Oral strip technology: Overview and future potential

Journal of Controlled Release

Volumn 139, Issue 2, 2009, Pages 94-107

  Dixit, R P ^a   Puthli, S P ^a  

^a Panacea Biotec Ltd   (India)

Author keywords

Buccal; Buccoadhesive; Formulation; Oral delivery; Strip

Indexed keywords

BUCCAL; BUCCOADHESIVE; FORMULATION; ORAL DELIVERY; STRIP;

AMINES; DRUG PRODUCTS;

TECHNOLOGY;

CARBOXYMETHYLCELLULOSE; CHLORPHENIRAMINE MALEATE; COLORING AGENT; EUDRAGIT; FLAVORING AGENT; GAS X; GELATIN; GLYCEROL; GLYCERYL TRINITRATE; HYDROXYPROPYLCELLULOSE; HYDROXYPROPYLMETHYLCELLULOSE; IBUPROFEN; MACROGOL; MACROGOL 4000; MULTIVITAMIN; NICOTINE; PECTIN; PHENOBARBITAL; PLASTICIZER; POLYMER; POLYOL; PROPYLENE GLYCOL; PULLULAN; SIMETHICONE; STABILIZING AGENT; STARCH; SWEETENING AGENT; TESTOSTERONE; THICKENING AGENT; UNCLASSIFIED DRUG; UNINDEXED DRUG; ZOLMITRIPTAN;

CHILD HEALTH CARE; CONTROLLED DRUG RELEASE; CONTROLLED STUDY; DRUG DELIVERY SYSTEM; DRUG FORMULATION; DRUG MANUFACTURE; DRUG SOLUBILITY; FIRST PASS EFFECT; GERIATRIC CARE; HUMAN; MIGRAINE; MOUTH CAVITY; MUCOADHESION; NONHUMAN; ORGANOLEPTIC PROPERTY; PRIORITY JOURNAL; REVIEW; TABLET DISINTEGRATION TIME; TENSILE STRENGTH; THICKNESS; TOBACCO DEPENDENCE; YOUNG MODULUS;

ADMINISTRATION, BUCCAL; DOSAGE FORMS; DRUG DELIVERY SYSTEMS; HUMANS;

EID: 70349087316     PISSN: 01683659     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jconrel.2009.06.014     Document Type: Review

References (123)

