alexa Optimization Of The Parameters Of Spherical Agglomeration Method
ISSN: 2167-7689

Pharmaceutical Regulatory Affairs: Open Access
Open Access

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9th Annual European Pharma Congress
June 26-28, 2017 Madrid, Spain

Orsolya Gyulai and Zoltan Aigner
University of Szeged, Hungary
Posters & Accepted Abstracts: Pharmaceut Reg Affairs
DOI: 10.4172/2167-7689-C1-025
Abstract
In the industry area, direct compression is one of the most important techniques for the formulation of solid form drugs. For this, the active agent, so as our target product should possess appropriate parameters for example increased flow rate generated by large-size (>100 m) spherical or nearly spherical (roundness < 1.5) crystals or crystal agglomerates. For improving the morphology, spherical crystallization techniques can be used, like typical and non-typical ones. In case of non-typical methods (like antisolvent crystallization, cooling crystallization or combined method) mainly the physico-chemical parameters are changed. Typical methods (like quasi emulsion solvent diffusion method) use three solvents. From our previous work it became clear that spherical agglomeration is suitable for improving the morphology of ambroxol hydrochloride (AMB-HCl). This work aims at the optimization of the parameters of this method. For this, a factorial design was applied and then the results were evaluated with STATISTICA for Windows program. The critical parameters were as follows: agitation type and time, temperature differences between the solvent (dimethyl sulfoxide) and the antisolvent (ethyl acetate), composition of the solvent system (solvent/antisolvent ratio). The average size, aspect ratio and roundness of the products were analysed by LEICA Q500 MC Image Processing and Analysis System, then the ones with proper morphology were chosen for further experiments. With an additional factorial design, effects of other parameters were examined such as saturation rate and feed rate of AMB-HCL solution. The products were also examined by an individuallydeveloped hardness test. Four products were proved to possess suitable morphology compared to the target product. The application of horizontal shaker with shorter mixing times and lower temperature differences had a positive impact on the morphology of AMBHCl. The hardness of the products was large enough to keep the spherical particles stable.
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