Design and evaluation of bilayered buccal film preparations for local administration of lidocaine hydrochloride

European Journal of Pharmaceutics and Biopharmaceutics

Volumn 86, Issue 3, 2014, Pages 552-561

  Preis, Maren ^a,b   Woertz, Christina ^a   Schneider, Katharina ^a   Kukawka, Jennifer ^a   Broscheit, Jens ^b,c   Roewer, Norbert ^b,c   Breitkreutz, Jörg ^a  

^a HEINRICH HEINE UNIVERSITY   (Germany)

^b Sapiotec GmbH   (Germany)

^c UNIVERSITY OF WÜRZBURG   (Germany)

Author keywords

Bilayered film; Buccal film; Fiber optic spectroscopy; Film manufacturing; Mechanical strength; Orodispersible film; Oromucosal film

Indexed keywords

HYDROXYPROPYLMETHYLCELLULOSE; LIDOCAINE; POLYMER; DRUG CARRIER;

ARTICLE; BILAYER MEMBRANE; BUCCAL FILM; DRUG ABSORPTION; DRUG RELEASE; DRUG SCREENING; DRUG SOLUBILITY; FIBER OPTICS; MOUTH CAVITY; SCANNING ELECTRON MICROSCOPY; TENSILE STRENGTH; X RAY DIFFRACTION; BUCCAL DRUG ADMINISTRATION; CHEMISTRY; DRUG DESIGN; DRUG EFFECTS; METABOLISM; MOUTH MUCOSA; PROCEDURES;

ADMINISTRATION, BUCCAL; DRUG CARRIERS; DRUG DESIGN; DRUG EVALUATION, PRECLINICAL; LIDOCAINE; MOUTH MUCOSA; TENSILE STRENGTH;

EID: 84898439078     PISSN: 09396411     EISSN: 18733441     Source Type: Journal    
DOI: 10.1016/j.ejpb.2013.12.019     Document Type: Article

References (27)

1. Oromucosal Preparations, European Directorate for the Quality of Medicines (EDQM), European Pharmacopoeia Commission in European Pharmacopoeia, 7.4 ed., EDQM, Strasbourg, France, 2012. pp. 4257-4259.
2. M. Preis, C. Woertz, P. Kleinebudde, and J. Breitkreutz Oromucosal film preparations: classification and characterization methods Expert Opin. Drug Deliv. 10 2013 1303 1317
3. C. Padula, G. Colombo, S. Nicoli, P.L. Catellani, G. Massimo, and P. Santi Bioadhesive film for the transdermal delivery of lidocaine: in vitro and in vivo behavior J. Control. Release 88 2003 277 285
4. A. Leopold, S. Wilson, J.S. Weaver, and A.M. Moursi Pharmacokinetics of lidocaine delivered from a transmucosal patch in children Anesth. Prog. 49 2002 82 87
5. N.W. Roller, and I.I. Ship Lidocaine topical film strip for oral mucosal biopsies J. Oral Med. 30 1975 55 58
6. R. Abu-Huwaij, S. Assaf, M. Salem, and A. Sallam Mucoadhesive dosage form of lidocaine hydrochloride: I. Mucoadhesive and physicochemical characterization Drug Dev. Ind. Pharm. 33 2007 855 864
7. R. Abu-Huwaij, S. Assaf, M. Salem, and A. Sallam Potential mucoadhesive dosage form of lidocaine hydrochloride: II. In vitro and in vivo evaluation Drug Dev. Ind. Pharm. 33 2007 437 448
8. 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
9. H. Okamoto, T. Nakamori, Y. Arakawa, K. Iida, and K. Danjo Development of polymer film dosage forms of lidocaine for buccal administration: II. Comparison of preparation methods J. Pharm. Sci. 91 2002 2424 2432
10. K. Ludwig, M. Krumme, Film Preparation for Biphasic Release of Pharmacologically Active or Other Substances, Patent WO 01/35934 A1, 2001.
11. B. Satishbabu, and B. Srinivasan Preparation and evaluation of buccoadhesive films of atenolol Indian J. Pharmaceut. Sci. 70 2 2008 175 179
12. Z. Cui, and R.J. Mumper Bilayer films for mucosal (genetic) immunization via the buccal route in rabbits Pharm. Res. 19 7 2002 947 953
13. K.G.H. Desai, and S.R. Mallery et al. Development and in vitro-in vivo evaluation of fenretinide-loaded oral mucoadhesive patches for site-specific chemoprevention of oral cancer Pharm. Res. 28 10 2011 2599 2609
14. K. Park, and J.R. Robinson Bioadhesive polymers as platforms for oral-controlled drug delivery: method to study bioadhesion Int. J. Pharm. 19 1984 107 127
15. C. Woertz, M. Preis, J. Breitkreutz, and P. Kleinebudde Assessment of test methods evaluating mucoadhesive polymers and dosage forms: an overview Eur. J. Pharm. Biopharm. 85 2013 843 853
16. N. Salamat-Miller, M. Chittchang, and T.P. Johnston The use of mucoadhesive polymers in buccal drug delivery Adv. Drug Deliv. Rev. 57 2005 1666 1691
17. J.O. Morales, and J.T. McConville Manufacture and characterization of mucoadhesive buccal films Eur. J. Pharm. Biopharm. 77 2011 187 199
18. 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
19. E.M. Hoffmann, A. Breitenbach, and J. Breitkreutz Advances in orodispersible films for drug delivery Expert Opin. Drug Deliv. 8 2011 299 316
20. K. Danjo, F. Higuchi, and A. Otsuka Release of lidocaine from polymer film dosage forms Chem. Pharm. Bull. 43 1995 1759 1763
21. V. Garsuch, and J. Breitkreutz Novel analytical methods for the characterization of oral wafers Eur. J. Pharm. Biopharm. 73 2009 195 201
22. DIN Deutsches Institut fur Normung DIN EN ISO 527-1 Bestimmung der Zugeigenschaften Teil 1: Allgemeine Grundsaetze 1996 Beuth Verlag GmbH Berlin
23. DIN Deutsches Institut fur Normung DIN EN ISO 527-3 Bestimmung der Zugeigenschaften Teil 3: Pruefbedingungen fuer Folien und Tafeln 2003 Beuth Verlag GmbH Berlin
24. M. Preis, M. Pein, and J. Breitkreutz Development of a taste-masked orodispersible film containing dimenhydrinate Pharmaceutics 4 2012 551 562
25. European Medicines Agency (EMA), Guideline on pharmaceutical development of medicines for paediatric use, 2013. < http://www.ema.europa.eu/docs/en-GB/ document-library/Scientific-guideline/2013/07/WC500147002.pdf > (accessed 11.09.13).
26. M. Preis, K. Knop, and J. Breitkreutz Mechanical strength test for orodispersible and buccal films Int. J. Pharm. 461 2014 22 29
27. Agency, E.M., ICH Topic Q3C (R4) Impurities: Guideline for Residual Solvents, 2008. < http://www.ema.europa.eu/docs/en-GB/document-library/ Scientific-guideline/2009/09/WC500002674.pdf >.