,110. Issued 14 February 2006.
13. Dugger HA III. Buccal, polar and non-polar spray or capsule containing drugs for treating disorders of the central nervous system. United States Patent 6,977,070. Issued 20 December 2005.
14. Dugger HA III. Buccal, polar and non-polar spray or capsule containing drugs for treating pain. United States Patent 6,969,508. Issued 29 November 2005.
15. Murrell W. Nitroglycerin as a remedy for angina pectoris, Lancet 1879; 151:225-7.
16. Simpson DM, Messina J, Xie F, Hale M. Fentanyl buccal tablet for the relief of breakthrough pain in opioid-tolerant adult patients with chronic neuropathic pain: a multicenter, randomized, double-blind, placebo-controlled study. Clin Ther 2007; 29(4): 588-601.
17. Harris D, Robinson JR. Drug delivery via the mucous membranes of the oral cavity. J Pharm Sci 1992; 81(1): 1-10.
18. Wertz PW, Squier CA. Cellular and molecular basis of barrier function in oral epithelium. Crit Rev Ther Drug Carrier Syst 1991; 8: 237-69.
19. Zhang J, Streisand J, Niu S, et al. Estimation of bucccal fentanyl absorption bioavailability by measuring drug depletion from vehicle solutions: validation of the method in dogs. Pharm Res 1992; 9: S177.
20. Kamimori GH, Karyekar CS, Otterstetter R, Cox DS, Belenky GL, Eddington ND. The rate of absorption and relative bioavailability of caffeine administered in chewing gum versus capsules to normal healthy volunteers. Int J Pharm 2002; 234: 159-67.
21. Beckett AH, Triggs EJ. Buccal absorption of basic drugs and its application as an in vivo model of passive drug transfer through lipid membranes. J Pharm Pharmacol 1967; 19: 31S.
22. Beckett AH, Moffat AC. The influence of substitution in phenylacetic acids on their performance in the buccal absorption test. J Pharm Pharmacol 1969; 21: 139S.
23. Rathbone MJ, Purves R, Ghazali FA, Ho PC. In vivo techniques for studying the oral mucosal absorption characteristics of drugs in animals and humans. In: Rathbone MJ, ed. Oral Mucosal Delivery. New York: Marcel Dekker, 1996.
24. Jasti B, Mahalingam R, Li X, Kulkarni U, Pather I. Influence of biological and experimental variables on the in vitro transbuccal permeation of antipyrine and caffeine. AAPS Journal, Vol. 8(S2): Abstract T2134 (2006).
25. Manganaro AM, Wertz PW. The effects of permeabilizers on the in vitro penetration of propranolol through porcine buccal epithelium. Mil Med 1996; 161(11): 669-72.
26. Işcan YY, Çapan Y, Şenel S, Şahin MF, Kes S, Duchêne D, Hıncal AA. Formulation and in vitro/in vivo evaluation of buccal bioadhesive captopril tablets. STP Pharma Sci 1998; 8(6): 357-63.
27. Lee Y, Chien YW. Oral mucosa controlled delivery of LHRH by bilayer mucoadhesive polymer systems. J Contr Rel 1995; 37(3): 251-61.
28. Shojaei AH, Zhuo S-L, Li X. Transbuccal delivery of acyclovir (II): feasibility, system design, and in vitro permeation studies. J Pharm Pharmaceut Sci 1998; 1(2): 66-73.
29. Jasti B, Mahalingam R, Li X, Kulkarni U, Pather I. Influence of the thickness of buccal mucosa and effect of heat separation on the in vitro transbuccal permeation of antipyrine and caffeine. AAPS Journal, Vol. 8(S2): Abstract T2133 (2006).
30. Kulkarni U, Mahalingam R, Pather SI, Li X, Jasti B. Effect of temperature on the in vitro transbuccal permeation. 34th Annual Meeting and Exposition of the Controlled Release Society, 7-11 July 2007.
31. Mattek Corporation, Ashland, MA. http://www.mattek.com
32. van der Bijl P, Penkler L, van Eyk AD. Permeation of sumatriptan through human vaginal and buccal mucosa. Headache 2000; 40(2): 137-41.
