Rapidly disintegrating oramucosal drug delivery technologies Rapidly disintegrating oramucosal drug delivery technologies

Pharmaceutical Development and Technology

Volumn 14, Issue 6, 2009, Pages 588-601

  Reddy, Deshika ^a   Pillay, Viness ^a   Choonara, Yahya E ^a   Du Toit, Lisa C ^a  

^a UNIVERSITY OF THE WITWATERSRAND   (South Africa)

Author keywords

Buccal drug delivery; Oral drug delivery; Oramucosa; Rapid release; Rapidly disintegrating; Transmucosal drug delivery

Indexed keywords

DIPHENHYDRAMINE; GLYCERYL TRINITRATE; MISOPROSTOL; ONDANSETRON; RAPAMYCIN; ZOLPIDEM;

DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG DELIVERY SYSTEM; DRUG PENETRATION; DRUG RELEASE; DRUG SOLUBILITY; EX VIVO STUDY; FILM; GERIATRICS; HUMAN; IN VITRO STUDY; IN VIVO STUDY; MARKET; MOUTH CAVITY; NONHUMAN; ORAMUCOSAL DRUG DELIVERY TECHNOLOGY; PEDIATRICS; PRIORITY JOURNAL; REVIEW;

EID: 70449336735     PISSN: 10837450     EISSN: 10979867     Source Type: Journal    
DOI: 10.3109/10837450902838700     Document Type: Review

References (153)

1. DiMasi JA, Hansen RW, Grabowski HG. The price of innovation: new estimates of drug development costs. J Health Economics 2003;22:151-185
2. Sastry SV, Nyashadham JR, Fix JA. Recent technological advances in oral drug delivery - a review. Pharm Sci Tech Today 2000;3:138-145
3. Baichwal A, Neville D. Advanced drug delivery technology infuses new life into product life-cycles. Business Briefing: Pharmactech 2002: Accessed 16 August 2007 from the website: http://www.penwest.com/penwest-article-2002.pdf
4. Bhatt AD, Vaidya AB. Bio-availability and drug delivery systems: clinical perspective. J Postgrad Med 1992;38:130-134
5. Shojaei AH, Chang RK, Guo X, et al. Systemic drug delivery via the buccal mucosal route. Pharm Tech 2001:70-81
6. Shojaei AH. Buccal mucosa as a route for systemic drug delivery: A review. J Pharm Pharmaceut Sci 1998;1:15-30
7. Harmon TM. Orally disintegrating tablets: A valuable life cycle management strategy. Pharmaceutical Commerce. Accessed 9 February 2009 from the website: www.pharmaceuticalcommerce. com
8. Patel R, Pillay V, Choonara YE. A novel cellulose-based hydrophilic wafer matrix for rapid bioactive delivery. J Bioactive Compatible Poly 2007;22:119-142
9. US industry forecasts for 2012 and 2017. Drug Delivery Systems, March 2008. Freedonia Group. Product Code FED00151
10. Thummel KE, Kunze KL, Shen DD. Enzyme-catalyzed processes at first-pass hepatic and intestinal drug extraction. J Adv Drug Deliv 1997;27:99-127
11. Artusi M, Santi P, Colombo P, et al. Buccal delivery of thiocolchicoside: in vitro and in vivo permeation studies. Int J Pharm 2003;250:203-213
12. Sudhakar Y, Kuotsu K, Bandyopadhyay AK. Buccal bioadhesive drug delivery - a promising option for orally less efficient drugs. J Control Rel 2006;114:15-40
13. Morishita M, Peppas NA. Is the oral route possible for peptide and protein delivery? Drug Discovery Today 2006;11:905-910
14. Harris D, Robinson JR. Drug delivery via the mucous membranes of the oral cavity. J Pharm Sci 1992;81:1-10
15. Rathbone MJ, Drummond BK, Tucker IG. The oral cavity as a site for systemic drug delivery. Adv Drug Deliv Rev 1994;13:1-22
16. Virley P, Yarwood R. Zydis - a novel, fast-dissolving dosage form. J Manufacturing Chem 1990;61:36-37
17. Dobetti L. Fast-melting tablets: Developments and technologies. Pharm Tech Eur 2000;12:32-42
