Provesicular granisetron hydrochloride buccal formulations: In vitro evaluation and preliminary investigation of in vivo performance

European Journal of Pharmaceutical Sciences

Volumn 60, Issue , 2014, Pages 10-23

  Ahmed, Sami ^a   El Setouhy, Doaa Ahmed ^a   El Latif Badawi, Alia Abd ^a   El Nabarawi, Mohamed Ahmed ^a  

^a CAIRO UNIVERSITY   (Egypt)

Author keywords

Bioavailability study; Buccal delivery; Granisetron hydrochloride; Proniosomes; Provesicular powder

Indexed keywords

CARBOPOL 974P; CHOLESTEROL; GRANISETRON; MALTODEXTRIN; NIOSOME; POLYMER; SORBITAN LAURATE; SORBITAN OLEATE; TORASEMIDE; XANTHAN; ANTIEMETIC AGENT; HEXOSE; POLYSACCHARIDE; TABLET;

ADULT; ANGLE OF REPOSE; ANIMAL EXPERIMENT; ANIMAL TISSUE; AREA UNDER THE CURVE; ARTICLE; BILAYER MEMBRANE; CONTROLLED STUDY; DRUG BIOAVAILABILITY; DRUG RELEASE; DRUG SCREENING; ENCAPSULATION; EXPERIMENTAL RABBIT; FIRST PASS EFFECT; HUMAN; HUMAN EXPERIMENT; HYDROPHILICITY; HYDROPHOBICITY; IN VITRO STUDY; IN VIVO STUDY; LIPID COMPOSITION; MALE; MAXIMUM PLASMA CONCENTRATION; MEAN RESIDENCE TIME; MOUTH CAVITY; MUCOADHESION; NONHUMAN; NORMAL HUMAN; PARTICLE SIZE; PRIORITY JOURNAL; SUSTAINED DRUG RELEASE; TABLET; TABLET FORMULATION; TABLET MACHINE; TABLET THICKNESS; TIME TO MAXIMUM PLASMA CONCENTRATION; TISSUE ADHESION; ADHESION; ANIMAL; BIOAVAILABILITY; BLOOD; BUCCAL DRUG ADMINISTRATION; CHEMISTRY; CHICKEN; HARDNESS; MEDICINAL CHEMISTRY; METABOLISM; MOUTH MUCOSA; RABBIT;

ADHESIVENESS; ADMINISTRATION, BUCCAL; ADULT; ANIMALS; ANTIEMETICS; BIOLOGICAL AVAILABILITY; CHEMISTRY, PHARMACEUTICAL; CHICKENS; CHOLESTEROL; GRANISETRON; HARDNESS; HEXOSES; HUMANS; IN VITRO TECHNIQUES; MALE; MOUTH MUCOSA; POLYSACCHARIDES; RABBITS; TABLETS;

EID: 84901273456     PISSN: 09280987     EISSN: 18790720     Source Type: Journal    
DOI: 10.1016/j.ejps.2014.04.013     Document Type: Article

References (65)