1. Rathbone M.J., and Hadgraft J. Absorption of drugs from the human oral cavity. Int. J. Pharm. 74 (1991) 9-24
2. Rojanasakul Y., Wang L.-Y., Bhat M., Glover D.D., Malanga C.J., and Ma J.K.H. The transport barrier of epithelia: a comparative study on membrane permeability and charge selectivity in the rabbit. Pharm. Res. 9 (1992) 1029-1034
3. Gore A.V., Liang A.C., and Chien Y.W. Comparative biomembrane permeation of tacrine using yucatan minipigs and domestic pigs as the animal model. J. Pharm. Sci. 87 (1998) 441-447
4. Shojaei A.H. Buccal mucosa as a route for systemic drug delivery: a review. J. Pharm. Pharm. Sci. 1 (1998) 15-30
5. Galey W.R., Lonsdale H.K., and Nacht S. The in vitro permeability of skin and buccal mucosa to selected drugs and tritiated water. J. Invest. Dermat. 67 (1976) 713-717
6. Gandhi R.B., and Robinson J.R. Oral cavity as a site for bioadhesive drug delivery. Adv. Drug Del. Rev. 13 (1994) 43-74
7. Wertz P.W., and Squier C.A. Cellular and molecular basis of barrier function in oral epithelium. Crit. Rev. Ther. Drug Carr. Sys. 8 (1991) 237-269
8. Peppas N.A., and Buri P.A. Surface, interfacial and molecular aspects of polymer bioadhesion on soft tissues. J. Control. Release 2 (1985) 257-275
9. Schenkels L., Gururaja T.L., and Levine M.J. In: Rathbone M.J. (Ed). Oral Mucosal Drug Delivery (1996), Marcel Dekker, New York 191-220
10. T.C. Kontis, M.E. Johns, Anatomy and physiology of salivary glands, in: Byron J. Bailey (Ed.), Head and Neck surgery-Otolaryngology, pp. 531-539.
11. Mattes R.D. Physiologic responses to sensory stimulation by food: nutritional implications. J. Am. Diet. Assoc. 97 (1997) 406-410
12. Harris D., and Robinson J.R. Drug delivery via the mucous membranes of the oral cavity. J. Pharm. Sci. 81 (1992) 1-10
13. Alur H.H., Johnston T.P., and Mitra A.K. Encyclopedia of pharmaceutical technology. In: Superbrick J., and Boylan J.C. (Eds). Peptides and Proteins: Buccal Absorption, vol. 20 (3) (2001), Marcel Dekker Inc., New York 193-218
14. Sudhakar Y., Kuotsu K., and Bandyopadhyay A.K. Buccal bioadhesive drug delivery - a promising option for orally less efficient drugs. J. Control. Release 114 (2006) 15-40
15. Tallury P., Alimohammadi N., and Kalachandra S. Poly(ethylene-co-vinyl acetate) copolymer matrix for delivery of chlorhexidine and acyclovir drugs for use in the oral environment: effect of drug combination, copolymer composition and coating on the drug release rate. Dent. Mater. 23 (2007) 404-409
16. Ciper M., and Bodmeier R. Modified conventional hard gelatin capsules as fast disintegrating dosage form in the oral cavity. Eur. J. Pharm. Biopharm. 62 (2006) 178-184
17. Birudaraj R., Mahalingam R., Li X., and Jasti B.R. Advances in buccal drug delivery. Crit. Rev. Ther. Drug Carrier Syst. 22 (2005) 295-330
18. Giannola L.I., De Caro V., Giandalia G., Siragusa M.G., D'Angelo M., Lo Muzio L., and Campisi G. Transbuccal tablets of carbamazepine: formulation, release and absorption pattern. Int. J. Immunopathol. Pharmacol. 18 (2005) 21-31
19. Rossi S., Sandri G., and Caramella C.M. Buccal drug delivery: a challenge already won?. Drug Discov. Today: Technol. 2 (2005) 59-65
20. Giannola L.I., De Caro V., Giandalia G., Siragusa M.G., Campisi G., Florena A.M., and Ciach T. Diffusion of naltrexone across reconstituted human oral epithelium and histomorphological features. Eur. J. Pharm. Biopharm. 65 (2007) 238-246
21. Giannola L.I., De Caro V., Giandalia G., Siragusa M.G., Tripodo C., Florena A.M., and Campisi G. Release of naltrexone on buccal mucosa: permeation studies, histological aspects and matrix system design. Eur. J. Pharm. Biopharm. 67 (2007) 425-433