18. Seager H. Drug-delivery products and the Zydis fast-dissolving dosage form. J Pharm Pharmacol 1998;50:375-382
19. Cardinal Health. Zydis product information. Accessed 23 May 2007 from the website: www.cardinal.com/pts/content/delivery/ dd-oral-zydis.asp
20. CIMA Labs, Inc. CIMA Technologies. Accessed 23 May 2007 from the website: http://cimalabs.com/tech.htm
21. Yamanouchi Pharma Technologies, Inc. WOWTab™. Accessed 23 May 2007 from the website: http://www.ypharma.com/wowtab. shtml
22. Mizumoto T, Masuda Y, Fukui M. US Patent Number 5,576,014. 1996
23. Cherukruri SR, Fuisz R. Process and apparatus for making tablets and tablets made therefrom. 1995. European Patent 0,677,147 A2
24. Cherukruri SR, Fuisz R. Process and apparatus for making tablets and tablets made therefrom. 1997. US Patent 5,654,003
25. Fox DA. Rapid-dissolving dosage forms: An expanding therapeutic approach. Paper presented at the 1996 Drug Delivery Workshop at the Institute of International Research
26. Bredenberg S, Duberg M, Lennernas B, et al. In vitro and in vivo evaluation of a new sublingual tablet system for rapid oramucosal absorption using fentanyl citrate as the active substance. Eur J Pharm Biopharm 2003;20:327-334
27. Brown B A-S, Hamed E. In Oral Transmucosal Delivery: OraVescent™ Technology offers greater oral transmucosal delivery. Drug Deliv Tech 2007;7:42-45
28. Ong CMY, Heard CM. Permeation of quinine across sublingual mucosa, in vitro. Int J Pharm 2009;366:58-64
29. Ryden L, Schaffrath R. Buccal versus sublingual nitroglycerin administration in the treatment of angina pectoris: A multicentre study. Eur Heart 1987;8:995-1001
30. Giannola LI, De Caro V, Giandelia G, et al. Current status in buccal drug delivery. Pharm Tech Eur 1 May 2008 (Accessed 18 March 2009) from the website: http://www.ptemag.com/ pharmtecheurope/Manufacturing+and+Processing/ Currentstatus- in-buccal-drug-delivery/ArticleStandard/Article/ detail/514485
31. Schaff E, Dicenzo R, Fielding SL. Comparison of misoprostol plasma concentrations following buccal and sublingual administration. Contraception 2008;71:22-25
32. Squier CA. The permeability of oral mucosa. Crit Rev Oral Biol Med 1991;2:13-32
33. Rathbone MJ, Drummond BK, Tucker IG. The oral cavity as a site for systemic drug delivery. Adv Drug Deliv Rev 1994;13:1-22
34. Nicolazzo JA, Reed BL, Finnin BC. Buccal penetration enhancers - how do they really work? J Control Rel 2005;105:1-15
35. Senel S, Huncal AA. Drug permeation via the buccal route: Possibilities and limitations. J Control Rel 2001;72:133-144
36. Salamat-Miller N, Chittchang M, Johnston TP. The use of mucoadhesive polymers in buccal drug delivery. Adv Drug Deliv Rev 2005;57:1666-1691
37. Rathbone MJ, Hadgraft J. Absorption of drugs from the human oral cavity. Int J Pharm 1991;74:9-24
38. Committee on Drugs. American Academy of Pediatrics: Alternative routes of drug administration - advantages and disadvantages (subject review). Pediatrics 1997;100:143-152
39. Nagai T, Konishi R. Buccal/gingival drug delivery systems. J Control Rel 1987;6:353-360
40. Danckwerts MP. Intraoral drug delivery: a comparative review. Am J Drug Delivery 2003;1:149-224
41. de Vries ME, Bodde HE, Verhoef JC, et al. Developments in buccal drug delivery. Crit Rev Therapeut Drug Carrier Syst 1991;8:271-303
42. Banga AK, Chien YW. Systemic delivery of peptides and proteins. Int J Pharm 1988;48:15-50
43. Squier CA, Johnson NW, Hopps RM. Human oral mucosa development, structure and function. Oxford: Blackwell; 1976
