How to assess orodispersible film quality? A review of applied methods and their modifications

1. M. Preis, Orally disintegrating films and mini-tablets – innovative dosage forms of choice for pediatric use, AAPSPharmSciTech. 16 (2015) 234–241; https://doi.org/10.1208/s12249-015-0313-110.1208/s12249-015-0313-1437096225739913Search in Google Scholar

2. R. Alany, Oral dosage forms and drug delivery systems: tablets, oral films, liquid dosage forms, oral bioavailability enhancement, Pharm. Dev. Technol. 22 (2017) 137; https://doi.org/10.1080/10837450.2017.128154310.1080/10837450.2017.128154328178908Search in Google Scholar

3. H. M. Batchelor and J. F. Marriott, Formulations for children: problems and solutions, Br. J. Clin. Pharmacol. 79 (2015) 405–418; https://doi.org/10.1111/bcp.1226810.1111/bcp.12268434595125855822Search in Google Scholar

4. P. Verma, A. S. Thakur, K. Deshmukh, A. K. Jha and S. Verma, Routes of drug administration, Int. J. Pharm. Studies Res. 1 (2010) 54–59.Search in Google Scholar

5. P. Dey and S. Maiti, Orodispersible tablets: a new trend in drug delivery, J. Nat. Sci. Biol. 1 (2010) 2–5; https://doi.org/10.4103/0976-9668.7166310.4103/0976-9668.71663321728622096326Search in Google Scholar

6. M. Nishimura, M. Matsuura, T. Tsukioka, H. Yamashit, N. Inagaki, T. Sugiyama and Y. Itoh, In vitro and in vivo characteristics of prochlorperazine oral disintegrating film, Int. J. Pharm. 368 (2009) 98–102; https://doi.org/10.1016/j.ijpharm.2008.10.00210.1016/j.ijpharm.2008.10.00218992311Search in Google Scholar

7. D. A. Satyanarayana and K. P. Keshavarao, Fast disintegrating films containing anatrozole as a dosage form for dysphagia patients, Arch. Pharmacal. Res. 35 (2012) 2171–2182; https://doi.org/10.1007/s12272-012-1215-310.1007/s12272-012-1215-323263812Search in Google Scholar

8. M. Scarpa, S. Stegemann, W. K. Hsiao, H. Pichler, S. Gaisford, M. Bresciani, A. Paudel and M. Orlu, Orodispersible films: towards drug delivery in special populations, Int. J. Pharm. 523 (2017) 327–335; https://doi.org/10.1016/j.ijpharm.2017.03.01810.1016/j.ijpharm.2017.03.01828302515Search in Google Scholar

9. R. Krampe, D. Sieber, M. Pein-Hackelbusch and J. Breitkreutz, A new biorelevant dissolution method for orodispersible films, Eur. J. Pharm. Biopharm. 98 (2016) 20–25; https://doi.org/10.1016/j.ejpb.2015.10.01210.1016/j.ejpb.2015.10.01226515261Search in Google Scholar

10. A. F. Borges, C. Silva, J. F. Coelho and S. Simões, Oral films: Current status and future perspectives I – Galenical development and quality attributes, J. Control. Release206 (2015) 1–19; https://doi.org/10.1016/j.jconrel.2015.03.00610.1016/j.jconrel.2015.03.00625747406Search in Google Scholar

11. M. Slavkova and J. Breitkreutz, Orodispersible drug formulations for children and elderly, Eur. J. Pharm. Sci. 75 (2015) 2–9; https://doi.org/10.1016/j.ejps.2015.02.01510.1016/j.ejps.2015.02.01525736528Search in Google Scholar

12. J. C. Visser, H. J. Woerdenbag, L. M. Hanff and H. W.Frijlink, Personalized medicine in pediatrics: the clinical potential of orodispersible films, AAPS PharmSciTech18 (2017) 267–272; https://doi.org/10.1208/s12249-016-0515-110.1208/s12249-016-0515-127044380Search in Google Scholar

13. J. C. Visser, H. J. Woerdenbag, S.Crediet, E. Gerrits, M. A. Lesschen, W. L. J. Hinrichs, J. Breitkreutz and H. W. Frijlink, Orodispersible films in individualized pharmacotherapy: the development of a formulation for pharmacy preparations, Int. J. Pharm. 478 (2015) 155–163; https://doi.org/10.1016/j.ijpharm.2014.11.01310.1016/j.ijpharm.2014.11.01325448577Search in Google Scholar

14. R. Bala, P. Pawar, K. Khanna and S. Arora, Orally dissolving strips: a new approach to oral drug delivery system, Int. J. Pharm. Investig. 3 (2013) 67–76; https://doi.org/10.4103/2230-973X.11489710.4103/2230-973X.114897375790224015378Search in Google Scholar

15. A. Arya, A. Chandra, V. Sharma and K. Pathak, Fast dissolving oral films: an innovative drug delivery system and dosage form, Int. J. Chem. Tech. Res. 2 (2010) 576–583.Search in Google Scholar

16. M. B. H. Mahboob, T. Riaz, M. Jamshaid, I. Bashir and S. Zulfiqar, Oral films: A comprehensive review, ICPJ5 (2016) 111–117.Search in Google Scholar

17. C. Vlachojannis, A. Al-Ahmad, E. Hellwig and S. Chrubasik, Listerine^® Products: an update on the efficacy and safety, Phytother. Res. 30 (2016) 367–373; https://doi.org/10.1002/ptr.555510.1002/ptr.555526931615Search in Google Scholar

18. Euroepean Pharmacopoeia 7.4, Strasbourg 2012.Search in Google Scholar

19. European Medicines Agency, Guideline on the Investigation of Bioequivalence, London 2010; http://www.ema.europa.eu/docs/en_GB/document_library/Other/2010/02/WC500073572.pdf; access date March 5, 2018.Search in Google Scholar

