کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
9386054 | 1280702 | 2005 | 11 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Development and performance of a new hydrofluoroalkane (HFA 134a)-based metered dose inhaler (MDI) of salmeterol
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کلمات کلیدی
CFCPSDECDMDIHFApMDIFPMcPMPbronchodilator - برونکودیلاتورParticle size distribution - توزیع اندازه ذراتMetered Dose Inhaler - دز انالایزر اندازه گیری شدهRelative humidity - رطوبت نسبیSalmeterol - سالمترولولEuropean Pharmacopoeia - فارماکوپه اروپاییPressurised metered dose inhaler - فشار انسداد دز انسدادHydrofluoroalkane - هیدروفلوآرکالنchlorofluorocarbon - کلروفلوئورو کربنCommittee for Proprietary Medicinal Products - کمیته دارویی دارویی اختصاصیDose uniformity - یکنواختی دز
موضوعات مرتبط
علوم پزشکی و سلامت
پزشکی و دندانپزشکی
پزشکی ریوی و تنفسی
پیش نمایش صفحه اول مقاله
چکیده انگلیسی
This paper details the pharmaceutical assessment of salmeterol HFA MDI and confirms that this product meets the current Committee for Proprietary Medicinal Products regulatory requirements, and is comparable to the CFC MDI in product performance. Criteria investigated included fine particle mass (FPM), dose delivery and uniformity, priming requirements and simulated-use-testing. Dose delivery was unaffected by changing product orientation during storage. The mean dose delivered per actuation ranged from 21.3 to 22.4 μg, and all individual doses were within the ±25% defined limits of the target ex-actuator dose of 21 μg. The FPM results, defined as the mass of particles between 1.1 and 4.7 μm in diameter (the sum of the mass deposited on stages 3-5 of the Andersen Cascade Impactor), were similar for the HFA and CFC products. The mean FPM values of the two HFA clinical batches were 8.7 and 10.1 μg, covering the values obtained during the development, and the one of the CFC clinical batch was 10.0 μg. Comparability in aerosol characteristics was also demonstrated when the salmeterol HFA inhaler was tested using a large volume spacer (Volumaticâ¢).
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Respiratory Medicine - Volume 99, Supplement 1, April 2005, Pages S20-S30
Journal: Respiratory Medicine - Volume 99, Supplement 1, April 2005, Pages S20-S30
نویسندگان
I.D. Peyron, I.L. Britto, L.B. Benissan, B.Z. Tardieu,