1. M. Aapro Granisetron: an update on its clinical use in the management of nausea and vomiting Oncologist 9 2004 673 686 (Pubitemid 39546407)
2. R. Abu-Huwaij, R.M. Obaidat, K. Sweidan, and Y. Al-Hiari Formulation and in vitro evaluation of xanthan gum or carbopol 934-based mucoadhesive patches, loaded with nicotine AAPS PharmSciTech. 12 2011 21 27
3. V. Agarwal, and B. Mishra Design, development, and biopharmaceutical properties of buccoadhesive compacts of pentazocine Drug Dev. Ind. Pharm. 25 1999 701 709 (Pubitemid 29239399)
4. J. Ali, R. Khar, A. Ahuja, and R. Kalra Buccoadhesive erodible disk for treatment of oro-dental infections: design and characterisation Int. J. Pharm. 238 2002 93 103 (Pubitemid 34457878)
5. G.P. Andrews, T.P. Laverty, and D.S. Jones Mucoadhesive polymeric platforms for controlled drug delivery Eur. J. Pharm. Biopharm. 71 2009 505 518
6. S. Anlar, Y. Capan, and A.A. Hincal Physico-chemical and bioadhesive properties of polyacrylic acid polymers Pharmazie 48 1993 285 287 (Pubitemid 23163922)
7. S. Anlar, Y. Capan, O. Guven, A. Gogus, T. Dalkara, and A.A. Hincal Formulation and in vitro-in vivo evaluation of buccoadhesive morphine sulfate tablets Pharm. Res. 11 1994 231 236 (Pubitemid 24076217)
8. G.S. Asane, S.A. Nirmal, K.B. Rasal, A.A. Naik, M.S. Mahadik, and Y.M. Rao Polymers for mucoadhesive drug delivery system: a current status Drug Dev. Ind. Pharm. 34 2008 1246 1266
9. P. Balakrishnan, S. Shanmugam, W.S. Lee, W.M. Lee, J.O. Kim, D.H. Oh, D.D. Kim, J.S. Kim, B.K. Yoo, H.G. Choi, J.S. Woo, and C.S. Yong Formulation and in vitro assessment of minoxidil niosomes for enhanced skin delivery Int. J. Pharm. 377 2009 1 8
10. C. Bernsdorff, A. Wolf, R. Winter, and E. Gratton Effect of hydrostatic pressure on water penetration and rotational dynamics in phospholipid- cholesterol bilayers Biophys. J. 72 1997 1264 1277 (Pubitemid 27113649)
11. S.B. Bhanja, P. Ellaiah, S.K. Martha, R.K. Kar, and B.B. Panigrahi Buccoadhesive drug delivery system of captopril: formulation and in vitro evaluation J. Pharm. Res. 3 2010 335 340
12. A.I. Blazek-Welsh, and D.G. Rhodes Maltodextrin-based proniosomes AAPS PharmSci. 3 2001 E1
13. A.I. Blazek-Welsh, and D.G. Rhodes SEM imaging predicts quality of niosomes from maltodextrin-based proniosomes Pharm. Res. 18 2001 656 661 (Pubitemid 32595795)
14. H. Boyapally, R. Nukala, P. Bhujbal, and D. Douroumis Controlled release from directly compressible theophylline buccal tablets Colloids Surf. B. Biointerfaces 77 2010 227 233
15. T. Buket, C. Yilmaz, G. Olgun, K. Sirri, and H. Atilla Design and evaluation of sustained-release and buccal adhesive propranolol hydrochloride tablets J. Control. Release 38 1996 11 20
16. M. Carafa, E. Santucci, F. Alhaique, T. Coviello, E. Murtas, F.M. Riccieri, G. Lucania, and M.R. Torrisi Preparation and properties of new unilamellar nonionic/ionic surfactant vesicles Int. J. Pharm. 160 1998 51 59 (Pubitemid 28059929)
17. R.L. Carr Evaluation flow properties of solids Chem. Eng. 72 1965 163 168
18. J. Cazares-Delgadillo, A. Ganem-Rondero, D. Quintanar-Guerrero, A. Lopez-Castellano, V. Merino, and Y. Kalia Using transdermal iontophoresis to increase granisetron delivery across skin in vitro and in vivo: effect of experimental conditions and a comparison with other enhancement strategies Eur. J. Pharm. Sci. 39 2010 387 393
19. J. Ceulemans, I. Vinckier, and A. Ludwig The use of xanthan gum in an ophthalmic liquid dosage form: rheological characterization of the interaction with mucin J. Pharm. Sci. 91 2002 1117 1127 (Pubitemid 34640936)
20. H.J. Cho, P. Balakrishnan, W.S. Shim, S.J. Chung, C.K. Shim, and D.D. Kim Characterization and in vitro evaluation of freeze-dried microparticles composed of granisetron-cyclodextrin complex and carboxymethylcellulose for intranasal delivery Int. J. Pharm. 400 2010 59 65
21. D. Duchene, F. Touchard, and N.A. Peppas Pharmaceutical and medical aspects of bioadhesive systems for drug administration Drug Dev. Ind. Pharm. 14 1988 283 318
