Manufacture and characterization of mucoadhesive buccal films

Javier O. Morales1, Jason T. McConville1
1College of Pharmacy, University of Texas at Austin, Austin, USA

Tài liệu tham khảo

Hariharan, 2009, Orally dissolving film strips: the final evolution of orally dissolving dosage forms, Drug Delivery Technology, 9, 24 Dixit, 2009, Oral strip technology: overview and future potential, Journal of Controlled Release, 139, 94, 10.1016/j.jconrel.2009.06.014 Li, 1998, Evaluation of a mucoadhesive buccal patch for delivery of peptides: in vitro screening of bioadhesion, Drug Development and Industrial Pharmacy, 24, 919, 10.3109/03639049809097271 Peh, 1999, Polymeric films as vehicle for buccal delivery: swelling, mechanical, and bioadhesive properties, Journal of Pharmacy and Pharmaceutical Sciences, 2, 53 Lee, 1995, Oral mucosa controlled delivery of LHRH by bilayer mucoadhesive polymer systems, Journal of Controlled Release, 37, 251, 10.1016/0168-3659(95)00082-8 Guo, 1999, Development of bioadhesive buccal patches, 541 Donnelly, 2007, Potential of photodynamic therapy in treatment of fungal infections of the mouth. Design and characterisation of a mucoadhesive patch containing toluidine blue O, Journal of Photochemistry and Photobiology B: Biology, 86, 59, 10.1016/j.jphotobiol.2006.07.011 Khanna, 1997, Preparation and evaluation of muco-adhesive buccal films of clotrimazole for oral candida infections, Indian Journal of Pharmaceutical Sciences, 59, 299 Repka, 2003, Production and characterization of hot-melt extruded films containing clotrimazole, Drug Development and Industrial Pharmacy, 29, 757, 10.1081/DDC-120021775 Senel, 2000, Chitosan films and hydrogels of chlorhexidine gluconate for oral mucosal delivery, International Journal of Pharmaceutics, 193, 197, 10.1016/S0378-5173(99)00334-8 Singh, 2008, Preparation and evaluation of buccal bioadhesive films containing clotrimazole, AAPS Pharmaceutical Science and Technology, 9, 660, 10.1208/s12249-008-9083-3 Squier, 1996, Structure and function of the oral mucosa and implications for drug delivery Ahuja, 1997, Mucoadhesive drug delivery systems, Drug Development and Industrial Pharmacy, 23, 489, 10.3109/03639049709148498 Pathan, 2008, Buccoadhesive drug delivery systems – extensive review on recent patents, Recent Patents on Drug Delivery and Formulation, 2, 177, 10.2174/187221108784534135 Ponchel, 1994, Formulation of oral mucosal drug delivery systems for the systemic delivery of bioactive materials, Advanced Drug Delivery Reviews, 13, 75, 10.1016/0169-409X(94)90027-2 Repka, 2004, Matrix- and reservoir-based transmucosal delivery systems: tailoring delivery solutions, American Journal of Drug Delivery, 2, 173, 10.2165/00137696-200402030-00003 Smart, 2004, Recent developments in the use of bioadhesive systems for delivery of drugs to the oral cavity, Critical Reviews in Therapeutic Drug Carrier Systems, 21, 319, 10.1615/CritRevTherDrugCarrierSyst.v21.i4.20 Nicolazzo, 2005, Buccal penetration enhancers – how do they really work?, Journal of Controlled Release, 105, 1, 10.1016/j.jconrel.2005.01.024 Asane, 2008, Polymers for mucoadhesive drug delivery system: a current status, Drug Development and Industrial Pharmacy, 34, 1246, 10.1080/03639040802026012 Mizrahi, 2008, Mucoadhesive polymers for delivery of drugs to the oral cavity, Recent Patents on Drug Delivery and Formulation, 2, 108, 10.2174/187221108784534126 Salamat-Miller, 2005, The use of mucoadhesive polymers in buccal drug delivery, Advanced Drug Delivery Reviews, 57, 1666, 10.1016/j.addr.2005.07.003 Wertz, 1991, Cellular and molecular basis of barrier function in oral epithelium, Critical Reviews in Therapeutic Drug Carrier Systems, 8, 237 Collins, 1987, The surface area of the adult human mouth and thickness of the salivary film covering the teeth and oral mucosa, Journal of Dental Research, 66, 1300, 10.1177/00220345870660080201 DeGrande, 