Gehrmann Sandra, Bunjes Heike
Technische Universität Braunschweig, Institut für Pharmazeutische Technologie, Mendelssohnstraße 1, 38106 Braunschweig, Germany; Zentrum für Pharmaverfahrenstechnik, Franz-Liszt-Straße 35a, 38106 Braunschweig, Germany.
Technische Universität Braunschweig, Institut für Pharmazeutische Technologie, Mendelssohnstraße 1, 38106 Braunschweig, Germany; Zentrum für Pharmaverfahrenstechnik, Franz-Liszt-Straße 35a, 38106 Braunschweig, Germany.
Int J Pharm. 2016 Sep 25;511(2):741-4. doi: 10.1016/j.ijpharm.2016.07.067. Epub 2016 Jul 28.
The possibility to prepare nanoemulsions as drug carrier systems on small scale was investigated with disposable materials. For this purpose premix membrane emulsification (premix ME) as a preparation method for nanoemulsions with narrow particle size distributions on small scale was used. The basic principle of premix ME is that the droplets of a coarse pre-emulsion get disrupted by the extrusion through a porous membrane. In order to implement the common preparation setup for premix ME with disposable materials, the suitability of different syringe filters (made from polyethersulfone, cellulose acetate, cellulose ester and nylon) and different pharmaceutically relevant emulsifiers (phospholipids, polysorbate 80 and sucrose laurate) for the preparation of nanoemulsions was investigated. Already the preparation of the premix could be realized by emulsification with the help of two disposable syringes. As shown for a phospholipid-stabilized emulsion, the polyethersulfone filter was the most appropriate one and was used for the study with different emulsifiers. With this syringe filter, the median particle size of all investigated emulsions was below 500nm after 21 extrusion cycles through a 200nm filter and a subsequent extrusion cycle through a 100nm filter. Furthermore, the particle size distribution of the polysorbate 80- and sucrose laurate-stabilized emulsions prepared this way was very narrow (span value of 0.7).
利用一次性材料研究了小规模制备纳米乳液作为药物载体系统的可能性。为此,采用预混膜乳化法(premix ME)作为小规模制备粒径分布窄的纳米乳液的方法。预混膜乳化法的基本原理是,粗预乳液的液滴通过多孔膜挤出时被破坏。为了用一次性材料实现预混膜乳化法的常规制备装置,研究了不同的注射器滤器(由聚醚砜、醋酸纤维素、纤维素酯和尼龙制成)和不同的药学相关乳化剂(磷脂、聚山梨酯80和月桂酸蔗糖酯)用于制备纳米乳液的适用性。借助两个一次性注射器进行乳化,即可实现预混液的制备。如磷脂稳定乳液所示,聚醚砜滤器是最合适的,用于不同乳化剂的研究。使用该注射器滤器,所有研究乳液在通过200nm滤器进行21次挤出循环并随后通过100nm滤器进行挤出循环后,中位粒径均低于500nm。此外,以这种方式制备的聚山梨酯80和月桂酸蔗糖酯稳定乳液的粒径分布非常窄(跨度值为0.7)。