20. FDA, CDER, Guidance for Industry – Orally Disintegrating Tablets, 2008; https://www.fda.gov/downloads/Drugs/Guidances/ucm070578.pdf; access date March 5, 2018.Search in Google Scholar

21. S. D. Barnhart, Modified Release Drug Delivery Technology, Informa Healthcare, London 2008, pp. 209–216.Search in Google Scholar

22. R. Sharma, R. K. Parikh, M. C. Gohel and M. M. Soniwala, Development of taste masked film of valdecoxib for oral use, Ind. J. Pharm. Sci. 2 (2007) 320–323.Search in Google Scholar

23. R. Mishra and A. Amin, Formulation and characterization of rapidly dissolving films of cetirizine hydrochloride using pullulan as a film forming agent, Indian J. Pharm. Educ. Res. 45 (2015) 71–77.Search in Google Scholar

24. E. M. Hoffmann, A. Breitenbach and J. Breitkreutz, Advances in orodispersible films for drug delivery, Expert Opin. Drug Deliv. 8 (2011) 299–316; https://doi.org/10.1517/17425247.2011.55321710.1517/17425247.2011.55321721284577Search in Google Scholar

25. M. Preis, Oromucosal film preparations for pharmaceutical use – formulation development and analytical characterization, 2014, Düsseldorf; https://docserv.uni-duesseldorf.de/servlets/Derivate-Servlet/Derivate-32499/Preis_Maren_Dissertation_pdfA.pdf; access date March 5, 2018.Search in Google Scholar

26. Spotscentoral care strips; http://www.comparepetstuff.com/products.php?q=SpotScent+Oral+Care+Strips+24Pack; access date March 5, 2018.Search in Google Scholar

27. R. P. Dixit and S. P. Puthil, Oral strip technology: overview and future potential, J. Control. Release139 (2009) 94–107; https://doi.org/10.1016/j.jconrel.2009.06.01410.1016/j.jconrel.2009.06.01419559740Search in Google Scholar

28. J. Krause and J. Breitkreutz, Improving drug delivery in pediatric medicine, Pharm. Med. 22 (2008) 41–50; https://doi.org/10.1007/BF0325668110.1007/BF03256681Search in Google Scholar

29. V. Reiner, N. Giarratana, N. C. Monti, A. Breitenbach and P. Klaffenbach, Rapidfilm: an innovative pharmaceutical form designed to improve patient compliance, Int. J. Pharm. 393 (2010) 55–60; https://doi.org/10.1016/j.ijpharm.2010.03.05510.1016/j.ijpharm.2010.03.05520363308Search in Google Scholar

30. Sildenafil Sandoz orodispersible film public assessment report, 2013; http://www.mhra.gov.uk/home/groups/par/documents/websiteresources/con303958.pdf; access date March 5, 2018.Search in Google Scholar

31. Ivy film patent information leaflet, 2014; http://lamar.co.za/sites/default/files/files/IvyFilm%20PIL%20L10024_14A_PROOF.pdf; access date March 5, 2018.Search in Google Scholar

32. Clobazam OSF data; http://www.pharmajournalist.com/pharma-news/fda-accepts-aquestive-therapeutics-nda-clobazam-osf-treating-lgs-patients/; access date March 5, 2018.Search in Google Scholar

33. S. V. Kumar, B. Gavaskar, G. Sharan and Y. Madhusudan Rao, Overview on fast dissolving films, Int. J. Pharm. Pharm. Sci. 2 (2010) 29–33.Search in Google Scholar

34. S. Karki, K. Hyeongmin, H. Kim, S. J. Na, D. Shin, K. Jo and J. Lee, Thin films as an emerging platform for drug delivery, AJPS. 11 (2016) 559–574; https://doi.org/10.1016/j.ajps.2016.05.00410.1016/j.ajps.2016.05.004Search in Google Scholar

35. M. Preis, J. Breitkreutz and N. Sandler, Perspective: Concepts of printing technologies for oral film formulations, Int. J. Pharm. 494 (2015) 578–584; https://doi.org/10.1016/j.ijpharm.2015.02.03210.1016/j.ijpharm.2015.02.03225683143Search in Google Scholar

36. SildenafiIBSAorodispersible film: https://www.drugs.com/uk/sildenafil-ibsa-100-mg-orodispersible-film-leaflet.html ; access date March 5, 2018.Search in Google Scholar

37. L. Loprete, C. Leuratii, V. Frangione and M. Radicioni, Pharmacokinetics of a novel sildenafil orodispersible film administered by the supralingual and the sublingual route to healthy men, Clin. Drug Investig. 38 (2018) 765–772; https://doi.org/10.1007/s40261-018-0665-x10.1007/s40261-018-0665-x606139929909432Search in Google Scholar

38. M. D. Siddiqui, G. Garg and P. Sharma, A short review on a novel approach in oral fast dissolving drug delivery system and their patents, Adv. Biol. Res. 5 (2011) 291–303.Search in Google Scholar

39. B. Bhyan, H. Jangra, M. Kaurand are H. Singh, Orally fast dissolving films: innovations in formulation and technology, Int. J. Pharm. Sci. Rev. Res. 9 (2011) 50–56.Search in Google Scholar

40. E. Chidi, N. Nwobodo and O. Raymond, Development and evaluation of fast dissolving thin films of aripiprazole, UJPR. 2 (2017) 23–27; https://doi.org/10.22270/ujpr.v2i5.R510.22270/ujpr.v2i5.R5Search in Google Scholar

41. M. Hariharan and A. Bogue, Orally dissolving film strips (ODFS): the final evolution of orally dissolving dosage forms, Drug Deliv. Technol. 9 (2009) 24–29.Search in Google Scholar

42. A. Alayoubi, L. Hayens, B. Daihom, R. Helms and H. Almoazen, Development of a fast dissolving film of epinephrine hydrochloride as a potential anaphylactic treatment for pediatrics, Pharm. Dev. Technol. 22 (2017) 1012–1016; https://doi.org/10.3109/10837450.2015.113171510.3109/10837450.2015.113171526740126Search in Google Scholar

