Investigation on drug dissolution and particle characteristics of pellets related to manufacturing process variables of high-shear granulation

Journal of Biochemical and Biophysical Methods

Volumn 69, Issue 1-2, 2006, Pages 197-205

  Dévay, Attila ^a   Mayer, Klára ^a   Pál, Szilárd ^a   Antal, István ^b  

^a UNIVERSITY OF PÉCS   (Hungary)

^b SEMMELWEIS UNIVERSITY   (Hungary)

Author keywords

Dissolution profile; Experimental design; High shear pelletisation; NIR diffuse reflectance spectra; Particle size

Indexed keywords

ETHYL CELLULOSE; LACTOSE; MICROCRYSTALLINE CELLULOSE; THEOPHYLLINE;

ARTICLE; DIFFUSE REFLECTANCE SPECTROSCOPY; DRUG RESEARCH; DRUG SOLUBILITY; IMPELLER; LINEAR REGRESSION ANALYSIS; PARTICLE SIZE; PRIORITY JOURNAL; SHEAR RATE;

DELAYED-ACTION PREPARATIONS; DOSAGE FORMS; DRUG COMPOUNDING; PARTICLE SIZE; SOLUBILITY; SPECTROPHOTOMETRY; TABLETS; TABLETS, ENTERIC-COATED; THEOPHYLLINE;

EID: 33749234214     PISSN: 0165022X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jbbm.2006.03.006     Document Type: Article

References (20)

1. Costa F.O., Sousa J.J.S., Pais A.A.C.C., and Formosinho S.J. Comparison of dissolution profiles of Ibuprofen pellets. J Control Release 89 (2003) 199-212
2. Rinaki E., Valsami G., and Macheras P. The power law can describe the entire drug release curve from HPMC-based matrix tablets. Int J Pharm 255 (2003) 199-207
3. Ramana V., and Uppoor S. Regulatory perspectives on in vitro (dissolution)/in vivo (bioavailability) correlations. J Control Release 72 (2001) 127-132
4. Siewert M., Dressman J., Brown C., and Shah V. FIP/AAPS guidelines for dissolution/in vitro release testing of novel/special dosage forms (February 2003), Dissolution Technologies 6-15
5. Costa P., and Lobo J.M.S. Modeling and comparison of dissolution profiles. Eur J Pharm Sci 13 (2001) 123-133
6. Macheras P., and Dokoumetzidis A. On the heterogeneity of drug dissolution and release. Pharm Res 17 (2000) 108-112
7. Järvinen A., Nykänen S., Paasiniemi L., Hirjärvi-Lahti T., and Mattila J. Enteric coating reduces upper gastrointestinal adverse reactions to doxycycline. Clin Drug Investig 10 (1995) 323-327
8. Chopra R., Alderborn G., Podczeck F., and Newton J.M. The influence of pellet shape and surface properties on the drug release from uncoated and coated pellets. Int J Pharm 239 (2002) 171-178
9. Chatlapalli R., and Rohera B.D. Physical characterization of HPMC and HEC and investigation of their use as pelletization aids. Int J Pharm 161 (1998) 179-193
10. Ghebre-Sellassie I. Pharmaceutical Pelletization Technology: Drugs and pharmaceutical sciences (1989), Marcel Dekker, New York 1-13
11. Musko Z., Bajdik J., Pintye-Hodi K., Szabo-Revesz P., Kelemen A., and Eros I. Preparation of pellets containing theophylline. Pharm Ind 64 (2002) 1194-1198
12. Thies R., and Kleinebudde P. Melt pelletisation of a hygroscopic drug in a high shear mixer, Part I. Influence of process variables. Int J Pharm 188 (1994) 131-143
13. Schwartz J.B., and O'Connor R.E. Optimization techniques in pharmaceutical formulation and processing. In: Banker G.S., and Rhodes C.T. (Eds). Modern Pharmaceutics. 3rd ed. (1997), Marcel Dekker, New York 727-752
14. Voinovich D., Moneghini M., Perissutti B., and Franceschinis E. Melt pelletization in high shear mixer using a hydrophobic melt binder: influence of some apparatus and process variables. Eur J Pharm Biopharm 52 (2001) 305-313
15. Faure A., York P., and Rowe R.C. Process control and scale-up of pharmaceutical wet granulation processes: a review. Eur J Pharm Biopharm 52 (2001) 269-277
16. Jorgensen A.C., Luukkonen P., Rantanen J., Schaefer R., Juppo A.M., and Vliruusi J. Comparison of torque measurements and near-infrared spectroscopy in characterization of a wet granulation process. J Pharm Sci 93 (2004) 2232-2243
17. Antal I., Zelko R., Roczey N., Plachy J., and Racz I. Dissolution and diffuse reflectance characteristics of coated theophylline particles. Int J Pharm 155 (1997) 83-89
18. Reich G. Near-infrared spectroscopy and imaging: basic principles and pharmaceutical applications. Adv Drug Deliv Rev 57 (2005) 1109-1143
19. Morisseau K.M., and Rhodes C.T. Pharmaceutical uses of near-infrared spectroscopy. Drug Dev Ind Pharm 21 (1995) 1071-1090
20. Langenbucher F. Parametric representation of dissolution-rate curves by the RRSBW distribution. Pharm Ind 38 (1976) 472-477