PMID- 15793812 OWN - NLM STAT- MEDLINE DCOM- 20050812 LR - 20161124 IS - 0022-3549 (Print) IS - 0022-3549 (Linking) VI - 94 IP - 5 DP - 2005 May TI - The effect of water to ethanol feed ratio on physical properties and aerosolization behavior of spray dried cromolyn sodium particles. PG - 1048-59 AB - Cromolyn sodium (CS) was spray dried under constant operation conditions from different water to ethanol feed ratios (50:50-0:100). The spray dried CS samples were characterized for their physicochemical properties including crystallinity, particle size distribution, morphology, density, and water/ethanol content. To determine quantitatively the crystallinity of the powders, an X-ray diffraction (XRD) method was developed using samples with different crystallinity prepared by physical mixing of 100% amorphous and 100% crystalline CS materials. The aerodynamic behavior of the CS samples was determined using an Andersen Cascade Impactor (ACI) with a Spinhaler at an air flow of 60 L/min. Binary mixtures of each spray dried CS powder and Pharmatose 325, a commercial alpha-lactose monohydrate available for DPI formulations, were prepared and in vitro aerosol deposition of the drug from the mixtures was analyzed using ACI to evaluate the effect of carrier on deposition profiles of the spray dried samples. CS spray dried from absolute ethanol exhibited XRD pattern characteristic for crystalline materials and different from patterns of the other samples. The crystallinity of spray dried CS obtained in the presence of water varied from 0% to 28.37%, depending on the ratio of water to ethanol in the feed suspensions. All samples presented different particle size, water/ethanol content, and bulk density values. CS particles spray dried from absolute ethanol presented uniform elongated shape whereas the other samples consisted mainly of particles with irregular shape. Overall, fine particle fraction increased significantly (p < 0.01) with decreasing d50% and water and ethanol content of spray dried CS samples. Significant difference (p < 0.01) in deposition profiles of the drug were observed between corresponding carrier free and carrier blended formulations. The difference in deposition profiles of CS aerosolized from various spray dried samples were described according to the particle size, shape, and water/ethanol contents of the powders. The results of this study indicate that enhanced aerosol performance of CS can be obtained by spray drying of the drug from suspensions containing > or = 87.5% v/v ethanol. CI - Copyright 2005 Wiley-Liss, Inc FAU - Gilani, Kambiz AU - Gilani K AD - Aerosol Research Laboratory, School of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran. FAU - Najafabadi, Abdolhossien Rouholamini AU - Najafabadi AR FAU - Barghi, Mohammadali AU - Barghi M FAU - Rafiee-Tehrani, Morteza AU - Rafiee-Tehrani M LA - eng PT - Journal Article PL - United States TA - J Pharm Sci JT - Journal of pharmaceutical sciences JID - 2985195R RN - 0 (Aerosols) RN - 0 (Anti-Asthmatic Agents) RN - 0 (Capsules) RN - 0 (Drug Carriers) RN - 0 (Powders) RN - 0 (Solvents) RN - 059QF0KO0R (Water) RN - 3K9958V90M (Ethanol) RN - Q2WXR1I0PK (Cromolyn Sodium) SB - IM MH - Aerosols MH - Anti-Asthmatic Agents/administration & dosage/*chemistry MH - Capsules MH - Chemical Phenomena MH - Chemistry, Pharmaceutical MH - Chemistry, Physical MH - Cromolyn Sodium/administration & dosage/*chemistry MH - Desiccation MH - Drug Carriers MH - Drug Compounding MH - Ethanol/*chemistry MH - Microscopy, Electron, Scanning MH - Particle Size MH - Powders MH - Solvents MH - Water/*chemistry MH - X-Ray Diffraction EDAT- 2005/03/29 09:00 MHDA- 2005/08/13 09:00 CRDT- 2005/03/29 09:00 PHST- 2005/03/29 09:00 [pubmed] PHST- 2005/08/13 09:00 [medline] PHST- 2005/03/29 09:00 [entrez] AID - S0022-3549(16)31755-5 [pii] AID - 10.1002/jps.20315 [doi] PST - ppublish SO - J Pharm Sci. 2005 May;94(5):1048-59. doi: 10.1002/jps.20315.