Advances in orodispersible films for drug delivery

Expert Opinion on Drug Delivery

Volumn 8, Issue 3, 2011, Pages 299-316

  Hoffmann, Eva Maria ^a   Breitenbach, Armin ^b   Breitkreutz, Jörg ^a  

^a HEINRICH HEINE UNIVERSITY   (Germany)

^b Labtec GmbH   (Germany)

Author keywords

buccal delivery; disintegration time; film forming polymer; oral soluble film; orodispersible film; solvent casting; tensile strength; thin strips

Indexed keywords

ALGINIC ACID; BUPRENORPHINE PLUS NALOXONE; DEXAMETHASONE; EUDRAGIT; EXCIPIENT; FENTANYL; GELATIN; KOLLICOAT; LISTERINE; LOPERAMIDE; MACROGOL; ONDANSETRON; ORGANIC SOLVENT; OXYCODONE; PECTIN; PLASTICIZER; POLYMER; POLYVINYL ALCOHOL; POVIDONE; PROCHLORPERAZINE; PULLULAN; RISPERIDONE; SELEGILINE; SILDENAFIL; TRIPTAN DERIVATIVE; UNCLASSIFIED DRUG; VALDECOXIB;

BIOEQUIVALENCE; BIOFILM; DISPERSION; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG DELIVERY SYSTEM; DRUG DOSAGE FORM; DRUG FORMULATION; DRUG MANUFACTURE; DRUG MARKETING; DRUG SOLUBILITY; DRUG STABILITY; HOT MELT EXTRUSION; HUMAN; MOLECULAR INTERACTION; NONHUMAN; ORAL DRUG ADMINISTRATION; ORODISPERSIBLE FILM; PHARMACEUTICS; REVIEW; SOLVENT CASTING; SUSTAINED DRUG RELEASE; TASTE; VISCOSITY;

ADMINISTRATION, ORAL; CHEMISTRY, PHARMACEUTICAL; DOSAGE FORMS; DRUG DELIVERY SYSTEMS;

EID: 79951886927     PISSN: 17425247     EISSN: None     Source Type: Journal    
DOI: 10.1517/17425247.2011.553217     Document Type: Review

References (89)

