Development of porous spray-dried inhalable particles using an organic solvent-free technique

GALLO LC; RAMÍREZ RIGO MV; BUCALÁ V

POWDER TECHNOLOGY

ELSEVIER SCIENCE SA

Lugar: Amsterdam; Año: 2019 vol. 342 p. 642 - 652

0032-5910

A simple technique to produce spray-dried porous particles forinhalatory administration was developed. The particles were producedusing water as solvent, Sodium Cromoglycate as model drug and ammoniumbicarbonate as pore forming agent. A central composite design wasemployed to study the influence of the: pore-forming agent concentration(in the drug aqueous solution fed to the spray dryer) and air inlettemperature on: process yield and powder properties. The powder particlesize distribution, moisture content, densities and estimated aerodynamicdiameters were studied. Also, particles morphology, hygroscopicity,surface area, in vitro aerosolization properties, dissolution rate andstability were evaluated for some selected samples. In addition, a novelfriability test was proposed for mechanical resistance evaluation of theporous materials.A pore forming agent concentration of 1.25 % (w/w) and an air inlettemperature of 170 ºC were the optimal process parameters to produceporous particles suitable for inhalatory administration. The processyield was high and it was demonstrated that the particles were free ofammonium bicarbonate. The porous powder, obtained by a simple andscalable technique, exhibited low tap density, good stability even atlong storage periods (12 months), appropriate mechanical resistance, highinitial dissolution rate and excellent aerosolization performance.