22. H.M. El-Laithy, O. Shoukry, and L.G. Mahran Novel sugar esters proniosomes for transdermal delivery of vinpocetine: preclinical and clinical studies Eur. J. Pharm. Biopharm. 77 2011 43 55
23. M.S. El-Samaligy, S.A. Yahia, and E.B. Basalious Formulation and evaluation of diclofenac sodium buccoadhesive discs Int. J. Pharm. 286 2004 27 39 (Pubitemid 39410471)
24. M.S. El-Samaligy, N.N. Afifi, and E.A. Mahmoud Evaluation of hybrid liposomes-encapsulated silymarin regarding physical stability and in vivo performance Int. J. Pharm. 319 2006 121 129 (Pubitemid 44051811)
25. a. Ghosh, UK. Bhaumik, A. Bose, U. Mandal, V. Gowda, B. Chatterjee, US. Chakrabarty, and TK. Pal Extended release dosage form of glipizide: development and validation of a level A in vitro-in vivo correlation Biol. Pharm. Bull. 31 2008 1946 1951
26. Y.F. Hao, F. Zhao, N. Li, Y. Yang, and K. Li Studies on a high encapsulation of colchicine by a niosome system Int. J. Pharm. 244 2002 73 80 (Pubitemid 35245447)
27. S.E. Harding Mucoadhesive interactions Biochem. Soc. Trans. 31 2003 1036 1041 (Pubitemid 37305042)
28. K.M. Hosny Ciprofloxacin as ocular liposomal hydrogel AAPS PharmSciTech. 11 2010 241 246
29. C. Hu, and D.G. Rhodes Proniosomes: a novel drug carrier preparation Int. J. Pharm. 185 1999 23 35 (Pubitemid 29333093)
30. C. Hunt, and S. Tsang α-Tocopherol retards auto-oxidation and prolongs the shelf-life of liposomes Int. J. Pharm. 8 1981 101 110 (Pubitemid 11078171)
31. R. Jukanti, S. Sheela, S. Bandari, and P.R. Veerareddy Enhanced bioavailability of exemestane via proliposomes based transdermal delivery J. Pharm. Sci. 100 2011 3208 3222
32. C. Kirby, J. Clarke, and G. Gregoriadis Effect of the cholesterol content of small unilamellar liposomes on their stability in vivo and in vitro Biochem. J. 186 1980 591 598
33. P.E. Luner, L.E. Kirsch, S. Majuru, E. Oh, A.B. Joshi, D.E. Wurster, and M.P. Redmon Preformulation studies on the S-isomer of oxybutynin hydrochloride, an Improved Chemical Entity (ICE) Drug Dev. Ind. Pharm. 27 2001 321 329 (Pubitemid 32531598)
34. A. Manosroi, P. Wongtrakul, J. Manosroi, H. Saki, F. Sugawara, M. Yuasa, and M. Abe Characterization of vesicles prepared with various non-ionic surfactants mixed with cholesterol Colloids Surf. B. Biointerfaces 30 2003 129 138 (Pubitemid 36623337)
35. S.A. Mortazavi, and J.D. Smart Factors influencing gel-strengthening at the mucoadhesive-mucus interface J. Pharm. Pharmacol. 46 1994 86 90 (Pubitemid 24070833)
36. A.M. Mumtaz, and H.-S. Ch'ng Design of a dissolution apparatus suitable for in situ release study of triamcinolone acetonide from bioadhesive buccal tablets Int. J. Pharm. 121 1995 129 139
37. M.K. Nair, and Y.W. Chien Development of anticandidal delivery systems: (II) mucoadhesive devices for prolonged drug delivery in the oral cavity Drug Dev. Ind. Pharm. 22 1996 243 253 (Pubitemid 26104640)
38. R.R.C. New Liposomes: A Practical Approach 1990 Oxford University Press
39. C.R. Palem, R. Gannu, S.K. Yamsani, V.V. Yamsani, and M.R. Yamsani Development of bioadhesive buccal tablets for felodipine and pioglitazone in combined dosage form: in vitro, ex vivo, and in vivo characterization Drug Deliv. 18 2011 344 352
40. B. Parodi, E. Russo, G. Caviglioli, S. Cafaggi, and G. Bignardi Development and characterization of a buccoadhesive dosage form of oxycodone hydrochloride Drug Dev. Ind. Pharm. 22 1996 445 450 (Pubitemid 26171575)
41. V.F. Patel, F. Liu, and M.B. Brown Advances in oral transmucosal drug delivery J. Control. Release 153 2011 106 116
42. J. Pereira-Lachataignerais, R. Pons, P. Panizza, L. Courbin, J. Rouch, and O. Lopez Study and formation of vesicle systems with low polydispersity index by ultrasound method Chem. Phys. Lipids 140 2006 88 97
43. L. Perioli, V. Ambrogi, C. Pagano, E. Massetti, and C. Rossi New solid mucoadhesive systems for benzydamine vaginal administration Colloids Surf. B. Biointerfaces 84 2011 413 420
