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The technologies used for developing orally disintegrating tablets: A review Cover

The technologies used for developing orally disintegrating tablets: A review

By: Bhatu Badgujar and  Atish Mundada  
Open Access
|Jun 2011

References

  1. European Pharmacopoeia, 5th ed., Council of Europe, Strasbourg, 2006, p. 628.
  2. S. Bandari, R. K. Mittapalli and Y. M. Gannu Rao, Orodispersible tablet: An overview, Asian J. Pharm. 2 (2008) 2-11. DOI: 10.4103/0973-8398.41557.10.4103/0973-8398.41557
  3. V. Agarwal, B. H. Kothari, D. V. Moe and R. K. Khankari, Drug delivery: Fast-dissolve Systems, in Encyclopedia of Pharmaceutical Technology (Ed. James Swarbrick), Informa Healthcare, New York 2006, pp. 1104-1114.
  4. S. V. Sastry, J. R. Nyshadham and J. A. Fix, Recent technological advances in oral drug delivery - a review, Pharm. Sci. Tech. Today 3 (2000) 138-145. DOI: 10.1016/S1461-5347(00)00247-9.10.1016/S1461-5347(00)00247-9
  5. P. Virely and R. Yarwood, Zydis - a novel fast dissolving dosage form, Manuf. Chem. 61 (1990) 36-37.
  6. S. W. Avery and D. M. Dellarosa, Approaches to treating dysphagia in patients with brain injury, Am. J. Occup. Ther. 48 (1994) 235-239.10.5014/ajot.48.3.235
  7. P. J. Kahrilas, Anatomy, physiology and pathophysiology of dysphagia, Acta Otorhinolaryngol. Belg. 48 (1994) 97-117.
  8. C. G. Wilson, N. Washington, J. Peach, G. R. Murray and J. Kennerley, The behavior of a fast dissolving dosage form (Expidet) followed by γ-scintigraphy, Int. J. Pharm. 40 (1987) 119-123; DOI: 10.1016/0378-5173(87)90056-1.10.1016/0378-5173(87)90056-1
  9. R. Chandrasekhar, Z. Hassan, F. Alhusban, A. M. Smith and A. R. Mohammed, The role of formulation excipients in the development of lyophilized fast-disintegrating tablets, Eur. J. Pharm. Biopharm. 72 (2009) 119-129; DOI: 10.1016/j.ejpb.2008.11.011.10.1016/j.ejpb.2008.11.01119073253
  10. I. S. Ahmed, M. M. Nafadi and F. A. Fatahalla, Formulation of fast-dissolving ketoprofen tablet using freeze-drying in blisters technique, Drug Dev. Ind. Pharm. 32 (2006) 437-442; DOI: 10.1080/03639040500528913.10.1080/0363904050052891316638681
  11. S. Kundu and P. K. Sahoo, Recent trends in the developments of orally disintegrating tablet technology, Pharma Times 40 (2008) 11-15.
  12. A. S. Mundada, S. Jain, N. O. Chachda and J. G. Avari, Taste masking approaches - a review: Part I, Am. Pharm. Rev. 11 (2008) 94-102.
  13. A. S. Mundada, S. Jain, N. O. Chachda and J. G. Avari, Taste masking approaches - a review: Part II, Am. Pharm. Rev. 11 (2008) 74-82.
  14. P. Busson and M. Schroeder, Process for Preparing a Pharmaceutical Composition, U.S. Pat. 6,534,087, 18 Mar 2003.
  15. A. Fini, V. Bergamante, G. C. Ceschel, C. Ronchi and C. A. Fonseca de Moraes, Fast dispersible/slow releasing ibuprofen tablets, Eur. J. Pharm. Biopharm. 69 (2008) 335-341; DOI: 10.1016/j.ejpb.2007.11.011.10.1016/j.ejpb.2007.11.01118182280
  16. K. G. Mohamed and C. A. Moji, High shear mixing granulation of ibuprofen and β-cyclodextrin: effects of process variables on ibuprofen dissolution, AAPS Pharm. SciTech. 8 (2007) 84; DOI: 10.1208/pt0804084.10.1208/pt080408418181545
  17. K. Masters, Spray Drying Fundamentals: Process stages and Layouts, in Spray Drying Handbook, 5th ed., Longman Scientific & Technical, New York 1991, pp. 23-64.
