Oral films: Current status and future perspectives
Tài liệu tham khảo
Hoffmann, 2011, Advances in orodispersible films for drug delivery, Expert Opin. Drug Deliv., 8, 299, 10.1517/17425247.2011.553217
FDA, 2009, Dosage Form
Dinge, 2008, Formulation and evaluation of fast dissolving films for delivery of triclosan to the oral cavity, AAPS PharmSciTech, 9, 349, 10.1208/s12249-008-9047-7
Cilurzo, 2008, Fast dissolving films made of maltodextrins, Eur. J. Pharm. Biopharm., 70, 895, 10.1016/j.ejpb.2008.06.032
H.G. Zerbe, J.H. Guo, A. Serino, Water soluble film for oral administration with instant wettability, in, Google Patents, 2003.
G.L. Myers, E. Dadey, Sublingual and buccal film compositions, in, Google Patents, 2014.
A. Breitenbach, S. BRAUN, R. Schliephacke, Orodispersible films for the manufacturing of individualised medicine or for large scale production, in, Google Patents, 2014.
Zajicek, 2013, A report from the pediatric formulations task force: perspectives on the state of child-friendly oral dosage forms, AAPS J., 15, 1072, 10.1208/s12248-013-9511-5
Stegemann, 2012, Swallowing dysfunction and dysphagia is an unrecognized challenge for oral drug therapy, Int. J. Pharm., 430, 197, 10.1016/j.ijpharm.2012.04.022
Dixit, 2009, Oral strip technology: overview and future potential, J. Control. Release, 139, 94, 10.1016/j.jconrel.2009.06.014
B.J., 2010, Review: oral drug delivery in personalized medicine: Unmet needs and novel approaches, Int. J. Pharm., 404, 1
IBISWorld
C.L.P., 2013, The generic pharmaceutical industry: moving beyond incremental innovation towards re-innovation, GaBI J., 2, 13, 10.5639/gabij.2013.0201.011
S.P., 2009
T.D.C. Company, 2006
ElMeshad, 2011, Characterization and optimization of orodispersible mosapride film formulations, AAPS PharmSciTech, 12, 1384, 10.1208/s12249-011-9713-z
Otoni, 2014, Effect of hydroxyl substitution and viscosity on thermal and mechanical properties of hydroxypropyl methylcellulose films
Gustafsson, 1999, Characterisation of particle properties and compaction behaviour of hydroxypropyl methylcellulose with different degrees of methoxy/hydroxypropyl substitution, Eur. J. Pharm. Sci., 9, 171, 10.1016/S0928-0987(99)00054-8
T.D.C. Company, 2002, METHOCEL cellulose ethers
Wen, 2011
Kumria, 2013, Oral buccoadhesive films of ondansetron: development and evaluation, Int. J. Pharm. Investig., 3, 112, 10.4103/2230-973X.114894
Repka, 2005, Characterization of cellulosic hot-melt extruded films containing lidocaine, Eur. J. Pharm. Biopharm., 59, 189, 10.1016/j.ejpb.2004.06.008
S.N., 2010, Development of taste masked fast disintegrating films of levocetirizine dihydrochloride for oral use, Curr. Drug Deliv., 7, 21, 10.2174/156720110790396454
A.M. Schobel, S.S.K.S. Vangala, Solid dosage form containing a taste masked active agent, in, Google Patents, 2010.
Liew, 2014, Effect of polymer, plasticizer and filler on orally disintegrating film, Drug development and industrial pharmacy, 40, 110, 10.3109/03639045.2012.749889
P.R., 2007, Development of taste masked film of Valdecoxib for oral use, Indian J. Pharm. Sci., 69, 318
T.P., 2010, Fast dissolving strips: a novel approach for the delivery of verapamil, J. Pharm. Bioallied Sci., 2, 325, 10.4103/0975-7406.72133
A.A., 2009
N.M., 2008, Formulation and evaluation of fast dissolving films for delivery of triclosan to the oral cavity, AAPS PharmSciTech, 9
S.S., 2009, A review on mouth dissolving films, Curr. Drug Deliv., 6, 469, 10.2174/156720109789941713
W.L. Bunnelle, R.M. Hume, L.C. Jannusch, Thermoplastic films and methods for making, in, Google Patents, 2005.
