Evaluation of the drug release patterns and long term stability of aqueous and organic coated pellets by using blends of enteric and gastrointestinal insoluble polymers.

作者: H. Kranz , S. Gutsche

DOI: 10.1016/J.IJPHARM.2009.07.013

关键词: Chemical engineeringAqueous solutionMethacrylic acidPolymer blendChromatographyPolymerEthyl acrylateSolubilityExcipientPelletsChemistry

摘要: Abstract The major aim of this study was to identify an efficient tool adjust drug release patterns from aqueous and organic ethylcellulose (a gastrointestinal insoluble polymer) coated pellets evaluate the long term stability film coatings. Drug monitored during open closed storage at 25 °C/60% RH (ambient conditions) 40 °C/75% (stress for up 24 months. Release vatalanib succinate, a poorly soluble that demonstrates pH-dependent solubility, pure slow irrespectively type coating medium. By addition enteric polymer methacrylic acid/ethyl acrylate copolymer (applied as Kollicoat MAE 30 DP dispersion or solution 100 P) broad ranges could be achieved. For coatings dispersions resulted in unaltered kinetics ambient stress conditions. stabilizing effect added might explained by more hydrophilic nature compared trapping water formation improving particle coalescence. However, ethylcellulose:Kollicoat conditions decreased due further gradual In contrast, rates P stored did not change which differences process. This clearly indicates presented concept combination with process is able achieve overcome instability.

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