  18. J. Xu, L. L. Bovet and K. Zhao, Taste masking microspheres for orally disintegrating tablets, Int. J. Pharm. 359 (2008) 63-69; DOI: 10.1016/j.ijpharm.2008.03. 019.
  19. L. Hughes, Selecting the right ion exchange resin, Pharma Quality 1 (2005) 54-56.
  20. N. Prasad, D. Straus and G. Reichart, Cyclodextrin Favor Delivery Systems, U.S. Pat. 6,287,603, 11 Sep 2001.
  21. S. H. Jeong and K. Park, Development of sustained release fast-disintegrating tablets using various polymer-coated ion-exchange resin complexes, Int. J. Pharm. 353 (2008) 195-204; DOI: 10.1016/j.ijpharm.2007.11.033.10.1016/j.ijpharm.2007.11.03318164882
  22. D. P. Venkatesh and C. G. Geetha Rao, Formulation of taste masked orodispersible tablets of ambroxol hydrochloride, Asian J. Pharm. 2 (2008) 261-264; DOI: 10.4103/0973-8398.45043.10.4103/0973-8398.45043
  23. J. A. Bakan, Microencapsulation, in The Theory and Practice of Industrial Pharmacy (Eds. H. A. Lieberman, L. Lanchman and J. L. Kanig), Varghese Publishing House, Bombay 1987, p. 420.
  24. A. Y. Ozer and A. A. Hincal, Studies on the masking of unpleasant taste of beclamide: micro-encapsulation and tableting, J. Microencapsul. 7 (1990) 327-339.10.3109/02652049009021843
  25. R. O'Connor and J. Schwartz, Extrusion and Spheronization Technology, in Pharmaceutical Pelletization Technology, Vol. 37, Marcel Dekker Inc., New York 1989, pp. 116-120.
  26. P. S. Zade, P. S. Kawtikwar and D. M. Sakharkar, Formulation, evaluation and optimization of fast dissolving tablet containing tizanidine hydrochloride, Int. J. Pharm. Tech. Res. 1 (2009) 34-42.
  27. T. Yajima, N. Umeki and S. Itai, Optimum spray congealing condition for masking the bitter taste of clarithromycin in wax matrix, Chem. Pharm. Bull. 47 (1999) 220-225.10.1248/cpb.47.220
  28. S. L. Nail, L. A. Gatlin, Freeze Drying: Principles and Practice, in Pharmaceutical Dosage Forms - Parenteral Medications, Marcel Dekker, New York 1993, p. 163.
  29. P. Kearney and S. K. Wong, Method of Making Freeze Dried Drug Dosage Forms, U.S. Pat. 5 631 023, 20 May 1997.
  30. P. Kearney, The Zydis Oral Fast Dissolving Dosage Form, in Modified-release Drug Delivery Technology (Eds. M. J. Rathbone, J. Hadgraft and M. S. Roberts), Marcel Dekker Inc., New York 2003, pp. 191-201.10.1201/9780203910337.ch15
  31. H. Seager, Drug delivery product and the Zydis fast-dissolving dosage form, J. Pharm. Pharmacol. 50 (1998) 375-382; DOI: 10.1111/j.2042-7158.
  32. L. Dobetti, Fast-melting tablets: Developments and technologies, Pharma Tech. Drug Deliv. 37 (2001) 44-50.
  33. S. Corveleyn and J. P. Remon, Formulation and production of rapidly disintegrating tablets by lyophilization using hydrochlorothiazide as a model drug, Int. J. Pharm. 152 (1997) 215-225; DOI: 10.1016/S0378-5173(97)00092-6.10.1016/S0378-5173(97)00092-6
  34. D. Kaushik, S. Dureja and T. R. Saini, An overview of melt in mouth tablet technologies and techniques, J. Pharm. Res. 3 (2004) 35-37.
