Long-term release and stability of pharmaceutical proteins delivered from solid lipid implants.

Long-term release and stability of pharmaceutical proteins delivered from solid lipid implants. Eur J Pharm Biopharm. 2017 Apr 22;: Authors: Vollrath M, Engert J, Winter G Abstract Solid lipid implants (SLIs) prepared by twin-screw (tsc) extrusion represent a promising technology platform for the sustained release of pharmaceutical proteins. In this work, we report on two aspects, long-term release and stability of released protein. First, SLIs were produced by tsc-extrusion containing the low melting triglyceride H12 and the high melting triglyceride Dynasan D118. Two different proteins available in a freeze-dried matrix containing hydroxypropyl-β-cyclodextrine (HP-β-CD) were incorporated into the lipid matrix: a monoclonal antibody (mAb) from the IgG1 class and the fab-fragment Ranibizumab (Lucentis(®)). SLIs, composed of 10% protein lyophilisate and both triglycerides, were extruded at 35°C and 40rpm. Sustained release of both proteins was observed in a sustained manner for approximately 120days. Protein load per implant was increased by three different approaches resulting in a protein load of 3.00mg per implant without affecting the release profiles. The incubation medium containing the released protein was collected, concentrated and analyzed including liquid chromatography (SE-HPLC, IEX, HIC), electrophoresis (SDS-PAGE, on-chip gel electrophoresis) and FT-IR spectroscopy. The mAb showed a monomer loss of up to 7% (SE-HPLC)...
Source: European Journal of Pharmaceutics and Biopharmaceutics - Category: Drugs & Pharmacology Authors: Tags: Eur J Pharm Biopharm Source Type: research