1996, Specialized oral mucosal drug delivery systems: patches Squier, 1989, Oral mucosa, 319 Gandhi, 1994, Oral cavity as a site for bioadhesive drug delivery, Advanced Drug Delivery Reviews, 13, 43, 10.1016/0169-409X(94)90026-4 Li, 2005, Preclinical assessment of oral mucosal drug delivery systems, 41 Matoltsy, 1965, Membrane-coating granules of keratinizing epithelia, Journal of Cell Biology, 24, 297, 10.1083/jcb.24.2.297 Squier, 1977, Membrane coating granules in nonkeratinizing oral epithelium, Journal of Ultrastructure Research, 60, 212, 10.1016/S0022-5320(77)80066-X Squier, 1982, Zinc iodide–osmium staining of membrane-coating granules in keratinized and non-keratinized mammalian oral epithelium, Archives of Oral Biology, 27, 377, 10.1016/0003-9969(82)90146-7 Wertz, 1993, Regional variation in the structure and permeability of oral mucosa and skin, Advanced Drug Delivery Reviews, 12, 1, 10.1016/0169-409X(93)90037-5 Law, 1995, Regional variation in content, composition and organization of porcine epithelial barrier lipids revealed by thin-layer chromatography and transmission electron microscopy, Archives of Oral Biology, 40, 1085, 10.1016/0003-9969(95)00091-7 Squier, 1973, The permeability of keratinized and nonkeratinized oral epithelium to horseradish peroxidase, Journal of Ultrastructure Research, 43, 160, 10.1016/S0022-5320(73)90076-2 Squier, 1986, The lipid composition of porcine epidermis and oral epithelium, Archives of Oral Biology, 31, 741, 10.1016/0003-9969(86)90006-3 Squier, 1991, Thin-layer chromatographic analyses of lipids in different layers of porcine epidermis and oral epithelium, Archives of Oral Biology, 36, 647, 10.1016/0003-9969(91)90017-O Squier, 1991, Lipid content and water permeability of skin and oral mucosa, Journal of Investigative Dermatology, 96, 123, 10.1111/1523-1747.ep12515931 Wertz, 1986, Lipids of epidermis and keratinized and non-keratinized oral epithelia, Comparative Biochemistry and Physiology Part B, 83, 529, 10.1016/0305-0491(86)90291-9 Barnett, 1973, Gap junctions in human gingival keratinized epithelium, Journal of Periodontal Research, 8, 117, 10.1111/j.1600-0765.1973.tb01750.x Harris, 1992, Drug delivery via the mucous membranes of the oral cavity, Journal of Pharmaceutical Sciences, 81, 1, 10.1002/jps.2600810102 Senel, 2001, Drug permeation enhancement via buccal route: possibilities and limitations, Journal of Controlled Release, 72, 133, 10.1016/S0168-3659(01)00269-3 Utoguchi, 1997, Carrier-mediated transport of monocarboxylic acids in primary cultured epithelial cells from rabbit oral mucosa, Pharmaceutical Research, 14, 320, 10.1023/A:1012046021028 Dowty, 1992, Transport of thyrotropin releasing hormone in rabbit buccal mucosa in vitro, Pharmaceutical Research, 9, 1113, 10.1023/A:1015883217858 Lesch, 1988, Penetration pathways different compounds through epidermis and oral epithelia, Journal of Oral Pathology & Medicine, 17, 512, 10.1111/j.1600-0714.1988.tb01326.x Hoogstraate, 1994, Diffusion rates and transport pathways of fluorescein isothiocyanate (FITC)-labeled model compounds through buccal epithelium, Pharmaceutical Research, 11, 83, 10.1023/A:1018949828548 Hoogstraate, 1996, Effects of bile salts on transport rates and routes of FITC-labelled compounds across porcine buccal epithelium in vitro, Journal of Controlled Release, 40, 211, 10.1016/0168-3659(95)00187-5 Lee, 2000, Bioadhesive-based dosage forms: the next generation, Journal of Pharmaceutical Sciences, 89, 850, 10.1002/1520-6017(200007)89:7<850::AID-JPS2>3.0.CO;2-G Peppas, 1985, Surface, interfacial and molecular aspects of polymer bioadhesion on soft tissues, Journal of Controlled Release, 2, 257, 10.1016/0168-3659(85)90050-1 Guo, 1994, Bioadhesive polymer buccal patches for buprenorphine controlled delivery: formulation, in-vitro adhesion and release properties, Drug Development and Industrial Pharmacy, 20, 2809, 10.3109/03639049409042682 