Polymer strip films as a robust, surfactant-free platform for delivery of BCS Class II drug nanoparticles

International Journal of Pharmaceutics

Volumn 489, Issue 1-2, 2015, Pages 45-57

  Krull, Scott M ^a   Susarla, Ramana ^a   Afolabi, Afolawemi ^a   Li, Meng ^a   Ying, Ye ^b   Iqbal, Zafar ^b   Bilgili, Ecevit ^a   Davé, Rajesh N ^a  

^a NEW JERSEY INSTITUTE OF TECHNOLOGY   (United States)

^b NEW JERSEY INSTITUTE OF TECHNOLOGY   (United States)

Author keywords

Drug nanoparticles; Film casting drying; Pharmaceutical films; Physical stability; Surfactant; Wet media milling

Indexed keywords

AZODICARBONAMIDE; DODECYL SULFATE SODIUM; FENOFIBRATE; GLYCEROL; GRISEOFULVIN; HYDROXYPROPYLMETHYLCELLULOSE; NAPROXEN; PHENYLBUTAZONE; PLASTICIZER; UNCLASSIFIED DRUG; UREA DERIVATIVE; 1,1-AZOBISFORMAMIDE; AZO COMPOUND; NANOPARTICLE;

ARTICLE; CONTROLLED STUDY; DISSOLUTION; DRUG BIOAVAILABILITY; DRUG DELIVERY SYSTEM; DRUG DISTRIBUTION; DRUG RELEASE; DRUG SOLUBILITY; HYDROGEN BOND; MOISTURE; MOLECULAR INTERACTION; MOLECULAR WEIGHT; PARTICLE SIZE; PHYSICAL CHEMISTRY; POLYMER STRIP FILLM; PRIORITY JOURNAL; RAMAN SPECTROMETRY; TENSILE STRENGTH; THERMOGRAVIMETRY; VISCOELASTICITY; VISCOSITY; CHEMISTRY; SOLUBILITY;

AZO COMPOUNDS; DRUG DELIVERY SYSTEMS; FENOFIBRATE; GLYCEROL; GRISEOFULVIN; HYPROMELLOSE DERIVATIVES; NANOPARTICLES; NAPROXEN; PHENYLBUTAZONE; SOLUBILITY;

EID: 84928557050     PISSN: 03785173     EISSN: 18733476     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2015.04.034     Document Type: Article

References (54)

