Physicochemical characterization of hot melt extruded bicalutamide- polyvinylpyrrolidone solid dispersions

Journal of Pharmaceutical Sciences

Volumn 99, Issue 3, 2010, Pages 1322-1335

  Andrews, Gavin P ^a   Abudiak, Osama A ^a   Jones, David S ^a  

^a QUEEN'S UNIVERSITY BELFAST   (United Kingdom)

Author keywords

Bicalutamide; Hot melt extrusion; Solid dispersions

Indexed keywords

BICALUTAMIDE; PLASTICIZER; POLYMER; POVIDONE;

ARTICLE; CRYSTALLIZATION; DIFFERENTIAL SCANNING CALORIMETRY; DRUG SOLUBILITY; HUMIDITY; INFRARED SPECTROSCOPY; MELTING POINT; MOLECULAR INTERACTION; PHYSICAL CHEMISTRY; POWDER DIFFRACTION; RAMAN SPECTROMETRY; SOLID STATE; THERMOGRAVIMETRY; X RAY DIFFRACTION;

EID: 76649140816     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.21914     Document Type: Article

References (32)

1. Leuner C, Dressman J. 2000. Improving drug solubility for oral delivery using solid dispersions. Eur J Pharm Biopharm 50:47-60.
2. Brewster ME, Vandecruys R, Verreck G, Peeters J. 2008. Supersaturating drug delivery systems: Effect of hydrophilic cyclodextrins and other excipients on the formation and stabilization of supersaturated drug solutions. Pharmazie 63: 217-220.
3. Serajuddin A. 1999. Solid dispersion of poorly water-soluble drugs: Early promises, subsequent problems and recent breakthroughs. J Pharm Sci 88:1058-1066.
4. Craig D. 2002. The mechanisms of drug release from solid dispersions in water-soluble polymers. Int J Pharm 231:131-144.
5. Vippagunta SR, Wang Z, Hornung S, Krill SL. 2007. Factors affecting the formation of eutectic solid dispersions and their dissolution behavior. J Pharm Sci 96:294-304.
6. Crowley MM, Zhang F, Repka MA, Thumma S, Upadhye SB, Battu SK, McGinity JW, Martin C. 2007. Pharmaceutical applications of hot-melt extrusion: Part I. Drug Dev Ind Pharm 33:909-926.
7. Chokshi RJ, Sandhu HK, Iyer RM, Shah NH, Malick AW, Zia H. 2005. Characterization of physicomechanical properties of indomethacin and polymers to assess their suitability for hot-melt extrusion process as a means to manufacture solid dispersion/solution. J Pharm Sci 94:2463-2474.
8. Verreck G, Decorte A, Heymans K, Adriaensen J, Liu D, Tomasko D, Arien A, Peeters J, Van den Mooter G, Brewster M. 2006. Hot stage extrusion of p-amino salicylic acid with EC using CO2 as a temporary plasticizer. Int J Pharm 327:45-50.
9. Hülsmann S, Backensfeld T, Keitel S, Bodmeier R. 2000. Melt extrusion-An alternative method for enhancing the dissolution rate of 17β-estradiol hemihydrate. Eur J Pharm Biopharm 49:237-242.
10. Forster A, Hempenstall J, Tucker I, Rades T. 2001. Selection of excipients for melt extrusion with two poorly water-soluble drugs by solubility parameter calculation and thermal analysis. Int J Pharm 226:147-161.
11. Forster A, Hempenstall J, Thomas R. 2001. Characterization of glass solutions of poorly-water soluble drugs produced by melt extrusion with hydrophilic amorphous polymers. J Pharm Pharmacol 53:303-315.
12. Matsumoto T, Zografi G. 1999. Physical properties of solid molecular dispersions of indomethacin with poly(vinylpyrrolidone) and poly (vinylpyrrolidone-co-vinylacetate) in relation to indomethacin crystallisation. Pharm Res 16:1722-1728.