Semalty, 2008, Formulation and characterization of mucoadhesive buccal films of glipizide, Indian Journal of Pharmaceutical Sciences, 70, 43, 10.4103/0250-474X.40330 Merkle, 1989, Evaluation of laminated muco-adhesive patches for buccal drug delivery, International Journal of Pharmaceutics, 49, 231, 10.1016/0378-5173(89)90347-5 Dubolazov, 2006, Design of mucoadhesive polymeric films based on blends of poly(acrylic acid) and (hydroxypropyl)cellulose, Biomacromolecules, 7, 1637, 10.1021/bm060090l Shidhaye, 2008, Mucoadhesive bilayered patches for administration of sumatriptan succinate, AAPS Pharmaceutical Science and Technology, 9, 909, 10.1208/s12249-008-9125-x Bogataj, 2003, The correlation between zeta potential and mucoadhesion strength on pig vesical mucosa, Biological and Pharmaceutical Bulletin, 26, 743, 10.1248/bpb.26.743 Cui, 2007, Nanoparticles incorporated in bilaminated films: a smart drug delivery system for oral formulations, Biomacromolecules, 8, 2845, 10.1021/bm070339e He, 2009, A polymeric composite carrier for oral delivery of peptide drugs: bilaminated hydrogel film loaded with nanoparticles, European Polymer Journal, 45, 368, 10.1016/j.eurpolymj.2008.11.004 Perumal, 2008, Formulation of monolayered films with drug and polymers of opposing solubilities, International Journal of Pharmaceutics, 358, 184, 10.1016/j.ijpharm.2008.03.005 Wong, 1999, Formulation and evaluation of controlled release Eudragit buccal patches, International Journal of Pharmaceutics, 178, 11, 10.1016/S0378-5173(98)00342-1 Yehia, 2009, Fluconazole mucoadhesive buccal films: in vitro/in vivo performance, Current Drug Delivery, 6, 17, 10.2174/156720109787048195 Cilurzo, 2003, Polymethacrylate salts as new low-swellable mucoadhesive materials, Journal of Controlled Release, 88, 43, 10.1016/S0168-3659(02)00459-5 Lehr, 1992, In vitro evaluation of mucoadhesive properties of chitosan and some other natural polymers, International Journal of Pharmaceutics, 78, 43, 10.1016/0378-5173(92)90353-4 Longer, 1986, Fundamental aspects of bioadhesion, Pharmacy International, 7, 114 Smart, 2005, The basics and underlying mechanisms of mucoadhesion, Advanced Drug Delivery Reviews, 57, 1556, 10.1016/j.addr.2005.07.001 BioDelivery Sciences International, Onsolis™. <http://www.bdsi.com/onsolis.php> (24.09.10). Reckitt Benckiser Pharmaceuticals Inc., Suboxone™ Sublingual Film (buprenorphine and naloxone). <http://www.suboxone.com/hcp/suboxone_film/Default.aspx> (24.09.10). Barnhart, 2008, Thin film oral dosage forms, 209 International Conference on Harmonization, ICH topic Q3C(R3) Impurities: Residual Solvents, 2009. <http://www.emea.europa.eu/pdfs/human/ich/028395en.pdf>. Jug, 2009, Novel cyclodextrin-based film formulation intended for buccal delivery of atenolol, Drug Development and Industrial Pharmacy, 35, 796, 10.1080/03639040802596212 Sahni, 2008, Design and in vitro characterization of buccoadhesive drug delivery system of insulin, Indian Journal of Pharmaceutical Sciences, 70, 61, 10.4103/0250-474X.40333 Satishbabu, 2008, Preparation and evaluation of buccoadhesive films of atenolol, Indian Journal of Pharmaceutical Sciences, 70, 175, 10.4103/0250-474X.41451 Eouani, 2001, In-vitro comparative study of buccal mucoadhesive performance of different polymeric films, European Journal of Pharmaceutics and Biopharmaceutics, 52, 45, 10.1016/S0939-6411(01)00146-1 Llabot, 2007, Design of novel antifungal mucoadhesive films: Part I. Pre-formulation studies, International Journal of Pharmaceutics, 330, 54, 10.1016/j.ijpharm.2006.08.042 W. Schmidt, Process for producing an administration or dosage form for drugs, reagents or other active ingredients, US Patent 4849246, July 18, 1989. R. Yang, R. Fuisz, G. Myers, J. Fuisz, Thin film with non-self-aggregating uniform heterogeneity and drug delivery systems made therefrom, US Patent 7425292, September 16, 2008. Perumal, 2008, Investigating a new approach