44. Meyer J, Squier CA, Gerson SJ. The structure and function of oral mucosa. Oxford: Pergamon; 1984
45. Rossi S, Sandri G, Caramella CM. Buccal drug delivery: A challenge already won? Drug Discovery Today: Technologies 2005;2:59-65
46. Giannola LI, De Caro V, Giandalia G, et al. Diffusion of naltrexone across reconstituted human oral epithelium and histomorphological features. Eur J Pharm Biopharmaceut 2007;65:238-246
47. Gandhi RB, Robinson JR. Bioadhesion in drug delivery. Ind J Pharm Sci 1988;50:145-152
48. Gandhi RB, Robinson JR. Oral cavity as a site for bioadhesive drug delivery. Adv Drug Deliv Rev 1994;13:43-74
49. Mannila J, Jarvinen T, Jarvinen K, et al. Effects of RM-β-CD on sublingual bioavailability of Δ9-tetrahydrocannabinol in rabbits. Eur J Pharmaceut Sci 2005;26:71-77
50. Jain AC, Aungst BJ, Adeyeye MC. Development and in vivo evaluation of buccal tablets prepared using danazol- sulfobutylether 7 Β-cyclodextrin (SBE7) complexes. J Pharm Sci 2002;91:1659-1668
51. Dobs AS, Hoover DR, Chen M-C, Allen R. Pharmacokinetic characteristics, efficacy, and safety of buccal testosterone in hypogonadal males: A pilot study. J Clin Endocrinol Metabolism 1998;83:33-39
52. Ku M. Use of the biopharmaceutical classification system in early drug development. The AAPS J 2008;10:208-212
53. Amidon GL, Lennernas H, Shah VP, et al. A theoretical basis for a Biopharmaceutical Drug Classification: The correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm Res 1995;12:413-420
54. Gothoskar AV, Khanganokar SM. Biopharmaceutical classi- fication of drugs. Latest Rev. 2005; 3(1). Accessed 3 February 2009 from the website: http://www.pharmainfo.net/reviews/ biopharmaceutical-classification-drugs
55. Devane J. Oral drug delivery technology: addressing the solubility/permeability paradigm. Pharm Tech 1998:68-74
56. Obradovic T, Hidalgo IJ. In vitro models for investigations of buccal drug permeation and metabolism. In: Ehrhardt C, Kim K-J, editors. Drug absorption studies. New York: Springer; 2008:167-182
57. Zhang H, Rathbone JR. In vitro methods for measuring permeability of the oral mucosa. In: Rathbone MJ, editor, Oral mucosal drug delivery. New York: Marcel Dekker; 1996:85-101
58. Adrian CL, Olin HBD, Dalhoff K, et al. In vivo permeation of nicotine. Int J Pharm 2006;311:196-202
59. Xiang J, Fang X, Li X. Transbuccal delivery of 2′ 3′-dideoxycytidine: In vitro permeation study and histological investigation. Int J Pharm 2002;231:57-66
60. Junginger HE, Hoogstraate JA, Verhoef JC. Recent advances in buccal drug delivery and absorption - in vitro and in vivo studies. J Control Rel 1999;62:149-159
61. Van Eyk AD, van der Bijl P. Comparative permeability of various chemical markers through human vaginal and buccal mucosa as well as porcine buccal and mouth floor mucosa. Arch Oral Biol 2004;49:387-392
62. Nielsen HM, Verhoef JC, Ponec M, et al. TR 146 cells grown on filters as a model of human buccal epithelium: Permeability of fluorescein isothiocyanate-labelled dextrans in the presence of sodium glycocholate. J Control Rel 1999;60:223-233
63. MatTek (Pty) Ltd. homepage. Accessed 3 February 2009 from the website: http://www.mattek.com/pages/products/ epioral
64. Ghilzai NMK, Desai A. Facing the challenges of transmucosal absorption - buccal, nasal and rectal routes. Business Briefing: Pharmatech 2004;104-106
