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Optimization of formulation and process parameters for the production of carvedilol nanosuspension by wet media milling

Authorized Users Only
2018
Authors
Medarević, Đorđe
Đuriš, Jelena
Ibrić, Svetlana
Mitrić, Miodrag
Kachrimanis, Kyriakos
Article (Published version)
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Abstract
The aim of this study is to develop nanosuspension of carvedilol (CRV) by wet media milling. Concentration of polymeric stabilizer (hydroxypropyl cellulose-HPC-SL), milling speed and size of milling beads were identified as critical formulation and process parameters and their effect on CRV particle size after 60 min of milling was assessed using a Box-Behnken experimental design. Optimized nanosuspension was solidified using spray drying and freeze drying and subjected to solid state characterization. Low stabilizer concentration (10%), low milling speed (300 rpm) with small milling beads (0.1 mm) were found as optimal milling conditions. Crystal lattice simulation identified potential slip plane within CRV crystals, where fractures are the most likely to occur. Calculated mechanical properties of CRV crystal indicates that low energy stress is sufficient to initiate fracture, if applied in the correct direction, explaining the advantage of using smaller milling beads. Only spray drie...d nanosuspension redispersed to original nanoparticles, while particle agglomeration during freeze drying prevented sample redispersion. Wet milling and spray drying did not induce polymorphic transition of CRV, while there is indication of polymorphic transition during freeze drying, making spray drying as the preferred solidification method.

Keywords:
Nanosuspensions / Nanocrystals / Wet media milling / Experimental design / Molecular modelling / Crystal polymorphism
Source:
International Journal of Pharmaceutics, 2018, 540, 1-2, 150-161
Publisher:
  • Elsevier Science BV, Amsterdam
Projects:
  • Advanced technologies for controlled release from solid drug delivery systems (RS-34007)

DOI: 10.1016/j.ijpharm.2018.02.011

ISSN: 0378-5173

PubMed: 29438724

WoS: 000427584900015

Scopus: 2-s2.0-85042093177
[ Google Scholar ]
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URI
http://farfar.pharmacy.bg.ac.rs/handle/123456789/3171
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  • Radovi istraživača / Researchers’ publications
Institution
Pharmacy

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