Comprehensive Review on Oral Disintegrating Films

Current Drug Delivery

Volumn 10, Issue 1, 2013, Pages 96-108

  Nagaraju, T ^a   Gowthami, R ^a   Rajashekar, M ^a   Sandeep, S ^a   Mallesham, M ^a   Sathish, D ^a,b   Kumar, Y Shravan ^a,b  

^a Vaagdevi College of Pharmacy   (India)

^b KAKATIYA UNIVERSITY   (India)

Author keywords

Disintegration; Geriatric patients; Oral cavity; Oral disintegrating films; Oral strip; Pediatric patients

Indexed keywords

ACRIVASTINE; ANALGESIC AGENT; ANTIINFECTIVE AGENT; AZATADINE MALEATE; CETIRIZINE; CHLORASEPTIC; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN; DICYCLOVERINE; DIPHENHYDRAMINE; DONEPEZIL; DRINKING WATER; FAMOTIDINE; FENTANYL; FLURAZEPAM; FOLIC ACID; GLYCERYL TRINITRATE; KETOPROFEN; LOPERAMIDE; LORATADINE; MECOBALAMIN; MULTIVITAMIN; NICOTINE; OMEPRAZOLE; ONDANSETRON; OXYCODONE; SUMATRIPTAN SUCCINATE; TRIPROLIDINE; UNINDEXED DRUG; ZOLMITRIPTAN;

CHEWABLE TABLET; DRUG ABSORPTION; DRUG DELIVERY DEVICE; DRUG FORMULATION; DRUG MANUFACTURE; DRUG PACKAGING; DRUG RELEASE; FILM COATING; HUMAN; MOUTH MUCOSA; ORAL DRUG ADMINISTRATION; PELLET EXTRUSION; PRIORITY JOURNAL; QUALITY CONTROL; REVIEW; SALIVA; TABLET DISINTEGRATION;

ADMINISTRATION, ORAL; CHEMISTRY, PHARMACEUTICAL; DOSAGE FORMS; DRUG DELIVERY SYSTEMS; DRUG PACKAGING; PHARMACEUTICAL PREPARATIONS; QUALITY CONTROL; SOLUBILITY;

EID: 84875309455     PISSN: 15672018     EISSN: 18755704     Source Type: Journal    
DOI: 10.2174/1567201811310010016     Document Type: Review

References (63)