43. J. Aggarwal, G. Singh, S. Saini and A. C. Rana, Fast dissolving films: a novel approach to oral drug delivery, IRJP2 (2011) 69–74.Search in Google Scholar

44. Y. Thabet and J. Breitkreutz, Orodispersible films: product transfer from lab-scale to continuous manufacturing, Int. J. Pharm. 535 (2018) 285–292; https://doi.org/10.1016/j.ijpharm.2017.11.02110.1016/j.ijpharm.2017.11.02129146537Search in Google Scholar

45. K. B. Liew, Y. T. Tan and K. K. Peh, Effect of polymer, plasticizer and filler on orally disintegrating film, Drug. Dev. Ind. Pharm. 40 (2014) 110–119; https://doi.org/10.3109/03639045.2012.74988910.3109/03639045.2012.74988923311593Search in Google Scholar

46. V. F. Patel, F. Liu and M. B. Brown, Advances in oral transmucosal drug delivery, J. Control. Release153 (2011) 106–116; https://doi.org/10.1016/j.jconrel.2011.01.02710.1016/j.jconrel.2011.01.02721300115Search in Google Scholar

47. A. V. Yadav, A. S. Shete, A. P. Dabke, P. V. Kulkarni and S. S. Sakhare, Co-crystals: a novel approach to modify physicochemical properties of active pharmaceutical ingredients, Indian J. Pharm. Sci. 71 (2009) 359–370; https://doi.org/10.4103/0250-474X.5728310.4103/0250-474X.57283286580620502540Search in Google Scholar

48. M. R. Gigliobianco, C. Casadidio, R. Censi and P. Di Martino, Nanocrystals of poorly soluble drugs: drug bioavailability and physicochemical stability, Pharmaceutics10 (2018) E134.;https://doi.org/10.3390/pharmaceutics1003013410.3390/pharmaceutics10030134616100230134537Search in Google Scholar

49. S. Rao, Y. Song, F. Peddie and A. M. Evans, Particle size reduction to the nanometer range: a promising approach to improve buccal absorption of poorly water-soluble drugs, Int. J. Nanomedicine6 (2011) 1245–1251; hhtps://doi.org/10.2147/IJN.S19151Search in Google Scholar

50. Z. Gao, S. Rohani, J. Gong and J. Wang, Recent developments in the crystallization process: toward the pharmaceutical industry, Engineering3 (2017) 343–353; https://doi.org/10.1016/J.ENG.2017.03.02210.1016/J.ENG.2017.03.022Search in Google Scholar

51. P. R. Vuddanda, M. Montenegro-Nicolini J. O. Morales and S. Velaga, Effect of surfactants and drug load on physico-mechanical and dissolution properties of nanocrystalline tadalafil-loaded oral films, Eur. J. Pharm. Biopharm. 85 (2013) 1348–1356; https://doi.org./10.1016/j.ejps.2017.08.01910.1016/j.ejpb.2013.09.01924103635Search in Google Scholar

52. B. D. Kevadiya, M. Barvaliya, L. Zhang, A. Anovadiya, H. Brahmbhatt, P. Paul and C. Tripathi, Fenofibrate nanocrystals embedded in oral strip-films for bioavailability enhancement, Bioengineering (Basel). 13 (2018) E16; https://doi.org/10.3390/bioengineering501001610.3390/bioengineering5010016587488229438297Search in Google Scholar

53. D. Steiner, J. H. Finke and A. Kwade, Efficient production of nanoparticle-loaded orodispersible films by process integration in a stirred media mill, Int. J. Pharm. 511 (2016) 804–813; https://doi.org/10.1016/j.ijpharm.2016.07.05810.1016/j.ijpharm.2016.07.05827477101Search in Google Scholar

54. V. Garsuch and J. Breitkreutz, Comparative investigations on different polymers for the preparation of fast-dissolving oral films, J. Pharm. Pharmacol. 62 (2010) 539–545; https://doi.org/10.1211/jpp.62.04.001810.1211/jpp.62.04.001820604845Search in Google Scholar

55. M. Irfan, S. Rabel, Q. Bukhtar, M. I. Quadir, F. Jabeen and A. Khan, Orally disintegrating films: a modern expansion in drug delivery systems, Saudi Pharm. J. 24 (2016) 537–546; https://doi.org/10.1016/j.jsps.2015.02.02410.1016/j.jsps.2015.02.024505983127752225Search in Google Scholar

56. M. J. Chen, G. Tirol, C. Bass, C. M. Corniello, G. Watson and I. Sanchezet, Castable edible pharmaceutical films, Drug. Delivery Technol. 8 (2008) 34–41.Search in Google Scholar

57. F. Cilurzo, I. E. Cupone, P. Minghetti, F. Selmin and L. Montanari, Fast dissolving films made of maltodextrins, Eur. J. Pharm. Biopharm. 70 (2008) 895–900; https://doi.org/:10.1016/j.ejpb.2008.06.03210.1016/j.ejpb.2008.06.03218667164Search in Google Scholar

58. F. Cilurzo, I. E. Cupone, P. Minghetti, S. Buratti, F. Selmin, C. G. M. Gennari and L. Montanari, Nicotine fast dissolving films made of maltodextrins: a feasibility study, AAPS PharmSciTech11 (2010) 1511–1517; https://doi.org/10.1208/s12249-010-9525-610.1208/s12249-010-9525-6301106820936440Search in Google Scholar

59. J. S. Boateng, K. H. Matthews, A. D. Auffret, M. J. Humphrey, H. N. Stevens and G. M. Eccleston, In vitro drug release studies of polymeric freeze-dried wafers and solvent-cast films using paracetamol as a model soluble drug, Int. J. Pharm. 378 (2009) 66–72; https://doi.org/10.1016/j.ijpharm.2009.05.03810.1016/j.ijpharm.2009.05.03819477255Search in Google Scholar