Alanazi, 2007, Formulation and physicochemical characterisation of buccoadhesive films containing ketorolac, J. Drug Deliv. Sci. Technol., 17, 183, 10.1016/S1773-2247(07)50034-1
K. Yasuda, T. Okubo, Y. Sawai, Rapidly soluble film-shaped preparation, in, Google Patents, 2011.
H.G. Zerbe, F. Al-Khalil, Rapidly disintegrating flavored film for precooked foods, in, Google Patents, 2003.
Baldwin, 1994
Saha, 2013, Novel probiotic dissolvable carboxymethyl cellulose films as oral health biotherapeutics: in vitro preparation and characterization, Expert Opin. Drug Deliv., 10, 1471, 10.1517/17425247.2013.799135
Nappinnai, 2008, Formulation and evaluation of nitrendipine buccal films, Indian J. Pharm. Sci., 70, 631, 10.4103/0250-474X.45402
Tongdeesoontorn, 2011, Effect of carboxymethyl cellulose concentration on physical properties of biodegradable cassava starch-based films, Chem. Cent. J., 5, 6, 10.1186/1752-153X-5-6
Lu, 2009, Starch-based completely biodegradable polymer materials, Express Polym. Lett., 3, 366, 10.3144/expresspolymlett.2009.46
Peh, 1999, Polymeric films as vehicle for buccal delivery: swelling, mechanical, and bioadhesive properties, J. Pharm. Pharm. Sci., 2, 53
Xie, 2012, Rheology to understand and optimize processibility, structures and properties of starch polymeric materials, Prog. Polym. Sci., 37, 595, 10.1016/j.progpolymsci.2011.07.002
G.M., 2010, Starch films: production, properties and potential of utilization, Semina Cienc. Agrar., 137
G.T., 2009, Mechanical and structural properties of solution-cast high amylose maize starch films, Int. J. Biol. Macromol., 46, 13
Cilurzo, 2010, Nicotine fast dissolving films made of maltodextrins: a feasibility study, AAPS PharmSciTech, 11, 1511, 10.1208/s12249-010-9525-6
Cilurzo, 2011, Diclofenac fast-dissolving film: suppression of bitterness by a taste-sensing system, Drug Dev. Ind. Pharm., 37, 252, 10.3109/03639045.2010.505928
F. Cilurzo, P. Minghetti, L. Montanari, Self-supporting films for pharmaceutical and food use, in, Google Patents, 2012.
Shamekh, 2002, Film formation properties of potato starch hydrolysates, Starch, 54, 20, 10.1002/1521-379X(200201)54:1<20::AID-STAR20>3.0.CO;2-M
A.H. Chapdelaine, M.J. Dzija, D. Zyck, Improved edible film formulations containing maltodextrin, in, Google Patents, 2003.
J.A., 2007, Evaluation of a novel modified starch polymer in an easy to formulate thin-film drug delivery system and comparison with some marketed formulations
El-Setouhy, 2010, Formulation of a novel tianeptine sodium orodispersible film, AAPS PharmSciTech, 11, 1018, 10.1208/s12249-010-9464-2
C.R. Cunningham, Starch Contrastcs, in: Formulation — Excipient Focus, https://www.colorcon.com/literature/marketing/ex/Starch%201500/pfq_starch.pdf.
Wire
GPC, 2014, Quick dissolve films
N. Kulkarni, L. Kumar, A. Sorg, Fast dissolving orally consumable films containing sucralose as a sweetener, in, Google Patents, 2006.
D.J. Fadden, N.M. Kulkarni, A.F. Sorg, Fast dissolving orally consumable films containing a modified starch for improved heat and moisture resistance, in, Google Patents, 2006.
