Development and characterization of an orodispersible film containing drug nanoparticles

European Journal of Pharmaceutics and Biopharmaceutics

Volumn 85, Issue 3 PART B, 2013, Pages 1348-1356

  Shen, Bao De ^a,b   Shen, Cheng Ying ^a,c   Yuan, Xu Dong ^d   Bai, Jin Xia ^a,c   Lv, Qing Yuan ^a   Xu, He ^a,c   Dai, Ling ^a,c   Yu, Chao ^a,b   Han, Jin ^a   Yuan, Hai Long ^a  

^a BEIJING 302 HOSPITAL   (China)

^b JIANGXI UNIVERSITY OF TRADITIONAL CHINESE MEDICINE   (China)

^c CHENGDU UNIVERSITY OF TRADITIONAL CHINESE MEDICINE   (China)

^d MONMOUTH UNIVERSITY   (United States)

Author keywords

Film casting; High pressure homogenization; Nanosuspensions; Orodispersible films

Indexed keywords

ANTIVIRUS AGENT; HERPETRIONE; HYDROXYPROPYLCELLULOSE; HYDROXYPROPYLMETHYLCELLULOSE; MACROGOL 400; MICROCRYSTALLINE CELLULOSE; NANOPARTICLE; PLANT EXTRACT; UNCLASSIFIED DRUG;

ANIMAL EXPERIMENT; AREA UNDER THE CURVE; ARTICLE; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG SOLUBILITY; DRUG STABILITY; DRUG STRUCTURE; FILM COATING; HERPETOSPERMUM CAUDIGERUM; IN VITRO STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; MEDICINAL PLANT; NONHUMAN; ORODISPERSIBLE FILM; PARTICLE SIZE; RAT; TIME TO MAXIMUM PLASMA CONCENTRATION; X RAY DIFFRACTION; ZETA POTENTIAL;

FILM CASTING; HIGH PRESSURE HOMOGENIZATION; NANOSUSPENSIONS; ORODISPERSIBLE FILMS;

ADMINISTRATION, ORAL; ANIMALS; ANTIVIRAL AGENTS; AREA UNDER CURVE; BIOLOGICAL AVAILABILITY; CELLULOSE; CHEMISTRY, PHARMACEUTICAL; DRUG COMPOUNDING; DRUG DELIVERY SYSTEMS; FURANS; MALE; METHYLCELLULOSE; NANOPARTICLES; PARTICLE SIZE; POLYETHYLENE GLYCOLS; RATS; RATS, WISTAR; SOLUBILITY; SOLUTIONS; SUSPENSIONS; WATER; X-RAY DIFFRACTION;

EID: 84889081298     PISSN: 09396411     EISSN: 18733441     Source Type: Journal    
DOI: 10.1016/j.ejpb.2013.09.019     Document Type: Article

References (50)