to film casting for enhanced drug content uniformity in polymeric films, Drug Development and Industrial Pharmacy, 34, 1036, 10.1080/03639040801928952 Ahmed, 2004, Penciclovir solubility in Eudragit films: a comparison of X-ray, thermal, microscopic and release rate techniques, Journal of Pharmaceutical and Biomedical Analysis, 34, 945, 10.1016/j.jpba.2003.11.018 Doijad, 2006, Buccoadhesive drug delivery system of isosorbide dinitrate: Formulation and evaluation, Indian Journal of Pharmaceutical Sciences, 68, 744, 10.4103/0250-474X.31007 Fountain, 2003, Near-infrared spectroscopy for the determination of testosterone in thin-film composites, Journal of Pharmaceutical and Biomedical Analysis, 33, 181, 10.1016/S0731-7085(03)00345-5 Jay, 2002, Transmucosal delivery of testosterone in rabbits using novel bi-layer mucoadhesive wax-film composite disks, Journal of Pharmaceutical Sciences, 91, 2016, 10.1002/jps.10198 Patel, 2006, Physicochemical characterization and evaluation of buccal adhesive patches containing propranolol hydrochloride, Current Drug Delivery, 3, 325, 10.2174/156720106777731082 Perugini, 2003, Periodontal delivery of ipriflavone: new chitosan/PLGA film delivery system for a lipophilic drug, International Journal of Pharmaceutics, 252, 1, 10.1016/S0378-5173(02)00602-6 Repka, 2006, Temperature stability and bioadhesive properties of Δ9-tetrahydrocannabinol incorporated hydroxypropylcellulose polymer matrix systems, Drug Development and Industrial Pharmacy, 32, 21, 10.1080/03639040500387914 Sharma, 2001, Formulation and evaluation of buccal mucoadhesive patches of terbutaline sulphate, STP Pharma Sciences, 11, 275 M. Mollan, Historical overview, in: I. Ghebre-Sellassie, C. Martin (Eds.), Pharmaceutical Extrusion Technology, CRC Press, 2003, pp. 1–18. Repka, 2007, Pharmaceutical applications of hot-melt extrusion: Part II, Drug Development and Industrial Pharmacy, 33, 1043, 10.1080/03639040701525627 Cilurzo, 2008, Fast dissolving films made of maltodextrins, European Journal of Pharmaceutics and Biopharmaceutics, 70, 895, 10.1016/j.ejpb.2008.06.032 Prodduturi, 2005, Solid-state stability and characterization of hot-melt extruded poly(ethylene oxide) films, Journal of Pharmaceutical Sciences, 94, 2232, 10.1002/jps.20437 Repka, 2005, Characterization of cellulosic hot-melt extruded films containing lidocaine, European Journal of Pharmaceutics and Biopharmaceutics, 59, 189, 10.1016/j.ejpb.2004.06.008 Repka, 2001, Bioadhesive properties of hydroxypropylcellulose topical films produced by hot-melt extrusion, Journal of Controlled Release, 70, 341, 10.1016/S0168-3659(00)00365-5 Thumma, 2008, Preformulation studies of a prodrug of Δ9-tetrahydrocannabinol, AAPS Pharmaceutical Science and Technology, 9, 982, 10.1208/s12249-008-9136-7 Repka, 1999, Influence of plasticizers and drugs on the physical–mechanical properties of hydroxypropylcellulose films prepared by hot melt extrusion, Drug Development and Industrial Pharmacy, 25, 625, 10.1081/DDC-100102218 Prodduturi, 2004, Water vapor sorption of hot-melt extruded hydroxypropyl cellulose films: effect on physico-mechanical properties, release characteristics, and stability, Journal of Pharmaceutical Sciences, 93, 3047, 10.1002/jps.20222 Kopcha, 1990, Evaluation of methodology for assessing release characteristics of thermosoftening vehicles, Journal of Pharmacy and Pharmacology, 42, 745, 10.1111/j.2042-7158.1990.tb07014.x Peppas, 1987, A simple equation for description of solute release. I: Fickian and non-Fickian release from non-swellable devices in the form of slabs, spheres, cylinders or discs, Journal of Controlled Release, 5, 23, 10.1016/0168-3659(87)90034-4 Thumma, 2008, Influence of plasticizers on the stability and release of a prodrug of [Delta]9-tetrahydrocannabinol incorporated in poly (ethylene oxide) matrices, European Journal of Pharmaceutics and Biopharmaceutics, 70, 605, 10.1016/j.ejpb.2008.06.009 