Dry powder aerosols generated by standardized entrainment tubes from drug blends with lactose monohydrate: 2. Ipratropium bromide monohydrate and fluticasone propionate

✍ Scribed by Zhen Xu; Heidi M. Mansour; Tako Mulder; Richard McLean; John Langridge; Anthony J. Hickey

• Book ID: 102400583
• Publisher: John Wiley and Sons
• Year: 2010
• Tongue: English
• Weight: 445 KB
• Volume: 99
• Category: Article
• ISSN: 0022-3549
• DOI: 10.1002/jps.22100

✦ Synopsis

The objectives of this study were: systematic investigation of dry powder aerosol performance using standardized entrainment tubes (SETs) and lactose-based formulations with two model drugs; mechanistic evaluation of performance data by powder aerosol deaggregation equation (PADE). The drugs (IPB and FP) were prepared in sieved and milled lactose carriers (2% w/w). Aerosol studies were performed using SETs (shear stresses t s ¼ 0.624-13.143 N/m 2 ) by twin-stage liquid impinger, operated at 60 L/min. PADE was applied for formulation screening. Excellent correlation was observed when PADE was adopted correlating FPF to t s . Higher t s corresponded to higher FPF values followed by a plateau representing invariance of FPF with increasing t s . The R 2 values for PADE linear regression were 0.9905-0.9999. Performance described in terms of the maximum FPF (FPF max : 15.0-37.6%) resulted in a rank order of ML-B/IPB > ML-A/IPB > SV-A/IPB > SV-B/IPB > ML-B/FP > ML-A/FP > SV-B/FP > SV-A/FP. The performance of IPB was superior to FP in all formulations. The difference in lactose monohydrate carriers was less pronounced for the FPF in IPB than in FP formulations. The novel PADE offers a robust method for evaluating aerodynamic performance of dry powder formulations within a defined t s range.