22. Crama A., Breitkreutzb J., Desset-Brèthesc S., Nunnd T., and Tuleuf C. Challenges of developing palatable oral pediatric formulations. Int J Pharm. 365 (2009) 1-3
23. Florence A.T. Neglected diseases, neglected technologies, neglected patients?. Int J Pharm. 350 (2008) 1-2
24. Committee for Medicinal Products for Human Use, European Medicines Agency EMEA, Reflection paper: formulation of choice for the pediatric population, 2006, (http://www.emea.europa.eu/pdfs/human/paediatrics/19481005en.pdf).
25. Guidance for Industry: Orally Disintegrating Tablets, Center for Drug Evaluation and Research (Centre for Drug Evaluation and Research, CDER) US FDA, Dec. 2008. (http://www.fda.gov/cder/Guidance/8528fnl.pdf).
26. Technology catalysts International Corporation, http://www.technology-catalysts.com. (http://www.technology-catalysts.com/pdf/ODT_PressRelease-0106.pdf).
27. Zhang H., Zhang J., and Streisand J.B. Oral mucosal drug delivery: clinical pharmacokinetics and therapeutic applications. Clin. Pharmacokinet. 41 9 (2002) 661-680
28. http://www.gas-x.com/.
29. Corniello C. Quick dissolving strips: from concept to commercialization. Drug Del. Technol. 6 2 (2006) 68-71
30. Harwood R.J. Hypromellose. In: Rowe R.C., and Sheskey P.J. (Eds). Handbook of Pharmaceutical Excipients (2006), Pharmaceutical Press, London 346-349
31. Harwood R.J. Hydroxypropyl cellulose. In: Rowe R.C., and Sheskey P.J. (Eds). Handbook of Pharmaceutical Excipients (2006), Pharmaceutical Press, London 336-340
32. Galichet L.Y. Starch. In: Rowe R.C., and Sheskey P.J. (Eds). Handbook of Pharmaceutical Excipients (2006), Pharmaceutical Press, London 725-730
33. http://www.accessdata.fda.gov/scripts/fcn/gras_notices/215492E.PDF.
34. Cook W. Pectin. In: Rowe R.C., and Sheskey P.J. (Eds). Handbook of Pharmaceutical Excipients (2006), Pharmaceutical Press, London 507-508
35. Price J.C. Gelatin. In: Rowe R.C., and Sheskey P.J. (Eds). Handbook of Pharmaceutical Excipients (2006), Pharmaceutical Press, London 295-298
36. Parson D. Carboxymethyl cellulose. In: Rowe R.C., and Sheskey P.J. (Eds). Handbook of Pharmaceutical Excipients (2006), Pharmaceutical Press, London 120-123
37. C. Frankhauser, G. Slominski, S. Meyer, Disintegrable oral films, U.S. Patent 2007/0202057, Aug. 30, 2007.
38. R. Scott, D. Cade, X. He, Pullulan film compositions, U.S. Patent 7,267,718, Sept. 11, 2007.
39. S. Lydzinski, T. Manegold, D. Solarek, J. Tsai, C. Puglisi, Film containing starch, U.S. Patent 2003/0099692, May 29, 2003.
40. N. Kulkarni, L.D. Kumar, A. Sorg, Fast dissolving orally consumable films containing an antitussive and a mucosa coating agent, U.S. Patent 2003/206942, Nov 6, 2003.
41. Ali S., and Quadir A. High molecular weight povidone polymer-based films for fast dissolving drug delivery applications. Drug Del. Technol. 7 6 (2007) 36-43
42. Cilurzo F., Cupone I.E., Minghetti P., Selmin F., and Montanari L. Fast dissolving films made of maltodextrins. Eur. J. Pharm. Biopharm. 70 3 (2008) 895-900
43. Nishimura M., Matsuura K., Tsukioka T., Yamashita H., Inagaki N., Sugiyama T., and Itoh Y. In vitro and in vivo characteristics of prochlorperazine oral disintegrating film. Int J Pharm. 368 1-2 (2009) 98-102
44. Consuelo I.D., Falson F., Guy R.H., and Jacques Y. Ex vivo evaluation of bioadhesive films for buccal delivery of fentanyl. J. Control. Release 122 (2007) 135-140
45. Perumal V.A., Lutchman D., Mackraj I., and Govender T. Formulation of monolayered films with drug and polymers of opposing solubilities. AAPS PharmSciTech. 8(3) 75 (2007) 184-191. http://www.aapspharmscitech.org http://www.aapspharmscitech.org
