Understanding the performance of melt-extruded poly(ethylene oxide)-bicalutamide solid dispersions: Characterisation of microstructural properties using thermal, spectroscopic and drug release methods

Journal of Pharmaceutical Sciences

Volumn 101, Issue 1, 2012, Pages 200-213

  Abu Diak, Osama A ^a   Jones, David S ^a   Andrews, Gavin P ^a  

^a QUEEN'S UNIVERSITY BELFAST   (United Kingdom)

Author keywords

Amorphous; Calorimetry (DSC); Dissolution; Extrusion; Solid dispersions

Indexed keywords

BICALUTAMIDE; MACROGOL;

ARTICLE; CONTROLLED STUDY; CRYSTAL STRUCTURE; DIFFERENTIAL SCANNING CALORIMETRY; DISPERSION; DRUG ANALYSIS; DRUG FORMULATION; DRUG RELEASE; DRUG SYNTHESIS; MISCIBILITY; SCANNING ELECTRON MICROSCOPY; SPECTROSCOPY; THERMAL ANALYSIS; X RAY DIFFRACTION;

EID: 82255179484     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.22748     Document Type: Article

References (24)

1. Serajuddin A. 1999. Solid dispersion of poorly water-soluble drugs: Early promises, subsequent problems, recent breakthroughs. J Pharm Sci 88:1058-1066.
2. Breitenbach J. 2002. Melt extrusion: From process to drug delivery technology. Eur J Pharm Biopharm 54:107-117.
3. Paradkar A, Kelly A, Coates P, York P. 2009. Shear and extensional rheology of hydroxypropyl cellulose melt using capillary rheometry. J Pharm Biomed Anal 49:304-310.
4. Vippagunta S, Wang Z, Krill S. 2007. Factors affecting the formation of eutectic solid dispersions and their dissolution behavior. J Pharm Sci 96:294-304.
5. 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(8):967-972.
6. Stachurek I, Pielichowski K. 2009. Preparation and thermal characterization of poly(ethylene oxide)/griseofulvin solid dispersions for biomedical applications. J App Poly Sci 111:1690-1696.
7. Guns S, Dereymaker A, Kayaert P, Mathot V, Martens JA, Van den Mooter G. 2011. Comparison between hot-melt extrusion and spray-drying for manufacturing solid dispersions of the graft copolymer of ethylene glycol and vinyl alcohol. Pharm Res 28:673-682.
8. Crowley M, Zhang F, Koleng J, McGinity J. 2002. Stability of polyethylene oxide in matrix tablets prepared by hot-melt extrusion. Biomaterials 23:4241-4248.
9. Vrandecic SN, Erceg M, Jakic M, Klaric I. 2010. Kinetic analysis of thermal degradation of poly(ethylene glycol) and poly(ethylene oxide)s of different molecular weight. Thermochimica Acta 49871-49880.
10. Repka M, Gerding T, Repka S, McGinity J. 1999. Influence of plasticizers and drugs on the physical-mechanical properties of hydroxypropylcellulose films prepared by hot melt extrusion. Drug Dev Ind Pharm 25:625-633.
11. Crowley M, Fredersdorf A, Schroeder B, Kucera S, Prodduturi S, Repka M, McGinity J. 2004. The influence of guaifenesin and ketoprofen on the properties of hot-melt extruded polyethylene oxide films. Eur J Pharm Sci 22:409-418.
12. Qian F, Tao J, Desikan S, Hussain M, Smith RL. 2007. Mechanistic investigation of pluronic based nano-crystalline drug-polymer solid dispersions. Pharm Res 24:1551-1560.
13. Andrews GP, Zhai H, Tipping S, Jones DS. 2009. Characterization of the thermal, spectroscopic and drug dissolution properties of mefenamic acid and polyoxyethylene-polyoxypropylene solid dispersions. J Pharm Sci 98(12):4545-4556.
14. Almeida A, Possemiers S, Boone MN, De Beer T, Quinten T, Van Hoorebeke L, Remon JP, Vervaet C. 2011. Ethylene vinyl acetate as matrix for oral sustained release dosage forms produced via hot-melt extrusion. Eur J Pharm Biopharm 77:297-305.
15. Andrews GP, Abu-Diak OA, Jones DS. 2010. Physicochemical characterization of hot-melt extruded bicalutamide-polyvinylpyrrolidone solid dispersions. J Pharm Sci 99:1322-1335.
16. Marsac PJ, Li T, Taylor LS. 2009. Estimation of drug-polymer miscibility and solubility in amorphous solid dispersions using experimentally determined interaction parameters. Pharm Res 26:139-151.
17. Marsac PJ, Shamblin SL, Taylor LS. 2006. Theoretical and practical approaches for prediction of drug/polymer miscibility and solubility. Pharm Res 23(10):2417-2426.
18. Prodduturi S, Manek R, Kolling W, Stodghill S, Repka M. 2005. Solid-state stability and characterization of hot-melt extruded poly(ethylene oxide) films. J Pharm Sci 94(10):2232-2245.
19. Li L, AbuBaker O, Shao Z. 2006. Characterization of poly(ethylene oxide) as a drug carrier in hot-melt extrusion. Drug Dev Ind Pharm 32(8):991-1002.
20. Zhu Q, Taylor LS, Harris MT. 2010. Evaluation of the microstructure of semicrystalline solid dispersions. Mol Pharm 7:1291-1300.
21. Gramaglia D, Conway BR, Kett VL, Malcolm RK, Batchelor HK. 2005. High speed DSC (hyper-DSC) as a tool to measure the solubility of a drug within a solid or semi-solid matrix. Int J Pharm 301:1-5.
22. Ozeki Y, Yuasa H, Kanaya Y. 1997. Application of the solid dispersion method to the controlled release of medicine. IX. Difference in the release of flurbiprofen from solid dispersions with poly(ethylene oxide) and hydroxypropylcellulose and the interaction between medicine and polymers. Int J Pharm 155:209-217.
23. Vega DR, Polla G, Martinez A, Mendioroz E, Reinoso M. 2007. Conformational polymorphism in bicalutamide. Int J Pharm 328:112-118.
24. Leskinen JTT, Hakulinen MA, Kuosmanen M, Ketolainen J, Abrahmsén-Alamid S, Lappalainen R. 2011. Monitoring of swelling of hydrophilic polymer matrix tablets by ultrasound techniques. Int J Pharm 404:142-147.