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

Open access

Abstract

In recent years, there has been a tendency toward creating innovative, easy to use and patient-friendly drug delivery systems suitable for every consumer profile, which would ensure safety, stability and acceptability of a drug. One of the relatively novel and promising approaches is the manufacture of orodispersible films (ODFs), which is an upcoming area of interest in drug delivery. They are defined as polymer thin films that disintegrate in the oral cavity within seconds, without drinking water or chewing, and eliminate the risk of choking. Gaining special usefulness in therapies of children and the elderly, ODFs seem to fill the gap in the range of preparations available for these groups of patients. As no detailed monography of ODFs including testing methods and uniform requirements has been presented in any of the pharmacopoeias to date, the aim of this article is to give an overview of the applied testing methods, their modifications and innovative approaches related to ODF quality assessment.

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/s12249-015-0313-1

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/10.1080/10837450.2017.1281543

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.12268

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.

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/10.4103/0976-9668.71663

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.2008.10.002

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/s12272-012-1215-3

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.2017.03.018

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.2015.10.012

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. Release 206 (2015) 1–19; https://doi.org/10.1016/j.jconrel.2015.03.006

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.2015.02.015

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 PharmSciTech 18 (2017) 267–272; https://doi.org/10.1208/s12249-016-0515-1

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.2014.11.013

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.114897

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.

16. M. B. H. Mahboob, T. Riaz, M. Jamshaid, I. Bashir and S. Zulfiqar, Oral films: A comprehensive review, ICPJ 5 (2016) 111–117.

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.5555

18. Euroepean Pharmacopoeia 7.4, Strasbourg 2012.

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.

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

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

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.

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.

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/10.1517/17425247.2011.553217

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.

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

27. R. P. Dixit and S. P. Puthil, Oral strip technology: overview and future potential, J. Control. Release 139 (2009) 94–107; https://doi.org/10.1016/j.jconrel.2009.06.014

28. J. Krause and J. Breitkreutz, Improving drug delivery in pediatric medicine, Pharm. Med. 22 (2008) 41–50; https://doi.org/10.1007/BF03256681

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.2010.03.055

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.

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.

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.

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.2016.05.004

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.2015.02.032

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

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-x

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.

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.

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.R5

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.

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/10.3109/10837450.2015.1131715

43. J. Aggarwal, G. Singh, S. Saini and A. C. Rana, Fast dissolving films: a novel approach to oral drug delivery, IRJP 2 (2011) 69–74.

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.2017.11.021

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/10.3109/03639045.2012.749889

46. V. F. Patel, F. Liu and M. B. Brown, Advances in oral transmucosal drug delivery, J. Control. Release 153 (2011) 106–116; https://doi.org/10.1016/j.jconrel.2011.01.027

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.57283

48. M. R. Gigliobianco, C. Casadidio, R. Censi and P. Di Martino, Nanocrystals of poorly soluble drugs: drug bioavailability and physicochemical stability, Pharmaceutics 10 (2018) E134.;https://doi.org/10.3390/pharmaceutics10030134

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. Nanomedicine 6 (2011) 1245–1251; hhtps://doi.org/10.2147/IJN.S19151

50. Z. Gao, S. Rohani, J. Gong and J. Wang, Recent developments in the crystallization process: toward the pharmaceutical industry, Engineering 3 (2017) 343–353; https://doi.org/10.1016/J.ENG.2017.03.022

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.2017.08.019

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/bioengineering5010016

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.2016.07.058

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.62.04.0018

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.2015.02.024

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.

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.2008.06.032

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 PharmSciTech 11 (2010) 1511–1517; https://doi.org/10.1208/s12249-010-9525-6

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.2009.05.038

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/10.1080/03639040902744704

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.

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.2016.09.011

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. Biointerfaces 112 (2013) 9–15; https://doi.org/10.1016/j.colsurfb.2013.07.019

64. Y. Murata, T. Isobe, K. Kofuji, N. Nishida and R. Kamaguchi, Preparation of fast dissolving films for oral dosage from natural polysaccharides, Materials 3 (2010) 4291–4299; https://doi.org/10.3390/ma3084291

65. P. Nagar, I. Chauhan and M. Yasir, Insights into polymers: film formers in mouth dissolving films, Drug Invent. Today 3 (2011) 280–289.

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.2016.01034

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.2009.11.001

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.

69. S. Ali and A. Quadir, High molecular weight povidone polymer-based films for fast-dissolving drug delivery application, Drug Delivery Technology 7 (2007) 36–43.

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.

71. N. Cao, X. Yang and Y. Fu, Effects of various plasticizers on mechanical and water vapor barrier properties of gelatin films, Food Hydrocolloids 23 (2009) 729–735; https://doi.org/10.1016/j.foodhyd.2008.07.017

72. A. Amelian, E. Szymańska and K. Winnicka, Formulation and characterization of loratadine containing orodispersible lyophilizates and films, Acta Pol. Pharm.-Drug Research 74 (2017) 1533–1541.