46. Patel V.M., Prajapati B.G., and Patel M.M. Effect of hydrophilic polymers on buccoadhesive eudragit patches of propranolol hydrochloride using factorial design. AAPS PharmSci.Tech. 8 (2 45 (2007) E1-E8. http://www.aapspharmscitech.org http://www.aapspharmscitech.org
47. Perioli L., Ambrogi V., Angelici F., Ricci M., Giovagnoli S., Capuccella M., and Rossi C. Development of mucoadhesive patches for buccal administration of ibuprofen. J. Control. Release 99 1 (2004) 73-82
48. Salamat-Miller N., Chittchang M., and Johnston T.P. The use of mucoadhesive polymers in buccal drug delivery. Adv. Drug Del. Rev. 57 11 (2005) 1666-1691
49. S. Meyer, G. Slominski, C. Frankhauser, Orally administrable films, WO Patent 2008/112124, Sept 18, 2008.
50. K. Furusawa, K. Sudeji, M. Kakichi, Y. Morimoto, T. Seki, Y. Sawai, Fentanyl compound-containing edible patch to be applied to oral mucosa, U.S. Patent 2004/0180080, Sept 16, 2004.
51. C. Georgiades, S. Mody, A. Soshinsky, Z. Zhang, Whitening products, U.S. Patent 2007/269519, Nov 22, 2007.
52. http://www.coriumgroup.com/technology.html.
53. http://www.quantumhealth.com/productgroups/dry_mouth_xerostomia_treatmen t.html.
54. www.compeed.com.
55. http://www.cankercover.com/.
56. http://www.striant.com/.
57. http://www.drugs.com/pro/dentipatch.html.
58. http://www.bdsinternational.com/BEMA.php.
59. Sakellariou P., and Rowe R.C. Interactions in cellulose derivative films for oral drug delivery. Prog. Polym. Sci. 20 (1995) 889-942
60. Banker G.S. Film coating theory and practice. J. Pharm. Sci. 55 (1966) 81-89
61. McIndoe L.M.E. Castor oil. In: Rowe R.C., Sheskey P.J., and Owen S.C. (Eds). Handbook of Pharmaceutical Excipients (2006), Pharmaceutical press, London 128-130
62. Guest R.T. Dibutyl phthalate. In: Rowe R.C., Sheskey P.J., and Owen S.C. (Eds). Handbook of Pharmaceutical Excipients (2006), Pharmaceutical press, London 234-235
63. Kennedy S.W. Dibutyl sebacate. In: Rowe R.C., Sheskey P.J., and Owen S.C. (Eds). Handbook of Pharmaceutical Excipients (2006), Pharmaceutical press, London 236-237
64. Guest R.T. Diethyl phthalate. In: Rowe R.C., Sheskey P.J., and Owen S.C. (Eds). Handbook of Pharmaceutical Excipients (2006), Pharmaceutical press, London 240-241
65. Price J.C. Polyethylene glycol. In: Rowe R.C., Sheskey P.J., and Owen S.C. (Eds). Handbook of Pharmaceutical Excipients (2006), Pharmaceutical press, London 545-550
66. Owen S.C., and Weller P.J. Propylene glycol. In: Rowe R.C., Sheskey P.J., and Owen S.C. (Eds). Handbook of Pharmaceutical Excipients (2006), Pharmaceutical press, London 624-626
67. Palmieri A. Triacetin. In: Rowe R.C., Sheskey P.J., and Owen S.C. (Eds). Handbook of Pharmaceutical Excipients (2006), Pharmaceutical press, London 790-791
68. Kennedy S.W. Tributyl citrate. In: Rowe R.C., Sheskey P.J., and Owen S.C. (Eds). Handbook of Pharmaceutical Excipients (2006), Pharmaceutical press, London 792-793
69. Kennedy W. Triethyl citrate. In: Rowe R.C., Sheskey P.J., and Owen S.C. (Eds). Handbook of Pharmaceutical Excipients (2006), Pharmaceutical press, London 796-797
70. Rowe R.C., and Forse S.F. The effect of polymer molecular weight on the incidence of film cracking and splitting on film coated tablets. J. Pharm. Pharmacol. 32 8 (1980) 583-584
71. Rowe R.C., and Forse S.F. The effect of film thickness on the incidence of the defect bridging of intagliations on film coated tablets. J. Pharm. Pharmacol. 32 9 (1980) 647-648
72. Rowe R.C., and Forse S.F. The effect of plasticizer type and concentration on the incidence of bridging of intagliations on film-coated tablets. J. Pharm. Pharmacol. 33 3 (1981) 174-175
73. Singh P., Guillory J.K., Sokoloski T.D., Benet L.Z., and Bhatia V.N. Effect of inert tablet ingredients on drug absorption I. Effect of polyethylene glycol 4000 on the intestinal absorption of four barbiturates. J. Pharm. Sci. 55 1 (1966) 63-68
