The technologies used for developing orally disintegrating tablets: A review
Tóm tắt
Từ khóa
Tài liệu tham khảo
<i>European Pharmacopoeia</i>, 5<sup>th</sup> ed., Council of Europe, Strasbourg, 2006, p. 628.
V. Agarwal, 2006, Drug delivery: Fast-dissolve Systems, in Encyclopedia of Pharmaceutical Technology, 1104
S. Sastry, 2000, Recent technological advances in oral drug delivery - a review, Pharm. Sci. Tech. Today, 3, 138, 10.1016/S1461-5347(00)00247-9
P. Virely, 1990, Zydis - a novel fast dissolving dosage form, Manuf. Chem, 61, 36
S. Avery, 1994, Approaches to treating dysphagia in patients with brain injury, Am. J. Occup. Ther, 48, 235, 10.5014/ajot.48.3.235
P. Kahrilas, 1994, Anatomy, physiology and pathophysiology of dysphagia, Acta Otorhinolaryngol. Belg, 48, 97
C. Wilson, 1987, The behavior of a fast dissolving dosage form (Expidet) followed by γ-scintigraphy, Int. J. Pharm, 40, 119, 10.1016/0378-5173(87)90056-1
R. Chandrasekhar, 2009, The role of formulation excipients in the development of lyophilized fast-disintegrating tablets, Eur. J. Pharm. Biopharm, 72, 119, 10.1016/j.ejpb.2008.11.011
I. Ahmed, 2006, Formulation of fast-dissolving ketoprofen tablet using freeze-drying in blisters technique, Drug Dev. Ind. Pharm, 32, 437, 10.1080/03639040500528913
S. Kundu, 2008, Recent trends in the developments of orally disintegrating tablet technology, Pharma Times, 40, 11
A. Mundada, 2008, Taste masking approaches - a review: Part I, Am. Pharm. Rev, 11, 94
A. Mundada, 2008, Taste masking approaches - a review: Part II, Am. Pharm. Rev, 11, 74
P. Busson and M. Schroeder, <i>Process for Preparing a Pharmaceutical Composition</i>, U.S. Pat. 6,534,087, 18 Mar 2003.
A. Fini, 2008, Fast dispersible/slow releasing ibuprofen tablets, Eur. J. Pharm. Biopharm, 69, 335, 10.1016/j.ejpb.2007.11.011
K. Mohamed, 2007, High shear mixing granulation of ibuprofen and β-cyclodextrin: effects of process variables on ibuprofen dissolution, AAPS Pharm. SciTech, 8, 84, 10.1208/pt0804084
K. Masters, 1991, Spray Drying Handbook, 23
J. Xu, 2008, Taste masking microspheres for orally disintegrating tablets, Int. J. Pharm, 359, 63, 10.1016/j.ijpharm.2008.03. 019
L. Hughes, 2005, Selecting the right ion exchange resin, Pharma Quality, 1, 54
N. Prasad, D. Straus and G. Reichart, <i>Cyclodextrin Favor Delivery Systems</i>, U.S. Pat. 6,287,603, 11 Sep 2001.
S. Jeong, 2008, Development of sustained release fast-disintegrating tablets using various polymer-coated ion-exchange resin complexes, Int. J. Pharm, 353, 195, 10.1016/j.ijpharm.2007.11.033
D. Venkatesh, 2008, Formulation of taste masked orodispersible tablets of ambroxol hydrochloride, Asian J. Pharm, 2, 261, 10.4103/0973-8398.45043
J. Bakan, 1987, The Theory and Practice of Industrial Pharmacy, 420
A. Ozer, 1990, Studies on the masking of unpleasant taste of beclamide: micro-encapsulation and tableting, J. Microencapsul, 7, 327, 10.3109/02652049009021843
R. O'Connor, 1989, Pharmaceutical Pelletization Technology, 37, 116
P. Zade, 2009, Formulation, evaluation and optimization of fast dissolving tablet containing tizanidine hydrochloride, Int. J. Pharm. Tech. Res, 1, 34
T. Yajima, 1999, Optimum spray congealing condition for masking the bitter taste of clarithromycin in wax matrix, Chem. Pharm. Bull, 47, 220, 10.1248/cpb.47.220
S. Nail, 1993, Pharmaceutical Dosage Forms - Parenteral Medications, 163
P. Kearney and S. K. Wong, <i>Method of Making Freeze Dried Drug Dosage Forms</i>, U.S. Pat. 5 631 023, 20 May 1997.
P. Kearney, 2003, Modified-release Drug Delivery Technology, 191
H. Seager, 1998, Drug delivery product and the Zydis fast-dissolving dosage form, J. Pharm. Pharmacol, 50, 375, 10.1111/j.2042-7158
L. Dobetti, 2001, Fast-melting tablets: Developments and technologies, Pharma Tech. Drug Deliv, 37, 44
S. Corveleyn, 1997, Formulation and production of rapidly disintegrating tablets by lyophilization using hydrochlorothiazide as a model drug, Int. J. Pharm, 152, 215, 10.1016/S0378-5173(97)00092-6
D. Kaushik, 2004, An overview of melt in mouth tablet technologies and techniques, J. Pharm. Res, 3, 35
R. G. Blank, D. S. Mody, R. J. Kenny and M. C. Aveson, <i>Fast Dissolving Dosage Forms</i>, U.S. Pat. 4946684, 9 May 1990.