Chickering, 1999, Definitions, mechanisms, and theories of bioadhesion Peppas, 1996, Hydrogels as mucoadhesive and bioadhesive materials: a review, Biomaterials, 17, 1553, 10.1016/0142-9612(95)00307-X Derjaguin, 1969 Kinloch, 1980, The science of adhesion. I: Surface and interfacial aspects, Journal of Materials Science, 15, 2141, 10.1007/BF00552302 Hench, 1982 Baszkin, 1990, Wettability of polymers by mucin aqueous solutions, Biorheology, 27, 503, 10.3233/BIR-1990-273-429 Prager, 1981, The healing process at polymer–polymer interfaces, Journal of Chemical Physics, 75, 5194, 10.1063/1.441871 Kammer, 1983, Adhesion between polymers. Review, Acta Polymerica, 34, 112, 10.1002/actp.1983.010340210 J. Smart, The role of water movement and polymer hydration in mucoadhesion, in: E. Mathiowitz, D. Chickering, C. Lehr (Eds.), Bioadhesive Drug Delivery Systems: Fundamentals, Novel Approaches, and Development, Marcel Dekker, Inc, New York, 1999, pp. 11–23. Kinloch, 1980, The science of adhesion. Part 1: Surface and interfacial aspects, Journal of Materials Science, 15, 2141, 10.1007/BF00552302 Mikos, 1986, Systems for controlled release of drugs. V: Bioadhesive systems, STP Pharma Sciences, 2, 705 Voiutskii, 1963 Chun, 2003, Preparation of buccal patch composed of carbopol, poloxamer and hydroxypropyl methylcellulose, Archives of Pharmacal Research, 26, 973, 10.1007/BF02980208 Mumper, 2002, Bilayer films for mucosal (genetic) immunization via the buccal route in rabbits, Pharmaceutical Research, 19, 947, 10.1023/A:1016454003450 Nafee, 2003, Mucoadhesive buccal patches of miconazole nitrate: in vitro/in vivo performance and effect of ageing, International Journal of Pharmaceutics, 264, 1, 10.1016/S0378-5173(03)00371-5 Nappinnai, 2008, Formulation and evaluation of nitrendipine buccal films, Indian Journal of Pharmaceutical Sciences, 70, 631, 10.4103/0250-474X.45402 Jain, 2008, Design and development of a mucoadhesive buccal film bearing progesterone, Pharmazie, 63, 129 Patel, 2009, Development and characterization of mucoadhesive buccal patches of salbutamol sulphate, Current Drug Delivery, 6, 140, 10.2174/156720109787048177 Perioli, 2004, Development of mucoadhesive patches for buccal administration of ibuprofen, Journal of Controlled Release, 99, 73, 10.1016/j.jconrel.2004.06.005 Patel, 2007, Effect of hydrophilic polymers on buccoadhesive Eudragit patches of propranolol hydrochloride using factorial design, AAPS Pharmaceutical Science and Technology, 8, E119, 10.1208/pt0802045 Remunan-Lopez, 1998, Design and evaluation of chitosan/ethylcellulose mucoadhesive bilayered devices for buccal drug delivery, Journal of Controlled Release, 55, 143, 10.1016/S0168-3659(98)00044-3 Wong, 1999, An in-vitro method for buccal adhesion studies: importance of instrument variables, International Journal of Pharmaceutics, 180, 47, 10.1016/S0378-5173(98)00402-5 Garg, 2007, Development and evaluation of a buccal bioadhesive system for smoking cessation therapy, Pharmazie, 62, 266 Kim, 2007, A novel mucoadhesive polymer film composed of carbopol, poloxamer and hydroxypropylmethylcellulose, Archives of Pharmacal Research, 30, 381, 10.1007/BF02977622 Llabot, 2007, Design of novel antifungal mucoadhesive films: Part II. Formulation and in vitro biopharmaceutical evaluation, International Journal of Pharmaceutics, 336, 263, 10.1016/j.ijpharm.2006.12.001 2004, 13 ASTM, Standard Test Methods for Tensile Properties of Thin Plastic Sheeting – D 882, American Standard Testing Methods, 1991. McGinity, 2000, Physical–mechanical, moisture absorption and bioadhesive properties of hydroxypropylcellulose hot-melt extruded films, Biomaterials, 21, 1509, 10.1016/S0142-9612(00)00046-6 Repka, 2001, Influence of chlorpheniramine maleate on topical hydroxypropylcellulose films produced by hot-melt extrusion, Pharmaceutical Development and Technology, 6, 297, 10.1081/PDT-100002610 El-Kamel, 