Enhanced bioavailability of buspirone hydrochloride via cup and core buccal tablets: Formulation and in vitro/in vivo evaluation

International Journal of Pharmaceutics

Volumn 463, Issue 1, 2014, Pages 68-80

  Kassem, Mohamed A A ^a   Elmeshad, Aliaa N ^a   Fares, Ahmed R ^a  

^a CAIRO UNIVERSITY   (Egypt)

Author keywords

Buccal tablets; Buspirone HCl; Cup and core tablets; LC MS MS; Mucoadhesive dosage forms; Pharmacokinetic study

Indexed keywords

ALGINIC ACID; BUSPIRONE; CARBOMER; CARBOXYMETHYLCELLULOSE; GUAR GUM; HYDROXYPROPYLMETHYLCELLULOSE;

ADULT; ARTICLE; BUCCAL MUCOADHESIVE TABLET; CHEEK MUCOSA; CONTROLLED STUDY; DRUG BIOAVAILABILITY; EX VIVO STUDY; HARDNESS; HUMAN; HUMAN EXPERIMENT; IN VITRO STUDY; IN VIVO STUDY; MALE; MUCOADHESION; MUCOADHESION FORCE; MUCOADHESION TIME; NORMAL HUMAN; PH; PRIORITY JOURNAL; SURFACE PROPERTY; SUSTAINED RELEASE FORMULATION; TABLET; THICKNESS; WEIGHT;

BUCCAL TABLETS; BUSPIRONE HCL; CUP AND CORE TABLETS; LC/MS/MS; MUCOADHESIVE DOSAGE FORMS; PHARMACOKINETIC STUDY;

ADMINISTRATION, BUCCAL; ADULT; ANIMALS; BIOLOGICAL AVAILABILITY; BUSPIRONE; CATTLE; CHEMISTRY, PHARMACEUTICAL; EXCIPIENTS; HUMANS; MALE; MOUTH MUCOSA; POLYMERS; SALIVA; SOLUBILITY; TABLETS;

EID: 84893020440     PISSN: 03785173     EISSN: 18733476     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2014.01.003     Document Type: Article

References (62)