65. Ghosh TK. Quick dissolving oral dosage forms: Clinical pharmacology, biopharmaceutical, and regulatory considerations. Paper presented at the annual meeting of the American Association of Pharmaceutical Scientists (AAPS), Salt Lake City, Utah, 29 October 2003
66. European Pharmacopoeia, 2001. 4th ed. Strasbourg, France
67. Borsadia SB, O'Halloran D, Osborne JL. Quick-dissolving films - a novel approach to drug delivery. Drug Deliv Tech 2001. Accessed 15 August 2007 from the website: http://www. drugdeliverytech.com/cgi-bin/articles.cgi?idArticle= 138. Accessed 18 March 2009
68. Pfister WR, Ghosh TK. Orally disintegrating tablets - products, technologies, and development issues. 2005; In PharmTech. com
69. Habib W, Khankari R, Hontz J. Fast-dissolving drug delivery system. Crit Rev Therapeut Drug Carrier Syst 2000;17:61-72
70. Bogner RH, Wilkosz MF. Fast-dissolving tablets. Accessed 17 August 2007 from the website: http://www.uspharmacist. com/oldformat.asp?url=newlook/files/ feat/fastdissolving. htm
71. Brown D. Orally disintegrating tablets: Taste over speed. Drug Deliv Tech 2001;3:58-61
72. Aurora J, Pathak V. Oral disintegrating technologies: Oral disintegrating dosage forms. An overview. Drug Deliv Tech 2005;5:50-54
73. Biradar SS, Bhagavati ST, Kuppasad IJ. Fast dissolving drug delivery systems: A brief overview. Int J Pharmacol 2006;4. Accessed 4 June 2008 from the website: http://www.ispub.com/ostia/index. php?xmlPrinter=true&xmlFilePath= journals/ijpharm/vol4n2/ drug.xml
74. Wilson CG, Washington N, Peach J, et al. The behavior of a fast dissolving dosage form (Expidet) followed by ö-scintigraphy. Int J Pharm 1987;40:119-123
75. Anderson O, Zweidorff Ok, Hjelde T, et al. Problems when swallowing tablets. Tidsskr Nor Laegeforen 1995;115:947-949
76. Patel PB, Chaudhary A, Gupta GD. Fast dissolving drug delivery systems: An update. Accessed 15 August 2007 from the website: Pharmainfo.net
77. Hamilton EL, Luts EM. Advanced orally disintegrating tablets bring significant benefit to patients and product life cycles. Drug Deliv Tech 2005;5:34-37
78. Mizumoto T, Masuda Y, Fakui M. Intrabuccally dissolving compressed moldings and production process thereof. 1996. US Patent 5,576,014
79. Cima Labs, Inc. Accessed 28 August 2007 from the website: http://www.cimalabs.com/technologies.html
80. Pather SI, Khankari RK, Moe DV. OraSolv and DuraSolv: Efficient technologies for the production of orally disintegrating tablets. Drugs Pharm Sci 2003;126:203-216
81. Humbert-Droz, Seidel, Matthias, et al. Fast disintegrating oral dosage form. 1998. US Patent 6,083,531
82. Chang RK, Guo X, Burnside B, et al. Fast-dissolving tablets. Pharm Tech 2000;24:52-58
83. Bolhuis GK, Zuurman K, Te Wierik GHP. Improvement of dissolution of poorly soluble drugs by solid deposition on a super disintegrant. II. The choice of super disintegrants and effect of granulation. Eur J Pharm Sci 1997;5:63-69
84. Jennings TA. Lyophilization: Introduction and basic principles. London: Informa Health Care; 1999
85. Kearney P. The Zydis oral fast-dissolving dosage form. Drugs Pharm Sci 2003;126:191-201
86. Cardinal Health: Zydis product information. Accessed 28 August 2007 from the website: www.cardinal.com/pts/content/delivery/ dd-oral-zydis.asp
87. Clarke A, Brewer F, Johnson ES, Mallard N, Hartig F, Taylor S, Corn TH. A new formulation of selegiline: Improved bioavailability and selectivity for MAO-B inhibition. J Neural Trans 2003;110:1241-1255 (Pubitemid 37500746)
