Immediate release of poorly soluble drugs from starch-based pellets prepared via extrusion/spheronisation

European Journal of Pharmaceutics and Biopharmaceutics

Volumn 67, Issue 3, 2007, Pages 715-724

  Dukić Ott, Aleksandra ^a   Remon, Jean Paul ^a   Foreman, Paul ^b   Vervaet, Chris ^a  

^a GHENT UNIVERSITY   (Belgium)

^b NATIONAL STARCH AND CHEMICAL COMPANY   (United States)

Author keywords

Extrusion spheronisation; Hydrochlorothiazide; In vivo evaluation; Pellets; Piroxicam; Starch

Indexed keywords

EXCIPIENT; HYDROCHLOROTHIAZIDE; HYDROXYPROPYLMETHYLCELLULOSE; METHYLCELLULOSE; PIROXICAM; SORBIDEX; SORBITOL; STARCH; UNCLASSIFIED DRUG; UNI PURE EX;

ANIMAL EXPERIMENT; ARTICLE; CHEMICAL INTERACTION; CHEMICAL MODIFICATION; CHEMICAL REACTION KINETICS; CONTROLLED DRUG RELEASE; CONTROLLED STUDY; DOG; DRUG BIOAVAILABILITY; DRUG DOSAGE FORM; DRUG PELLET; DRUG SOLUBILITY; MALE; NONHUMAN;

ALGORITHMS; ANIMALS; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; AREA UNDER CURVE; BIOLOGICAL AVAILABILITY; CALIBRATION; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DIURETICS; DOGS; DRUG COMPOUNDING; EXCIPIENTS; HYDROCHLOROTHIAZIDE; MALE; MICROSCOPY, ELECTRON, SCANNING; MOLECULAR WEIGHT; PARTICLE SIZE; PHARMACEUTICAL PREPARATIONS; PIROXICAM; SOLUBILITY; STARCH;

EID: 35348852075     PISSN: 09396411     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejpb.2007.04.014     Document Type: Article

References (36)