1. N. Al-Zoubi, H.S. Alkhatib, Y. Bustanji, K. Aiedeh, and S. Malamataris Sustained-release of buspirone HCl by co spray-drying with aqueous polymeric dispersions Eur. J. Pharm. Biopharm. 69 2008 735 742
2. 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
3. S. Botha, and A. Löttter Compatibility study between naproxen and tablet excipients using differential scanning calorimetry Drug Dev. Ind. Pharm. 16 1990 673 683 (Pubitemid 20092100)
4. P. Bottenberg, R. Cleymaet, C. de Muynck, J.P. Remon, D. Coomans, Y. Michotte, and D. Slop Development and testing of bioadhesive, fluoride-containing slow-release tablets for oral use J. Pharm. Pharmacol. 43 1991 457 464
5. H. Boyapally, R.K. Nukala, P. Bhujbal, and D. Douroumis Controlled release from directly compressible theophylline buccal tablets Colloids Surf. B: Biointerfaces 77 2010 227 233
6. M.E. Campos-Aldrete, and L. Villafuerte-Robles Influence of the viscosity grade and the particle size of HPMC on metronidazole release from matrix tablets Eur. J. Pharm. Biopharm. 43 1997 173 178 (Pubitemid 28298798)
7. G.C. Ceschel, P. Maffei, S. Lombardi Borgia, and C. Ronchi Design and evaluation of buccal adhesive hydrocortisone acetate (HCA) tablets Drug Deliv. 8 2001 161 171 (Pubitemid 32896306)
8. S. Chandran, L.A. Asghar, and C.B. Chure Assessment of suitability of guar gum with pH sensitive polymer matrix bases for colon specific delivery Der Pharm. Lett. 3 2011 425 441
9. W.M. Chew, M.-J. Xu, C.A. Cordova, and H.-H.S. Chow Quantification of a cytochrome P450 3A4 substrate, buspirone, in human plasma by liquid chromatography-tandem mass spectrometry J. Chromatogr. B 844 2006 235 239 (Pubitemid 44792000)
10. F. Cilurzo, C.G. Gennari, F. Selmin, J.B. Epstein, G.M. Gaeta, G. Colella, and P. Minghetti A new mucoadhesive dosage form for the management of oral lichen planus: formulation study and clinical study Eur. J. Pharm. Biopharm. 76 2010 437 442
11. B.P. Commission British Pharmacopoeia, Online Version 2012 HMSO London
12. S. Conti, L. Maggi, L. Segale, E. Ochoa Machiste, U. Conte, P. Grenier, and G. Vergnault Matrices containing NaCMC and HPMC 1. Dissolution performance characterization Int. J. Pharm. 333 2007 136 142 (Pubitemid 46283280)
13. M.K. Darwish, and A.N. Elmeshad Buccal mucoadhesive tablets of flurbiprofen: characterization and optimization Drug Discov. Ther. 3 2009 181 189
14. K.G. Desai, and T.M. Kumar Preparation and evaluation of a novel buccal adhesive system AAPS PharmSciTech 5 2004 1 9
15. FDA Guidance of Industry, Food-effect Bioavailability and Bioequivalence Studies 2002
16. R. Gannu, C.R. Palem, S.K. Yamsani, V.V. Yamsani, and M.R. Yamsani Enhanced bioavailability of buspirone from reservoir-based transdermal therapeutic system, optimization of formulation employing Box-Behnken statistical design AAPS PharmSciTech 11 2010 976 985
17. R. Gannu, S.K. Yamsani, C.R. Palem, V.V. Yamsani, H. Kotagiri, and M.R. Yamsani Development of high performance liquid chromatography method for buspirone in rabbit serum: application to pharmacokinetic study Anal. Chim. Acta 647 2009 226 230
18. R.S. Harland, A. Gazzaniga, M.E. Sangalli, P. Colombo, and N.A. Peppas Drug/polymer matrix swelling and dissolution Pharm. Res. 5 1988 488 494
19. D.O. Helsinki As Amended by the 52nd World Medical Assembly (WMA) 2000 World Medical Association Scotland, Edinburgh
20. T. Higuchi Mechanism of Sustained-Action Medication. Theoretical Analysis of Rate of Release of Solid Drugs Dispersed in Solid Matrices J. Pharm. Sci. 52 1963 1145 1149
21. G. Ikinci, S. Senel, C.G. Wilson, and M. Sumnu Development of a buccal bioadhesive nicotine tablet formulation for smoking cessation Int. J. Pharm. 277 2004 173 178 (Pubitemid 38670432)
22. B.K. Jadhav, K.R. Khandelwal, A.R. Ketkar, and S.S. Pisal Formulation and evaluation of mucoadhesive tablets containing eugenol for the treatment of periodontal diseases Drug Dev. Ind. Pharm. 30 2004 195 203 (Pubitemid 38420264)