2007, Micromatricial metronidazole benzoate film as a local mucoadhesive delivery system for treatment of periodontal diseases, AAPS Pharmaceutical Science and Technology, 8, E184, 10.1208/pt0803075 Zhang, 2002, Properties and biocompatibility of chitosan films modified by blending with PEG, Biomaterials, 23, 2641, 10.1016/S0142-9612(01)00403-3 Mashru, 2005, Development and evaluation of fast-dissolving film of salbutamol sulphate, Drug Development and Industrial Pharmacy, 31, 25, 10.1081/DDC-43947 Sudhakar, 2006, Buccal bioadhesive drug delivery – a promising option for orally less efficient drugs, Journal of Controlled Release, 114, 15, 10.1016/j.jconrel.2006.04.012 Perumal, 2008, Formulation of monolayered films with drug and polymers of opposing solubilities, International Journal of Pharmaceutics, 358, 184, 10.1016/j.ijpharm.2008.03.005 L. Felton, P. O’Donell, J. McGinity, Mechanical properties of polymeric films prepared from aqueous dispersions, in: J. McGinity, L. Felton (Eds.), Aqueous Polymeric Coatings for Pharmaceutical Dosage Forms, third ed., Informa Healthcare, New York, 2008, pp. 105–128. Aulton, 1981, The mechanical properties of hydroxypropylmethylcellulose films derived from aqueous systems: the influence of solid inclusions, Drug Development and Industrial Pharmacy, 7, 649, 10.3109/03639048109055689 Heng, 2003, Influence of storage conditions and type of plasticizers on ethylcellulose and acrylate films formed from aqueous dispersions, Journal of Pharmacy & Pharmaceutical Sciences: A Publication of the Canadian Society for Pharmaceutical Sciences, Société Canadienne Des Sciences Pharmaceutiques., 6, 334 ASTM, Standard Test Method for Tear Resistance (Graves Tear) of Plastic Film and Sheeting – D 1004, American Standard Testing Methods, 2008. Deshmane, 2009, Chitosan based sustained release mucoadhesive buccal patches containing verapamil HCL, International Journal of Pharmacy and Pharmaceutical Sciences, 1, 216 Danjo, 1995, Release of lidocaine from polymer film dosage forms, Chemical and Pharmaceutical Bulletin, 43, 1759, 10.1248/cpb.43.1759 Jacques, 1997, Human buccal absorption of codeine phosphate from a bioadhesive drug delivery device, STP Pharma Sciences, 7, 289 Abu-Huwaij, 2007, Potential mucoadhesive dosage form of lidocaine hydrochloride: II. In vitro and in vivo evaluation, Drug Development and Industrial Pharmacy, 33, 437, 10.1080/03639040601150211 Alanazi, 2007, Formulation and physicochemical characterisation of buccoadhesive films containing ketorolac, Journal of Drug Delivery Science and Technology, 17, 183, 10.1016/S1773-2247(07)50034-1 Alsarra, 2007, Clinical evaluation of novel buccoadhesive film containing ketorolac in dental and post-oral surgery pain management, Pharmazie, 62, 773 Diaz del Consuelo, 2007, Ex vivo evaluation of bioadhesive films for buccal delivery of fentanyl, Journal of Controlled Release, 122, 135, 10.1016/j.jconrel.2007.05.017 Raghuraman, 2002, Design and evaluation of propranolol hydrochloride buccal films, Indian Journal of Pharmaceutical Sciences, 64, 32 Ching, 2008, A novel diffusion cell ideal for the study of membrane extraction/permeation processes and for device/sensor development, Sensors and Actuators B: Chemical, 129, 30, 10.1016/j.snb.2007.07.070 Connolly, 2002, Opportunities at the skin interface for continuous patient monitoring: a reverse iontophoresis model tested on lactate and glucose, IEEE Transactions on Nanobioscience, 1, 37, 10.1109/TNB.2002.806939 H. Zhang, J. Robinson, In vitro methods for measuring permeability of the oral mucosa, in: M. Rathbone (Ed.), Oral Mucosal Drug Delivery, Informa Health Care, 1996, pp. 85–100. Sohi, 2010, Critical evaluation of permeation enhancers for oral mucosal drug delivery, Drug Development and Industrial Pharmacy, 1 de Vries, 1991, Localization of the permeability barrier inside porcine buccal mucosa: a combined in vitro study of drug permeability, electrical