期刊
INTERNATIONAL JOURNAL OF PHARMACEUTICS
卷 501, 期 1-2, 页码 124-138出版社
ELSEVIER
DOI: 10.1016/j.ijpharm.2016.01.066
关键词
Dry powder inhaler; Particle engineering; Spray drying; L-Leucine; Rivastigmine hydrogen tartrate
资金
- FAPERJ (Rio de Janeiro, Brazil)
- CAPES (Brasilia, Brazil) [3372/13-8]
- Science Foundation Ireland [12/RC/2275]
The purpose of this study was to prepare engineered particles of rivastigmine hydrogen tartrate (RHT) and to characterize the physicochemical and aerodynamic properties, in comparison to a lactose carrier formulation (LCF). Microparticles were prepared from ethanol/water solutions containing RHT with and without the incorporation of L-leucine (Leu), using a spray dryer. Dry powder inhaler formulations prepared were characterized by scanning electron microscopy, powder X-ray diffraction, laser diffraction particle sizing, ATR-FTIR, differential scanning calorimetry, bulk and tapped density, dynamic vapour sorption and in vitro aerosol deposition behaviour using a next generation impactor. The smooth-surfaced spherical morphology of the spray dried microparticles was altered by adding Leu, resulting in particles becoming increasingly wrinkled with increasing Leu. Powders presented low densities. The glass transition temperature was sufficiently high (>90 degrees C) to suggest good stability at room temperature. As Leu content increased, spray dried powders presented lower residual solvent content, lower particle size, higher fine particle fraction (FPF < 5 mu m), and lower mass median aerodynamic diameter (MMAD). The LCF showed a lower FPF and higher MMAD, relative to the spray dried formulations containing more than 10% Leu. Spray dried RHT powders presented better aerodynamic properties, constituting a potential drug delivery system for oral inhalation. (C) 2016 Elsevier B.V. All rights reserved.
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