1. C.A. Lipinski Drug-like properties and the causes of poor solubility and poor permeability J. Pharmacol. Toxicol. Methods 44 1 2000 235 249
2. F. Kesisoglou, S. Panmai, and Y. Wu Nanosizing-oral formulation development and biopharmaceutical evaluation Adv. Drug Delivery Rev. 59 7 2007 631 644
3. T. Io, T. Fukami, K. Yamamoto, T. Suzuki, J.D. Xu, K. Tomono, and A. Ramamoorthy Homogeneous nanoparticles to enhance the efficiency of a hydrophobic drug, antihyperlipidemic probucol, characterized by solid-state NMR Mol. Pharm. 7 1 2010 299 305
4. J. Salazar, O. Heinzerling, R.H. Müller, and J.P. Möschwitzer Process optimization of a novel production method for nanosuspensions using design of experiments (DoE) Int. J. Pharm. 420 2 2011 395 403
5. D. Mou, H. Chen, J. Wan, H. Xu, and X. Yang Potent dried drug nanosuspensions for oral bioavailability enhancement of poorly soluble drugs with pH-dependent solubility Int. J. Pharm. 413 1-2 2011 237 244
6. B.E. Rabinow Nanosuspensions in drug delivery Nat. Rev. Drug Discov. 3 9 2004 785 796
7. C.M. Keck, and R.H. Müller Drug nanocrystals of poorly soluble drugs produced by high pressure homogenization Eur. Pharm. Biopharm. 62 1 2006 3 16
8. L. Gao, D. Zhang, and M. Chen Drug nanocrystals for the formulation of poorly soluble drugs and its application as a potential drug delivery system J. Nanopart. Res. 10 5 2008 845 862
9. H.S. Ali, P. York, A.M. Ali, and N. Blagden Hydrocortisone nanosuspensions for ophthalmic delivery: a comparative study between microfluidic nanoprecipitation and wet milling J. Controlled Release 149 2 2011 175 181
10. Y.X. Zhao, H.Y. Hua, M. Chang, W.J. Liu, Y. Zhao, and H.M. Liu Preparation and cytotoxic activity of hydroxycamptothecin nanosuspensions Int. J. Pharm. 392 1-2 2010 64 71
11. Y. Liu, D. Zhang, C. Duan, L. Jia, P. Xie, D. Zheng, F. Wang, G. Liu, L. Hao, X. Zhang, and Q. Zhang Studies on pharmacokinetics and tissue distribution of bifendate nanosuspensions for intravenous delivery J. Microencapsul. 29 2 2012 194 203
12. A.A. Date, and V.B. Patravale Current strategies for engineering drug nanoparticles Curr. Opin. Colloid Interface Sci. 9 3-4 2004 222 235
13. B. Van Eerdenbrugh, L. Froyen, J. Van Humbeeck, J.A. Martens, P. Augustijns, and G. Vanden Mooter Drying of crystalline drug nanosuspensions - the importance of surface hydrophobicity on dissolution behavior upon redispersion Eur. J. Pharm. Sci. 35 1-2 2008 127 135
14. L. Wu, J. Zhang, and W. Watanabe Physical and chemical stability of drug nanoparticles Adv. Drug Delivery Rev. 63 6 2011 456 469
15. 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 1-2 2011 145 152
16. R. Shegokar, and R.H. Müller Nanocrystals: industrially feasible multifunctional formulation technology for poorly soluble actives Int. J. Pharm. 399 1-2 2010 129 139
17. B. Van Eerdenbrugh, G. Van den Mooter, and P. Augustijns Top-down production of drug nanocrystals: nanosuspension stabilization, miniaturization and transformation into solid products Int. J. Pharm. 364 1 2008 64 75
18. M.V. Chaubal, and C. Popescu Conversion of nanosuspensions into dry powders by spray drying: a case study Pharm. Res. 25 10 2008 2302 2308
19. H. Ohshima, A. Miyagishima, T. Kurita, Y. Makino, Y. Iwao, T. Sonobe, and S. Itai Freeze-dried nifedipine-lipid nanoparticles with long-term nano-dispersion stability after reconstitution Int. J. Pharm. 377 1-2 2009 180 184
20. W. Abdelwahed, G. Degobert, S. Stainmesse, and H. Fessi Freeze-drying of nanoparticles: formulation, process and storage considerations Adv. Drug Delivery Rev. 58 15 2006 1688 1713
21. S. Kim, and J. Lee Effective polymeric dispersants for vacuum, convection and freeze drying of drug nanosuspensions Int. J. Pharm. 397 1-2 2010 218 224
22. J. Lee Drug nano- and microparticles processed into solid dosage forms: physical properties J. Pharm. Sci. 92 10 2003 2057 2068
23. E.M. Hoffmann, A. Breitenbach, and J. Breitkreutz Advances in orodispersible films for drug delivery Expert Opin. Drug Delivery 8 3 2011 299 316
24. M. Hariharan, and A. Bogue Orally dissolving film strips (ODFS): the final evolution of orally dissolving dosage forms Drug Delivery Technol. 9 2 2009 24 29
25. A. Chaturvedi, P. Srivastava, S. Yadav, M. Bansal, G. Garg, and P.K. Sharma Fast dissolving films: a review Curr. Drug Delivery 8 4 2011 373 380
26. A. Arya, A. Chandra, V. Sharma, and K. Pathak Fast dissolving oral films: an innovative drug delivery system and dosage form Int. J. ChemTech Res. 2 1 2010 576 583