1. Hariharan M, Bogue A. Orally dissolving film strips (ODFS): the final evolution of orally dissolving dosage forms. Drug Deliv Technol 2009;9(2):24-9
2. Barnhart SD. Thin film oral dosage forms. In: Rathbone M, Hadgraft J, Roberts M, Lane M, editors. Modified release drug delivery technology. Informa Healthcare, London. 2 edition 2008. p. 209-16
3. Garsuch V, Breitkreutz J. Novel analytical methods for the characterization of oral wafers. Eur J Pharm Biopharm 2009;73(1):195-201
4. Siebenand S. Auf die Zunge, fertig, los. Pharmazeutische Zeitung 2010;155(38):28-9
5. European Medicines Agency. Overview of comments received on draft guideline on the investigation of bioequivalence. CPMP/EWP/QWP/1401/98 REV. 1. London 2010
6. European Medicines Agency. Guideline on the investigation of bioequivalence. London 2010
7. Data standards of structured product labeling. FDA U.S. Food and Drug Administration. 2009. Available from: http://www.fda.gov/ForIndustry/ DataStandards/StructuredProduct Labeling/ucm162038.htm [Last accessed 14 December 2010]
8. Deadman LLF; New Impregnated or Coated Films. GB 1061557. 1964
9. Best Inventions 2002. Time Magazine. Tampa, Florida: 2002. Available from: http://www.time.com/time/specials/ packages/article/0,28804,1934259- 1934672-1934708,00.html [Last accessed 28 September 2010]
10. OTC market sees another oral strip entrant. Pharma Technologist. Montpellier Decision News Media SAS; 2004 http://www. in-pharmatechnologist.com/ Materials-Formulation/OTC-market-seesanother- oral-strip-entrant [Last accessed 07 September 2010]
11. MonoSol Rx Announces FDA Approval of Zuplenz- Oral Soluble Film for Treatment of Nausea and Vomiting. Monosol Rx. Warren, NJ: 2010. Available from: http://www. monosolrx.com/news-10/news-070710. html [Last accessed 09 November 2010]
12. European Approval of Ondasetron Rapidfilm-. Labtec GmbH. Langenfeld: 2010. Available from:http://www. labtec-pharma.com/eng/newsletter/issue1/ european-approval-of-ondansetronrapidfilm,1517040,1.html [Last accessed 28 September 2010]
13. Nishimura M, Matsuura K, Tsukioka T, et al. In vitro and in vivo characteristics of prochlorperazine oral disintegrating film. Int J Pharm 2009;368(1-2):98-102
14. Garsuch V. Preparation and characterization of fast-dissolving oral films for pediatric use [Doctoral thesis]: Heinrich Heine University, Dusseldorf; 2009
15. Liang AC, Chen LH. Fast-dissolving intraoral drug delivery systems. Expert Opin Ther Patents 2001;11(6):981-6 (Pubitemid 32536833)
16. Borsadia SB, O'Halloran D, Osborne JL. Quick-dissolving films - a novel approach to drug delivery. Drug Deliv Technol 2003;3(3):63-6
17. Reiner V, Giarratana N, Monti NC, et al. Rapidfilm: an innovative pharmaceutical form designed to improve patient compliance. Int J Pharm 2010;393(1-2):55-60
18. Patel AR, Prajapati DS, Raval JA. Fast dissolving films (FDFs) as a newer venture in fast dissolving dosage forms. Int J Drug Dev Res 2010;2(2):232-46
19. Dixit RP, Puthli SP. Oral strip technology: overview and future potential. J Control Release 2009;139(2):94-107
20. Breitkreutz J. Schnell zerfallende orale Arzneiformen. In: Mader K, Weidenauer U, editors. Innovative Arzneiformen. Wissenschaftliche Verlagsgesellschaft mbH, Stuttgart; 2010. p. 37-52
21. Mishra R, Amin A. Formulation development of taste-masked rapidly dissolving films of cetirizine hydrochloride. Pharm Technol 2009;33(2):48-56
22. Peh KK, Wong CF. Polymeric films as vehicle for buccal delivery: Swelling, mechanical, and bioadhesive properties. J Pharm Pharm Sci 1999;2(2):53-61
23. Cilurzo F, Cupone IE, Minghetti P, et al. Fast dissolving films made of maltodextrins. Eur J Pharm Biopharm 2008;70(3):895-900
