Process development and scale-up of oral fast-dissolving tablets

Drug Delivery to the Oral Cavity: Molecules to Market

Volumn , Issue , 2005, Pages 311-336

  Sastry, Srikonda V ^a   Nyshadham, Janakiram ^b  

^a XenoPort Inc   (United States)

^b CV THERAPEUTICS INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84885518215     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Chapter

References (50)

1. Annual report on drug delivery-Controlling their destiny (1996) Med. Ad. News. 15, 1-32.
2. Chang, R.K. et al. (2000) Fast dissolving tablets. Pharm. Tech., June, 52-58.
3. Drug Delivery 2003: New technologies in the global market. Med. Ad. News. 27-30.
4. Brown, D. (2003) Orally disintegrating tablets-Taste over speed. Drug Deliv. Technol. Vol. 3, No. 6, 58-61.
5. Ostrander, K. (2003) Oral fast dispersing systems: Recent advances-Advances in Zydis® fast dispersing technology, October, AAPS, National Meeting.
6. Fasano, A. (1998) Novel approaches in oral delivery of macromolecules. J. Pharm. Sci. 1351-1356.
7. Avery, S.W. and Dellarosa, D.M. (1994) Approaches to treating dysphagia in patients with brain injury. Am. J. Occup. Ther. 48, 235-239.
8. Gisel, E.G. (1994) Oral motor skills following sensorimotor intervention in the moderately eating impaired child with cerebral palsy. Dysphagia 9, 180-192.
9. Anderson, O. et al. (1995) Problems when swallowing tablets. Tidsskr Nor Laegeforen. 115, 947-949.
10. Wilson, C.G. et al. (1987) The behavior of a fast dissolving dosage form (Expidet) followed by β-scintigraphy. Int. J. Pharm. 40, 119-123.
11. Fix, J.A. (1998) Advances in quick-dissolving tablets technology employing WOWTAB. In IIR Conference on Drug Delivery Systems, October, Washington, DC.
12. Virely. P. and Yarwood, R. (1990) Zydis-A novel, fast dissolving dosage form. Manuf. Chem. February, 36-37.
13. Seager, H. (1998) Drug delivery products and the Zydis® fast dissolving dosage form. J. Pharm. Pharmacol. 50, 375-382.
14. Takao. M. et al. (1996) Intrabuccally dissolving compressed molding and production process thereof. US Patent 5,576,014.
15. Hontz. J. (1999) Development of a rapidly dissolving famotidine tablet. In 41st Annual International Industrial Pharmaceutical Research Conference, June, Madison, WI.
16. Wehling, F. et al. (1993) Pediatric effervescent dosage form. US Patent 5,223,264.
17. Wehling, F. et al. (1993) Effervescent dosage form with microparticles. US Patent 5,178,878.
18. Wehling, F. and Schuehle, S. (1996) Base coated acid particles and effervescent formulation incorporating same. US Patent 5,503,846.
19. Gregory, G.K.E. et al. (1983) Articles for carrying chemicals. US Patent 4,371,516.
20. Gregory, G.K.E. and Ho, D.S.S. (1981) Pharmaceutical dosage form packages. US Patent 4,305,502.
21. Gregory, G.K.E. (1988) Solid shaped articles. US Patent 4,758,598.
22. Buxton, I.R. and Feldman, H. (1988) Solid shaped articles. US Patent 4,754,597.
23. Iles, M.C. et al. (1993) Freeze-dried dosage forms and methods for preparing the same. US Patent 5,188,825.
24. Courteille, F. and Vanhoeve, M. (1993) Porous pharmaceutical form and its preparation. US Patent 5,206,025.
25. Cynthia, B.M. and Shah, M.N. (1993) Aqueous pharmaceutical suspension for pharmaceutical actives. US Patent 5,272,137.
26. Kearney, P. and Wong, S.K. (1997) Method for making freeze dried drug dosage form. US Patent 5,631,023.
27. Deasy, P.B. (1984) Release of drug from microcapsules and microparticles. In Microencapsulation and Related Drug Processes (Deasy, P.B., ed.), pp. 289-319, New York: Marcel Dekker.
28. Parakh, S.R. and Gothoskar, A.V. (2003) Mouth dissolving tablet technologies. Pharm. Technol. November, 92-100.
29. Cherukuri, S.R. et al. (1996) Process for forming quickly dispersing comestible unit and product therefrom. US Patent 5,587,172.
30. Fuisz. R. (1997) Ulcer prevention method using a melt-spun hydrogel. US Patent 5,622,717.
31. Cherukruri, S.R. and Fuisz, R. (1995) Process and apparatus for making tablets and tablets made therefrom. European Patent 0677,147 A2.
32. Myers, G.L. et al. (1996) Delivery of controlled-release systems. US Patent 5,567,439.
33. Myers, G.L. et al. (1999) Apparatus for making rapidly dissolving dosage units. US Patent 5,871,781.
34. Cherukuri, S.R. and Fuisz, R. (1997) Process and apparatus for making tablets and tablets made therefrom. US Patent 5,654,003.
35. Myers, G.L. et al. (1997) Ulcer prevention method using a melt-spun hydrogel. US Patent 5,622,719.
36. Juran, J.M. (1974) Quality Control Hand Book, 3rd edition. New York: McGraw-Hill.
37. Berry, I.R and Nash, R. (1993) Pharmaceutical Process Validation, 2nd edition, New York: Marcel Dekker Series, Volume 57, xiii-xxxix.
38. Kane, V.E. (1986) Process capability indices. J. Qual. Technol., 18, pp 41-52.
39. King, P. (2001) Process validation-Establishing the minimum process capability for drug product manufacturing-I & II, Pharmaceutical Engineering, 11/12, 1999 and 3/4, 2001.
40. Gunter, H. (1989) Manual for Software STATISTICAB. “The Use and Abuse of Cpk,” part 2 and 3. Quality Progress, March & May 1989.
41. Rodriguez, R.N. (1992) Recent developments in process capability analysis, J. Qual. Technol., 24, pp 176-187.
42. Kotz, S. (2002) Process capability indices-A review, 1992-2000, J. Qual. Technol., 34, pp 2-19.
43. Torbeck, L. (1998) Pharm Technol., June, 66-76.
44. Nyshadham, R. (2001) Process development and scale-up of oral fast disintegrating tablet (FDT) technology-WOWTAB®. In Advanced Practices in Pharmaceutical Tablet and Capsule Technology Conference, May, Las Vegas.
45. Chu, J. (2003) Product development, scale-up and technology aspects of WOWTAB® technology, Oct, AAPS, National Meeting.
46. Dobetti, L. (2001) Fast melt tablets: Developments and technologies, Pharm. Technol:Drug Delivery, 44-50.
47. Ghosh, T. (2003) Quick dissolving oral dosage forms: Clinical pharmacology, biopharmaceutics and regulatory considerations, October, AAPS, National Meeting.
48. Bi, Y.X. et al. (1996) Preparation and evaluation of a compressed tablet rapidly disintegrating in the oral cavity, Chem. Pharm. Bull. 44 (11), 2121-2127.
49. Dor, J.M., Fix, J.A., and Johnson, M.I. (1999) In vitro method to measure the disintegration time of a fast-disintegration tablet, Proc. Intl Symp. Control. Rel. Bioact. Mater. 26, 939-940.
50. Klanke, J. (2003) Dissolution testing of orally disintegrating tablets, Diss. Technol. Vol. 10(2), May, 6-8.