27. M. Dahiya, S. Saha, and A.F. Shahiwala A review on mouth dissolving films Curr. Drug Deliv. 6 5 2009 469 476
28. S.V. Kumar, B. Gavaskar, G. Sharan, and Y.M. Rao Overview on fast dissolving films Int. J. Pharm. Pharm. Sci. 2 3 2010 29 33
29. R.P. Dixit, and S.P. Puthli Oral strip technology: overview and future potential J. Controlled Release 139 2 2009 94 107
30. F. Cilurzo, I.E. Cupone, P. Minghetti, F. Selmin, and L. Montanari Fast dissolving films made of maltodextrins Eur. J. Pharm. Biopharm. 70 3 2008 895 900
31. A. Jyoti, S. Gurpreet, S. Seema, and A.C. Rana Fast dissolving films: a novel approach to oral drug delivery Int. Res. J. Pharm. 2 12 2011 69 74
32. L. Xiao, T. Yi, Y. Liu, A new self-microemulsifying mouth dissolving film to improve the oral bioavailability of poorly water soluble drugs, Drug Dev. Ind. Pharm. (2012 September 26) (Epub ahead of print).
33. L. Xiao, T. Yi, Y. Liu, D. Huan, and J.K. He Optimization of novel self-microemulsifying mouth dissolving films by response surface methodology Yao Xue Xue Bao 46 5 2011 586 591
34. L. Xiao, T. Yi, Y. Liu, D. Huan, and J.K. He Preparation and characterization of self-microemulsifying oral fast dissolving films of total ginkgo flavonoid Zhong Cao Yao 42 8 2011 1517 1522
35. A. Dinge, and M. Nagarsenker Formulation and evaluation of fast dissolving films for delivery of triclosan to the oral cavity AAPS PharmSciTech 9 2 2008 349 356
36. H.L. Yuan, M. Yang, X.Y. Li, R.H. You, Y. Liu, J. Zhu, H. Xie, and X.H. Xiao Hepatitis B virus inhibiting constituents from Herpetospermum caudigerum Chem. Pharm. Bull. 54 11 2006 1592 1594
37. H.L. Yuan, J.J. Guo, X.Y. Li, J.L. Lv, Preparation and Application of Herperione and Its Capsule, China Patent CN102040101A, 2011 August 3.
38. J.J. Guo, P.F. Yue, J.L. Lv, J. Han, S.S. Fu, S.X. Jin, S.Y. Jin, and H.L. Yuan Development and in vivo/in vitro evaluation of novel herpetrione nanosuspension Int. J. Pharm. 441 1-2 2013 227 233
39. R. Mishra, and A. Amin Formulation development of taste-masked rapidly dissolving films of cetirizine hydrochloride Pharm. Technol. 33 2 2009 48 56
40. C.Y. Shen, H. Xu, B.D. Shen, J.X. Bai, J. Han, H.L. Yuan, Optimization of a novel oral orodispersible films containing herpetrione nanosuspension by Box-Behnken response surface methodology, Zhong Cao Yao (submitted for publication).
41. M. Nishigaki, K. Kawahara, M. Nawa, M. Futamura, M. Nishimura, K. Matsuura, K. Kitaichi, Y. Kawaguchi, T. Tsukioka, K. Yoshida, and Y. Itoh Development of fast dissolving oral film containing dexamethasone as an antiemetic medication: clinical usefulness Int. J. Pharm. 424 1-2 2012 12 17
42. D.R. Choudhary, V.A. Patel, U.K. Chhalotiya, H.V. Patel, and A.J. Kundawala Development and characterization of pharmacokinetic parameters of fast-dissolving films containing levocetirizine Sci. Pharm. 80 3 2012 779 787
43. 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 3 2009 361 365
44. L. Prasanna, and A.K. Giddam Nano-suspension technology: a review Int. J. Pharm. Pharm. Sci 2 4 2010 35 40
45. S. Gramdorf, S. Hermann, A. Hentschel, K. Schrader, R.H. Muller, M. KumpugdeeVollrath, and M. Kraume Crystallized miniemulsions: influence of operating parameters during high-pressure homogenization on size and shape of particles Colloids Surf., A: Physicochem. Eng. Asp. 331 1-2 2008 108 113
46. X.H. Pu, J. Sun, M. Li, and Z.G. He Formulation of nanosuspensions as a new approach for the delivery of poorly soluble drugs Curr. Nanosci. 5 4 2009 417 427
47. F. Lai, C. Sinico, G. Ennas, F. Marongiu, G. Marongiu, and A.M. Fadda Diclofenac nanosuspensions: influence of preparation procedure and crystal form on drug dissolution behaviour Int. J. Pharm. 373 1-2 2009 124 132
48. C.D. Hou, J.X. Wang, Y. Le, H.K. Zou, and H. Zhao Preparation of azithromycin nanosuspensions by reactive precipitation method Drug Dev. Ind. Pharm. 38 7 2012 848 854
49. X. Pu, J. Sun, Y. Wang, X. Liu, P. Zhang, X. Tang, W. Pan, J. Han, and Z. He Development of a chemically stable 10-hydroxycamptothecin nanosuspensions Int. J. Pharm. 379 1 2009 167 173
50. Y. Xu, X. Liu, R. Lian, S. Zheng, Z. Yin, Y. Lu, and W. Wu Enhanced dissolution and oral bioavailability of aripiprazole nanosuspensions prepared by nanoprecipitation/homogenization based on acid-base neutralization Int. J. Pharm. 438 1-2 2012 287 295