resistance and tissue morphology, International Journal of Pharmaceutics, 76, 25, 10.1016/0378-5173(91)90340-T Fabrizio, 2009, In vitro permeation of desmopressin across rabbit nasal mucosa from liquid nasal sprays: the enhancing effect of potassium sorbate, European Journal of Pharmaceutical Sciences, 37, 36, 10.1016/j.ejps.2008.12.015 Imbert, 1999, Buccal mucosa in vitro experiments: I. Confocal imaging of vital staining and MTT assays for the determination of tissue viability, Journal of Controlled Release, 58, 39, 10.1016/S0168-3659(98)00143-6 B. Aungst, Oral mucosal permeation enhancement: possibilities and limitations, in: M.J. Rathbone (Ed.), Oral Mucosal Drug Delivery, Informa Health Care, 1996. B.R. Jasti, V. Marasanapalle, X. Li, Modulation of oral transmucosal permeability: permeation enhancers, in: T.K. Ghosh, W.R. Pfister (Eds.), Drug Delivery to the Oral Cavity, Taylor & Francis, New York, 2005. Deneer, 2002, Buccal transport of flecainide and sotalol: effect of a bile salt and ionization state, International Journal of Pharmaceutics, 241, 127, 10.1016/S0378-5173(02)00229-6 Senel, 1997, Enhancement of transbuccal permeation of morphine sulfate by sodium glycodeoxycholate in vitro, Journal of Controlled Release, 45, 153, 10.1016/S0168-3659(96)01568-4 Shojaei, 1998, Buccal mucosa as a route for systemic drug delivery: a review, Journal of Pharmacy & Pharmaceutical Sciences: A Publication of the Canadian Society for Pharmaceutical Sciences, Société Canadienne Des Sciences Pharmaceutiques., 1, 15 Xiang, 2002, Transbuccal delivery of 2′,3′-dideoxycytidine: in vitro permeation study and histological investigation, International Journal of Pharmaceutics, 231, 57, 10.1016/S0378-5173(01)00865-1 Okamoto, 2001, Development of polymer film dosage forms of lidocaine for buccal administration: I. Penetration rate and release rate, Journal of Controlled Release, 77, 253, 10.1016/S0168-3659(01)00509-0 Sekhar, 2008, Transbuccal delivery of chlorpheniramine maleate from mucoadhesive buccal patches, Drug Delivery, 15, 185, 10.1080/10717540801952639 Tiwari, 2009, L9 orthogonal design assisted formulation and evaluation of chitosan based buccoadhesive films of miconazole nitrate, Current Drug Delivery, 6, 305, 10.2174/156720109788680921 Kharenko, 2008, Mucoadhesive drug delivery systems: quantitative assessment of interaction between synthetic and natural polymer films and mucosa, Pharmaceutical Chemistry Journal, 42, 392, 10.1007/s11094-008-0132-8 Arakawa, 2005, Effect of low-molecular-weight beta-cyclodextrin polymer on release of drugs from mucoadhesive buccal film dosage forms, Biological and Pharmaceutical Bulletin, 28, 1679, 10.1248/bpb.28.1679 Kohda, 1997, Controlled release of lidocaine hydrochloride from buccal mucosa-adhesive films with solid dispersion, International Journal of Pharmaceutics, 158, 147, 10.1016/S0378-5173(97)00241-X Okamoto, 2002, Development of polymer film dosage forms of lidocaine for buccal administration: II. Comparison of preparation methods, Journal of Pharmaceutical Sciences, 91, 2424, 10.1002/jps.10228 Takeuchi, 2008, In vitro and clinical evaluation of an oral mucosal adhesive film containing indomethacin, Yakugaku zasshi: Journal of the Pharmaceutical Society of Japan, 128, 1791, 10.1248/yakushi.128.1791 Yanagi, 2008, Oral candidiasis deteriorated by local application of a glucocorticoid-containing film in a mouse model, Biological and Pharmaceutical Bulletin, 31, 278, 10.1248/bpb.31.278 Juliano, 2008, Preparation, in vitro characterization and preliminary in vivo evaluation of buccal polymeric films containing chlorhexidine, AAPS Pharmaceutical Science and Technology, 9, 1153, 10.1208/s12249-008-9153-6 Averineni, 2009, Development of mucoadhesive buccal films for the treatment of oral sub-mucous fibrosis: a preliminary study, Pharmaceutical Development and Technology, 14, 199, 10.1080/10837450802498928 Skulason, 