23. G.V. Joshi, B.D. Kevadiya, and H.C. Bajaj Design and evaluation of controlled drug delivery system of buspirone using inorganic layered clay mineral Micropor. Mesopor. Mater. 132 2010 526 530
24. G.M. Khan, and J.B. Zhu Studies on drug release kinetics from ibuprofen-carbomer hydrophilic matrix tablets: influence of co-excipients on release rate of the drug J. Control. Release 57 1999 197 203
25. R. Korsmeyer, R. Gumy, E. Doelker, P. Buri, and N. Peppas Mechanisms of solute release from porous hydrophilic polymers Int. J. Pharm. 15 1983 25 35 (Pubitemid 13092121)
26. S. Li, S. Lin, B.P. Daggy, H.L. Mirchandani, and Y.W. Chien Effect of HPMC and carbopol on the release and floating properties of gastric floating drug delivery system using factorial design Int. J. Pharm. 253 2003 13 22 (Pubitemid 36197827)
27. C.V. Liew, L.W. Chan, A.L. Ching, and P.W. Heng Evaluation of sodium alginate as drug release modifier in matrix tablets Int. J. Pharm. 309 2006 25 37 (Pubitemid 43129461)
28. A.C. Moffat, M.D. Osselton, and B. Widdop Monographs: buspirone J. Watts, Clarke's Analysis of Drugs and Poisons 4th ed. 2011 Pharmaceutical Press London 1014 1015
29. N.M. Morsi, G.A. Abdelbary, and M.A. Ahmed Silver sulfadiazine based cubosome hydrogels for topical treatment of burns: development and in vitro/in vivo characterization Eur. J. Pharm. Biopharm. 2013
30. N.A. Nafee, F.A. Ismail, N.A. Boraie, and L.M. Mortada Mucoadhesive buccal patches of miconazole nitrate: in vitro/in vivo performance and effect of ageing Int. J. Pharm. 264 2003 1 14 (Pubitemid 37297629)
31. N.A. Nafee, F.A. Ismail, N.A. Boraie, and L.M. Mortada Mucoadhesive delivery systems. I. Evaluation of mucoadhesive polymers for buccal tablet formulation Drug Dev. Ind. Pharm. 30 2004 985 993 (Pubitemid 39453050)
32. J.R. Nash, and D.J. Nutt Pharmacotherapy of anxiety F. Holsboer, A. Ströhle, Anxiety and Anxiolytic Drugs 2005 Springer Germany 469 501
33. D. Palmer, M. Levina, A. Nokhodchi, D. Douroumis, T. Farrell, and A. Rajabi-Siahboomi The influence of sodium carboxymethylcellulose on drug release from polyethylene oxide extended release matrices AAPS PharmSciTech 12 2011 862 871
34. C.R. Park, and D.L. Munday Development and evaluation of a biphasic buccal adhesive tablet for nicotine replacement therapy Int. J. Pharm. 237 2002 215 226 (Pubitemid 34326435)
35. C.R. Park, and D.L. Munday Evaluation of selected polysaccharide excipients in buccoadhesive tablets for sustained release of nicotine Drug Dev. Ind. Pharm. 30 2004 609 617 (Pubitemid 38924631)
36. V.F. Patel, F. Liu, and M.B. Brown Modeling the oral cavity: in vitro and in vivo evaluations of buccal drug delivery systems J. Control. Release 161 2012 746 756
37. V.M. Patel, B.G. Prajapati, and M.M. Patel Formulation, evaluation, and comparison of bilayered and multilayered mucoadhesive buccal devices of propranolol hydrochloride AAPS PharmSciTech 8 2007 E147 E154
38. N.A. Peppas, and J.J. Sahlin A simple equation for the description of solute release. III. Coupling of diffusion and relaxation Int. J. Pharm. 57 1989 169 172 (Pubitemid 20011841)
39. L. Perioli, V. Ambrogi, S. Giovagnoli, M. Ricci, P. Blasi, and C. Rossi Mucoadhesive bilayered tablets for buccal sustained release of flurbiprofen AAPS PharmSciTech 8 2007 E54
40. L. Perioli, V. Ambrogi, C. Pagano, S. Scuota, and C. Rossi FG90 chitosan as a new polymer for metronidazole mucoadhesive tablets for vaginal administration Int. J. Pharm. 377 2009 120 127
41. L. Perioli, V. Ambrogi, D. Rubini, S. Giovagnoli, M. Ricci, P. Blasi, and C. Rossi Novel mucoadhesive buccal formulation containing metronidazole for the treatment of periodontal disease J. Control. Release 95 2004 521 533 (Pubitemid 38340502)
