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Optimizing Dry Powder Inhaler Design: Integrating Particle Engineering, Formulation Development, and Packaging 

Stegemann S, DuBose D, Vodak D.

RDD Asia 2016. Volume , 2016: 177-186.

Abstract:

Particle engineering is an emerging field for the pulmonary delivery of high dose small molecules (e.g., >25 mg) as well as the delivery of biologic compounds. Spray drying is an established pharmaceutical technology capable of manufacturing particles in micrometer size with favorable aerodynamic characteristics. Formulations used in spray drying for pulmonary drug delivery are based on approved excipients that provide certain functionality to the physical as well as pharmacological performance of the particles. In addition to the formulation, the spray drying process conditions as well as equipment design must be understood to achieve reproducible particle quality, especially with respect to scale-up. Salbutamol sulfate was used as a model compound to develop a high drug payload dry powder inhaler (DPI) formulation for a capsule-based DPI delivery system. A blend of lactose, leucine, and sodium chloride containing 10% and 40% salbutamol sulfate was developed at laboratory and pilot scale and filled in hydroxypropyl methylcellulose (HPMC) capsules. Characterization of the particles and in vitro performance evaluation was conducted using a standard inhalation device. The in vitro performance of the particles was in accordance with the performance criteria for dry powder inhalation products. This confirms that particle engineering for inhaled drugs using spray drying technology is suitable to achieve drug deposition in the deep lungs at high dose ranges.