SPEAKER:
Ogienko Andrey G.
REPORT TITLE:
Development of inhaled dry-powder formulations by novel particle engineering technology. freeze-drying of APIs solution in systems with clathrate formation
TALKING POINTS:
Large porous particles, which are generally produced via spray drying technology, are becoming increasingly popular as carriers for pulmonary drug delivery for local and systemic applications [1 - 3]. These systems have high geometric diameters (5-30 mm) but low mass density (~0.4-0.1 g/cm3 or less), so that the aerodynamic diameter remains low (1-5 mm). Recently, we proposed an alternative method of producing novel improved forms of APIs based on spray-freeze drying of API solutions in “volatile organic liquid – water” systems [4, 5] giving clathrate hydrates [6] at low temperatures. In vitro tests by Anderson Cascade Impactor indicated that formulations of salbutamol and budesonide exhibited significantly higher fine particle fractions of 59,0% and 51,5% compared to the known behavior of nano-salbutamol sulphate blends (45,2%), micronized salbutamol sulfate blends (31,3%), and DPI budesonide formulation (19 %), respectively [7, 8]. Besides, as the value of the fine particle fraction also is strongly dependent on the construction of the device, we suppose that employment of high-precision DPIs [3, 9, 10] would increase the amount of this fraction of the composition. Herein we present a novel dry powder inhaler formulation design using molecular-level encapsulation of an API in a large porous composite matrix. This approach can be used to incorporate low-dosage drugs in a matrix (as an alternative to the PulmoSphereTM technology [3, 11, 12]) to achieve specific pulmonary drug deposition.
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