60. J. S. Boateng, H. N. Stevens, G. M. Eccleston, A. D. Auffret, M. J. Humphrey and K. H. Matthews, Development and mechanical characterization of solvent-cast polymeric films as potential drug delivery systems to mucosal surfaces, Drug Dev. Ind. Pharm. 35 (2009) 986–996; https://doi.org/10.1080/0363904090274470410.1080/0363904090274470419365780Search in Google Scholar

61. Y. S. Pathare, V. S. Hastak and A. N. Bajaj, Polymers used for fast disintegrating oral films: a review, Int. J. Pharm. Sci. Rev. Res. 21 (2013) 169–178.Search in Google Scholar

62. P. R. Vuddanda, M. Montenegro-Nicolini, J. O. Morales and S. Velaga, Effect of plasticizers on the physico-mechanical properties of pullulan based pharmaceutical oral films, Eur. J. Pharm. Sci. 96 (2017) 290–298; https://doi.org/10.1016/j.ejps.2016.09.01110.1016/j.ejps.2016.09.01127629498Search in Google Scholar

63. C. Giovino, I. Ayensu, J. Tetteh and J. S. Boateng, An integrated buccal delivery system combining chitosan films impregnated with peptide loaded PEG-b-PLA nanoparticles, Colloids Surf. B. Biointerfaces112 (2013) 9–15; https://doi.org/10.1016/j.colsurfb.2013.07.01910.1016/j.colsurfb.2013.07.01923928054Search in Google Scholar

64. Y. Murata, T. Isobe, K. Kofuji, N. Nishida and R. Kamaguchi, Preparation of fast dissolving films for oral dosage from natural polysaccharides, Materials3 (2010) 4291–4299; https://doi.org/10.3390/ma308429110.3390/ma3084291544582328883330Search in Google Scholar

65. P. Nagar, I. Chauhan and M. Yasir, Insights into polymers: film formers in mouth dissolving films, Drug Invent. Today3 (2011) 280–289.Search in Google Scholar

66. I. Ito, A. Ito and S. Unezaki, Preparation of an oral acetaminophen film that is expected to improve medication administration: effect of polyvinylpyrrolidone on physical properties of the film, Drug Discov. Ther. 10 (2016) 156–162; https://doi.org/10.5582/ddt.2016.0103410.5582/ddt.2016.0103427301710Search in Google Scholar

67. D. Jain, E. Carvalho and R. Banerjee, Biodegradable hybrid polymeric membranes for ocular drug delivery, Acta Biomater. 6 (2010) 1370–1379; https://doi.org/10.1016/j.actbio.2009.11.00110.1016/j.actbio.2009.11.00119900594Search in Google Scholar

68. A. S. Kulkarni, H. A. Doekule, M. S. Mane and D. M. Ghadge, Exploration of different polymers for using the formulation of oral fast dissolving strips, J. Curr. Pharm. Res. 1 (2010) 33–35.Search in Google Scholar

69. S. Ali and A. Quadir, High molecular weight povidone polymer-based films for fast-dissolving drug delivery application, Drug Delivery Technology7 (2007) 36–43.Search in Google Scholar

70. Y. Sakuda, A. Ito, M. Sasatsu and Y. Machida, Preparation and evaluation of medicinal carbon oral films, Chem. Pharm. Bull. 58 (2010) 454–457.10.1248/cpb.58.45420410622Search in Google Scholar

71. N. Cao, X. Yang and Y. Fu, Effects of various plasticizers on mechanical and water vapor barrier properties of gelatin films, Food Hydrocolloids23 (2009) 729–735; https://doi.org/10.1016/j.foodhyd.2008.07.01710.1016/j.foodhyd.2008.07.017Search in Google Scholar

72. A. Amelian, E. Szymańska and K. Winnicka, Formulation and characterization of loratadine containing orodispersible lyophilizates and films, Acta Pol. Pharm.-Drug Research74 (2017) 1533–1541.Search in Google Scholar

73. M. Preis, M. Pein and J. Breitkreutz, Development of a taste-masked orodispersible film containing dimenhydrinate, Pharmaceutics4 (2012) 551–562; https://doi.org/10.3390/pharmaceutics404055110.3390/pharmaceutics4040551383493324300370Search in Google Scholar

74. P. L. Travers, Mary Poppins, New York, Howe, 1934.Search in Google Scholar

75. C. K. Brown, H. D. Friedel, A. R. Barker, L. F. Buhse, S. Keitel, T. L. Cecil, J. Kraemer, J. M. Morris, C. Reppas, M. P. Stickelmeyer, C. Yomota and P. V. Shah, FIP/AAPS joint workshop report: dissolution/in vitro release testing of novel/special dosage forms, AAPS PharmSciTec12 (2011) 782–794; https://doi.org/10.1208/s12249-011-9634-x10.1208/s12249-011-9634-x313464521688063Search in Google Scholar

76. Plastics – determination of tensile properties, DIN EN ISO 527-3, 2012; https://www.iso.org/standard/56045.html; access date March 5, 2018.Search in Google Scholar

77. Standard test method for tensile properties of thin plastic sheeting, ASTM D 882-02, 2012; https://www.astm.org/Standards/D882; access date March 5, 2018.Search in Google Scholar

78. M. Preis, K. Knop and J. Breitkreutz, Mechanical strength test for orodispersible and buccal films, Int. J. Pharm. 461 (2014) 22–29; https://doi.org/10.1016/j.ijpharm.2013.11.03310.1016/j.ijpharm.2013.11.03324291075Search in Google Scholar

79. S. Klein, The use of biorelevant dissolution media to forecast the in vivo performance of a drug, AAPS J12 (2010) 397–406; https://doi.org/10.1208/s12248-010-9203-310.1208/s12248-010-9203-3289543820458565Search in Google Scholar

80. T. Nagaraju, T. Gowthami, M. Rajashekar, S. Sandeep, M. Mallesham, D. Sathish and Y. S. Kumar, Comprehensive review on oral disintegrating films, Curr. Drug Deliv. 10 (2013) 96–108.10.2174/156720181131001001622920576Search in Google Scholar