K. Masaki, <i>Intrabuccally Disintegrating Preparation and Production Thereof</i>, U.S. Pat. 5,466,464, 14 Nov 1995.
A. Modi, 2006, Enhancement of dissolution profile by solid dispersion (kneading) technique, AAPS PharmSciTech, 7, 10.1208/pt070368
R. Laitinen, 2009, Intraorally fast-dissolving particles of a poorly soluble drug: Preparation and in vitro characterization, Eur. J. Pharm. Biopharm, 71, 271, 10.1016/j.ejpb.2008.09.001
T. Harmon, 2007, Orally disintegrating tablets: A valuable life cycle management strategy, Issue Pharm. Comm, 1
T. E. Chiver and O. Minn, <i>Process for Making Candy Floss</i>, U.S. Pat. 7,30,057, 13 Feb 2003.
G. L. Mayers, G. E. Battisk and R. C. Fluiz, <i>Process and Apparatus for Making Rapidly Dissolving Dosage Uunits and Product Thereform</i>, PCT Pat. WC 95/24293-A1, 1995.
T. Mizumoto, 2005, Formulation design of a novel fast-disintegrating tablet, Int. J. Pharm, 306, 83, 10.1016/j.ijpharm.2005.09.009
M. Sugimoto, 2006, Development of manufacturing method for rapidly disintegrating oral tablets using the crystalline transition of amorphous sucrose, Int. J. Pharm, 320, 71, 10.1016/j.ijpharm.2006.04.004
M. Sugimoto, 2006, Effect of formulated ingredients on rapidly disintegrating oral tablets prepared by the crystalline transition method, Chem. Pharm. Bull, 54, 175, 10.1248/cpb.54.175
G. Abdelbary, 2004, The preparation of orally disintegrating tablets using a hydrophilic waxy binder, Int. J. Pharm, 278, 423, 10.1016/j.ijpharm.2004.03.023
G. Abdelbary, 2005, Determination of the in vitro disintegration profile of rapidly disintegrating tablets and correlation with oral disintegration, Int. J. Pharm, 292, 29, 10.1016/j.ijpharm.2004.08.019. 26
B. Perissutti, 2003, Formulation design of carbamazepine fast-release tablets prepared by melt granulation technique, Int. J. Pharm, 256, 53, 10.1016/0378-5173(89)90061-6
Y. Kuno, 2008, Effect of preparation method on properties of orally disintegrating tablets made by phase transition, Int. J. Pharm, 355, 87, 10.1016/j.ijpharm.2007.11.046
Y. Kuno, 2008, 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, 986, 10.1016/j.ejpb.2008.02.016
D. Patel, 2008, Optimization of fast dissolving etoricoxib tablet by sublimation technique, Indian J. Pharm. Sci, 70, 71, 10.4103/0250-474X.40335
S. Suresh, 2007, Preparation and evaluation of mouth dissolving tablet of salbutamol sulphate, Indian J. Pharm. Sci, 69, 467, 10.4103/0250-474X.34568
B. J. Roser and J. Blair, <i>Rapidly Soluble Oral Solid Dosage Forms, Methods of Making Same, and Compositions Thereof</i>, U.S. Pat. 5,762,961, 9 June 1998.
