The influence of milling on the dissolution performance of simvastatin

Pharmaceutics

Volumn 2, Issue 4, 2010, Pages 419-431

  Zimper, Ulrike ^a   Aaltonen, Jaakko ^b   Krauel Goellner, Karen ^c   Gordon, Keith C ^a   Strachan, Clare J ^a   Rades, Thomas ^a  

^a UNIVERSITY OF OTAGO   (New Zealand)

^b UNIVERSITY OF EASTERN FINLAND   (Finland)

^c BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG   (Germany)

Author keywords

Ball milling; Dissolution rate; Process induced disorder; Response surface modeling; Simvastatin

Indexed keywords

SIMVASTATIN;

ARTICLE; CONTROLLED STUDY; DRUG FORMULATION; DRUG SOLUBILITY; FACTORIAL DESIGN; IMAGE ANALYSIS; PARTICLE SIZE; PHARMACOLOGICAL PARAMETERS; PROCESS OPTIMIZATION; RAMAN SPECTROMETRY; RESPONSE SURFACE METHOD; SCANNING ELECTRON MICROSCOPY; SOLID STATE; X RAY POWDER DIFFRACTION;

EID: 79952144176     PISSN: None     EISSN: 19994923     Source Type: Journal    
DOI: 10.3390/pharmaceutics2040419     Document Type: Article

References (15)

1. Brereton, R.G. Applied Chemometrics for Scientists; John Wiley & Sons, Ltd: Chichester, UK, 2007; pp. 25-44.
2. Bergman, R.; Johansson, M.E.; Lundstedt, T.; Seifert, E.; Aberg, J. Optimization of a granulation and tabletting process by sequential design and multivariate analysis. Chemometr. Intell. Lab. Syst. 1998, 44, 271-286.
3. Krogars, K.; Antikainen, O.; Heinamaki, J.; Laitinen, N.; Yliruusi, J. Tablet film-coating with amylose-rich maize starch. Eur. J. Pharm. Sci. 2002, 17, 23-30.
4. Lundstedt, T.; Seifert, E.; Abramo, L.; Thelin, B.; Nystrom, A.; Pettersen, J.; Bergman, R. Experimental design and optimization. Chemometr. Intell. Lab. Syst. 1998, 42, 3-40.
5. Esbensen, K.H. Multivariate Data Analysis-In Practice, 5th ed.; CAMO Process AS: Oslo, Norway, 2004; pp. 361-400.
6. De Beer, T.R.M.; Vercruysse, P.; Burggraeve, A.; Quinten, T., Ouyang, J.; Zhang, X.; Vervaet, C.; Remon, J.P. Baeyens, W.R.G. In-Line and Real-Time Process Monitoring of a Freeze Drying Process Using Raman and NIR Spectroscopy as Complementary Process Analytical Technology (PAT) Tools. J. Pharm. Sci. 2009, 98, 3430-3446.
7. Fisher, E.S. Milling of Active Pharmaceutical Ingredients. In Encyclopedia of Pharmaceutical Technology, 3rd ed.; Swarbrick, J., Ed.; Informa healthcare: New York, NY, USA, 2006; Volume 4, pp. 2339-2351.
8. Noyes, A.A., Whitney, W.R. The rate of solution of solid substances in their own solutions. J. Am. Chem. Soc. 1897, 19, 930-934.
9. Zimper, U.; Aaltonen, J.; McGoverin, C.M.; Gordon, K.C.; Krauel-Goellner, K.; Rades, T. Quantification of Process Induced Disorder in Milled Samples Using Different Analytical Techniques. Pharmaceutics 2010, 2, 30-49.
10. Hilfiker, R.; Blatter, F.; von Raumer, M. Relevance of Solid-State Properties for Pharmaceutical Products. In Polymorphism in the Pharmaceutical Industry; Hilfiker, R., Ed.; Wiley-Vch Verlag GmbH & Co. KGaA: Weinheim, Germany, 2006; pp. 1-19.
11. Brittain, H.G.; Grant, D.J.W. Effects of Polymorphism and Solid-State Solvation on Solubility and Dissolution Rate. In Polymorphism in Pharmaceutical Solids; Brittain, H.G., Ed.; Marcel Dekker, Inc.: New York, NY, USA, 1999; pp. 279-330.
12. Pandya, P.; Gattani, S.; Jain, P.; Khirwal, L.; Surana, S. Co-solvent Evaporation Method for Enhancement of Solubility and Dissolution Rate of Poorly Aqueous Soluble Drug Simvastatin: In vitro-In vivo Evaluation. AAPS Pharm. Sci. Technol. 2008, 9, 1247-1252.
13. Singla, N.; Gupta, G.D.; Kohli, K.; Singla, A.K. A Discriminatory and Biorelevant Dissolution Test Method for Simvastatin Drug Products. Dissolution Technol. 2009, 16, 11-13.
14. The United States Pharmacopeial Convention. United States Pharmacopeia-National Formulary, USP 32-NF 27; United Book Press: Baltimore, ML, USA, 2009; Volume 3, p. 3558.
15. Merisko-Liversidge, E.; Liversidge, G.G.; Cooper, E.R. Nanosizing: a formulation approach for poorly-water-soluble compounds. Eur. J. Pharm. Sci. 2003, 18, 113-120.