81. D. Markl and I. A. Zeitler, A review of disintegration mechanisms and measurement techniques, Pharm. Res. 34 (2017) 890–917; https://doi.org/10.1007/s11095-017-2129-z10.1007/s11095-017-2129-zSearch in Google Scholar

82. M. Siewert, J. Dressman, C. Brown and V. P. Shah, FIP/AAPS guidelines for dissolution/in vitro release testing of novel/special dosage forms, AAPS PharmSciTech. 4 (2003) 43–52; https://doi.org/10.1208/pt04010710.1208/pt040107Search in Google Scholar

83. European Pharmacopoeia 8, Strasbourg 2014.Search in Google Scholar

84. United States Pharmacopoeia 37, National Formulary 32, US Pharmacopeial Convention, Rockville 2014.Search in Google Scholar

85. J. Al-Gousous and P. Langguth, Oral solid dosage form disintegration testing – the forgotten test, J. Pharm. Sci. 104 (2015) 2664–2675; https://doi.org/10.1002/jps.2430310.1002/jps.24303Search in Google Scholar

86. S. Gittings, N. Turnbull, C. J. Roberts and P. Gershkovich, Dissolution methodology for taste masked oral dosage forms, J. Control. Release173 (2014) 32–42; https://doi.org/10.1016/j.jconrel.2013.10.03010.1016/j.jconrel.2013.10.030Search in Google Scholar

87. H. K. Batchelor, N. Fotaki and S. Klein, Paediatric oral biopharmaceutics: key considerations and current challenges, Adv. Drug Deliv. Rev. 73 (2014) 102–126; https://doi.org/10.1016/j.addr.2013.10.00610.1016/j.addr.2013.10.006Search in Google Scholar

88. J. C. Visser, W. M. Dohmen, W. L. Hinrichs, J. Breitkreutz, H. W. Frijlinkand and H. J. Woerdenbag, Quality by design approach for optimizing the formulation and physical properties of extemporaneously prepared orodispersible films, Int. J. Pharm. 485 (2015) 70–76; https://doi.org/10.1016/j.ijpharm.2015.03.00510.1016/j.ijpharm.2015.03.005Search in Google Scholar

89. H. Okamoto, H. Taguchi, K. Iida and K. Danjo, Development of polymer film dosage forms of lidocaine for buccal administration, I. Penetration rate and release rate, J. Control. Release77 (2001) 253–260.10.1016/S0168-3659(01)00509-0Search in Google Scholar

90. K. Müller, C. Fingueroa, C. Martinez, M. Madel, E. Obreque, A. Peña-Neira, I. Morales-Bozo, H. Toledo and R. O. Lopez-Solis, Measurement of saliva volume in the mouth of members of a trained sensory panel using a beetroot (Beta vulgaris) extract, Food Quality and Preference21 (2010) 569–574; https://doi.org/10.1016/j.foodqual.2010.03.00510.1016/j.foodqual.2010.03.005Search in Google Scholar

91. M. Gohel, M. Patel, A. Amin, R. Agrawal, R. H. Dave and N. Bariya, Formulation design and optimization of mouth dissolve tablets of nimesulide using vacuum drying technique, AAPS Pharm-SciTech. 5 (2004) e36; https://doi.org/10.1208/pt05033610.1208/pt050336275026015760070Search in Google Scholar

92. P. C. Patil, S. K. Shirvastava, S. Vaidehi and P. Ashwini, Oral fast dissolving drug delivery system: a modern approach for patient compliance, Int. J. Drug Regulat. Affairs2 (2014) 49–60.Search in Google Scholar

93. D. A. El-Setouhy and N. S. A. El-Malak, Formulation of novel tianeptine sodium orodispersible film, AAPS PharmSciTech11 (2010) 1018–1025; https://doi.org/10.1208/s12249-010-9464-210.1208/s12249-010-9464-2297411420532710Search in Google Scholar

94. I. Speer, D. Steiner, Y. Thabet, J. Breitkreutz and A. Kwade, Comparative study on disintegration methods for oral film preparations, Eur. J. Pharm. Biopharm. 132 (2018) 50–61; https://doi.org/10.1016/j.ejpb.2018.09.00510.1016/j.ejpb.2018.09.00530201569Search in Google Scholar

95. M. Preis, D. Gronkowsky, D. Grytzan and J. Breitkreutz, Comparative study on novel test systems to determine disintegration time of orodispersible films, J. Pharm. Pharmacol. 66 (2014) 1102–1111; https://doi.org/10.1111/jphp.1224610.1111/jphp.1224624673551Search in Google Scholar

96. A. Low, S. L. Kok, Y. M. Khong, S. Y. Chan and R. Gokhale, A new test unit for disintegration endpoint determination of orodispersible films, J. Pharm. Sci. 104 (2015) 3893–3903; https://doi.org/10.1002/jps.2460910.1002/jps.2460926296236Search in Google Scholar

97. G. Szakonyi and R. Zelkó, Prediction of oral disintegration time of fast disintegrating tablets using texture analyzer and computational optimization, Int. J. Pharm. 448 (2013) 346–353; https://doi.org/10.1016/j.ijpharm.2013.03.04710.1016/j.ijpharm.2013.03.04723558313Search in Google Scholar

98. R. H. Dave, D. A. Shah and P. G. Patel, Development and evaluation of high loading oral dissolving film of aspirin and acetaminophen, J. Pharm. Sci. Pharmacol. 1 (2014) 112–122; https://doi.org/10.1166/jpsp.2014.101410.1166/jpsp.2014.1014Search in Google Scholar

99. PharmaTest^® film disintegration tester PTZ AUTO EZ: https://www.pharma-test.de/en/products/galenic-instruments/tablet-disintegration-testing/p-pt-odf/; access date October 20, 2018.Search in Google Scholar