24. Corniello CM. Quick-dissolve strips: from concept to commercialization. Drug Deliv Technol 2006;6(2):68-71
25. Barnhart SD, Sloboda MS. The future of dissolvable films. Drug Deliv Technol 2007;7(8):34-7
26. Goel H, Rai P, Rana V, et al. Orally disintegrating systems: innovations in formulation and technology. Recent Pat Drug Deliv Formul 2008;2(3):258-74
27. Boateng JS, Stevens HNE, Eccleston GM, et al. Development and mechanical characterization of solvent-cast polymeric films as potential drug delivery systems to mucosal surfaces. Drug Dev Ind Pharm 2009;35(8):986-96
28. Gaisford S, Verma A, Saunders M, et al. Monitoring crystallisation of drugs from fast-dissolving oral films with isothermal calorimetry. Int J Pharm 2009;380(1-2):105-11
29. Arya A, Chandra A, Sharma V, et al. Fast dissolving oral films: an innovative drug delivery system and dosage form. Int J ChemTech Res 2010;2(1):576-83
30. Ghebre-Sellassie I, Martin C, editors. Pharmaceutical extrusion technology. Marcel Dekker, Inc., New York; 2003
31. Koster M, Thommes M. Hot-Melt Extrusion - a new production technique for oral applicable films? Annual Meeting of DPhG; Braunschweig; 2010
32. Yang RK, Fuisz RC, Myers GL, et al. Thin Film with non-self-aggregating uniform heterogeneity an drug delivery systems made therefrom. US 20080226695; 2008
33. Davidson RS, Kehoe GS. Water-soluble film for oral use. EP1532973. 2004
34. Yu D-G, Yang J-M, Branford-White C, et al. Third generation solid dispersions of ferulic acid in electrospun composite nanofibers. Int J Pharm 2010;400(1-2):158-64
35. Nagy ZK, Nyul K, Wagner I, et al. Electrospun water soluble polymer mat for ultrafast release of Donepezil HCl. eXPRESS Polymer Lett 2010;4(12):763-72
36. Malke S, Shidhaye S, Desai J, et al. Oral films - patient compliant dosage form for pediatrics. Int J Pediatr Neonatol 2010;11(2). Available from: http://www. ispub.com/journal/the-internet-journal- of-pediatrics-and- neonatology/ volume-11-number-2-10/article/ oral-films-patient-compliant- dosageform- for-pediatrics.html [Last accessed 26 January 2011]
37. Allen J, Mungall DR. Biotrack, Inc. Integrated drug dosage form and metering system. EP 0224335; 1986
38. Lehrke I, Vollmer U, Maier S. Primary packaging unit for flat administration forms. WO 2006056161; 2006
39. Film Strips and Pharmaceuticals. Frey P. Adhesive Research, 2006. Available from: http://www.adhesivesresearch.com/Files/ PMPS%20Winter%2006%20Film% 20Strips%20&%20Pharm.pdf [Last accessed 03 September 2010]
40. Breitkreutz J, Boos J. Paediatric and geriatric drug delivery. Expert Opin Drug Deliv 2007;4(1):37-45 (Pubitemid 46117485)
41. Chen MJ, Tirol G, Bass C, et al. Castable edible pharmaceutical films. Drug Deliv Technol 2008;8(6):34-41
42. Dinge A, Nagarsenker M. Formulation and evaluation of fast dissolving films for delivery of triclosan to the oral cavity. AAPS PharmSciTech 2008;9(2):349-56
43. Cilurzo F, Cupone I, Minghetti P, et al. Nicotine fast dissolving films made of maltodextrins: a Feasibility Study. AAPS PharmSciTech 2010;11(4):1511-17
44. Boateng JS, Auffret AD, Matthews KH, et al. Characterisation of freeze-dried wafers and solvent evaporated films as potential drug delivery systems to mucosal surfaces. Int J Pharm 2010;389(1-2):24-31
45. Boateng JS, Matthews KH, Auffret AD, et al. In vitro drug release studies of polymeric freeze-dried wafers and solvent-cast films using paracetamol as a model soluble drug. Int J Pharm 2009;378(1-2):66-72
46. Dahiya M, Saha S, Shahiwala AF. A review on mouth dissolving films. Curr Drug Deliv 2009;6:469-76