1. R.K. Averineni, S.G. Sunderajan, S. Mutalik, U. Nayak, G. Shavi, K. Armugam, S.R. Meka, S. Pandey, and U. Nayanabhirama Development of mucoadhesive buccal films for the treatment of oral sub-mucous fibrosis: a preliminary study Pharm. Dev. Technol. 14 2009 199 207
2. M. Azad, C. Arteaga, B. Abdelmalek, R. Davé, and E. Bilgili Spray drying of drug-swellable dispersant suspensions for preparation of fast-dissolving, high drug-loaded, surfactant-free nanocomposites Drug Dev. Ind. Pharm. 2014 10.3109/03639045.2014.976574
3. A. Balakrishnan, B.D. Rege, G.L. Amidon, and J.E. Polli Surfactant-mediated dissolution: contributions of solubility enhancement and relatively low micelle diffusivity J. Pharm. Sci. 93 2004 2064 2075
4. C. Beck, L. Sievens-Figueroa, K. Gärtner, J.I. Jerez-Rozo, R.J. Romañach, E. Bilgili, and R.N. Davé Effects of stabilizers on particle redispersion and dissolution from polymer strip films containing liquid antisolvent precipitated griseofulvin particles Powder Technol. 236 2013 37 51
5. A. Bhakay, M. Azad, E. Bilgili, and R. Dave Redispersible fast dissolving nanocomposite microparticles of poorly water-soluble drugs Int. J. Pharm. 461 2014 367 379
6. A. Bhakay, M. Azad, E. Vizzotti, R.N. Dave, and E. Bilgili Enhanced recovery and dissolution of griseofulvin nanoparticles from surfactant-free nanocomposite microparticles incorporating wet-milled swellable dispersants Drug Dev. Ind. Pharm. 40 2014 1509 1522
7. A. Bhakay, R. Davé, and E. Bilgili Recovery of BCS Class II drugs during aqueous redispersion of core-shell type nanocomposite particles produced via fluidized bed coating Powder Technol. 236 2013 221 234
8. A. Bhakay, M. Merwade, E. Bilgili, and R.N. Dave Novel aspects of wet milling for the production of microsuspensions and nanosuspensions of poorly water-soluble drugs Drug Dev. Ind. Pharm. 37 2011 963 976
9. E. Bilgili, and A. Afolabi A combined microhydrodynamics-polymer adsorption analysis for elucidation of the roles of stabilizers in wet stirred media milling Int. J. Pharm. 439 2012 193 206
10. C.G. Biliaderis, A. Lazaridou, and I. Arvanitoyannis Glass transition and physical properties of polyol-plasticised pullulan-starch blends at low moisture Carbohydr. Polym. 40 1999 29 47
11. J.S. Boateng, K.H. Matthews, A.D. Auffret, M.J. Humphrey, G.M. Eccleston, and H.N. Stevens Comparison of the in vitro release characteristics of mucosal freeze-dried wafers and solvent-cast films containing an insoluble drug Drug Dev. Ind. Pharm. 38 2012 47 54
12. J.C. Brackman Sodium dodecyl sulfate-induced enhancement of the viscosity and viscoelasticity of aqueous solutions of poly(ethylene oxide). A rheological study on polymer-micelle interaction Langmuir 7 1991 469 472
13. A.M. Cerdeira, M. Mazzotti, and B. Gander Miconazole nanosuspensions: influence of formulation variables on particle size reduction and physical stability Int. J. Pharm. 396 2010 210 218
14. P. Costa, and J.M.S. Lobo Modeling and comparison of dissolution profiles Eur. J. Pharm. Sci. 13 2001 123 133
15. Davé, R.N., Susarla, R., Bilgili, E., Sievens-Figueroa, L., Khusid, B., Muzzio, F., Bhakay, A., 2014. System and method for fabrication of uniform polymer films containing nano and micro particles via continuous drying process. Patent application, PCT/US14/30506; filed 3/17/2014.
16. M.M. de Villiers Influence of agglomeration of cohesive particles on the dissolution behaviour of furosemide powder Int. J. Pharm. 136 1996 175 179
17. R.P. Dixit, and S.P. Puthli Oral strip technology: overview and future potential J. Control. Release 139 2009 94 107
18. M. George, and I. Ghosh Identifying the correlation between drug/stabilizer properties and critical quality attributes (CQAs) of nanosuspension formulation prepared by wet media milling technology Eur. J. Pharm. Sci. 48 2013 142 152