100. J. I. Kim, S. M. Cho, J. H. Cui, Q. R. Cao, E. Oh and B. J. Lee, In vitro and in vivo correlation of disintegration and bitter taste masking using orally disintegrating tablet containing ion exchange resin-drug complex, Int. J. Pharm. 455 (2013) 31–39; https://doi.org/10.1016/j.ijpharm.2013.07.07210.1016/j.ijpharm.2013.07.07223933050Search in Google Scholar

101. S. Gittings, N. Turnbull, B. Henry, C. J. Roberts and P. Gershkovich, Characterisation of human saliva as a platform for oral dissolution medium development, Eur. J. Pharm. Biopharm. 91 (2015) 16–24; https://doi.org/.1016/j.ejpb.2015.01.00710.1016/j.ejpb.2015.01.00725603197Search in Google Scholar

102. M. Tiwari, Science behind human saliva, J. Nat. Sci. Biol. Med. 2 (2011) 53–58.10.4103/0976-9668.82322331270022470235Search in Google Scholar

103. G. R. Batista, C. Rocha Gomes Torres, B. Sener, T. Attin and A. Wiegand, Artificial saliva formulations versus human saliva pretreatment in dental erosion experiments, Caries Res. 50 (2016) 78–86; https://doi.org/10.4103/0976-9668.8232210.4103/0976-9668.82322Search in Google Scholar

104. R. G. Schipper, E. Silletti and M. H. Vingerhoeds, Saliva as research material: biochemical, physicochemical and practical aspects, Arch. Oral Biol. 52 (2007) 1114–1135; https://doi.org/10.1016/j.archoralbio.2007.06.00910.1016/j.archoralbio.2007.06.00917692813Search in Google Scholar

105. S. P. Humphrey and R. T. Williamson, A review of saliva: normal composition, flow and function, J. Prosthet. Dent. 85 (2001) 162–169; https://doi.org/10.1067/mpr.2001.11377810.1067/mpr.2001.11377811208206Search in Google Scholar

106. S. Saini, A. Nanda, M. Hooda and K. Chaudhary, Fast dissolving films (FDF): innovative drug delivery system, Pharmacologyonline2 (2011) 919–928.Search in Google Scholar

107.M. R. C. Marques, R. Loebenberg and M. Almukainzi, Simulated biological fluids with possible application in dissolution testing, Dissolut. Technol. 18 (2011) 15–28; https://doi.org/10.14227/DT180311P15.10.14227/DT180311P15Search in Google Scholar

108. S. Gittings, Development of biorelevant simulated salivary fluids for application in dissolution testing, PhD thesis, University of Nottingham; http://eprints.nottingham.ac.uk/39862/1/Thesis%20FINAL%20version%20for%20submission_Sally%20Gittings.pdf; access date March 5, 2018.Search in Google Scholar

109. M. Guhmann, M. Preis, F. Gerber, N. Pollinger and J. Breitkreutz, W. Weitschies, Development of oral taste masked diclofenac formulations using a taste sensing system, Int. J. Pharm. 438 (2012) 81–90; https://doi.org/10.1016/j.ijpharm.2012.08.04710.1016/j.ijpharm.2012.08.04722982164Search in Google Scholar

110. A. S. S. Amal, S. Hussain and M. A. Jalaluddin, Preparation of artificial saliva formulation, 2015; https://www.researchgate.net/publication/316472372; access date March 5, 2018.Search in Google Scholar

111. G. M. Queiroz, L. F. Silva, J. T. Ferreira, J. A. Gomes and L. Sathler, Electrochemical behavior and pH stability of artificial salivas for corrosion tests, Braz. Oral Res. 21 (2007) 209–215.10.1590/S1806-8324200700030000417710285Search in Google Scholar

112. Q. Wang, N. Fotaki and Y. Mao, Biorelevant dissolution: methodology and application in drug development, Dissolution Technologies16 (2018) 6–12; https://doi.org/10.14227/DT160309P610.14227/DT160309P6Search in Google Scholar

113. Artificial salivas by Pickering laboratories; http://www.pickeringtestsolutions.com/artificial-saliva2/; access data March 5, 2018.10.1007/s41894-018-0033-5Search in Google Scholar

114. M. Dilea, A. Mazare, D. Ionita and I. Demetrescu, Comparison between corrosion behaviour of implant alloys Ti6Al7Nb and Ti6Al4Zr in artificial saliva, Materials and Corrosion64 (2013) 493–499; https://doi.org/10.1002/maco.20120652610.1002/maco.201206526Search in Google Scholar

115. European Pharmacopoeia 5 with Supplements 5.1 and 5.2, Strasbourg 2005.Search in Google Scholar

116. United States Pharmacopeia 29, National Formulary 24, US Pharmacopeial Convention, Rockville 2006.Search in Google Scholar

117. W. Brniak, R. Jachowicz and P. Pełka, The practical approach to the evaluation of methods used to determine the disintegration time of orally disintegrating tablets (ODTs), Saudi Pharm. J. 23 (2015) 437–443; https://doi.org/10.1016/j.jsps.2015.01.01510.1016/j.jsps.2015.01.015483468327134547Search in Google Scholar

118. B. Shen, C. Shen, X. D. Yuan, J. X. Bai, Q. Y. Lv, H. Xu, L. Dai, C. Yu, J. Han and H. L. Yua, Development and characterization of an orodispersible film containing drug nanoparticles, Eur. J. Pharm. Biopharm. 85 (2013) 1348–1356; https://doi.org/10.1016/j.ejpb.2013.09.01910.1016/j.ejpb.2013.09.01924103635Search in Google Scholar

119. H. Shimoda, K. Taniguchi, M. Nishimura, K. Matsuura, T. Tsukioka, H. Yamashita, N. Inagaki, K. Hirano, M. Yamamoto, Y. Kinosada and Y. Itoh, Preparation of a fast dissolving oral thin film containing dexamethasone: a possible application to antiemesis during cancer chemotherapy, Eur. J. Pharm. Biopharm. 73 (2009) 361–365; https://doi.org/10.1016/j.ejpb.2009.08.01010.1016/j.ejpb.2009.08.01019735731Search in Google Scholar