47. Sharma R, Parikh RK, Gohel MC, et al. Development of taste masked film of valdecoxib for oral use. Indian J Pharm Sci 2007;69(2):320-3 (Pubitemid 47026130)
48. Ali S, Quadir A. High molecular weight povidone polymer-based films for fast-dissolving drug delivery applications. Drug Deliv Technol 2007;7(6):36-43
49. Kulkarni AS, Deokule HA, Mane MS, et al. Exploration of different polymers for use in the formulation of oral fast dissolving strips. J Curr Pharm Res 2010;2(1):33-5
50. Sakuda Y, Ito A, Sasatsu M, et al. Preparation and evaluation of medicinal carbon oral films. Chem Pharm Bull 2010;58(4):454-7
51. Garsuch V, Breitkreutz J. Comparative investigations on different polymers for the preparation of fast-dissolving oral films. J Pharm Pharmacol 2010;62(4):539-45
52. Cilurzo F, Cupone IE, Minghetti P, et al. Diclofenac fast-dissolving film: suppression of bitterness by a taste-sensing system. Drug Dev Ind Pharm 2011;37(3):252-9
53. Patel R, Shardul N, Patel J, et al. Formulation development and evaluation of mouth melting film of ondansetron. Arch Pharm Sci Res 2009;1(2):212-17
54. El-Setouhy DA, El-Malak NS. Formulation of a novel tianeptine sodium orodispersible film. AAPS PharmSciTech 2010;11(3):1018-25
55. Asane GS, Nirmal SA, Rasal KB, et al. Polymers for mucoadhesive drug delivery system: a current status. Drug Dev Ind Pharm 2008;34(11):1246-66
56. Repka MA, Prodduturi S, Stodghill SP. Production and characterization of hot-melt extruded films containing clotrimazole. Drug Dev Ind Pharm 2003;29(7):757-65 (Pubitemid 36899882)
57. Mashru RC, Sutariya VB, Sankalia MG, et al. Development and evaluation of fast-dissolving film of salbutamol sulphate. Drug Dev Ind Pharm 2005;31(1):25-34 (Pubitemid 40170585)
58. Brown D. Orally disintegrating tablets - taste over speed. Drug Deliv Technol 2003;3(6):58-61
59. Gavaskar B, Kumar SV, Sharan G, et al. Overview on fast dissolving films. Int J Pharmacy Pharm Sci 2010;2(3):29-33
60. Cram A, Breitkreutz J, Desset-Brethes S, et al. Challenges of developing palatable oral paediatric formulations. Int J Pharm 2009;365(1-2):1-3
61. Nicolazzo JA, Reed BL, Finnin BC. Buccal penetration enhancers-how do they really work? J Control Release 2005;105(1-2):1-15 (Pubitemid 40805471)
62. Hao J, Heng PW. Buccal delivery systems. Drug Dev Ind Pharm 2003;29(8):821-32 (Pubitemid 37203684)
63. Vondrak B, Barnhart S. Dissolvable films: dissolvable films for flexible product format in drug delivery. Pharm Tech 2008. Available from: http:// pharmtech.findpharma.com/pharmtech/ Drug+delivery+Article/Dissolvable-Films- Dissolvable-Films-for-Flexible-P/ ArticleStandard/Article/detail/505380 [Last accessed 26 January 2011]
64. DIN Deutsches Institut fur Normung. DIN EN ISO 527-1 Bestimmung der Zugeigenschaften Teil 1: Allgemeine Grundsatze. Beuth Verlag GmbH, Berlin; 1996
65. DIN Deutsches Institut fur Normung. DIN EN ISO 527-3 Bestimmung der Zugeigenschaften Teil 3: Prufbedingungen fur Folien und Tafeln. Beuth Verlag GmbH, Berlin; 2003
66. Radebaugh GW. Methods for evaluating the puncture and shear properties of pharmaceutical polymeric films. Int J Pharm 1988;45:39-46
67. U.S Department of Health and Human Sevirces, FDA, CDER. Guidance for Industry - Orally Disintegrating Tablets. 2008
68. European Directorate for the Quality of Medicines & HealthCare. Tablets: Orodispersible Tablets. European Pharmacopoeia 6.8., Strasbourg 2010. p. 750
69. Bi YX, Sunada H, Yonezawa Y, et al. Preparation and evaluation of a compressed tablet rapidly disintegrating in the oral cavity. Chem Pharm Bull 1996;44(11):2121-7 (Pubitemid 26396765)