  35. R. G. Blank, D. S. Mody, R. J. Kenny and M. C. Aveson, Fast Dissolving Dosage Forms, U.S. Pat. 4946684, 9 May 1990.
  36. K. Masaki, Intrabuccally Disintegrating Preparation and Production Thereof, U.S. Pat. 5,466,464, 14 Nov 1995.
  37. A. Modi and P. Tayade, Enhancement of dissolution profile by solid dispersion (kneading) technique, AAPS PharmSciTech. 7 (2006) Article 68; DOI: 10.1208/pt070368.10.1208/pt070368275051017025249
  38. R. Laitinen, E. Suihko, K. Toukola, M. Bjorkqvist, J. Riikonen, V. P. Lehto, K. Jarvinen and J. Ketolainen, Intraorally fast-dissolving particles of a poorly soluble drug: Preparation and in vitro characterization, Eur. J. Pharm. Biopharm. 71 (2009) 271-281; DOI: 10.1016/j.ejpb.2008.09.001.10.1016/j.ejpb.2008.09.00118824096
  39. T. M. Harmon, Orally disintegrating tablets: A valuable life cycle management strategy, Issue Pharm. Comm. (2007) 1-4.
  40. T. E. Chiver and O. Minn, Process for Making Candy Floss, U.S. Pat. 7,30,057, 13 Feb 2003.
  41. G. L. Mayers, G. E. Battisk and R. C. Fluiz, Process and Apparatus for Making Rapidly Dissolving Dosage Uunits and Product Thereform, PCT Pat. WC 95/24293-A1, 1995.
  42. T. Mizumoto, Y. Masuda, T. Yamamoto, E. Yonemochi and K. Terada, Formulation design of a novel fast-disintegrating tablet, Int. J. Pharm. 306 (2005) 83-90; DOI: 10.1016/j.ijpharm.2005.09.009.10.1016/j.ijpharm.2005.09.00916257154
  43. M. Sugimoto, S. Narisawa, K. Matsubara, H. Yoshino, M. Nakano and T. Handa, Development of manufacturing method for rapidly disintegrating oral tablets using the crystalline transition of amorphous sucrose, Int. J. Pharm. 320 (2006) 71-78; DOI: 10.1016/j.ijpharm.2006.04.004.10.1016/j.ijpharm.2006.04.00416750604
  44. M. Sugimoto, S. Narisawa, K. Matsubara, H. Yoshino, M. Nakano and T. Handa, Effect of formulated ingredients on rapidly disintegrating oral tablets prepared by the crystalline transition method, Chem. Pharm. Bull. 54 (2006) 175-180.10.1248/cpb.54.17516462059
  45. G. Abdelbary, P. Prinderre, C. Eouani, J. Joachim, J. P. Reynier and P. H. Piccerelle, The preparation of orally disintegrating tablets using a hydrophilic waxy binder, Int. J. Pharm. 278 (2004) 423-433; DOI: 10.1016/j.ijpharm.2004.03.023.10.1016/j.ijpharm.2004.03.02315196646
  46. G. Abdelbary, C. Eouani, P. Prinderre, J. Joachim, J. P. Reynier and P. H. Piccerelle, Determination of the in vitro disintegration profile of rapidly disintegrating tablets and correlation with oral disintegration, Int. J. Pharm. 292 (2005) 29-41; DOI: 10.1016/j.ijpharm.2004.08.019. 26.10.1016/j.ijpharm.2004.08.019
  47. B. Perissutti, F. Rubessa, M. Moneghini and D. Voinovich, Formulation design of carbamazepine fast-release tablets prepared by melt granulation technique, Int. J. Pharm. 256 (2003) 53-63; DOI: 10.1016/0378-5173(89)90061-6.10.1016/0378-5173(89)90061-6
  48. Y. Kuno, M. Kojima, S. Ando and H. Nakagami, Effect of preparation method on properties of orally disintegrating tablets made by phase transition, Int. J. Pharm. 355 (2008) 87-92; DOI: 10.1016/j.ijpharm.2007.11.046.10.1016/j.ijpharm.2007.11.04618182258
  49. Y. Kuno, M. Kojima, H. Nakagami, E. Yonemochi and K. Terada, Effect of the type of lubricant on the characteristics of orally disintegrating tablets manufactured using the phase transition of sugar alcohol, Eur. J. Pharm. Biopharm. 69 (2008) 986-992; DOI: 10.1016/j.ejpb.2008.02.016.10.1016/j.ejpb.2008.02.01618396020
  50. D. M. Patel and M. M. Patel, Optimization of fast dissolving etoricoxib tablet by sublimation technique, Indian J. Pharm. Sci. 70 (2008) 71-76; DOI: 10.4103/0250-474X.40335.10.4103/0250-474X.40335285206520390084
  51. S. Suresh, V. Pandit and P. Joshi, Preparation and evaluation of mouth dissolving tablet of salbutamol sulphate, Indian J. Pharm. Sci. 69 (2007) 467-469; DOI: 10.4103/0250-474X.34568.10.4103/0250-474X.34568
  52. B. J. Roser and J. Blair, Rapidly Soluble Oral Solid Dosage Forms, Methods of Making Same, and Compositions Thereof, U.S. Pat. 5,762,961, 9 June 1998.