13. Van den Mooter G, Wuyts M, Blaton N, Busson R, Grobet P, Augustijns P, Kinget R. 2001. Physical stabilisation of amorphous ketoconazole in solid dispersions with polyvinylpyrrolidone K25. Eur J Pharm Sci 12:261-269.
14. Furr B, Tucker H. 1996. The preclinical development of bicalutamide: Pharmacodynamics and mechanism of action. Urology 47:13-25.
15. Goa K, Spencer C. 1998. Bicalutamide in advanced prostate cancer. Drugs Aging 12:401-422.
16. Cockshott ID. 2004. Bicalutamide: Clinical pharmacokinetics and metabolism. Clin Pharmacokinet 43:855-878.
17. Proudfoot S. Factors affecting bioavailability: Factors influencing drug absorption from the gastrointestinal tract. In: Aulton ME, editor. Pharmaceutics: The science of dosage form design. Edinburgh: Churchill, Livingstone. pp. 135-173.
18. Ren F, Jing Q, Tang Y, Shen Y, Chen J, Gao F, Cui J. 2006. Characteristics of bicalutamide solid dispersions and improvement of the dissolution. Drug Dev Ind Pharm 32:967-972.
19. Repka MA, Gerding TG, Repka SL, McGinity JW. 1999. Influence of plasticizers and drugs on the physical-mechanical properties of hydroxypropyl-cellulose films prepared by hot melt extrusion. Drug Dev Ind Pharm 25:625-633.
20. Le Y, Chen J-F, Shen Z, Yun J, Pu M. 2009. Nanosized bicalutamide and its molecular structure in solvents. Int J Pharm 370:175-180.
21. Vega DR, Polla G, Martinez A, Mendioroz E, Reinoso M. 2007. Conformational polymorphism in bicalutamide. Int J Pharm 328:112-118.
22. Lu Q, Zografi G. 1998. Phase behaviour of binary and ternary amorphous mixtures containing indomethacin, citric acid, and PVP. Pharm Res 15: 1202-1206.
23. Taylor L, Zografi G. 1997. Spectroscopic characterization of interactions between PVP and indomethacin in amorphous molecular dispersion. Pharm Res 14:1691-1698.
24. Gupta P, Bansal AK. 2005. Molecular interactions in celecoxib-PVP- meglumine amorphous system. J Pharm Pharmacol 57:303-310.
25. Wang X, Michoel A, Van den Mooter G. 2005. Solid state characteristics of ternary solid dispersions composed of PVP VA64, Myrj 52 and itraconazole. Int J Pharm 303:54-61.
26. Tang XC, Pikal MJ, Taylor LS. 2002. A spectroscopic investigation of hydrogen bond patterns in crystalline and amorphous phases in dihydropyridine calcium channel blockers. Pharm Res 19:477-483.
27. Konno H, Taylor LS. 2008. Ability of different polymers to inhibit the crystallization of amorphous felodipine in the presence of moisture. Pharm Res 25:969-978.
28. Jeffrey GA. 1997. An introduction to hydrogen bonding. New York: Oxford University Press.
29. Thybo P, Kristensen J, Hovgaard L. 2007. Characterization and physical stability of tolfenamic acid-PVP K30 solid dispersions. Pharm Dev Technol 12:43-53.
30. Smrecki V, Baranovic G, Kerestury G, Meic Z. 1997. Near-infrared Fourier transform Raman spectra of protonated and deuterated trans-azobenzene isotopomers. J Mol Struct 408/409: 405-408.
31. Brittain H. 2009. Vibrational spectroscopic studies of cocrystals and salts.1. The benzamide-benzoic acid system. Crystal Growth Design 5:2492-2499.
32. Kaushal AM, Chakraborti AK, Bansal AK. 2008. FTIR studies on differential intermolecular association in crystalline and amorphous states of structurally related non-steroidal antiinflammatory drugs. Mol Pharm 5:937-945.