CLSM as quantitative method to determine the size of drug crystals in a solid dispersion

Pharmaceutical Research

Volumn 28, Issue 10, 2011, Pages 2567-2574

  De Waard, Hans ^a   Hessels, Martin J T ^a   Boon, Maarten ^a   Sjollema, Klaas A ^b   Hinrichs, Wouter L J ^a   Eissens, Anko C ^a   Frijlink, Henderik W ^a  

^a UNIVERSITY OF GRONINGEN   (Netherlands)

^b UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

Author keywords

confocal laser scanning miscroscopy; controlled crystallization during freeze drying; dipyridamole; dissolution; freeze drying

Indexed keywords

DIPYRIDAMOLE; MANNITOL; NANOPARTICLE;

ARTICLE; AUTOFLUORESCENCE; CONFOCAL LASER MICROSCOPY; CONTROLLED STUDY; CRYSTAL; DISPERSION; DISSOLUTION; DRUG CRYSTAL SIZE; DRUG MIXTURE; DRUG PURITY; FREEZE DRYING; IMAGE ANALYSIS; INTERMETHOD COMPARISON; LASER DIFFRACTION; PARTICLE SIZE; PARTICLE SIZE DISTRIBUTION; PHYSICAL PHENOMENA; POWDER; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; SCANNING ELECTRON MICROSCOPY; SOLID DISPERSION; SOLID STATE; TABLET FORMULATION; VALIDATION PROCESS; X RAY POWDER DIFFRACTION;

CHEMISTRY, PHARMACEUTICAL; DIPYRIDAMOLE; FREEZE DRYING; MANNITOL; MICROSCOPY, CONFOCAL; PARTICLE SIZE; PHARMACEUTICAL PREPARATIONS; POWDERS; SOLUBILITY; TABLETS;

EID: 80054765250     PISSN: 07248741     EISSN: 1573904X     Source Type: Journal    
DOI: 10.1007/s11095-011-0484-8     Document Type: Article

References (25)

