Ultrasonic atomization and subsequent desolvation for monoclonal antibody (mAb) to the glycoprotein (GP) IIIa receptor into drug eluting stent

Abstract

An eluting-stent system with mAb dispersed in the PLLA (poly (L-lactic acid)) was validated in vitro. Specifically designed spray equipment based on the principle of ultrasonic atomization was used to produce a thin continuous PLLA (poly (L-lactic acid)) polymer coating incorporating monoclonal antibody (mAb). This PLLA coating was observed in light microscopy (LM) and scanning electron microscopy (SEM). The concentration of the monoclonal antibody (mAb) to the platelet glycoprotein (GP) IIIa receptor and the eluting rate were then measured by a radioisotope technique with (125)I-labelled GP IIIa mAb. An in vitro perfusion circuit was designed to evaluate the release rates at different velocities (10 or 20 ml min(-1)). The PLLA coating was thin and transparent, uniformly distributed on the surface of the stent. Three factors influenced its thickness: PLLA concentration, duration and gas pressure. The concentration of mAb was influenced by the duration of absorption and the concentration of the mAb solution; the maximum was 1662.23 + or - 38.83 ng. The eluting rate was fast for the first 2 h, then decreased slowly and attained 80% after 2 weeks. This ultrasonic atomization spray equipment and technological process to prepare protein eluting-stents were proved to be effective and reliable.

Study on the biodegradability and biocompatibility of WE magnesium alloys

“…They need to be further modified to reduce their hemolytic activity and improve their biocompatibility. So the proper surface modifications, such as plasma surface deposition [37], endothelial cell seeding [38], micropatterned surface modification [39], composite membrane coating [40,41], drug eluting coating [42] etc., should be adopted to improve their hemocompatibility [21,43,44].…”

In-vitro dissolution methods for controlled release parenterals and their applicability to drug-eluting stent testing

“…[78] The most striking advantage of using the flow-through cell for DES testing is that the flow conditions can be adapted to the flow conditions present at the site of in-vivo release. The impact of different flow rates on release from DES has been shown by Wang et al [30] in a perfusion circuit. As already described above, the system can be operated over a wide range of media volumes, which can easily be adapted with each experiment to assure sink conditions.…”

“…[24,25] There have been, however, reports of using blood or blood components for dissolution testing of parenteral dosage forms. [26][27][28][29][30] Rarely, other additives from natural sources have been used for the preparation of dissolution media, such as rat brain homogenate. [31] Some authors report the use of liquids referred to as simulated body fluids or for example simulated synovial fluid, simulated tear fluid or simulated lung fluids, [30][31][32][33][34][35][36] but these were mostly intended to evaluate issues other than drug release, such as bone-bonding ability.…”

Endothelialization and in‐stent restenosis on the surface of glycoprotein IIIa monoclonal antibody eluting stent

“…L-polylactic acid polymer-coated stents were prepared by a specific spray equipment based on the principle of ultrasonic atomization using previously described methods. 14 The stents were expanded thrice (30 s each instance) at 10 atm without cracking, tilting, or shedding of the coating layer ( Fig. 1).…”