120. J. Shen and D. J. Burgess, In vitro dissolution testing strategies for nanoparticulate drug delivery systems: recent developments and challenges, Drug Deliv. Transl. Res. 3 (2013) 409–415; https://doi.org/10.1007/s13346-013-0129-z10.1007/s13346-013-0129-z377961524069580Search in Google Scholar

121. R. C. Mashru, V. B. Sutariya, M. G. Sankalia and P. P. Parikh, Development and evaluation of fast-dissolving film of salbutamol sulphate, Drug Dev. Ind. Pharm. 31 (2005) 25–34; https://doi.org/10.1081/DDC-43947.10.1081/DDC-4394715704855Search in Google Scholar

122. A. B. Nair, R. Kumria, S. Harsha, M. Attimarad, B. E. Al-Dhubiab and I. A. Alhaider, In vitro techniques to evaluate buccal films, J. Control. Release166 (2013) 10–21; https://doi.org/10.1016/j.jconrel.2012.11.01910.1016/j.jconrel.2012.11.01923219961Search in Google Scholar

123. R. Kumria, V. Gupta, S. Bansal, J. Wadhwa and A. B. Nair, Oral buccoadhesive films of ondansetron: development and evaluation, Int. J. Pharm. Investig. 3 (2013) 112–118; https://doi.org/10.4103/2230-973X.11489410.4103/2230-973X.114894375790124015383Search in Google Scholar

124. W. Brniak, E. Maślak and R. Jachowicz, Orodispersible films and tablets with prednisolone microparticles, Eur. J. Pharm. Sci. 75 (2015) 81–90; https://doi.org/10.1016/j.ejps.2015.04.00610.1016/j.ejps.2015.04.00625889975Search in Google Scholar

125. A. Adrover, A. Pedacchia, S. Petralito and R. Spera, In vitro dissolution testing of oral thin films: A comparison between USP 1, USP 2 apparatuses and a new millifluidic flow-through device, ChERD. 95 (2015) 173–178; https://doi.org/10.1016/j.cherd.2014.10.02010.1016/j.cherd.2014.10.020Search in Google Scholar

126. Y. Xia, F. Chen, H. Zhang and C. Luo, A new method for evaluating the dissolution oforodispersible films, Pharm. Dev. Technol. 20 (2015) 375–379; https://doi.org/10.3109/10837450.2014.88293610.3109/10837450.2014.88293624483710Search in Google Scholar

127. L. Perioli, V. Ambrogi, F. Angelici, M. Ricci, S. Giovagnoli, M. Capuccella and C. Rossi, Development of mucoadhesive patches for buccal administration of ibuprofen, J. Control. Release99 (2005) 73–82; https://doi.org/10.1016/j.jconrel.2004.06.00510.1016/j.jconrel.2004.06.00515342182Search in Google Scholar

128. M. A. Repka, K. Gutta, S. Prodduturi, M. Munjal and S. P. Stodghill, Characterization of cellulosic hot-melt extruded films containing lidocaine, Eur. J. Pharm. Biopharm. 59 (2005) 189–196; https://doi.org/10.1016/j.ejpb.2004.06.00810.1016/j.ejpb.2004.06.00815567317Search in Google Scholar

129. J. O. Morales and J. T. McConville, Manufacture and characterization of mucoadhesive buccal films, Eur. J. Pharm. Biopharm. 77 (2011) 187–199; https://doi.org/10.1016/j.ejpb.2010.11.02310.1016/j.ejpb.2010.11.02321130875Search in Google Scholar

130. K. K. Peh and C. F. Wong, Polymeric films as vehicle for buccal delivery: swelling, mechanical, and bioadhesive properties, J. Pharm. Pharm. Sci. 2 (1999) 53–61.Search in Google Scholar

131. A. Tai, R. Bianchini and R. Jachowicz, Texture analysis of cosmetic/pharmaceutical raw materials and formulation, Int. J. Cosmet. Sci. 36 (2014) 291–304; https://doi.org/10.1111/ics.1212510.1111/ics.1212524575934Search in Google Scholar

132. T. S. Naik, A. Khsle and H. Kanekar, Evaluation of mouth dissolving films: physical and chemical method, Int. J. Pharm. Phytopharmacol. Res. 4 (2014) 62–65.Search in Google Scholar

133. H. Landová and D. Vetchý, Evaluation of the influence of formulation and process variables on mechanical properties of oral mucoadhesive films using multivariate data analysis, Biomed Res. Int. 7 (2014) 9; https://doi.org/10.1155/2014/17956810.1155/2014/179568412967125136560Search in Google Scholar

134. M. S. Ali and C. D. Vijendar, Formulation and evaluation of fast dissolving oral films of diazepam, J. Pharmacovigilance4 (2016) 210; https://doi.org/10.4172/2329-6887.100021010.4172/2329-6887.1000210Search in Google Scholar

135. V. Y. Londhe and K. B. Umalkar, Formulation development and evaluation of fast dissolving film of telmisartan, Ind. J. Pharm. Sci. 74 (2012) 122–126; https://doi.org/10.4103/0250-474X.10384Search in Google Scholar

136. D. Mukherjee and S. Bharath, Design and characterization of double layered mucoadhesive system containing bisphosphonate derivative, ISRN Pharm. 19 (2013) 604–690; https://doi.org/10.1155/2013/60469010.1155/2013/604690388075024455313Search in Google Scholar

137. Standard test method for flexibility determination of supported adhesive films by mandrel bend, ASTM D 4338–97, 2016; https://www.astm.org/Standards/D4338.htm; access data March 5, 2018.Search in Google Scholar