1. Alpesh, R.; Dharmendra, S.; Jignyasha, A. Fast dissolving films (fdfs) as a newer venture in fast dissolving dosage forms. Int. J. Drug Develop. Res., 2010, 2(2), 232-246.
2. Dixit, R.P.; Puthli, S.P. Oral strip technology: Overview and future potential. J. Control Release, 2009, 139(2), 94-10.
3. Suresh, B.; Rajender, K. Mittapalli; Ramesh Gannu.; Madhusudan, Rao Y. Orol dispersible tablets: An overview. Asian. J. Pharm., 2008, 2(1), 2-11.
4. Barnhart, S.D.; Sloboda, M.S. Dissolvable films the future of dissolvable films. Drug Dev. Tech., 2007, 1, 34-35.
5. Guidance for Industry: Orally Disintegrating Tablets, Center for Drug Evaluation and Research (Centre for Drug Evaluation and Research, CDER) US FDA, Dec. 2008.
6. Barnhart, S.D.; Sloboda, M.S. Dissolvable films the future of dissolvable films. Drug Dev. Tech., 2007, 1, 34-35.
7. Vondrak, B.; Barnhart, S. Dissolvable Films for Flexible Product Format in Drug Delivery. Pharmaceutical Technology Supplement, April 2008.
8. www.ondrugdelivery.com
9. M.; Avaniamin. Pharm. Technol., 2009, 33(2), 48-56.
10. Ito, A.; Sugihara, M. Chem. Pharm. Bull, 1996, 44 (11), 2132-2136.
11. Chang, R.K.; Guo, X.; Burnside, B.A.; Couch, R.A. Pharma. Tech., 2000, 24(6), 52-58.
12. Kuchekar, B.S.; Arumugam, V. Indian J. Pharm. Edu., 2001, 35, 150.
13. Verena, G. Preparation and characterization of fast-dissolving oral films for pediatric use [dissertation]. Düsseldorf, Heinrich- Heine University, 2009, 13.
14. Frey, P. Film Strips and Pharmaceuticals. Pharma. Mfg. Packag. Sourcer, winter, 2006, 92-93.
15. Zhang, H.; Zhang, J.; Streisand, J.B. Oral mucosal drug delivery: clinical pharmaco-kinetics and therapeutic applications. Clin. Pharmacokinet, 2002, 41(9), 661-680.
16. http://www.kvpharma.com/tech.oraquick 28 may 2004.
17. http://www.gas-x.com.
18. Barnhart, S.D.; Sloboda, M.S. The future of dissolvable films. Drug Del. Technol., 2007, 7(8), 34-37.
19. Meathrel, B.; Moritz, C. Dissolvable Films and their Potential. IVD Technol., 2007, 13(9), 53-58.
20. Kulkarni, N.; Kumar, L.D.; Sorg, A. Fast dissolving orally consumable films containing an antitussive and a mucosa coating agent. U.S. Patent 2003/206942, Nov 6, 2003.
21. Ali, S.; Quadir, A. High molecular weight povidone polymer-based films for fast dissolving drug delivery applications. Drug Del. Technol., 2007, 7(6), 36-43.
22. Hariharan, M.; Bogue, A. Orally dissolving film strips (ODFS): the final evolution of orally dissolving dosage forms. Drug Del. Tech-nol., 2009, 9(2), 24-29.
23. Sohi, H.; Sultana, Y.; Khar, R.K. Taste masking technologies in oral pharmaceuticals:recent developments and approaches. Drug. Dev. Ind. Pharm., 2004, 30, 429-448.
24. http://www.nutraceuticalsworld.com/articles/2008/01/online-exclusive-emerging-edible-films.
25. Corniello, C. Quick dissolving strips: from concept to commercialization. Drug Del. Technol., 2006, 6(2), 68-71.
26. Frankhauser, C.; Slominski, G.; Meyer, S. Disintegrable oral films, U.S. Patent 2007/0202057, Aug. 30, 2007.
27. Lydzinski, S.; Manegold, T.; Solarek, D.; Tsai, J.; Puglisi, C. Film containing starch, U.S. Patent 2003/0099692, May 29, 2003.
28. Kulkarni, A. S.; Deokule, H.A.; Mane, M.S.; Ghadge, D.M. Exploration of different polymers for use in the formulation of oral fast dissolving strips. J. Curr. Pharm. Res., 2010, 2(1), 33-35.
29. Sakellariou, P.; Rowe, R.C. Interactions in cellulose derivative films for oral drug delivery. Prog. Polym. Sci., 1995, 20, 889-942.
30. Banker, G.S. Film coating theory and practice. J. Pharm. Sci., 1966, 55, 81-89.
31. Rowe, F.C.; Forse, S.F. The effect of polymer molecular weight on the incidence of film cracking and splitting on film coated tablets. J. Pharm. Pharmacol., 1980, 32(8), 583-584.
32. Rowe, R.C.; Forse, S.F. The effect of plasticizer type and concentration on the incidence of bridging of intagliations on film-coated tablets. J. Pharm. Pharmacol., 1981, 33(3), 174-175.
33. Singh, P.; Guillory, J.K.; Sokoloski, T.D; Benet, L.Z.; 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., 1966, 55(1), 6-68.
34. Browhn, G.L. Formation of films from polymer dispersions. J. Polym. Sci., 1956, 22 (102), 423-434.
