Kuru Toz İnhalerler: Formülasyonlar ve Aerodinamik Davranışlar

Year 2018, Volume: 38 Issue: 1, 39 - 52, 15.01.2018

Yağmur Akdağ Çaylı Selma Şahin Levent Öner

Abstract

İnhalerler genel olarak; nebülizer, ölçülü doz inhaler ve kuru toz inhaler (KTİ) başlıkları altında incelenebilir. KTİ’ler, hem lokal hem de sistemik etki elde etmek amacıyla kullanılabilen inhaler formülasyonlarıdır. İnhalerlerin etki mekanizmalarının değerlendirilmesi aşamasında, solunum sisteminin anatomi ve fizyolojisinin anlaşılması önemli bir husustur. KTİ’lerde ilaç etkinliğini etkileyen en önemli unsur partiküllerin aerodinamik davranışlarıdır. Aerodinamik davranışları değerlendirmek için; Cam İkili Ayrıştırıcı, Marple Miller Kademeli Ayrıştırıcı, Andersen Kademeli Ayrıştırıcı, Çok Aşamalı Sıvı Ayrıştırıcı, Yeni Nesil Ayrıştırıcı gibi Avrupa ve Amerika Birleşik Devletleri Farmakopeleri’nde kayıtlı cihazlar kullanılmaktadır. KTİ formülasyonlarında etkin maddenin akciğerlerde dağılmasını sağlayabilmek için, partiküllerin 5 µm’den küçük olması istenir. Bu nedenle partikül büyüklüğü dağılımı, formülasyondaki en önemli yanıt değişkenlerden birisidir. Püskürterek kurutma yöntemi hem endüstriye uygulanabilirlik yönünden, hem de 5 μm’nin altında partikül üretimi için uygun yöntemlerden biridir. Üretim parametreleri değiştirilerek; partikül büyüklüğü, partikül büyüklüğü dağılımı, dansite, şekil, yük, salım hızı gibi ölçütler optimize edilebilmektedir. Sonuç olarak, KTİ’ler, birçok üstünlüğü bulunan ve sıklıkla tercih edilen bir sistemdir. 

Keywords

Kuru toz inhaler, aerodinamik özellikler, inhalasyon sistemleri, formülasyon geliştirme

Dry Powder Inhalers: Formulations and Aerodynamic Behaviours

Abstract

Inhalers can generally be examined under the titles: nebulizer, metered dose inhaler and dry powder inhaler (DPI). DPIs are inhaler formulations that can be used to achieve both local and systemic effects. During the assessment of the mechanisms of action of inhalers, understanding of the anatomy and physiology of the respiratory system is an important issue. The most important factor affecting drug efficacy in DPIs is the aerodynamic behavior of the particles. To evaluate aerodynamic behaviors; Glass Twin Impinger, Marple Miller Cascade Impactor, Andersen Cascade Impactor, Multi Stage Liquid Impinger, Next Generation Impactor, which are registered in European and United States Pharmacopoeia, are used. In DPI formulations, it is desirable that the particles be less than 5 µm in order to be able to distribute the active substance in the lungs. For this reason, particle size distribution is one of the most important response
variables in the formulation. Spray drying is one of the suitable methods for particle production below 5 μm and for applicability to the industry. By changing production parameters; particle size, particle size distribution, density, shape, charge, release rate can be optimized. As a result, DPIs are a system of many advantages and often preferred.

Keywords

Dry powder inhaler, aerodynamic characteristics, inhalation systems, formulation development

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