1. CA Lipinski, et al. 2001 Experimental and computational approaches to estimate solubility and permeability in drug discovery and development settings Adv Drug Deliv Rev. 46 3 26 11259830 10.1016/S0169-409X(00)00129-0 1:CAS:528:DC%2BD3MXitVOhs7o%3D (Pubitemid 33653411)
2. GL Amidon, et al. 1995 A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability Pharm Res. 12 413 420 7617530 10.1023/A:1016212804288 1:CAS:528:DyaK2MXksVGqur8%3D
3. R Lobenberg GL Amidon 2000 Modern bioavailability, bioequivalence and biopharmaceutics classification system. New scientific approaches to international regulatory standards Eur J Pharm Biopharm. 50 3 12 10840189 10.1016/S0939-6411(00)00091-6 1:CAS:528:DC%2BD3cXjslyju7g%3D (Pubitemid 30326685)
4. W Curatolo 1998 Physical chemical properties of oral drug candidates in the discovery and exploratory development settings Pharm Sci Technol Today. 1 387 393 10.1016/S1461-5347(98)00097-2 1:CAS:528:DC%2BD3cXptlWjtg%3D%3D (Pubitemid 28559133)
5. N Blagden, et al. 2007 Crystal engineering of active pharmaceutical ingredients to improve solubility and dissolution rates Adv Drug Deliv Rev. 57 617 630 10.1016/j.addr.2007.05.011 (Pubitemid 47285407)
6. J Hu KP Johnston RO Williams 3rd 2004 Nanoparticle engineering processes for enhancing the dissolution rates of poorly water soluble drugs Drug Dev Ind Pharm. 30 233 45 15109023 10.1081/DDC-120030422 (Pubitemid 38451748)
7. J Jinno, et al. 2008 In vitro-in vivo correlation for wet-milled tablet of poorly water-soluble cilostazol J Control Release. 130 29 37 18582979 10.1016/j.jconrel.2008.05.013 1:CAS:528:DC%2BD1cXps1ahurw%3D
8. J Möschwitzer, et al. 2004 Development of an intravenously injectable chemically stable aqueous omeprazole formulation using nanosuspension technology Eur J Pharm Biopharm. 58 615 619 15451536 10.1016/j.ejpb.2004.03.022 (Pubitemid 39297108)
9. D Hou, et al. 2003 The production and characteristics of solid lipid nanoparticles (SLNs) Biomaterials. 24 1781 1785 12593960 10.1016/S0142-9612(02) 00578-1 1:CAS:528:DC%2BD3sXht1Wnt7k%3D (Pubitemid 36184733)
10. AA Noyes WR Whitney 1897 The rate of solution of solid substances in their own solutions J Am Chem Soc. 19 930 934 10.1021/ja02086a003
11. H de Waard WLJ Hinrichs HW Frijlink 2008 A novel bottom-up process to produce drug nanocrystals: controlled crystallization during freeze drying J Control Release 128 179 183 18423767 10.1016/j.jconrel.2008.03.002
12. H de Waard, et al. 2010 Controlled crystallization of the lipophilic drug fenofibrate during freeze-drying: Elucidation of the mechanism by in-line Raman spectroscopy AAPS J. 12 569 575 20625865 10.1208/s12248-010-9215-z 1:CAS:528:DC%2BC3cXhsFCqsbbJ
13. DF Driscoll, et al. 2001 Physicochemical assessments of parenteral lipid emulsions: light obscuration versus laser diffraction Int J Pharm. 219 21 37 11337163 10.1016/S0378-5173(01)00626-3 1:CAS:528:DC%2BD3MXjtV2ltLk%3D (Pubitemid 32391362)
14. CM Keck RH Müller 2008 Size analysis of submicron particles by laser diffractometry-90% of the published measurements are false Int J Pharm. 355 150 163 18201848 10.1016/j.ijpharm.2007.12.004 1:CAS:528:DC%2BD1cXkt1yhurg%3D
15. S Verma R Gokhale DJ Burgess 2009 A comparative study of top-down and bottom-up approaches for the preparation of micro/nanosuspensions Int J Pharm. 380 216 222 19596059 10.1016/j.ijpharm.2009.07.005 1:CAS:528:DC%2BD1MXhtV2hsbzF
16. W Wu GH Nancollas 1999 Determination of interfacial tension from crystallization and dissolution data: a comparison with other methods Adv Colloid Interface Sci. 79 229 279 10696260 10.1016/S0001-8686(98)00072-4 1:CAS:528:DyaK1MXptVKktQ%3D%3D (Pubitemid 128634243)
17. DE Bugay 2001 Characterization of the solid-state: spectroscopic techniques Adv Drug Deliv Rev. 48 43 65 11325476 10.1016/S0169-409X(01)00101-6 1:CAS:528:DC%2BD3MXivFejsrk%3D (Pubitemid 32452291)
18. WH Doub, et al. 2007 Raman chemical imaging for ingredient-specific particle size characterization of aqueous suspension nasal spray formulations: a progress report Pharm Res. 24 934 945 17372686 10.1007/s11095-006-9211-2 1:CAS:528:DC%2BD2sXkslWgtLo%3D (Pubitemid 46675394)
19. SR Pygall, et al. 2007 Pharmaceutical applications of confocal laser scanning microscopy: The physical characterisation of pharmaceutical systems Adv Drug Deliv Rev. 59 1434 1452 17945376 10.1016/j.addr.2007.06.018 1:CAS:528:DC%2BD2sXhtlCrtr7L (Pubitemid 350130271)
20. ES Kostewicz, et al. 2002 Forecasting the oral absorption behavior of poorly soluble weak bases using solubility and dissolution studies in biorelevant media Pharm Res. 19 345 349 11934243 10.1023/A:1014407421366 1:CAS:528:DC%2BD38XisFGnsr8%3D (Pubitemid 34211853)
21. JE Patterson, et al. 2005 The influence of thermal and mechanical preparative techniques on the amorphous state of four poorly soluble compounds J Pharm Sci. 94 1998 2012 16052554 10.1002/jps.20424 1:CAS:528: DC%2BD2MXpslOgtL0%3D (Pubitemid 41551483)
22. L Iuliano, et al. 2000 Fluorescence quenching of dipyridamole associated to peroxyl radical scavenging: a versatile probe to measure the chain breaking antioxidant activity of biomolecules Biochem Biophys Acta. 1474 177 182 10742597 1:CAS:528:DC%2BD3cXitVSrtrk%3D (Pubitemid 30162983)
23. A Annapragada A Adjei 1996 An analysis of the Fraunhofer Diffraction method for particle size distribution analysis and its application to aerosolized sprays Int J Pharm. 127 219 227 10.1016/0378-5173(95)04217-2 1:CAS:528:DyaK28XhslegtLo%3D
24. Sibarita J-B. Deconvolution microscopy. In: Rietdorf J, editor. Microscopy techniques. Berlin Heidelberg: Springer-Verlag; 2005. p. 1288-91.
25. A Burger, et al. 2000 Energy/temperature diagram and compression behavior of the polymorphs of D-mannitol J Pharm Sci. 89 457 468 10737907 10.1002/(SICI)1520-6017(200004)89:4<457::AID-JPS3>3.0.CO;2-G 1:CAS:528:DC%2BD3cXis12ktbo%3D