2009, Evaluation of polymeric films for buccal drug delivery, Pharmazie, 64, 197 Thimmasetty, 2008, Design and in vivo evaluation of carvedilol buccal mucoadhesive patches, Pakistan Journal of Pharmaceutical Sciences, 21, 241 Singh, 2010, In vitro and in vivo evaluation of buccal bioadhesive films containing salbutamol sulphate, Chemical and Pharmaceutical Bulletin, 58, 307, 10.1248/cpb.58.307 Patel, 2007, Formulation, evaluation, and comparison of bilayered and multilayered mucoadhesive buccal devices of propranolol hydrochloride, AAPS Pharmaceutical Science and Technology, 8, 147, 10.1208/pt0801022 Juliano, 2007, Preparation and characterisation of polymeric films containing propolis, Journal of Drug Delivery Science and Technology, 17, 177, 10.1016/S1773-2247(07)50033-X Rossi, 2003, Buccal delivery of acyclovir from films based on chitosan and polyacrylic acid, Pharmaceutical Development and Technology, 8, 199, 10.1081/PDT-120018490 Aksungur, 2004, Chitosan delivery systems for the treatment of oral mucositis: in vitro and in vivo studies, Journal of Controlled Release, 98, 269, 10.1016/j.jconrel.2004.05.002 Brown, 2001, Release of PEGylated granulocyte–macrophage colony-stimulating factor from chitosan/glycerol films, Journal of Controlled Release, 72, 35, 10.1016/S0168-3659(01)00260-7 Cui, 2009, Preparation and evaluation of chitosan–ethylenediaminetetraacetic acid hydrogel films for the mucoadhesive transbuccal delivery of insulin, Journal of Biomedical Materials Research Part A, 89A, 1063, 10.1002/jbm.a.32071 Pongjanyakul, 2009, Alginate–magnesium aluminum silicate films for buccal delivery of nicotine, Colloids and Surfaces B: Biointerfaces, 74, 103, 10.1016/j.colsurfb.2009.06.033 Ahuja, 2003, Effect of dental films containing amoxycillin and metronidazole on periodontal pathogens: microbiological response, Pharmazie, 58, 716 Benes, 1997, Transmucosal, oral controlled-release, and transdermal drug administration in human subjects: a crossover study with melatonin, Journal of Pharmaceutical Sciences, 86, 1115, 10.1021/js970011z Guo, 1998, Theoretical approaches and practical investigations in carbopol buccal patches for drug delivery, Drug Development and Industrial Pharmacy, 24, 175, 10.3109/03639049809085603 McQuinn, 1995, Sustained oral mucosal delivery in human volunteers of buprenorphine from a thin non-eroding mucoadhesive polymeric disk, Journal of Controlled Release, 34, 243, 10.1016/0168-3659(95)00008-V Abu-Huwaij, 2007, Mucoadhesive dosage form of lidocaine hydrochloride: I. Mucoadhesive and physicochemical characterization, Drug Development and Industrial Pharmacy, 33, 855, 10.1080/03639040701377516 Cui, 2002, Buccal transmucosal delivery of calcitonin in rabbits using thin-film composites, Pharmaceutical Research, 19, 1901, 10.1023/A:1021462012442 Nicolazzo, 2004, Assessment of the effects of sodium dodecyl sulfate on the buccal permeability of caffeine and estradiol, Journal of Pharmaceutical Sciences, 93, 431, 10.1002/jps.10559 Borrás-Blasco, 1997, Influence of sodium lauryl sulphate on the in vitro percutaneous absorption of compounds with different lipophilicity, European Journal of Pharmaceutical Sciences, 5, 15, 10.1016/S0928-0987(96)00184-4 Manganaro, 1996, The effects of permeabilizers on the in vitro penetration of propranolol through porcine buccal epithelium, Military Medicine, 161, 669, 10.1093/milmed/161.11.669 Morishita, 2001, Pluronic® F-127 gels incorporating highly purified unsaturated fatty acids for buccal delivery of insulin, International Journal of Pharmaceutics, 212, 289, 10.1016/S0378-5173(00)00615-3 Nicolazzo, 2004, Modification of buccal drug delivery following pretreatment with skin penetration enhancers, Journal of Pharmaceutical Sciences, 93, 2054, 10.1002/jps.20113 Howie, 2001, Short-term exposure to alcohol increases the permeability of human oral mucosa, Oral Diseases, 7, 349, 10.1034/j.1601-0825.2001.00731.x