88. Kinon BJ, Hill AL, Hong L, et al. Olanzapine orally disintegrating tablets in the treatment of acutely ill non-compliant patients with schizophrenia. Int J Neuropsychopharmacol 2003;6:97-102
89. Fuisz R. Ulcer prevention method using a melt-spun hydrogel. 1997. US Patent 5,622,717
90. Sharma N, Ahuja A, Ali J, et al. Manufacturing technology choices for mouth dissolving tablets. Pharm Tech 2003;27:10-13
91. Giuseppina S, Bonferoni MC, Franca F, et al. Differentiating factors between oral fast-dissolving technologies. Am J Drug Deliv 2006;4:249-262
92. Biovail (Pty) Ltd. Accessed 2 February 2009 from the website: http://www.biovail.com/english/products/default.asp?s=1&pr oduct=553&viewer=doctor&state=displayProduct&country=Ca nada
93. Biovail (Pty) Ltd. Technology. Accessed 2 February 2009 from the website: http://www.biovail.com/english/drug%20delivery%20 tech/ drug%20delivery%20technologies/default.asp?s=1
94. Cerform™. Accessed 28 August 2007 from the website: http:// www.biovail.com/english/drug%20delivery%20tech/drug%20 delivery%20technologies/ default.asp?s=1#ceform
95. FlashTab™. Accessed 2 February 2009 from the website: http:// findarticles.com/p/articles/mi-m0EIN/is-/ai-113652702
96. www.elan.com/EDT/nanocrystal-technology. Accessed 28 August 2007
97. ElanCorp Technology: http://www.elan.com/Images/Elan- Technology-07v1-tcm3-17145.pdf. Accessed 2 February 2009
98. Deshpande AA, Shah NH, Rhodes CT, et al. Evaluation of films used in the development of a novel controlled-release system for gastric retention. Int J Pharm 1997;159:255-258
99. Peh KK, Wong CF. Polymeric films as a vehicle for buccal delivery: swelling, mechanical and bioadhesive properties. J Pharm Sci 1999;2:53-61
100. Guo JH, Cremer K. Development of bioadhesive buccal patches. In: E. Mathiowitz, et al., editors. Bioadhesive drug delivery systems. New York: Marcel Dekker; 1999:541-562
101. Eouani C, Piccerelle P, Prinderre P, et al. In vitro comparative study of buccal mucoadhesive performance of different polymeric films. Eur J Pharm Biopharmaceut 2001;52:45-55
102. Perioli L, Ambrogi V, Angelici F, et al. Development of mucoadhesive patches for buccal administration of ibuprofen. J Control Rel 2004;99:73-82
103. Anders R, Merkle HP. Evaluation of laminated mucoadhesive patches for buccal drug delivery. Int J Pharm 1989;49:231-240
104. Collins AE, Deasey PB. Bio-adhesive lozenge for the improved delivery of cetylpyridinium chloride. J Pharm Sci 1990;79:116-119
105. Noven (Pty) Ltd. Accessed 3 September 2007 from the website: http://www.noven.com/products.htm
106. Atrix Laboratories (Pty) Ltd. Accessed from the website: http:// www.atrixlabs.com/ourtech/bema.cfm
107. Finn AL. Buccal delivery of analgesics for breakthrough pain. Drug Deliv Tech 2006;6:69-71
108. Lab Inc. (Pty) Ltd. Accessed 2 February 2009 from the website: http://www.labinc.ca/technologies.html
109. Repka MA, Repka SL, Mcginty JW, et al. Bioadhesive hot-melt extruded film for topical and mucosal adhesion applications and drug delivery and process for preparation thereof, US Patent 6375963
110. Taken from the website: http://www.ptemag.com/ pharmtecheurope/ Manufacturing+&+Processing/Hot- meltextrusion- an-emerging-drug-delivery- techn/ArticleStandard/ Article/detail/574856. Accessed 2 February 2009
111. Wong JT-F, Tam MS-C. Pulmonary drug delivery system. US Patent 5,451,569
112. Pankaj M. Aerosol formulations for buccal and pulmonary application, US Patent 6436367