  53. Y. Yamamoto, M. Fujii, K. Watanabe, M. Tsukamoto, Y. Shibata, M. Kondoh and Y. Watanabe, Effect of powder characteristics on oral tablet disintegration, Int. J. Pharm. 365 (2009) 116-120; DOI: 10.1016/j.ijpharm. 2008.08.031.
  54. M. El-Barghouthi, A. Eftaiha, I. Rashid, M. Ai. Remarps and A. Badwan, A novel superdisintegrating agent made from physically modified chitosan with silicon dioxide, Drug Dev. Ind. Pharm. 34 (2008) 373-383; DOI: 10.1080/03639040701657792.10.1080/0363904070165779218401779
  55. Y. Bi, H. Sunada, Y. Yonezawa, K. Danjo, A. Otsuka and K. Iida, Preparation and evaluation of a compressed tablet rapidly disintegrating in the oral cavity, Chem. Pharm. Bull. 44 (1996) 2121-2127.10.1248/cpb.44.21218945778
  56. A. Ito and M. Sugihara, Development of oral dosage form for elderly patients: Use of agar as base of rapidly disintegrating oral tablets, Chem. Pharm. Bull. 44 (1996) 2132-2136.
  57. S. G. Gattani, B. G. Shiyani, K. N. Kakade, A. B. Patil and S. J. Surana, Formulation and development of mouth dissolving tablet of ondensetron hydrochloride by using superdisintegrants, Indian Drugs 46 (2009) 44-50.
  58. J. Fukami, A. Ozawa, Y. Yoshihashi, E. Yonemochi and K. Terada. Development of fast disintegrating compressed tablets using amino acid as disintegration accelerator: evaluation of wetting and disintegration of tablet on the basis of surface free energy, Chem. Pharm. Bull. 53 (2005) 1536-1539.
  59. T. Koseki, H. Onishin, Y. Takahashi, M. Uchida and Y. Machida, Development of novel fast-disintegrating tablets by direct compression using sucrose stearic acid ester as a disintegration-accelerating agent, Chem. Pharm. Bull. 56 (2008) 1384-1388.10.1248/cpb.56.138418827375
  60. T. Shu, H. Suzuki, K. Hironaka and K. Ito, Studies of rapidly disintegrating tablets in the oral cavity using co-ground mixtures of mannitol with crospovidone, Chem. Pharm. Bull. 50 (2002) 193-198.10.1248/cpb.50.19311848208
  61. S. G. Late, Y. Yu and A. K. Banga, Effects of disintegration-promoting agent, lubricants and moisture treatment on optimized fast disintegrating tablets, Int. J. Pharm. 365 (2009) 4-11; DOI: 10.1016/j.ijpharm. 2008.08.010.
  62. N. Zhao and L. L. Augsburger, The influence of granulation on superdisintegrant performance, Pharm. Dev. Technol. 11 (2006) 47-53.10.1080/1083745050046382816544908
  63. P. Di Martino, S. Martelli and P. Wehrle, Evaluation of different fast melting disintegrants by means of a central composite design, Drug Dev. Ind. Pharm. 31 (2005) 109-121; DOI: 10.1081/DDC-44233.10.1081/DDC-44233
  64. A. A. Joshi and D. Xavier, Added functionally excipients: An answer to challenging formulations, Pharm. Tech. 2004, 12-19.