Prajapati, 2013, Pullulan: an exopolysaccharide and its various applications, Carbohydr. Polym., 95, 540, 10.1016/j.carbpol.2013.02.082
X.Q., 2008, Preparation and properties of pullulan–alginate–carboxymethylcellulose blend films, Food Res. Int., 41, 1007, 10.1016/j.foodres.2008.08.005
G.G., 2008, Miscibility, thermal, and mechanical studies of hydroxypropyl methylcellulose/pullulan blends, J. Appl. Polym. Sci., 110, 444, 10.1002/app.28575
M.K., 2003, Dependence of the mechanical properties of a pullulan film on the preparation temperature, Biosci. Biotechnol. Biochem., 67, 893, 10.1271/bbb.67.893
S.P., 2002, Polymerized rosin: novel film forming polymer for drug delivery, Int. J. Pharm., 249, 175, 10.1016/S0378-5173(02)00529-X
Galgatte, 2013, 5, 1465
R. Puri, R.G. Zielinski, Dissolvable film, in, Google Patents, 2007.
Khairnar, 2010, Development of buccal drug delivery system based on mucodhesive polymers, International Journal of PharmTech Research, 2, 719
C. Leichs, A. Breitenbach, I. Lehrke, P. Galfetti, Non-mucoadhesive film dosage forms, in, Google Patents, 2008.
M. Horstmann, W. Laux, Individually dosed foil-form presentation which decomposes rapidly on contact with liquid and contains an active substance, in particular an aromatic substance, in, Google Patents, 2004.
C.G., 2010, Development of mucoadhesive films for buccal administration of flufenamic acid: effect of cyclodextrin complexation, J. Pharm. Sci., 99, 3019, 10.1002/jps.22068
J. Bougaret, D.S.I. Ribeiro, M. Sournac, Rapid-disintegration monolayer film for the oral administration of active substances, in, Google Patents, 2009.
D. Asari, M. Hori, T. Shishido, Film-form preparation, in, Google Patents, 2011.
2009, C.f.D. control, prevention, prevalence and most common causes of disability among adults—United States, 2005, MMWR Morb. Mortal. Wkly Rep., 58, 421
C.K. Chu, J.P. Ryoo, Z. Wang, Dosage form for insertion into the mouth, in, Google Patents, 2012.
D.H., 2010, Exploration of different polymers for use in the formulation of oral fast dissolving strips, J. Curr. Pharm. Res., 2, 33
T.G., 2006, Film-forming polymers in fast-dissolve oral films
G.L. Myers, S.D. Hilbert, B.J. Boone, B.A. Bogue, P. Sanghvi, M. Hariharan, Sublingual and buccal film compositions, in, Google Patents, 2011.
G.L. Myers, High dose film compositions and methods of preparation, in, Google Patents, 2008.
C. Bruce, M. Manning, Melt extruded nicotine thin strips, in, Google Patents, 2011.
R.K. Yang, R.C. Fuisz, G.L. Myers, J.M. Fuisz, Polyethylene oxide-based films and drug delivery systems made therefrom, in, Google Patents, 2006.
Laffleur, 2014, Mucoadhesive polymers for buccal drug delivery, Drug Dev. Ind. Pharm., 40, 591, 10.3109/03639045.2014.892959
Andrews, 2009, Mucoadhesive polymeric platforms for controlled drug delivery, Eur. J. Pharm. Biopharm., 71, 505, 10.1016/j.ejpb.2008.09.028
Morales, 2011, Manufacture and characterization of mucoadhesive buccal films, Eur. J. Pharm. Biopharm., 77, 187, 10.1016/j.ejpb.2010.11.023
Woertz, 2013, Assessment of test methods evaluating mucoadhesive polymers and dosage forms: an overview, Eur. J. Pharm. Biopharm., 85, 843, 10.1016/j.ejpb.2013.06.023
Preis, 2013, Oromucosal film preparations: classification and characterization methods, Expert Opin. Drug Deliv., 10, 1303, 10.1517/17425247.2013.804058
Jayakumar, 2010, Biomedical applications of chitin and chitosan based nanomaterials—a short review, Carbohydr. Polym., 82, 227, 10.1016/j.carbpol.2010.04.074