113. Taken from the website: http://www.generex.com (enter site through Flash or non-Flash option, select Platform Technology, select Buccal Delivery). Accessed 4 June 2007
114. Modi P. Methods of administering and enhancing absorption of pharmaceutical agents. 2006, US Patent 7,087,215
115. Modi P, Mihic M, Lewin A. The evolving role of oral insulin in the treatment of diabetes using a novel RapidMist system. Diabetes Metabolic Res Rev 2002;1:38-42
116. Modi P. Development of the RapidMist™ drug delivery system for the development of diabetes, cardiovascular diseases and breakthrough cancer pain. Drugs of the Future 2005;30:271
117. Taken from the website: http://www.novadel.com. Accessed 25 August 2007
118. Dugger HA III. Buccal polar spray or capsule. 2006. Canadian Intellectual Property Office. CA 2,252,038
119. Ciper M, Bodmeier R. Preparation and characterization of novel fast disintegrating capsules (Fastcaps) for administration in the oral cavity. Int J Pharm 2005;303:62-71
120. Ciper M, Bodmeier R. Modified conventional hard gelatin capsules as fast disintegrating dosage form in the oral cavity. Eur J Pharm Biopharm 2006;62:178-184
121. Hyrup B, Andersen C, Andersen LV, et al. The MediChew technology platform. Expert Opin Drug Deliv 2005;2:927-933
122. Jacobsen J, Christrup L, Jensen NH.Medicated chewing gum: Pros and cons. Healthcare technology review. Am J Drug Deliv 2004;2:75-88
123. Emilion T. Process for the preparation of medicated chewing gum provided with a pleasant taste independent from the active contained within. 2003. Canadian Intellectual Property Office. CA 2,196,150
124. Badetti R. Composition for medicated chewing gums, process for manufacturing the same and tablets so obtained. 1999. Canadian Intellectual Property Office. CA 2,366,845
125. Boyd BJ, Whittaker DV, Khoo S, et al. Hexosomes formed by glycerate surfactants-Formulation as a colloidal carrier for irinotecan. Int. J. Pharm. 2006; 318:154-162
126. Taken from the website: http://www.camurus.se/index. php?id= nanoparticles0. Accessed 7 March 2008
127. Swarnakar NK, Jain V, Dubey V, et al. Enhanced oramucosal delivery of progesterone via hexosomes. Pharm Res 2007;24:2224-2230
128. Wheeler M, Birmingham PK, Dsida RM, et al. Uptake pharmacokinetics of the Fentanyl Oralet in children scheduled for central venous access removal: implications for the timing of initiating painful procedures. Pediatric Anaesthesia 2002;12:594-599
129. Committee on Drugs. American Academy of Pediatrics: Alternative routes of drug administration - advantages and disadvantages (subject review). Pediatrics 1997;100:143-152
130. Stanky TH, Haque B, et al. Methods and compositions for noninvasive administration of sedatives, analgesics and anaesthetics. 1987, US Patent 4,671,953
131. Pather SI, Khankari RK, Eichman JD, et al. Sublingual Buccal Effervescent, 2001, US Patent 6,200,604
132. Wehling F, Schuele S, Madamala N, et al. Paediatric effervescent dosage form, 1993, US Patent 5,223,264
133. Fernandes C, Junqueira RG, Campos LMM, et al. Dissolution test for lamivudine tablets: Optimization and statistical analysis. J Pharm Biomed Anal 2006;42:601-606
134. FDA. Guidance for industry: Dissolution testing of immediate release oral dosage forms. Food and Drug Administration. Rockville; 1997
135. FDA. Guidance for industry: waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics system. Food and Drug Administration. Rockville; 2000