19. A.N. Ghebremeskel, C. Vemavarapu, and M. Lodaya Use of surfactants as plasticizers in preparing solid dispersions of poorly soluble API: selection of polymer-surfactant combinations using solubility parameters and testing the processability Int. J. Pharm. 328 2007 119 129
20. A. Heinz, K.C. Gordon, C.M. McGoverin, T. Rades, and C.J. Strachan Understanding the solid-state forms of fenofibrate - a spectroscopic and computational study Eur. J. Pharm. Biopharm 71 2009 100 108
21. J. Hu, K.P. Johnston, and R.O. Williams III Nanoparticle engineering processes for enhancing the dissolution rates of poorly water soluble drugs Drug Dev. Ind. Pharm. 30 2004 233 245
22. J. Huang, R.J. Wigent, and J.B. Schwartz Drug-polymer interaction and its significance on the physical stability of nifedipine amorphous dispersion in microparticles of an ammonio methacrylate copolymer and ethylcellulose binary blend J. Pharm. Sci. 97 2008 251 262
23. S. Jamzad, and R. Fassihi Role of surfactant and pH on dissolution properties of fenofibrate and glipizide - a technical note AAPS PharmSciTech 7 2006 E17 E22
24. J. Jinno, D.M. Oh, J.R. Crison, and G.L. Amidon Dissolution of ionizable water-insoluble drugs: the combined effect of pH and surfactant J. Pharm. Sci. 89 2000 268 274
25. M. Kakran, N.G. Sahoo, L. Li, Z. Judeh, Y. Wang, K. Chong, and L. Loh Fabrication of drug nanoparticles by evaporative precipitation of nanosuspension Int. J. Pharm. 383 2010 285 292
26. E. Karavas, E. Georgarakis, M.P. Sigalas, K. Avgoustakis, and D. Bikiaris Investigation of the release mechanism of a sparingly water-soluble drug from solid dispersions in hydrophilic carriers based on physical state of drug, particle size distribution and drug-polymer interactions Eur. J. Pharm. Biopharm. 66 2007 334 347
27. C.M. Keck, and R.H. Müller Drug nanocrystals of poorly soluble drugs produced by high pressure homogenisation Eur. J. Pharm. Biopharm. 62 2006 3 16
28. J.E. Kipp The role of solid nanoparticle technology in the parenteral delivery of poorly water-soluble drugs Int. J. Pharm. 284 2004 109 122
29. C. Knieke, M.A. Azad, R.N. Davé, and E. Bilgili A study of the physical stability of wet media-milled fenofibrate suspensions using dynamic equilibrium curves Chem. Eng. Res. Des. 91 2013 1245 1258
30. C. Knieke, M.A. Azad, D. To, E. Bilgili, and R.N. Davé Sub-100 micron fast dissolving nanocomposite drug powders Powder Technol. 271 2015 49 60
31. W.M. Kulicke, O. Arendt, and M. Berger Rheological characterization of the dilatant flow behavior of highly substituted hydroxypropylmethyl- cellulose solutions in the presence of sodium lauryl sulfate Colloid. Polym. Sci. 276 1998 617 626
32. C. Lee, S.K. Park, K.C. Min, Y. Kim, and N.S. Lee Vibrational analysis and intermolecular hydrogen bonding of azodicarbonamide in the pentamer cluster Bull. Korean Chem. Soc. 29 2008 1951 1959
33. S.Y. Lin, C.J. Lee, and Y.Y. Lin Drug-polymer interaction affecting the mechanical properties, adhesion strength and release kinetics of piroxicam-loaded Eudragit E films plasticized with different plasticizers J. Control. Release 33 1995 375 381
34. C. Mangwandi, M.J. Adams, M.J. Hounslow, and A.D. Salman Influence of fill factor variation in high shear granulation on the post granulation processes: compression and tablet properties Powder Technol. 263 2014 135 141
35. E. Merisko-Liversidge, and G.G. Liversidge Nanosizing for oral and parenteral drug delivery: a perspective on formulating poorly-water soluble compounds using wet media milling technology Adv. Drug Deliv. Rev. 63 2011 427 440
36. E. Merisko-Liversidge, G.G. Liversidge, and E.R. Cooper Nanosizing: a formulation approach for poorly-water-soluble compounds Eur. J. Pharm. Sci. 18 2003 113 120
