Impact of process variables on the micromeritic and physicochemical properties of spray-dried microparticles - Part II. Physicochemical characterisation of spray-dried materials

Journal of Pharmacy and Pharmacology

Volumn 64, Issue 11, 2012, Pages 1583-1591

  Paluch, Krzysztof J ^a   Tajber, Lidia ^a   Amaro, Maria I ^a   Corrigan, Owen I ^a   Healy, Anne Marie ^a  

^a TRINITY COLLEGE DUBLIN   (Ireland)

Author keywords

amorphous; critical relative humidity of recrystallisation; oxidation of organic solvent; permitted daily exposure; residual solvent level; spray drying

Indexed keywords

ACETIC ACID DERIVATIVE; BENZOTHIADIAZINE DERIVATIVE; BUTYL ACETATE; CHLOROTHIAZIDE; CHLOROTHIAZIDE POTASSIUM; FORMALDEHYDE; METHANOL; ORGANIC SOLVENT; UNCLASSIFIED DRUG; WATER;

ARTICLE; CRYSTALLIZATION; DECOMPOSITION; DRUG STABILITY; DRUG TRANSFORMATION; GAS CHROMATOGRAPHY; GLASS TRANSITION TEMPERATURE; HUMIDITY; MICROPARTICLE; OXIDATION; PARTICLE SIZE; POWDER; SPRAY DRYING; STORAGE; THERMAL ANALYSIS; X RAY DIFFRACTION;

CHEMISTRY, PHARMACEUTICAL; CHLOROTHIAZIDE; CHROMATOGRAPHY, GAS; DRUG STABILITY; DRUG STORAGE; ORGANIC CHEMICALS; OXIDATION-REDUCTION; POWDERS; SOLVENTS; TEMPERATURE; TRANSITION TEMPERATURE; X-RAY DIFFRACTION;

EID: 84867574090     PISSN: 00223573     EISSN: 20427158     Source Type: Journal    
DOI: 10.1111/j.2042-7158.2012.01543.x     Document Type: Article

References (25)

1. Masters K,. Spray drying in practice. SprayDryConsult Internation ApS 2002.
2. Corrigan OI, et al,. Amorphous forms of diuretics prepared by spray drying. Int J Pharm 1984; 18: 195-200.
3. Tajber L, et al,. Physicochemical evaluation of PVP-thiazide diuretic interactions in co-spray-dried composites-analysis of glass transition composition relationships. Eur J Pharm Sci 2005; 24: 553-563.
4. Tajber L, et al,. Spray drying of budesonide, formoterol fumarate and their composites. I. Physicochemical characterisation. Int J Pharm 2009; 367: 79-85.
5. Al-Obaidi H, et al,. Anomalous properties of spray dried solid dispersions. J Pharm Sci 2009; 98: 4724-4737.
6. Nolan LM, et al,. Particle engineering of materials for oral inhalation by dry powder inhalers. II-sodium cromoglycate. Int J Pharm 2011; 405: 36-46.
7. NíO'gáin O, et al,. Particle engineering of materials for oral inhalation by dry powder inhalers. I-Particles of sugar excipients (trehalose and raffinose) for protein delivery. Int J Pharm 2011; 405: 23-35.
8. Paluch KJ, et al,. Impact of process variables on the micromeritic and physicochemical properties of spray dried microparticles Part I-introduction of a new morphology classification system. J Pharm Pharmacol 2012, in press.
9. Harjunen P, et al,. Effects of ethanol to water ratio in feed solution on the crystallinity of spray-dried lactose. Drug Dev Ind Pharm 2002; 28: 949-955.
10. Gilani K, et al,. The effect of water to ethanol feed ratio on physical properties and aerosolization behavior of spray dried cromolyn sodium particles. J Pharm Sci 2005; 94: 1048-1059.
11. Hancock BC, Zografi G,. Characteristics and significance of the amorphous state in pharmaceutical systems. J Pharm Sci 1997; 86: 1-12.
12. Burnett DJ, et al,. Determining the critical relative humidity for moisture-induced phase transitions. Int J Pharm 2004; 287: 123-133.
13. Hancock BC, Zografi G,. The relationship between the glass transition temperature and the water content of amorphous pharmaceutical solids. Pharm Res 1994; 11: 471-477.
14. Dobry DE, et al,. A model-based methodology for spray-drying process development. J Pharm Innov 2009; 4: 133-142.
15. Gil M, et al,. Scale-up methodology for pharmaceutical spray drying. CHIM OGGI 2010; 28: 18-22.
16. Kim BS, Kim JH,. Characterization of solvent induced crystalline and amorphous homoharringtonine. Korean J Chem Eng 2009; 26: 1090-1093.
17. Paluch KJ, et al,. Physicochemical analysis of crystalline chlorothiazide and chlorothiazide sodium. Eur J Pharm Sci 2010; 41: 603-611.
18. Paluch KJ, et al,. Preparation and physicochemical analysis of crystalline forms of chlorothiazide potassium. Eur J Pharm Sci 2011; 42: 220-229.
19. Holubová J, et al,. The study of the glass transition by the Step Scan DSC technique. J Optoelectron Adv M 2005; 7: 2671-2676.
20. Quesenberry MS, Lee YC,. A rapid formaldehyde assay using purpald reagent: application under periodation conditions. Anal Biochem 1996; 234: 50-55.
21. Ulvi V, Keski-Hynnilä H,. First-derivative UV spectrophotometric and high-performance liquid chromatographic analysis of some thiazide diuretics in the presence of their photodecomposition products. J Pharm Biomed Anal 1994; 12: 917-922.
22. Council of Europe. European Pharmacopoeia. 6th Ed., Monograph 5.4. Residual Solvents. Strasbourg, 2010.
23. Seidell A,. Solubilities of Inorganic and Organic Compounds: A Compilation of Quantitative Solubility Data from the Periodical Literature, Vol. 1. 2nd edn. Charleston, SC: Nabu Press, 2010.
24. Mollica JA, et al,. Hydrolysis of hydrochlorothiazide. J Pharm Sci 1969; 58: 635-636.
25. Mollica JA, et al,. Hydrolysis of benzothiadiazines. J Pharm Sci 1971; 60: 1380-1384.