136. Furlanetto S, Maestrelli F, Pinzauti S, et al. Optimization for dissolution test precision for a ketoprofen oral extended-release product. J Pharm Biomed Anal. 2003;32:159-165
137. Azarmi S, Roa W, Lobenberg R. Current perspectives in dissolution testing of conventional and novel dosage forms. Int J Pharm 2007;328:12-21
138. Abdelbary G, Eouani C, Prinderre P, et al. Determination of the in vitro disintegration profile of rapidly disintegrating tablets and correlation with oral disintegration. Int J Pharm 2005;292:29-41
139. Siewert M, Dressman J, Brown C, et al. FIP/AAPS guidelines for dissolution/in vitro release testing of novel/special dosage forms. Dissolution Tech 2003;10:10-13
140. Klancke J. Dissolution testing of orally disintegrating tablets. Dissolution Tech 2003;2-8
141. Narazaki R, Harada T, Takami N, et al. A new method for disintegration studies of rapid disintegrating tablet. Chem Pharm Bull 2004;52:704-707
142. Fabregas JL, Garcia N. In vitro studies on buccoadhesive tablet formulations of hydrocortisone hemisuccinate. Drug Dev Ind Pharm 1995;21:1689-1696
143. Amidon GL, Lennernas H, Shah VP, Crison JR. A theoretical basis for a Biopharmaceutics Drug Classification: The correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm Res 1995;12:413-420
144. Guidance for industry, Immediate Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes, November 1995, CDER/FDA
145. Draft guidance for industry, Waiver of in vivo bioavailability and bioequivalence studies for immediate release solid oral dosage forms containing certain active moieties/active ingredients based on a Biopharmaceutics Classification System, February 1999, CDER/ FDA
146. Tammara VK, Hossain M, Malinowski H, Hussain AS. Evaluation of the proposed Biopharmaceutics Classification System (BCS) class boundaries: A survey of recent neuropharmacological drugs. AAPS Annual Meeting, Boston, MA, November 1997
147. Kaus LC, Gillespie WR, Hussain AS, Amidon GA. The effect of in vivo dissolution, gastric emptying rate, and intestinal transit time on the peak concentration and area-under-the-curve of drugs with different gastrointestinal permeabilities. Pharm Res 1999;16:272-280
148. Guidance for industry, dissolution testing of immediate release solid oral dosage forms, FDA, CDER, August 1997, CDER/FDA. Accessed from the website: http://www.fda.gov/cder/regguide. htm
149. Dor Ph JM, Chau A, Prevysh-Rogers V, et al. A new in vitro method vs. the standard USP method to measure the disintegration time of fast-disintegration time tablets. Proceedings at the International Symposium of Controlled Release of Bioactive Materials. Controlled Release Society Inc. 2000; 27: #6232
150. El-Arini SK, Clas S-D. Evaluation of disintegration testing of different fast dissolving tablets using the texture analyzer. Pharm Dev Tech 2002;7:361-371
151. Hughes L, Gehris A. A new method of characterizing buccal dissolution of drugs. Rohm and Haas Research Laboratories - Spring House. Accessed 23 June 2008 from the website: http://www. rohmhaas.com/ionexchange/Pharmaceuticals/ Formulations- doc/buccal-dissolution.pdf
152. Taken from the website: GlobalSpec.com: http://www.globalspec. com/reference/5779/Evaluation-of-Orally-Disintegrating- Tablets-ODTs-Using- Precision-Compressive-Loading. Accessed 10 February 2009
153. Link obtained from GlobalSpec.com: http://www.bose- electroforce.com/pdf/ Appbrief-ODTs.pdf. Accessed 10 February 2009