74. Browhn G.L. Formation of films from polymer dispersions. J. Polym. Sci. 22 102 (1956) 423-434
75. Sakellariou P., and Rowe R.C. Interactions in cellulose derivative films for oral drug delivery. Prog. Polym. Sci. 20 (1995) 889-942
76. Cao N., Yang X., and Fu Y. Effects of various plasticizers on mechanical and water vapor barrier properties of gelatin films. Food Hydrocolloids 23 (2009) 729-735
77. Wu C., and McGinity J.W. Influence of ibuprofen as a solid-state plasticizer in Eudragit RS 30 D on the physicochemical properties of coated beads. AAPS PharmSciTech. 2 4 (2001) 24
78. Sakellariou P., Rowe R.C., and White E.F.T. An evaluation of the interaction and plasticizing efficiency of the polyethylene glycols in ethylcellulose and hydrokypropyl methylcellulose films using the torsional braid pendulum. Int J Pharm. 31 (1986) 55-64
79. Hariharan M., and Bogue A. Orally dissolving film strips (ODFS): the final evolution of orally dissolving dosage forms. Drug Del. Technol. 9 2 (2009) 24-29
80. Sohi H., Sultana Y., and Khar R.K. Taste masking technologies in oral pharmaceuticals: recent developments and approaches. Drug Dev. Ind. Pharm. 30 (2004) 429-448
81. Szejtli J., and Szente L. Elimination of bitter, disgusting tastes of drugs and foods by cyclodextrins. Eur. J. Pharm. Biopharm. 61 3 (2005) 115-125
82. Agresti C., Tu Z., Ng C., Yang Y., and Liang J.F. Specific interactions between diphenhydramine and α-helical poly(glutamic acid) - a new ion-pairing complex for taste masking and pH-controlled diphenhydramine release. Eur. J. Pharm. Biopharm. 70 1 (2008) 226-233
83. Agarwal R., Mittal R., and Singh A. Studies of ion-exchange resin complex of chloroquine phosphate. Drug Dev. Ind. Pharm. 26 (2000) 773-776
84. Suzuki H., Onishi H., Takahashi Y., Iwata M., and Machida Y. Development of oral acetaminophen chewable tablets with inhibited bitter taste. Int J Pharm. 251 1-2 (2003) 123-132
85. Sugao H., Yamazaki S., Shiozawa H., and Yano K. Taste masking of bitter drug powder without loss of bioavailability by heat treatment of wax-coated microparticles. J. Pharm. Sci. 87 (1998) 96-100
86. Xu J., Bovet L.L., and Zhao K. Taste masking microspheres for orally disintegrating tablets. Int J Pharm. 359 1-2 (2008) 63-69
87. Al-Omran M.F., Al-Suwayeh S.A., El-Helw A.M., and Saleh S.I. Taste masking of diclofenac sodium using microencapsulation. J. Microencapsul. 19 (2002) 45-52
88. Hashimoto Y., Tanaka M., Kishimoto H., Shiozawa H., Hasegawa K., Matsuyama K., and Uchida T. Preparation, characterization and taste-masking properties of polyvinylacetal diethylaminoacetate microspheres containing trimebutine. J. Pharm. Pharmacol. 54 (2002) 1323-1328
89. A. Schobel, S. Vangala, Solid dosage form containing a taste masked active agent, U.S. Patent 2007/0292515, Dec 20, 2007.
90. Yoshida T., Tasaki H., Maeda A., Katsuma M., Sako K., and Uchida T. Salting-out taste-masking system generates lag time with subsequent immediate release. Int J Pharm. 365 1-2 (2009) 81-88
91. R. McGregor, H. Homan, S. Gravina, Fast dissolving film delivery of nucleotides that inhibit the unpleasant taste of bitter tasting medications, WO Patent 2004/19885, March 11, 2004.
92. http://www.nutraceuticalsworld.com/articles/2008/01/online-exclusive-eme rging-edible-films.
93. Mennella J.A., and Beauchamp G.K. Optimizing oral medications for children. Clin. Ther. 30 11 (2008) 2120-2132
94. Hutteau F., Mathlouthi M., Portmann M.O., and Kilcast D. Physicochemical and psychophysical characteristics of binary mixtures of bulk and intense sweeteners. Food Chem. 63 1 (1998) 9-16