Dash, 2011, Chitosan—a versatile semi-synthetic polymer in biomedical applications, Prog. Polym. Sci., 36, 981, 10.1016/j.progpolymsci.2011.02.001
M.J., 2011, Manufacture and characterization of mucoadhesive buccal films, Eur. J. Pharm. Biopharm., 77, 187, 10.1016/j.ejpb.2010.11.023
Zhu, 2013, The development of polycarbophil as a bioadhesive material in pharmacy, Asian J. Pharm. Sci., 8, 218, 10.1016/j.ajps.2013.09.003
Graessley, 1974, The entanglement concept in polymer rheology, 1
Madsen, 1998, A rheological examination of the mucoadhesive/mucus interaction: the effect of mucoadhesive type and concentration, J. Control. Release, 50, 167, 10.1016/S0168-3659(97)00138-7
Hassan, 1990, A simple rheological method for the in vitro assessment of mucin-polymer bioadhesive bond strength, Pharm. Res., 7, 491, 10.1023/A:1015812615635
Nakamura, 1996, In vitro and in vivo nasal mucoadhesion of some water-soluble polymers, Int. J. Pharm., 134, 173, 10.1016/0378-5173(95)04416-7
Cilurzo, 2003, Polymethacrylate salts as new low-swellable mucoadhesive materials, J. Control. Release, 88, 43, 10.1016/S0168-3659(02)00459-5
Bernkop-Schnurch, 2000, Synthesis and characterisation of mucoadhesive thiolated polymers, Int. J. Pharm., 194, 239, 10.1016/S0378-5173(99)00387-7
Bonengel, 2014, Thiomers—from bench to market, J. Control. Release, 195, 120, 10.1016/j.jconrel.2014.06.047
Ijaz, 2015, Preactivated thiomers: their role in drug delivery, Expert Opin. Drug Deliv., 20, 1
Garhofer, 2012
M.U.o.V.
C.-P. GmbH
Leitner, 2004, Thiomers in noninvasive polypeptide delivery: in vitro and in vivo characterization of a polycarbophil–cysteine/glutathione gel formulation for human growth hormone, J. Pharm. Sci., 93, 1682, 10.1002/jps.20069
Hornof, 2002, In vitro evaluation of the permeation enhancing effect of polycarbophil–cysteine conjugates on the cornea of rabbits, J. Pharm. Sci., 91, 2588, 10.1002/jps.10258
Kast, 2003, Development and in vivo evaluation of an oral delivery system for low molecular weight heparin based on thiolated polycarbophil, Pharm. Res., 20, 931, 10.1023/A:1023803706746
Bernkop-Schnurch, 2000, Polycarbophil–cysteine conjugates as platforms for oral polypeptide delivery systems, J. Pharm. Sci., 89, 901, 10.1002/1520-6017(200007)89:7<901::AID-JPS7>3.0.CO;2-0
Hoyer, 2009, Design and in vivo evaluation of a patch system based on thiolated polymers, J. Pharm. Sci., 98, 620, 10.1002/jps.21480
Bernkop-Schnurch, 2000, Development of controlled drug release systems based on thiolated polymers, J. Control. Release, 66, 39, 10.1016/S0168-3659(99)00256-4
Werle, 2009, Development and in vitro characterization of liposomes coated with thiolated poly(acrylic acid) for oral drug delivery, Drug Dev. Ind. Pharm., 35, 209, 10.1080/03639040802244326
Hornof, 2003, Mucoadhesive ocular insert based on thiolated poly(acrylic acid): development and in vivo evaluation in humans, J. Control. Release, 89, 419, 10.1016/S0168-3659(03)00135-4
Bernkop-Schnurch, 2003, Preparation and in vitro characterization of poly(acrylic acid)–cysteine microparticles, J. Control. Release, 93, 29, 10.1016/S0168-3659(03)00339-0
Leitner, 2003, Mucoadhesive and cohesive properties of poly(acrylic acid)–cysteine conjugates with regard to their molecular mass, Eur. J. Pharm. Sci., 18, 89, 10.1016/S0928-0987(02)00245-2
Guggi, 2004, Matrix tablets based on thiolated poly(acrylic acid): pH-dependent variation in disintegration and mucoadhesion, Int. J. Pharm., 274, 97, 10.1016/j.ijpharm.2003.06.001