73. M. Preis, M. Pein and J. Breitkreutz, Development of a taste-masked orodispersible film containing dimenhydrinate, Pharmaceutics 4 (2012) 551–562; https://doi.org/10.3390/pharmaceutics4040551

74. P. L. Travers, Mary Poppins, New York, Howe, 1934.

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 PharmSciTec 12 (2011) 782–794; https://doi.org/10.1208/s12249-011-9634-x

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

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.

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.2013.11.033

79. S. Klein, The use of biorelevant dissolution media to forecast the in vivo performance of a drug, AAPS J 12 (2010) 397–406; https://doi.org/10.1208/s12248-010-9203-3

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.

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-z

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/pt040107

83. European Pharmacopoeia 8, Strasbourg 2014.

84. United States Pharmacopoeia 37, National Formulary 32, US Pharmacopeial Convention, Rockville 2014.

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.24303

86. S. Gittings, N. Turnbull, C. J. Roberts and P. Gershkovich, Dissolution methodology for taste masked oral dosage forms, J. Control. Release 173 (2014) 32–42; https://doi.org/10.1016/j.jconrel.2013.10.030

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.2013.10.006

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.2015.03.005

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. Release 77 (2001) 253–260.

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 Preference 21 (2010) 569–574; https://doi.org/10.1016/j.foodqual.2010.03.005

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/pt050336

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. Affairs 2 (2014) 49–60.

93. D. A. El-Setouhy and N. S. A. El-Malak, Formulation of novel tianeptine sodium orodispersible film, AAPS PharmSciTech 11 (2010) 1018–1025; https://doi.org/10.1208/s12249-010-9464-2

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.2018.09.005

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.12246

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.24609

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.2013.03.047

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.2014.1014

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.

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.2013.07.072

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.2015.01.007

102. M. Tiwari, Science behind human saliva, J. Nat. Sci. Biol. Med. 2 (2011) 53–58.

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/10.4103/0976-9668.82322

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.2007.06.009

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.2001.113778

106. S. Saini, A. Nanda, M. Hooda and K. Chaudhary, Fast dissolving films (FDF): innovative drug delivery system, Pharmacologyonline 2 (2011) 919–928.

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.

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.

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.2012.08.047

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.

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.

112. Q. Wang, N. Fotaki and Y. Mao, Biorelevant dissolution: methodology and application in drug development, Dissolution Technologies 16 (2018) 6–12; https://doi.org/10.14227/DT160309P6

113. Artificial salivas by Pickering laboratories; http://www.pickeringtestsolutions.com/artificial-saliva2/; access data March 5, 2018.

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 Corrosion 64 (2013) 493–499; https://doi.org/10.1002/maco.201206526

115. European Pharmacopoeia 5 with Supplements 5.1 and 5.2, Strasbourg 2005.

116. United States Pharmacopeia 29, National Formulary 24, US Pharmacopeial Convention, Rockville 2006.

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.2015.01.015

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.2013.09.019

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.2009.08.010

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-z

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.

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. Release 166 (2013) 10–21; https://doi.org/10.1016/j.jconrel.2012.11.019

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.114894

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.2015.04.006

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.2014.10.020

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/10.3109/10837450.2014.882936

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. Release 99 (2005) 73–82; https://doi.org/10.1016/j.jconrel.2004.06.005

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.2004.06.008

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.2010.11.023

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.

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.12125

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.

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/10.1155/2014/179568

134. M. S. Ali and C. D. Vijendar, Formulation and evaluation of fast dissolving oral films of diazepam, J. Pharmacovigilance 4 (2016) 210; https://doi.org/10.4172/2329-6887.1000210

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.10384

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/10.1155/2013/604690

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.

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.2009.07.006

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/10.3109/10837450902967947

140. K. B. Liew, Y. T. Tan and K. K. Peh, Characterization of oral disintegrating film containing donepezil for Alzheimer disease, AAPS PharmSciTech 13 (2012) 134–142; https://doi.org/10.1208/s12249-011-9729-4

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/10.3109/03639045.2011.644294

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.2009.05.010

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.

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.

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.2014.06.017

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.

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.

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.2013.06.007

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.2016.12.007

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.

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-2017-0002

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/10.3109/03639045.2010.505928

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.2010.11.028

154. S. Gittings, N. Turnbull, C. J. Roberts and P. Gershkovich, Dissolution methodology for taste masked oral dosage forms, J. Control. Release 173 (2014) 32–42; https://doi.org/10.1016/j.jconrel.2013.10.030

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.2017.06.001

Acta Pharmaceutica

The Journal of Croatian Pharmaceutical Society

Journal Information


IMPACT FACTOR 2017: 1.071
5-year IMPACT FACTOR: 1.623

CiteScore 2017: 1.46

SCImago Journal Rank (SJR) 2017: 0.362
Source Normalized Impact per Paper (SNIP) 2017: 0.642

Metrics

All Time Past Year Past 30 Days
Abstract Views 0 0 0
Full Text Views 193 193 112
PDF Downloads 82 82 47