Y. Yamamoto, 2009, Effect of powder characteristics on oral tablet disintegration, Int. J. Pharm, 365, 116, 10.1016/j.ijpharm. 2008.08.031
M. El-Barghouthi, 2008, A novel superdisintegrating agent made from physically modified chitosan with silicon dioxide, Drug Dev. Ind. Pharm, 34, 373, 10.1080/03639040701657792
Y. Bi, 1996, Preparation and evaluation of a compressed tablet rapidly disintegrating in the oral cavity, Chem. Pharm. Bull, 44, 2121, 10.1248/cpb.44.2121
A. Ito, 1996, Development of oral dosage form for elderly patients: Use of agar as base of rapidly disintegrating oral tablets, Chem. Pharm. Bull, 44, 2132, 10.1248/cpb.44.2132
S. Gattani, 2009, Formulation and development of mouth dissolving tablet of ondensetron hydrochloride by using superdisintegrants, Indian Drugs, 46, 44
J. Fukami, 2005, 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, 1536, 10.1248/cpb.53.1536
T. Koseki, 2008, Development of novel fast-disintegrating tablets by direct compression using sucrose stearic acid ester as a disintegration-accelerating agent, Chem. Pharm. Bull, 56, 1384, 10.1248/cpb.56.1384
T. Shu, 2002, Studies of rapidly disintegrating tablets in the oral cavity using co-ground mixtures of mannitol with crospovidone, Chem. Pharm. Bull, 50, 193, 10.1248/cpb.50.193
S. Late, 2009, Effects of disintegration-promoting agent, lubricants and moisture treatment on optimized fast disintegrating tablets, Int. J. Pharm, 365, 4, 10.1016/j.ijpharm. 2008.08.010
N. Zhao, 2006, The influence of granulation on superdisintegrant performance, Pharm. Dev. Technol, 11, 47, 10.1080/10837450500463828
P. Di Martino, 2005, Evaluation of different fast melting disintegrants by means of a central composite design, Drug Dev. Ind. Pharm, 31, 109, 10.1081/DDC-44233
A. Joshi, 2004, Added functionally excipients: An answer to challenging formulations, Pharm. Tech, 12
N. Zhao, 2006, The influence of product brand-to-brand variability on superdisintegrant performance. A case study with croscarmellose sodium, Pharm. Dev. Technol, 11, 179, 10.1080/10837450600561281
Y. Fu, 2005, Fast-melting tablets based on highly plastic granules, J. Control. Release, 109, 203, 10.1016/j.jconrel.2005.09.021
J. Shery, 2009, Preparation and evaluation of fast-disintegrating effervescent tablets of glibenclamide, Drug Dev. Ind. Pharm, 35, 321, 10.1080/03639040802337021
G. Bankar, 1987, The Theory and Practice of Industrial Pharmacy, 293
F. Wehling, S. Schuehle and N. Madamala, <i>Effervescent Dosage Form with Microparticles</i>, U.S. Pat. 5,178,878, 12 Jan 1993.
F. Wehling, S. Schuehle and N. Madamala, <i>Pediatric Effervescent Dosage Form</i>, U.S. Pat. 5,223,264, 29 Jun 1993.
F. Wehling and S. Schuehle, <i>Base Coated Acid Particles and Effervescent Formulation Incorporating same</i>, U.S. Pat. 5,503,846, 2 Apr 1996.
M. C. Iles, A. D. Atherton and N. M. Copping, <i>Freeze-dried Dosage Forms and Methods for Preparing the Same</i>, U.S. Pat. 5,188,825, 23 Feb 1993.
S. R. Cherukuri, G. L. Myers, G. E. Battist and R. C. Fuisz, <i>Process for Forming Quickly Dispersing Comestible Unit and Product Therefrom</i>, U.S. Pat. 5,587,172, 24 Dec 1996.
R. C. Fuisz, <i>Ulcer Prevention Method Using a Melt-spun Hydrogel</i>, U.S. Pat. 5,622,717, 22 Apr 1997.
S. R. Cherukuri and R. Fuisz, <i>Process and Apparatus for Making Tablets and Tablets Made Therefrom</i>, Eur. Pat. 0677,147 A2, 1995.
G. L. Myers, G. E. Battist and R. C. Fuisz, <i>Delivery of Controlled-release Systems</i>, U.S. Pat. 5,567, 439, 22 Oct 1996.
G. L. Myers, G. E. Battist and R. C. Fuisz, <i>Apparatus for Making Rapidly Dissolving Dosage Units</i>, U.S. Pat. 5,871,781, 16 Feb 1999.
S. R. Cherukuri and R. Fuisz, <i>Process and Apparatus for Making Tablets and Tablets Made Therefrom</i>, U.S. Pat. 5,654,003, 5 Aug 1997.
G. L. Myers, G. E. Battist and R. C. Fuisz, <i>Process and Apparatus for Making Rapidly Dissolving Dosage Units and Product Therefrom</i>, U.S. Pat. 5,622,719, 22 April 1997.
L. Lafon. <i>Galenic Form for Oral Administration and its Method of Preparation by Lyophilization of an Oil-in-water Emulsion</i>, Eur. Pat. 0,159,237, 1985.
A. Liang, 2001, Fast-dissolving intraoral drug delivery systems, Expert Opin. Ther. Pat, 11, 981, 10.1517/13543776.11.6.981
W. R. Pfister, L. H. Chen and D. W. Ren, <i>Compositions and Methods for Mucosal Delivery</i>, U.S. Pat. 6,552,024, 22 Apr 2003.