37. A. Monteiro, A. Afolabi, and E. Bilgili Continuous production of drug nanoparticle suspensions via wet stirred media milling: a fresh look at the Rehbinder effect Drug Dev. Ind. Pharm. 39 2013 266 283
38. R. Nair, N. Nyamweya, S. Gönen, L.J. Martínez-Miranda, and S.W. Hoag Influence of various drugs on the glass transition temperature of poly(vinylpyrrolidone): a thermodynamic and spectroscopic investigation Int. J. Pharm. 225 2001 83 96
39. R.L. Oberle, T.J. Moore, and D.A.P. Krummel Evaluation of mucosal damage of surfactants in rat jejunum and colon J. Pharmacol. Toxicol. Methods 33 1995 75 81
40. S. Prodduturi, R.V. Manek, W.M. Kolling, S.P. Stodghill, and M.A. Repka Solid-state stability and characterization of hot-melt extruded poly (ethylene oxide) films J. Pharm. Sci. 94 2005 2232 2245
41. S. Puttipipatkhachorn, J. Nunthanid, K. Yamamoto, and G.E. Peck Drug physical state and drug-polymer interaction on drug release from chitosan matrix films J. Control. Release 75 2001 143 153
42. M. Rodríguez, J. Osés, K. Ziani, and J.I. Maté Combined effect of plasticizers and surfactants on the physical properties of starch based edible films Food Res. Int. 39 2006 840 846
43. L. Sievens-Figueroa, A. Bhakay, J.I. Jerez-Rozo, N. Pandya, R.J. Romañach, B. Michniak-Kohn, Z. Iqbal, E. Bilgili, and R.N. Davé Preparation and characterization of hydroxypropyl methyl cellulose films containing stable BCS Class II drug nanoparticles for pharmaceutical applications Int. J. Pharm. 423 2012 496 508
44. L. Sievens-Figueroa, N. Pandya, A. Bhakay, G. Keyvan, B. Michniak-Kohn, E. Bilgili, and R. Davé Using USP I and USP IV for discriminating dissolution rates of nano- and microparticle-loaded pharmaceutical strip-films AAPS PharmSciTech 13 2012 1473 1482
45. R. Susarla, L. Sievens-Figueroa, A. Bhakay, Y. Shen, J.I. Jerez-Rozo, W. Engen, B. Khusid, E. Bilgili, R.J. Romañach, K.R. Morris, B. Michniak-Kohn, and R.N. Davé Fast drying of biocompatible polymer films loaded with poorly water-soluble drug nano-particles via low temperature forced convection Int. J. Pharm. 455 2013 93 103
46. A.A. Thorat, and S.V. Dalvi Liquid antisolvent precipitation and stabilization of nanoparticles of poorly water soluble drugs in aqueous suspensions: recent developments and future perspective Chem. Eng. J. 181-182 2012 1 34
47. Trout, B.L., Hatton, T.A., Chang, E., Evans, J.M.B., Mascia, S., Kim W., Slaughter, R.R., Du, Y., Dhamankar, H.H., Forward, K.M., 2012. Layer processing for pharmaceuticals. Patent application, US13/458222; filed 4/27/2012.
48. B. Van Eerdenbrugh, J. Vermant, J.A. Martens, L. Froyen, J. Van Humbeeck, P. Augustijns, and G. Van den Mooter A screening study of surface stabilization during the production of drug nanocrystals J. Pharm. Sci. 98 2009 2091 2103
49. S. Verma, S. Kumar, R. Gokhale, and D.J. Burgess Physical stability of nanosuspensions: investigation of the role of stabilizers on Ostwald ripening Int. J. Pharm. 406 2011 145 152
50. K. Verschueren 4 ed Handbook of Environmental Data on Organic Chemicals 2001 John Wiley & Sons
51. S.M. Wong, I.W. Kellaway, and S. Murdan Enhancement of the dissolution rate and oral absorption of a poorly water soluble drug by formation of surfactant-containing microparticles Int. J. Pharm. 317 2006 61 68
52. C. Wu, and J.W. McGinity Non-traditional plasticization of polymeric films Int. J. Pharm. 177 1999 15 27
53. Y. Xie, P. Li, J. Zhang, H. Wang, H. Qian, and W. Yao Comparative studies by IR, Raman, and surface-enhanced Raman spectroscopy of azodicarbonamide, biurea and semicarbazide hydrochloride Spectrochim. Acta Part A Mol. Biomol. Spectrosc. 114 2013 80 84
54. S.H. Yalkowsky Handbook of Aqueous Solubility Data 2003 CRC Press