  65. N. Zhao and L. L. Augsburger, The influence of product brand-to-brand variability on superdisintegrant performance. A case study with croscarmellose sodium, Pharm. Dev. Technol. 11 (2006) 179-185.10.1080/1083745060056128116749528
  66. Y. Fu, S. H. Jeong and K. Park, Fast-melting tablets based on highly plastic granules, J. Control. Release 109 (2005) 203-210; DOI: 10.1016/j.jconrel.2005.09.021.10.1016/j.jconrel.2005.09.02116260059
  67. J. Shery, A. Shirwaikar and A. Nair, Preparation and evaluation of fast-disintegrating effervescent tablets of glibenclamide, Drug Dev. Ind. Pharm. 35 (2009) 321-328; DOI: 10.1080/03639040802337021.10.1080/0363904080233702118821151
  68. G. S. Bankar and N. R. Anderson, Tablets, in The Theory and Practice of Industrial Pharmacy (Eds. L. Lanchman, H. A. Lieberman and J. L. Kanig), Varghese Publishing House, Bombay 1987, pp. 293-345.
  69. F. Wehling, S. Schuehle and N. Madamala, Effervescent Dosage Form with Microparticles, U.S. Pat. 5,178,878, 12 Jan 1993.
  70. F. Wehling, S. Schuehle and N. Madamala, Pediatric Effervescent Dosage Form, U.S. Pat. 5,223,264, 29 Jun 1993.
  71. F. Wehling and S. Schuehle, Base Coated Acid Particles and Effervescent Formulation Incorporating same, U.S. Pat. 5,503,846, 2 Apr 1996.
  72. M. C. Iles, A. D. Atherton and N. M. Copping, Freeze-dried Dosage Forms and Methods for Preparing the Same, U.S. Pat. 5,188,825, 23 Feb 1993.
  73. S. R. Cherukuri, G. L. Myers, G. E. Battist and R. C. Fuisz, Process for Forming Quickly Dispersing Comestible Unit and Product Therefrom, U.S. Pat. 5,587,172, 24 Dec 1996.
  74. R. C. Fuisz, Ulcer Prevention Method Using a Melt-spun Hydrogel, U.S. Pat. 5,622,717, 22 Apr 1997.
  75. S. R. Cherukuri and R. Fuisz, Process and Apparatus for Making Tablets and Tablets Made Therefrom, Eur. Pat. 0677,147 A2, 1995.
  76. G. L. Myers, G. E. Battist and R. C. Fuisz, Delivery of Controlled-release Systems, U.S. Pat. 5,567, 439, 22 Oct 1996.
  77. G. L. Myers, G. E. Battist and R. C. Fuisz, Apparatus for Making Rapidly Dissolving Dosage Units, U.S. Pat. 5,871,781, 16 Feb 1999.
  78. S. R. Cherukuri and R. Fuisz, Process and Apparatus for Making Tablets and Tablets Made Therefrom, U.S. Pat. 5,654,003, 5 Aug 1997.
  79. G. L. Myers, G. E. Battist and R. C. Fuisz, Process and Apparatus for Making Rapidly Dissolving Dosage Units and Product Therefrom, U.S. Pat. 5,622,719, 22 April 1997.
  80. L. Lafon. Galenic Form for Oral Administration and its Method of Preparation by Lyophilization of an Oil-in-water Emulsion, Eur. Pat. 0,159,237, 1985.
  81. A. C. Liang and H. Chen Li-Lan, Fast-dissolving intraoral drug delivery systems, Expert Opin. Ther. Pat. 11 (2001) 981-986; DOI: 10.1517/13543776.11.6.981.10.1517/13543776.11.6.981
  82. W. R. Pfister, L. H. Chen and D. W. Ren, Compositions and Methods for Mucosal Delivery, U.S. Pat. 6,552,024, 22 Apr 2003.
DOI: https://doi.org/10.2478/v10007-011-0020-8 | Journal eISSN: 1846-9558 | Journal ISSN: 1330-0075
Language: English
Page range: 117 - 139
Published on: Jun 17, 2011
Published by: Croatian Pharmaceutical Society
In partnership with: Paradigm Publishing Services
Publication frequency: 4 issues per year
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© 2011 Bhatu Badgujar, Atish Mundada, published by Croatian Pharmaceutical Society
This work is licensed under the Creative Commons License.

Volume 61 (2011): Issue 2 (June 2011)