Department of Pharmaceutical Science and Technology, School of Chemical and Pharmaceutical Sciences, University of Chile, Santos Dumont 964, 4to piso, Oficina # 09, Independencia, 8380494, Santiago, Chile.
Instituto de Salud Pública de Chile, 7780050, Santiago, Chile.
AAPS PharmSciTech. 2018 Nov;19(8):3376-3387. doi: 10.1208/s12249-018-1105-1. Epub 2018 Jun 22.
The buccal mucosa appears as a promissory route for biologic drug administration, and pharmaceutical films are flexible dosage forms that can be used in the buccal mucosa as drug delivery systems for either a local or systemic effect. Recently, thin films have been used as printing substrates to manufacture these dosage forms by inkjet printing. As such, it is necessary to investigate the effects of printing biologics on films as substrates in terms of their physical and mucoadhesive properties. Here, we explored solvent casting as a conventional method with two biocompatible polymers, hydroxypropyl methylcellulose, and chitosan, and we used electrospinning process as an electrospun film fabrication of polycaprolactone fibers due to its potential to elicit mucoadhesion. Lysozyme was used as biologic drug model and was formulated as a solution for printing by thermal inkjet printing. Films were characterized before and after printing by mechanical and mucoadhesive properties, surface, and ultrastructure morphology through scanning electron microscopy and solid state properties by thermal analysis. Although minor differences were detected in micrographs and thermograms in all polymeric films tested, neither mechanical nor mucoadhesive properties were affected by these differences. Thus, biologic drug printing on films was successful without affecting their mechanical or mucoadhesive properties. These results open way to explore biologics loading on buccal films by inkjet printing, and future efforts will include further in vitro and in vivo evaluations.
颊黏膜是生物药物给药的有希望的途径,而薄膜是一种灵活的剂型,可作为药物输送系统用于颊黏膜的局部或全身作用。最近,薄膜已被用作喷墨打印的打印基底来制造这些剂型。因此,有必要研究在作为基底的薄膜上打印生物制剂对其物理和粘膜粘附特性的影响。在这里,我们探索了溶剂浇铸作为一种常规方法,使用两种生物相容性聚合物,羟丙基甲基纤维素和壳聚糖,我们使用静电纺丝工艺作为聚己内酯纤维的电纺膜制造,因为它有可能引起粘膜粘附。溶菌酶被用作生物药物模型,并被配制成通过热喷墨打印进行打印的溶液。通过扫描电子显微镜对打印前后的薄膜进行机械和粘膜粘附特性、表面和超微结构形态的特性,以及通过热分析进行固态特性的特性进行了表征。尽管在所有测试的聚合物薄膜中都检测到微观照片和热谱图中的微小差异,但机械和粘膜粘附特性都不受这些差异的影响。因此,生物药物在薄膜上的打印成功,而不会影响其机械或粘膜粘附特性。这些结果为通过喷墨打印探索颊部薄膜上的生物制剂负载开辟了道路,未来的努力将包括进一步的体外和体内评估。