95. Prakash I., DuBois G.E., Clos J.F., Wilkens K.L., and Fosdick L.E. Development of rebiana, a natural, non-caloric sweetener. Food Chem. Toxicol. 46 (2008) S75-S82
96. Sharma R., Parikh R.K., Gohel M.C., and Soniwala M.M. Development of taste masked film of Valdecoxib for oral use. Ind. J. Pharm. Sci. 69 2 (2007) 320-322
97. S. Sau-hung, S. Robert, D. Lori, Fast dissolving orally consumable films, U.S. Patent 6,596,298, July 22, 2003.
98. K. Israel, M. Leo, Salivary stimulant, U.S. Patent 4820506, April 11, 1989.
99. Brown D. Orally disintegrating tablets - taste over speed. Drug Del. Technol. 3 6 (2003)
100. T. Maibach, Film comprising nitroglycerin, WO Patent PCT/US2008/053466, Aug 14 2008.
101. P. Obermeier, T. Kohr, K. Kramer, K. Kolkkers, Oral, quickly disintegrating film, which cannot be spit out, for an antiemetic or antimigraine agent, U.S. Patent 2008/0213343 A1, Sept 4, 2008.
102. International Conference on Harmonization, ICH topic Q3C(R3) Impurities: residual solvents. Note for guidance on Impurities: residual solvents. (CPMP/ICH/283/95), (www.emea.europa.eu/pdfs/human/ich/028395en.pdf).
103. E. Greb, Are orally dissolving strips easy for manufacturers to swallow? http://pharmtech.findpharma.com., Jan 21 2009.
104. G. Sward, Drying time, in: G. Sward (Ed.), Paint Testing Manual- physical and chemical examination of paints varnishes lacquers, and colors, 13th Ed., American Society for Testing and Materials. pp. 268.
105. L. Felton, P. O'Donnell, J. McGinity, Mechanical properties of polymeric films prepared from aqueous dispersions, in: Aqueous polymeric coatings for pharmaceutical dosage forms, 3rd edition, J. McGinity, L. Felton (Eds), Vol. 176, Drugs and the pharmaceutical sciences, pp. 108.
106. Fulzele S.V., Sattuwar P.M., and Dorle A.K. Polymerized rosin: novel film forming polymer for drug delivery. Int J Pharm. 249 (2002) 175-184
107. American Standard of Testing and Materials, ASTM D1004 - 08 Standard Test Method for Tear Resistance (Graves Tear) of Plastic Film and Sheeting.
108. Shinde A.J., Garala K.C., and More H.N. Development and characterization of transdermal therapeutics system of tramadol hydrochloride. Asian J. Pharm. 2 4 (2008) 265-269
109. S. Barnhart, Thin film oral dosage forms, in: Modified release drug delivery technology, M. Rathborne, J. Hadgraft, M. Roberts, M. Lane (Eds) vol. 183, 2nd edition, Drugs and the pharmaceutical sciences, pp. 209-216.
110. Nishimura M., Matsuura K., Tsukioka T., Yamashita H., Inagaki N., Sugiyama T., and Itoh Y. In vitro and in vivo characteristics of prochlorperazine oral disintegrating film. Int J Pharm. 368 1-2 (2009) 98-102
111. Anand V., Kataria M., Kukkar V., Saharan V., and Choudhury P.K. The latest trends in the taste assessment of pharmaceuticals. Drug Discovery Today 12 (2007) 257-265
112. Murray O.J., Dang W., and Bergstrom D. Using an electronic tongue to optimize taste-masking in a lyophilized orally disintegrating tablet formulation. Pharm. Technol. (2004) pharmtech.findpharma.com/pharmtech/article/articleDetail.jsp?id = 112227
113. World Health Organization Working document QAS/08.257, Feb 2008, (http://www.who.int/medicines/services/expertcommittees/pharmprep/Pediat ricMedicinesPharmDevelopment_QAS08_257_29022008.pdf).
114. http://www.listerine.com/product-pocket-paks.jsp.
115. http://www.triaminic.com.
116. http://www.biofilm.co.uk.
117. http://www.labtec-pharma.com/index.php?article_id=24.
118. http://www.bioenvelop.com/english/prd_technology.html.
119. http://www.monosolrx.com/index.html.
120. http://www.snoreeze.com/the-snoreeze-range/snoreeze-oral-strips.
121. http://www.aridispharma.com/oral.html.
122. http://www.meldexinternational.com/pages/content/index.asp?PageID=50.
123. http://www.technology-catalysts.com/pdf/ODT5_brochure.pdf.