138. S. Gaisford, A. Verma, M. Saunders and P. G. Rovall, Monitoring crystallisation of drugs from fast-dissolving oral films with isothermal calorimetry, Int J. Pharm. 380 (2009) 105–111; https://doi.org/10.1016/j.ijpharm.2009.07.00610.1016/j.ijpharm.2009.07.00619596058Search in Google Scholar

139. A. P. Gorle and S. G. Gattani, Development and evaluation of ocular drug delivery system, Pharm. Dev. Technol. 15 (2010) 46–52; https://doi.org/10.3109/1083745090296794710.3109/1083745090296794719552545Search in Google Scholar

140. K. B. Liew, Y. T. Tan and K. K. Peh, Characterization of oral disintegrating film containing donepezil for Alzheimer disease, AAPS PharmSciTech13 (2012) 134–142; https://doi.org/10.1208/s12249-011-9729-410.1208/s12249-011-9729-4329945822167416Search in Google Scholar

141. F. Kianfar, B. Z. Chowdhry, M. D. Antonijevic and J. S. Boateng, Novel films for drug delivery via the buccal mucosa using model soluble and insoluble drugs, Drug Dev. Ind. Pharm. 38 (2012) 1207–1220; https://doi.org/10.3109/03639045.2011.64429410.3109/03639045.2011.64429422204701Search in Google Scholar

142. V. Garsuch and J. Breitkreutz, Novel analytical methods for the characterization of oral wafers, Eur. J. Pharm. Biopharm. 73 (2009) 195–201; https://doi.org/10.1016/j.ejpb.2009.05.01010.1016/j.ejpb.2009.05.01019482082Search in Google Scholar

143. R. Bahri-Najafi, N. Tavakoli, M. Senemar and M. Peikanpour, Preparation and pharmaceutical evaluation of glibenclamide slow release mucoadhesive buccal film, Res. Pharm. Sci. 9 (2014) 213–223.Search in Google Scholar

144. R. Patel, S. Naik, J. Patel and A. Baria, Formulation development and evaluation of mouth melting film of ondansetron, Arch. Pharm. Sci. Res. 1 (2009) 212–217.Search in Google Scholar

145. K. Hermans, D. Van den Plas, S. Kerimova, R. Carleer, P. Adriaensens, W. Weyenberg and A. Ludwig, Development and characterization of mucoadhesive chitosan films for ophthalmic delivery of cyclosporine, Int. J. Pharm. 472 (2014) 10–19; https://doi.org/10.1016/j.ijpharm.2014.06.01710.1016/j.ijpharm.2014.06.01724929014Search in Google Scholar

146. G. L. Prabhushankar, B. Gopalkrishna, K. M. Manjunatha and C. H. Girisha, Formulation and evaluation of levofloxacin dental films for periodontitis, Int. J. Pharm. Pharm. Sci. 2 (2010) 162–168.Search in Google Scholar

147. R. Krampe, C. Visser, H. W. Frijlink, J. Breitkreutz, H. J. Woerdenbag and M. Preis, Oromucosal film preparations: points to consider for patient centricity and manufacturing processes, Expert Opin. Drug Deliv. 13 (2016) 493–506.10.1517/17425247.2016.111804826559519Search in Google Scholar

148. J. A. Mennella and A. C. Spector, The bad taste of medicines: overview of basic research on bitter taste, Clin. Ther. 35 (2013) 1225–1246; https://doi.org/10.1016/j.clinthera.2013.06.00710.1016/j.clinthera.2013.06.007377266923886820Search in Google Scholar

149. L. Lu, X. Hu and Z. Zhu, Biomimetic sensors and biosensors for qualitative and quantitative analyses of five basic tastes, TrAC. 83 (2017) 58–70; https://doi.org/10.1016/j.trac.2016.12.00710.1016/j.trac.2016.12.007Search in Google Scholar

150. N. Funasaki, I. Uratsuji, T. Okuno, S. Hirota and S. Neya, Masking mechanisms of bitter taste of drugs studied with ion selective electrodes, Chem. Pharm. Bull. 54 (2006) 1155–1161.10.1248/cpb.54.115516880661Search in Google Scholar

151. A. Amelian, M. Szekalska, P. Ciosek, A. Basa and K. Winnicka, Characterization and taste masking evaluation of microparticles with cetirizine dihydrochloride and methacrylate-based copolymer obtained by spray drying, Acta Pharm. 67 (2017) 113–124; https://doi.org/10.1515/acph-2017-000210.1515/acph-2017-000228231047Search in Google Scholar

152. F. Cilurzo, I. E. Cupone, P. Minghetti, S. Buratti, C. G. Gennari and L. Montanari, Diclofenac fast-dissolving film: suppression of bitterness by a taste-sensing system, Drug Dev. Ind. Pharm. 37 (2011) 252–259; https://doi.org/10.3109/03639045.2010.50592810.3109/03639045.2010.50592820704459Search in Google Scholar

153. K. Woertz, C. Tissen, P. Kleinebudde and J. Breitkreutz, Taste sensing systems (electronic tongues) for pharmaceutical applications, Int. J. Pharm. 417 (2011) 256–271; https://doi.org/10.1016/j.ijpharm.2010.11.02810.1016/j.ijpharm.2010.11.02821094230Search in Google Scholar

154. S. Gittings, N. Turnbull, C. J. Roberts and P. Gershkovich, Dissolution methodology for taste masked oral dosage forms, J. Control. Release173 (2014) 32–42; https://doi.org/10.1016/j.jconrel.2013.10.03010.1016/j.jconrel.2013.10.03024184344Search in Google Scholar

155. A. Amelian, K. Wasilewska, M. Wesoły, P. Ciosek-Skibińska and K. Winnicka, Taste-masking assessment of orally disintegrating tablets and lyophilisates with cetirizine dihydrochloridemicroparticles, Saudi Pharm. J. 25 (2017) 1144–1150; https://doi.org/10.1016/j.jsps.2017.06.00110.1016/j.jsps.2017.06.001611112330166902Search in Google Scholar