Correlation between polymer properties, extrusion process parameters and permeability of etonogestrel in ethylene vinyl acetate films

IF 3.7 3区医学 Q2 CHEMISTRY, MEDICINAL Journal of pharmaceutical sciences Pub Date : 2025-02-01 DOI:10.1016/j.xphs.2024.10.057

Ziyue Zhong , Angela Ren , Lance Arbilo , Qiangnan Zhang , William Smith , Bin Qin , Yan Wang , Feng Zhang

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Abstract

Ethylene vinyl acetate (EVA) copolymers have been extensively used in controlled drug delivery systems due to its good biocompatibility and tunable applicability based on simple variations in vinyl acetate (VA) content. We investigated impacts of polymer properties and extrusion process parameters of EVA on permeability of etonogestrel in EVA films. Among all factors studied, the VA content was the most dominant factor that controls drug permeability by affecting crystallinity of EVA. EVA molecular weight, drawing, and cooling of EVA during extrusion process exhibited less significant effects. The impacts of these factors on crystallinity, crystallite size, and degree of crystalline orientation of EVA were characterized using polarized light microscope (PLM), differential scanning calorimetry (DSC) and wide-angle X-ray scattering (WAXS). Based on solution-diffusion model, the mechanisms by which the crystalline properties controlled drug solubility and diffusivity in EVA were discussed. These results can be applied to investigate the effects of EVA material properties and manufacturing process conditions on drug release properties of reservoir-type EVA-based drug delivery systems designed with a rate-controlling EVA membrane.

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材料特性和挤压工艺参数对乙烯-醋酸乙烯共聚物（EVA）薄膜中依诺孕酮渗透性的影响。

乙烯-醋酸乙烯共聚物（EVA）具有良好的生物相容性，且可根据醋酸乙烯（VA）含量的简单变化进行调整，因此已被广泛应用于可控给药系统。我们研究了 EVA 的材料特性（包括 VA 含量和分子量）以及挤出工艺参数（包括拉伸比和冷却速度）对 EVA 薄膜中依托孕烯渗透性的影响。在所有研究因素中，VA 含量是通过影响 EVA 的结晶度来控制药物渗透性的最主要因素。MW、DDR 和冷却速率的影响较小。利用偏光显微镜、差示扫描量热仪（DSC）和广角 X 射线散射（WAXS）分析了这些因素对 EVA 的结晶度、晶粒尺寸和结晶取向度的影响。根据溶液扩散模型，讨论了结晶特性控制药物在 EVA 中的溶解度和扩散性的机制。这些结果可用于研究 EVA 的材料特性和生产工艺条件对带有速率控制膜的储层型 EVA 给药系统的药物释放特性的影响。

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来源期刊

Journal of pharmaceutical sciences 医学-化学综合

CiteScore

7.30

自引率

13.20%

发文量

367

审稿时长

33 days

期刊介绍： The Journal of Pharmaceutical Sciences will publish original research papers, original research notes, invited topical reviews (including Minireviews), and editorial commentary and news. The area of focus shall be concepts in basic pharmaceutical science and such topics as chemical processing of pharmaceuticals, including crystallization, lyophilization, chemical stability of drugs, pharmacokinetics, biopharmaceutics, pharmacodynamics, pro-drug developments, metabolic disposition of bioactive agents, dosage form design, protein-peptide chemistry and biotechnology specifically as these relate to pharmaceutical technology, and targeted drug delivery.