42. L. Perioli, C. Pagano, S. Mazzitelli, C. Rossi, and C. Nastruzzi Rheological and functional characterization of new antiinflammatory delivery systems designed for buccal administration Int. J. Pharm. 356 2008 19 28
43. A. Portero, D.T. Osorio, M.J. Alonso, and C.R. López Development of chitosan sponges for buccal administration of insulin Carbohydr. Polym. 68 2007 617 625 (Pubitemid 46412455)
44. J.R.K. Reddy, Y.I. Muzib, and K.P.R. Chowdary Development and in-vivo characterization of novel trans buccal formulations of Amiloride hydrochloride J. Pharm. Res. 6 2013 647 652
45. P.L. Ritger, and N.A. Peppas A simple equation for description of solute release II. Fickian and anomalous release from swellable devices J. Control. Release 5 1987 37 42 (Pubitemid 17106644)
46. S. Rossi, G. Sandri, F. Ferrari, M.C. Bonferoni, and C. Caramella Buccal delivery of acyclovir from films based on chitosan and polyacrylic acid Pharm. Dev. Technol. 8 2003 199 208 (Pubitemid 36548984)
47. A. Sakr, and M. Andheria Pharmacokinetics of buspirone extended-release tablets: a single-dose study J. Clin. Pharmacol. 41 2001 783 789 (Pubitemid 32612443)
48. N. Salamat-Miller, M. Chittchang, and T.P. Johnston The use of mucoadhesive polymers in buccal drug delivery Adv. Drug Deliv. Rev. 57 2005 1666 1691 (Pubitemid 41443474)
49. J.M. Sankalia, M.G. Sankalia, and R.C. Mashru Drug release and swelling kinetics of directly compressed glipizide sustained-release matrices: establishment of level A IVIVC J. Control. Release 129 2008 49 58
50. H.J. Shah, G. Subbaiah, D.M. Patel, and C.N. Patel In vitro-in vivo correlation of modified release dosage form of lamotrigine Biopharm. Drug Dispos. 30 2009 524 531
51. S.S. Shidhaye, N.S. Saindane, S. Sutar, and V. Kadam Mucoadhesive bilayered patches for administration of sumatriptan succinate AAPS PharmSciTech 9 2008 909 916
52. M. Shumilov, and E. Touitou Buspirone transdermal administration for menopausal syndromes, in vitro and in animal model studies Int. J. Pharm. 387 2010 26 33
53. J. Siepmann, and N.A. Peppas Modeling of drug release from delivery systems based on hydroxypropyl methylcellulose (HPMC) Adv. Drug Deliv. Rev. 48 2001 139 157 (Pubitemid 32434400)
54. B. Sreenivasa Rao, A. Seshasayana, S.V. Pardha Saradhi, N. Ravi Kumar, C.P. Narayan, and K.V. Ramana Murthy Correlation of in vitro release and in vivo absorption characteristics of rifampicin from ethylcellulose coated nonpareil beads Int. J. Pharm. 230 2001 1 9 (Pubitemid 32973854)
55. A. Streubel, J. Siepmann, and R. Bodmeier F loating matrix tablets based on low density foam powder: effects of formulation and processing parameters on drug release Eur. J. Pharm. Sci. 18 2002 37 45 (Pubitemid 36120553)
56. Y. Sudhakar, K. Kuotsu, and A.K. Bandyopadhyay Buccal bioadhesive drug delivery - a promising option for orally less efficient drugs J. Control. Release 114 2006 15 40 (Pubitemid 44128620)
57. S. Takka, S. Rajbhandari, and A. Sakr Effect of anionic polymers on the release of propranolol hydrochloride from matrix tablets Eur. J. Pharm. Biopharm. 52 2001 75 82 (Pubitemid 32594790)
58. S. Tenjarla, P. Puranajoti, R. Kasina, and T. Mandal Preparation, characterization, and evaluation of miconazole-cyclodextrin complexes for improved oral and topical delivery J. Pharm. Sci. 87 1998 425 429 (Pubitemid 28175801)
59. V.R. Uppoor Regulatory perspectives on in vitro (dissolution)/in vivo (bioavailability) correlations J. Control. Release 72 2001 127 132 (Pubitemid 32522350)
60. J. Varshosaz, and Z. Dehghan Development and characterization of buccoadhesive nifedipine tablets Eur. J. Pharm. Biopharm. 54 2002 135 141 (Pubitemid 34919385)
61. M.V. Velasco, J.L. Ford, P. Rowe, and A.R. Rajabi-Siahboomi Influence of drug:hydroxypropylmethylcellulose ratio, drug and polymer particle size and compression force on the release of diclofenac sodium from HPMC tablets J. Control. Release 57 1999 75 85 (Pubitemid 29005075)
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)