1. Erkoboni D.F. Extrusion/spheronization. Pharmaceutical Extrusion Technology (2003), Marcel Dekker Inc., New York and Basel 277-322
2. Harris M.R., and Ghebre-Sellasie I. Formulation variables. Pharmaceutical Pelletization Technology (1989), Marcel Dekker Inc., New York and Basel 217-239
3. O'Connor R.E., and Schwartz J.B. Spheronization II: drug release from drug-diluent mixtures. Drug Dev. Ind. Pharm. 11 (1985) 1837-1857
4. Vervaet C., Baert L., and Remon J.P. Enhancement of in-vitro drug-release by using polyethylene-glycol-400 and peg-40 hydrogenated castor-oil in pellets made by extrusion/spheronisation. Int. J. Pharm. 108 (1994) 207-212
5. Souto C., Rodriguez A., Parajes S., and Martinez-Pacheco R. A comparative study of the utility of two superdisintegrants in microcrystalline cellulose pellets prepared by extrusion-spheronization. Eur. J. Pharm. Biopharm. 61 (2005) 94-99
6. Baert L., and Remon J.P. Influence of amount of granulation liquid on the drug release rate from pellets made by extrusion-spheronisation. Int. J. Pharm. 95 (1993) 135-141
7. Millili G.P., and Schwartz J.B. The strength of microcrystalline cellulose pellets - the effect of granulating with water ethanol mixtures. Drug Dev. Ind. Pharm. 16 (1990) 1411-1426
8. Schroeder M., and Kleinebudde P. Structure of disintegrating pellets with regard to fractal geometry. Pharm. Res. 12 (1995) 1694-1700
9. Junnila R., Palviainen P., Heinämäki J., Myllärinen P., Forssell P., and Yliruusi J. Waxy corn starch: a potent cofiller in pellets produced by extrusion-spheronisation. Pharm. Dev. Technol. 5 (2000) 67-76
10. Tho I., Sande S.A., Kleinebudde P., and acid P. a novel excipient for production of pellets by extrusion/spheronisation: preliminary studies. Eur. J. Pharm. Biopharm. 54 (2002) 95-99
11. Alvarez L., Concheiro A., Gomez-Amoza J.L., Souto C., and Martinez-Pacheco R. Powdered cellulose as excipient for extrusion-spheronization pellets of a cohesive hydrophobic drug. Eur. J. Pharm. Biopharm. 55 (2003) 291-295
12. Tho I., Sande S.A., and Kleinebudde P. Disintegrating pellets from a water-insoluble pectin derivative produced by extrusion/spheronisation. Eur. J. Pharm. Biopharm. 56 (2003) 371-380
13. Liew C.V., Gu L., Soh J.L.P., and Heng P.W.S. Functionality of cross-linked polyvinylpyrrolidone as a spheronization aid: a promising alternative to microcrystalline cellulose. Pharm. Res. 22 (2005) 1387-1398
14. Almeida Prieto S., Blanco Mendez J., and Otero Espinar F.J. Starch-dextrin mixtures as base excipients for extrusion-spheronization pellets. Eur. J. Pharm. Biopharm. 59 (2005) 511-521
15. Howard M.A., Neau S.H., and Sack J.S. PEO and MPEG in high drug load extruded and spheronised beads that are devoid of MCC. Int. J. Pharm. 307 (2006) 66-76
16. Thommes M., and Kleinebudde P. Use of kappa-carrageenan as alternative pelletisation aid to microcrystalline cellulose in extrusion/spheronisation. I. Influence of type and fraction of filler. Eur. J. Pharm. Biopharm. 63 (2006) 59-67
17. Thommes M., and Kleinebudde P. Use of kappa-carrageenan as alternative pelletisation aid to microcrystalline cellulose in extrusion/spheronisation. II. Influence of drug and filler type. Eur. J. Pharm. Biopharm. 63 (2006) 68-75
18. Dukić A., Mens R., Adriaensens P., Foreman P., Gelan J., Remon J.P., and Vervaet C. Development of starch-based pellets via extrusion/spheronisation. Eur. J. Pharm. Biopharm. 66 (2007) 83-94
19. US Patent No. 5281276.
20. Podczeck F., and Newton J.M. A shape factor to characterize the quality of spheroids. J. Pharm. Pharmacol. 46 (1994) 82-85
21. Vervaet C., and Remon J.P. Bioavailability of hydrochlorothiazide from pellets, made by extrusion/spheronisation, containing polyethylene glycol 400 as a dissolution enhancer. Pharm. Res. 14 (1997) 1644-1646
22. Baert L., Fanara D., Debaets P., and Remon J.P. Instrumentation of a gravity feed extruder and the influence of the composition of binary and ternary mixtures on the extrusion forces. J. Pharm. Pharmacol. 43 (1991) 745-749
23. Hileman G.A., Upadrashta S.M., and Neau S.H. Drug solubility effects on predicting optimum conditions for extrusion and spheronisation of pellets. Pharm. Dev. Technol. 2 (1997) 43-52
24. Lustig-Gustafsson C., Johal H.K., Podczeck F., and Newton J.M. The influence of water content and drug solubility on the formulation of pellets by extrusion and spheronisation. Eur. J. Pharm. Sci. 8 (1999) 147-152
25. Sousa J.J., Sousa A., Podczeck F., and Newton J.M. Factors influencing the physical characteristics of pellets obtained by extrusion-spheronization. Int. J. Pharm. 232 (2002) 91-106
26. Holm P. High shear mixer granulators. Handbook of Pharmaceutical Granulation Technology (1997), Marcel Dekker Inc., New York and Basel 151-204
27. Kristensen H.G., Holm P., and Schaefer T. Mechanical properties of moist agglomerates in relation to granulation mechanisms: part 2. Effect of particle size distribution. Powder Technol. 44 (1985) 239-247
28. Bains D., Boutell S.L., and Newton J.M. The influence of moisture content on the preparation of spherical granules of barium sulphate and microcrystalline cellulose. Int. J. Pharm. 69 (1991) 233-237
29. Agrawal A.M., Howard M.A., and Neau S.H. Extruded and spheronized beads containing no microcrystalline cellulose: influence of formulation and process variables. Pharm. Dev. Technol. 9 (2004) 197-217
30. Baert L., Vermeersch H., Remon J.P., Smeyers-Verbeke J., and Massart D.L. Study of parameters important in the spheronisation process. Int. J. Pharm. 96 (1993) 225-229
31. Chopra R., Podczeck F., Newton J.M., and Alderborn G. The influence of pellet shape and film coating on the filling of pellets into hard shell capsules. Eur. J. Pharm. Biopharm. 53 (2002) 327-333
32. Augsburger L.L., and Vuppala M.K. Theory of granulation. Handbook of Pharmaceutical Granulation Technology (1997), Marcel Dekker Inc., New York and Basel 7-24
33. Schreiner T., Schaefer U.F., and Loth H. Immediate drug release from solid oral dosage forms. J. Pharm. Sci. 94 (2005) 120-133
34. Hoener B., and Benet L.Z. Factors influencing drug absorption and drug availability. Modern Pharmaceutics (1996), Marcel Dekker Inc., New York and Basel 121-153
35. Beermann B., Groschinsky-Grind M., and Rosén A. Absorption, metabolism and excretion of hydrochlorothiazide. Clin. Pharm. Ther. 19 (1976) 531-537
36. Dalton J.T., and Meyer M.C. Bioavailability of drugs and bioequivalence. Encyclopedia of Pharmaceutical Technology (2002), Marcel Dekker Inc., New York, Basel 125-135