Aher, 2014, Bilayered films based on novel polymer derivative for improved ocular therapy of gatifloxacin, Sci. World J., 2014, 9, 10.1155/2014/297603
Bernkop-Schnurch, 2001, Improvement in the mucoadhesive properties of alginate by the covalent attachment of cysteine, J. Control. Release, 71, 277, 10.1016/S0168-3659(01)00227-9
J.A.B., 2010, Synthesis of thiolated alginate and evaluation of mucoadhesiveness, cytotoxicity and release retardant properties, Indian J. Pharm. Sci., 72, 766, 10.4103/0250-474X.84590
Roldo, 2004, Mucoadhesive thiolated chitosans as platforms for oral controlled drug delivery: synthesis and in vitro evaluation, Eur. J. Pharm. Biopharm., 57, 115, 10.1016/S0939-6411(03)00157-7
Liu, 2014, A novel thermo-sensitive hydrogel based on thiolated chitosan/hydroxyapatite/beta-glycerophosphate, Carbohydr. Polym., 110, 62, 10.1016/j.carbpol.2014.03.065
Bernkop-Schnurch, 2005, The use of thiolated polymers as carrier matrix in oral peptide delivery—proof of concept, J. Control. Release, 106, 26, 10.1016/j.jconrel.2005.04.004
Hauptstein, 2013, Preactivated thiomers: evaluation of gastroretentive minitablets, Int. J. Pharm., 456, 473, 10.1016/j.ijpharm.2013.08.032
Hauptstein, 2014, Development and in vitro evaluation of a buccal drug delivery system based on preactivated thiolated pectin, Drug Dev. Ind. Pharm., 40, 1530, 10.3109/03639045.2013.836213
G.I., 2003, Periodontal delivery of ipriflavone: new chitosan/PLGA film delivery system for a lipophilic drug, Int. J. Pharm., 252, 1, 10.1016/S0378-5173(02)00602-6
Jones, 2014, In vitro comparative evaluation of monolayered multipolymeric films embedded with didanosine-loaded solid lipid nanoparticles: a potential buccal drug delivery system for ARV therapy, Drug Dev. Ind. Pharm., 40, 669, 10.3109/03639045.2014.892957
Shen, 2014, Formulation and optimization of a novel oral fast dissolving film containing drug nanoparticles by Box–Behnken design-response surface methodology, Drug Dev. Ind. Pharm., 40, 649, 10.3109/03639045.2014.884116
Rana, 2013, Formulation and evaluation of mucoadhesive buccal films impregnated with carvedilol nanosuspension: a potential approach for delivery of drugs having high first-pass metabolism, Drug Deliv., 20, 224, 10.3109/10717544.2013.779331
Dott, 2013, A mucoadhesive electrospun nanofibrous matrix for rapid oramucosal drug delivery, J. Nanomater., 2013, 19, 10.1155/2013/924947
Cavallari, 2013, Mucoadhesive multiparticulate patch for the intrabuccal controlled delivery of lidocaine, Eur. J. Pharm. Biopharm., 83, 405, 10.1016/j.ejpb.2012.10.004
Low, 2013, Effect of type and ratio of solubilising polymer on characteristics of hot-melt extruded orodispersible films, Int. J. Pharm., 455, 138, 10.1016/j.ijpharm.2013.07.046
Preis, 2014, Mechanical strength test for orodispersible and buccal films, Int. J. Pharm., 461, 22, 10.1016/j.ijpharm.2013.11.033
Cao, 2009, Effects of various plasticizers on mechanical and water vapor barrier properties of gelatin films, Food Hydrocoll., 23, 729, 10.1016/j.foodhyd.2008.07.017
Nair, 2013, In vitro techniques to evaluate buccal films, J. Control. Release, 166, 10, 10.1016/j.jconrel.2012.11.019
Ortega-Toro, 2014, Properties of starch-hydroxypropyl methylcellulose based films obtained by compression molding, Carbohydr. Polym., 109, 155, 10.1016/j.carbpol.2014.03.059