70. Shimoda H, Taniguchi K, Nishimura M, et al. Preparation of a fast dissolving oral thin film containing dexamethasone: a possible application to antiemesis during cancer chemotherapy. Eur J Pharm Biopharm 2009;73(3):361-5
71. Siewert M, Dressman J, Brown C, et al. FIP/AAPS Guidelines for Dissolution/In Vitro Release Testing of Novel/Special Dosage Forms. AAPS PharmSciTech 2003;4(1):Article 7
72. A New Method of Characterizing the Buccal Dissolution of Drugs. Hughes L, Gehris A. Spring House, PA: Rohm and Haas Research Laboratories, 2008. Available from: https://www.rohmhaas. com/ionexchange/Pharmaceuticals/ Formulations-doc/buccal-dissolution.pdf [Last accessed 12 April 2009]
73. Pather SI, Rathbone MJ, Senel S. Current status and the future of buccal drug delivery systems. Expert Opin Drug Deliv 2008;5(5):531-42 (Pubitemid 351877432)
74. Shojaei AH. Buccal mucosa as a route for systemic drug delivery: a review. J Pharm Pharm Sci 1998;1(1):15-30
75. Klancke J. Dissolution testing of orally disintegrating tablets. Dissolution Technologies 2003;10(2):6-8
76. Anand V, Kataria M, Kukkar V, et al. The latest trends in the taste assessment of pharmaceuticals. Drug Discov Today 2007;12(5-6):257-65
77. Woertz K, Tissen C, Kleinebudde P, et al. Taste sensing systems (electronic tongues) for pharmaceutical applications. Int J Pharm doi:10.1016/j.ijpharm. 2010.11.0282010, online on November 19, 2010
78. Tumuluri SVS, Prodduturi S, Crowley MM, et al. The use of near-infrared spectroscopy for the quantitation of a drug in hot-melt extruded films. Drug Dev Ind Pharm 2004;30(5):505-11 (Pubitemid 38821862)
79. Haag M, Brüning M, Molt K. Quantitative analysis of diphenhydramine hydrochloride in pharmaceutical wafers using near infrared and Raman spectroscopy. Anal Bioanal Chem 2009;395(6):1777-85
80. Tumuluri VS, Kemper MS, Lewis IR, et al. Off-line and on-line measurements of drug-loaded hot-melt extruded films using Raman spectroscopy. Int J Pharm 2008;357(1-2):77-84
81. Smart JD. Buccal drug delivery. Expert Opin Drug Deliv 2005;2(3):507-17 (Pubitemid 41683224)
82. Reddy D, Pillay V, Choonara YE, et al. Rapidly disintegrating oramucosal drug delivery technologies. Pharm Dev Technol 2009;14(6):588-601
83. Clarke A, Brewer F, Johnson ES, et al. A new formulation of selegiline: improved bioavailability and selectivity for MAO-B inhibition. J Neural Transm 2003;110(11):1241-55 (Pubitemid 37500746)
84. Clarke A, Johnson ES, Mallard N, et al. A new low-dose formulation of selegiline: clinical efficacy, patient preference and selectivity for MAO-B inhibition. J Neural Transm 2003;110(11):1257-71 (Pubitemid 37500747)
85. Hexal AG. Fachinformation Risperidon Hexal- SF Schmelzfilm. Holzkirchen 2010
86. Reckitt Benckiser Pharmaceuticals, Inc. Receives FDA Approval for Suboxone- (Buprenorphine and Naloxone) Sublingual Film C-III. Reckitt Benckiser Pharmaceuticals, Inc. Bristol: 2010. Available from: http://www.rb. com/FDA-Approval-for-Suboxone- Sublingual-FilmC-III [Last accessed 28 October 2010]
87. Orally Disintegrating Tablet and Film Technologies 5th Edition - Brochure. Technology Catalysts International. Falls Church, VA: 2008. Available from: http://www. technology-catalysts.com/reports-services/ [Last accessed 03 September 2010]
88. Students Device Oral Quick-dissolve Strips For Rotavirus Vaccine. Johns Hopkins University. Rockville, MD: ScienceDaily, 2007. Available from: http://www.sciencedaily.com/releases/ 2007/05/070514110616.htm [Last accessed 06 September 2010]
89. Dissolvable films and their potential in IVDs. Meathrel W, Moritz C. Los Angeles, CA IVD Technology, 2007. Available from: http://www. ivdtechnology.com/article/dissolvablefilms- and-their-potential-ivds [Last accessed October 21 2010]