44. A.A. Petrovic, S.M. Petricevic, S.M. Ristic, S.R. Ibric, S.S. Simic, Z.R. Djuric, and R.B. Popovic Preliminary evaluation of the in vitro release and in vivo absorption in rabbits of the modified-release dosage forms Drug Dev. Ind. Pharm. 39 2013 889 900
45. Pharmacopoeia, 2007. British Pharmacopoeia Commission, London. HMSO, Electronic Version.
46. F. Pinguet, F. Bressolle, P. Martel, D. Salabert, and C. Astre High-performance liquid chromatographic determination of granisetron in human plasma J. Chromatogr. B Biomed. Appl. 675 1996 99 105 (Pubitemid 26036973)
47. K. Ruckmani, B. ayakar, and S.K. Ghosal Nonionic surfactant vesicles (niosomes) of cytarabine hydrochloride for effective treatment of leukemias: encapsulation, storage, and in vitro release Drug Dev. Ind. Pharm. 26 2000 217 222 (Pubitemid 30111645)
48. R.B. Shah, M.A. Tawakkul, and M.A. Khan Comparative evaluation of flow for pharmaceutical powders and granules AAPS PharmSciTech. 9 2008 250 258
49. M. Singh, A.K. Tiwary, and G. Kaur Investigations on interpolymer complexes of cationic guar gum and xanthan gum for formulation of bioadhesive films Res. Pharm. Sci. 5 2010 79 87
50. S. Sweetman Martindale: The Complete Drug Reference 33rd ed. 2002 The Pharmaceutical Press
51. S. Takka, A. Sakr, and A. Goldberg Development and validation of an in vitro-in vivo correlation for buspirone hydrochloride extended release tablets J. Control. Release 88 2003 147 157 (Pubitemid 36173960)
52. M.M. Talukdar, and R. Kinget Swelling and drug release behaviour of xanthan gum matrix tablets Int. J. Pharm. 120 1995 63 72
53. M. Tan Granisetron: new insights into its use for the treatment of chemotherapy-induced nausea and vomiting Expert Opin. Pharmacother. 4 2003 1563 1571 (Pubitemid 37120902)
54. S.A. Tayel, I.I. Soliman, and D. Louis Formulation of ketotifen fumarate fast-melt granulation sublingual tablet AAPS PharmSciTech. 11 2 2010 679 685
55. I.F. Uchegbu, and A.T. Florence Non-ionic surfactant vesicles (niosomes) physical and pharmaceutical chemistry Adv. Colloid Interface Sci. 58 1995 1 55
56. I. Uchegbu, and S. Vyas Non-ionic surfactant based vesicles (niosomes) in drug delivery Int. J. Pharm. 172 1998 33 70 (Pubitemid 28430243)
57. J. Varshosaz, and Z. Dehghan Development and characterization of buccoadhesive nifedipine tablets Eur. J. Pharm. Biopharm. 54 2002 135 141 (Pubitemid 34919385)
58. T. Vollmer, and H.R. Henney Pharmacokinetics and tolerability of single escalating doses of fampridine sustained-release tablets in patients with multiple sclerosis: a Phase I-II, open-label trial Clin. Ther. 31 2009 2206 2214
59. I. Wada, T. Takeda, M. Sato, H. Saitoh, T. Nakabayashi, K. Mino, T. Honma, M. Takada, and K. Hirano Pharmacokinetics of granisetron in adults and children with malignant diseases Biol. Pharm. Bull. 24 2001 432 435 (Pubitemid 32377616)
60. L.S. Wan, W.S. Heng, and L.F. Wong Relationship between swelling and drug release in a hydrophilic matrix Drug Dev. Ind. Pharm. 19 1993 1201 1210 (Pubitemid 23130427)
61. M. Wong, and T.E. Thompson Aggregation of dipalmitoylphosphatidylcholine vesicles Biochemistry 21 1982 4133 4139
62. C.F. Wong, K.H. Yuen, and K.K. Peh An in-vitro method for buccal adhesion studies: importance of instrument variables Int. J. Pharm. 180 1999 47 57 (Pubitemid 29131442)
63. H. Xu, L. He, S. Nie, J. Guan, X. Zhang, X. Yang, and W. Pan Optimized preparation of vinpocetine proliposomes by a novel method and in vivo evaluation of its pharmacokinetics in New Zealand rabbits J. Control. Release 140 2009 61 68
64. P. Yedurkar, M.K. Dhiman, K. Petkar, and K. Sawant Mucoadhesive bilayer buccal tablet of carvedilol-loaded chitosan microspheres: in vitro, pharmacokinetic and pharmacodynamic investigations J. Microencapsul. 29 2012 126 137
65. D. Young In vitro-in vivo correlation for modified release parenteral drug delivery systems D.M. Chilukuri, G. Sunkara, D. Young, Pharmaceutical Product Development In Vitro-In Vivo Correlation 2007 Informa Healthcare USA, Inc. 143 146