Koo, 2011, Investigation into stability of poly(vinyl alcohol)-based Opadry(R) II films, AAPS PharmSciTech, 12, 746, 10.1208/s12249-011-9630-1
A. Government, 2011, Australian public assessment report for buprenorphine/naloxone
U.S.D.o.H.a.H. Services, 2008
Gala, 2014, Taste masking techniques in the pharmaceutical industry
K.A.W., 2010, Pharmaceutical Compounding and Dispensing, 288
A.J.T., 2010
W.E.C.o.S.f.P. Preparations, 2012, Development of paediatric medicines: points to consider in formulation, 29
Slade, 2012
Kunte, 2010, Fast dissolving strips: a novel approach for the delivery of verapamil, J. Pharm. Bioallied Sci., 2, 325, 10.4103/0975-7406.72133
F.a.D. Administration, 2009, Q8(R2) Pharmaceutical Development
Mashru, 2005, Development and evaluation of fast-dissolving film of salbutamol sulphate, Drug Dev. Ind. Pharm., 31, 25, 10.1081/DDC-43947
Garsuch, 2010, Comparative investigations on different polymers for the preparation of fast-dissolving oral films, J. Pharm. Pharmacol., 62, 539, 10.1211/jpp.62.04.0018
Mura, 2010, Development of mucoadhesive films for buccal administration of flufenamic acid: effect of cyclodextrin complexation, J. Pharm. Sci., 99, 3019, 10.1002/jps.22068
Nishimura, 2009, In vitro and in vivo characteristics of prochlorperazine oral disintegrating film, Int. J. Pharm., 368, 98, 10.1016/j.ijpharm.2008.10.002
Perumal, 2008, Formulation of monolayered films with drug and polymers of opposing solubilities, Int. J. Pharm., 358, 184, 10.1016/j.ijpharm.2008.03.005
Nagaraju, 2013, Comprehensive review on oral disintegrating films, Curr. Drug Deliv., 10, 96, 10.2174/1567201811310010016
Renuka Mishra, 2011, Manufacturing techniques of orally dissolving films, Pharm. Technol., 70
Janssen, 2013, Drug-printing by flexographic printing technology—a new manufacturing process for orodispersible films, Int. J. Pharm., 441, 818, 10.1016/j.ijpharm.2012.12.023
I.A.c.e. worldwide
Wilson, 2013
Johannes, 2011, 32
A.M., 2011, Inkjet printing of drug substances and use of porous substrates-towards individualized dosing, J. Pharm. Sci., 100, 3386, 10.1002/jps.22526
Buanz, 2011, Preparation of personalized-dose salbutamol sulphate oral films with thermal ink-jet printing, Pharm. Res., 28, 2386, 10.1007/s11095-011-0450-5
Garsuch, 2009, Novel analytical methods for the characterization of oral wafers, Eur. J. Pharm. Biopharm., 73, 195, 10.1016/j.ejpb.2009.05.010
Xia, 2014, A new method for evaluating the dissolution of orodispersible films, Pharm. Dev. Technol., 0, 1
Shimoda, 2009, Preparation of a fast dissolving oral thin film containing dexamethasone: a possible application to antiemesis during cancer chemotherapy, Eur. J. Pharm. Biopharm., 73, 361, 10.1016/j.ejpb.2009.08.010
Gohel, 2009, Application of simplex lattice design and desirability function for the formulation development of mouth dissolving film of salbutamol sulphate, Curr. Drug Deliv., 6, 486, 10.2174/156720109789941696
A.C., 2010, 2, 576
Gupta, 2011, Enhancement of dissolution rate of rapidly dissolving oral film of meclizine hydrochloride by complexation of Meclizine hydrochloride with β-cyclodextrine, J. Appl. Pharm. Sci., 1, 150
Liew, 2012, Characterization of oral disintegrating film containing donepezil for Alzheimer disease, AAPS PharmSciTech, 13, 134, 10.1208/s12249-011-9729-4
Sri, 2012, Montelukast sodium oral thin films: formulation and in vitro evaluation, Asian J. Pharm. Clin. Res., 5
Warren
I. Par Pharmaceutical, 2010, ZUPLENZ (ondansetron) oral soluble film, 4mg and 8mg