33. Thompson IOC, van der Bijl P, van Wyk CW, van Eyk AD. A comparative light-microscopic, electron-microscopic and chemical study of human vaginal and buccal epithelium. Archives of oral biology 2001; 46(12): 1091-8.
34. Novadel press release, 3 November 2006. NovaDel Pharma receives FDA approval of NitroMist™. http://www.integratir.com/newsrelease.asp?news=2130980802&ticker=NVD&lang=EN
35. Novadel press release, 5 June 2007. NovaDel announces positive data from two studies comparing zolpidem oral spray to Ambien® Tablets. http://www.integratir. com/newsrelease.asp?news=2130983049&ticker=NVD&lang=EN
36. Hana Biosciences press release, 20 February 2007. Hana Biosciences reports likely delay in launch of Zensana™. http://ir.hanabiosciences.com/phoenix. zhtml?c=183701&p=irol-newsArticle&ID=965237&highlight=
37. Novadel press release, 20 February 2007. Novadel comments on delay in Zensana™Launch, as announced by Hana BioSciences. http://www.integratir. com/newsrelease.asp?news=2130981877&ticker=NVD&lang=EN
38. Novadel press release, 1 August 2007 NovaDel announces sublicense agreement for Zensana™. http://www.integratir.com/newsrelease.asp?news=2130983541&ticker=NVD&lang=EN
39. Transcept Pharmaceuticals press release, 13 June 2007. TransOral Pharmaceuticals, Inc. reports positive Phase 3 trial results with Intermezzo™(low dose sublingual zolpidem tartrate) in treating insomnia patients with middle of the night awakenings. http://www.transcept.com/index.php?option=com_ content&task=view&id=21&Itemid=31
40. Medical News Today, 11 May 2005. First regulatory approval of non-injectible insulin, Generex Biotechnology announces. http://www.medicalnewstoday. com/articles/24174.php
41. Medical News Today, 14 March 2005. Generex Biotechnology’s Oral-lyn™matches fast-acting insulin in phase IIb study. http://www.medicalnewstoday. com/articles/21213.php
42. Reuters, 25 June 2007.UPDATE 1-Generex to start phase 3 trials for insulin spray. http://www.reuters.com/article/comktnews/idUSN2539964020070625?rpc=77
43. Biodelivery Sciences International press release, 24 August 2004. BioDelivery Sciences International, Inc. announces the closing of the Arius Pharmaceuticals acquisition. http://www.biodeliverysciences.com/news/webpr/pdf/8-24-2004% 20Arius%20Acquisition.pdf
44. Biodelivery Sciences International press release, 2 May 2005. BDSI Announces submission of NDA for Emezine. http://www.biodeliverysciences.com/news/documents/5-2-2005NDA.pdf
45. Biodelivery Sciences International press release, 9 February 2005. BDSI completes clinical trials for its formulation of Emezine. http://www.biodeliverysciences. com/news/documents/2-9-2005ClinicalTrialsforEmezineComplete.pdf
46. Biodelivery Sciences International press release, 20 July 2005. BDSI announces acceptance of Emezine® NDA for review by FDA. http://www.biodeliverysciences.com/news/documents/07-20-05EmezineNDAReview.pdf
47. Biodelivery Sciences International press release, 1 March 2006. BioDelivery Sciences receives non-approvable notification from FDA on Emezine®. http://www.biodeliverysciences.com/news/documents/03-01-06EmezineNot Approvable.pdf
48. Biodelivery Sciences International press release, 9 June 2006. BioDelivery Sciences announces promising results of meeting with FDA on Emezine®. http://www.bio deliverysciences.com/news/documents/06-09-06BDSIReleaseFDAMeeting.pdf
49. Biotech Patent News, 1 July 2004. Atrix licenses BEMA technology to Arius. Reported in Allbusiness. http://www.allbusiness.com/technology/206530-2.html
50. PricewaterhouseCooper Report. Pharma 2020: The vision (2007). http://www.pwc.com/gx/eng/about/ind/pharma/pharma2020final.pdf
51. Senel S, Hıncal AA. Drug permeation enhancement via buccal route: possibilities and limitations. J Control Release 2001; 72(1-3): 133-44.