35. Hariharan, M.; Bogue, A. Orally dissolving film strips (ODFS): the final evolution of Orally dissolving dosage forms. Drug Del. Tech-nol., 2009, 9(2), 24-29.
36. Mennella, J.A.; Beauchamp, G.K. Optimizing oral medications for children. Clin. Ther., 2008, 30(11), 2120-2132.
37. Hutteau, F.; Mathlouthi, M.; Portmann, M.O.; Kilcast, D. Physico-chemical and psychophysical characteristics of binary mixtures of bulk and intense sweeteners. Food Chem., 1998, 63(1), 9-16.
38. Prakash, I.; DuBois, G.E.; Clos, J.F.; Wilkens, K.L.; Fosdick, L.E. Development of rebiana, a natural, non-caloric sweetener. Food Chem. Toxicol. 2008, 46 S, 75-82.
39. Sharma, R.; Parikh, R.K.; Gohel, M.C.; Soniwala, M.M. Development of taste masked film of Valdecoxib for oral use. Ind. J. Pharm. Sci., 2007, 69(2), 320-322.
40. Sau-hung, S.; Robert, S.; Lori, D. Fast dissolving orally consumable films, U.S. Patent 6,596,298, July 22, 2003.
41. Israel, K.; Leo, M. Salivary stimulant, U.S. Patent 4820506, April 11, 1989.
42. McGregor, R.; Homan, H.; Gravina, S.; Fast dissolving film delivery of nucleotides that inhibit the unpleasant taste of bitter tasting medications, WO Patent 2004/19885, March 11, 2004.
43. Maibach, T. Film comprising nitroglycerin. WO Patent PCT/ US2008/053466, Aug 14, 2008.
44. Obermeier, P.; Kohr, T.; Kramer, K.; Kolkkers, K. Oral, quickly disintegrating film, which cannot be spit out, for an antiemetic or antimigraine agent, U.S. Patent 2008/0213343 A1, Sept 4, 2008.
45. 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).
46. 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).
47. nd Edition (Marcel Dekker Inc, New York, NY USA, 2002;1488-1504.
48. Gole. Pharmaceutical and other dosage forms. United States Patent No:5648093; July 15/1997.
49. Baron. (6900 jericho turnpike, syosset, ny, 11791, us) United States Patent Application 20080226695.
50. http://www.meldexinternational.com/Development/Enabling_Sys-tems/Orally_Dissolving_Films.
51. th Ed., American Society for Testing and Materials. 268.
52. Felton, L.; Donnell, P.O.; McGinity, J. Mechanical properties of polymeric films prepared from aqueous dispersions, in: Aqueous polymeric coatings for pharmaceutical dosage forms, 3rd edition, McGinity J, Felton L Drugs and the pharmaceutical sciences, 108.
53. Fulzele, S.V.; Sattuwar, P.M.; Dorle, A.K. Polymerized rosin: novel film forming polymer for drug delivery. Int. J. Pharm., 2002, 249, 175-184.
54. American Standard of Testing and Materials, ASTM D1004-08 Standard Test Method for Tear Resistance (Graves Tear) of Plastic film and Sheeting.
55. Shinde, A.J.; Garala, K.C.; More, H.N.; Development and characterization of transdermal therapeutics system of tramadol hydro-chloride. Asian. J. Pharm., 2008, 4, 265-269.
56. Mashru, R.C.; Sutariya, B.C.; Parikh, P.P. Development and evaluation of fast dissolving films of salbutamol sulphate. Drug Dev. Ind. Pharm., 2005, 31, 25-34.
57. Peh, K.K.; Wong, C.F. Polymeric film as vehicle for buccal delivery: swelling, Mechanical and Bioadhesive properties. J. Pharm. Pharm. Sci., 1999, 2, 53-61.
58. Bettini, R.; Antonello, A.; Mariana, M.; Borghetti, F. Physiochemi-cal and cell adhesion properties of chitosan films prtepared from sugar and phosphate containing solutions. Eu. J. Pharm. Bio-pharm., 2008, 68, 74-81.
59. nd edition, Drugs and the pharmaceutical sciences, p.209-216.
60. Nishimura, M.; Matsuura, K.; Tsukioka, T.; Yamashita, H.; Ina-gaki, N.; Sugiyama, T.; Itoh, Y. In vitro and in vivo characteristics of prochlorperazine oral disintegrating film. Int. J. Pharm., 2009, 368(12), 98-102.
61. Mashru, R.C.; Sutariya, V.B.; Sankalia, M.G.; Parikh, P.P. Development and evaluation of fast-dissolving film of salbutamol sulphate. Drug Develop. Industrial Pharm., 2005, 31(1), 25-34.
62. Anand, V.; Kataria, M.; Kukkar, V.; Saharan, V.; Choudhury, P.K. The latest trends in the tasteassessment of pharmaceuticals. Drug Discov. Today, 2007, 12, 257-265.
63. Murray, O.J.; Dang, W.; Bergstrom, D. Using an electronic tongue to optimize taste masking in a lyophilized orally disintegrating tablet formulation. Pharm. Technol., 2004.