Sagar Narala, Ahmed Adel Ali Youssef, Siva Ram Munnangi, Nagarjuna Narala, Preethi Lakkala, Sateesh Kumar Vemula, Michael Repka
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引用次数: 0
摘要
简介:美国食品和药物管理局批准了首款三维(3D)打印片剂 Spritam®,从而引发了人们对使用三维打印技术制造多种给药系统以满足不同给药途径需求的浓厚兴趣。通过三维打印技术实现的高度制造灵活性有助于制备含有多种活性成分的剂型,这些活性成分具有复杂的、量身定制的释放特征,可以满足患者的个性化需求:本综述深入探讨了目前用于制药研究的几种 3D 打印技术。此外,该综述还深入探讨了阴道解剖学和生理学、用于阴道应用的 3D 打印给药系统、最新研究成果以及 3D 打印技术面临的挑战和未来的可能性:3D打印技术可以生产出针对阴道应用进行优化的给药装置或植入物,包括阴道环、阴道内插入物或装载药物的生物可降解微型装置,所有这些都是为给特定药物提供可控释放特性而定制的。然而,尽管3D打印技术在阴道给药方面的潜力令人期待,但在这些技术被广泛采用并批准用于临床之前,仍有许多挑战和监管障碍需要克服。要确保安全性、有效性和生物兼容性,还需要进行广泛的研究和测试。
3D printing in vaginal drug delivery: a revolution in pharmaceutical manufacturing.
Introduction: The Food and Drug Administration's approval of the first three-dimensional (3D) printed tablet, Spritam®, led to a burgeoning interest in using 3D printing to fabricate numerous drug delivery systems for different routes of administration. The high degree of manufacturing flexibility achieved through 3D printing facilitates the preparation of dosage forms with many actives with complex and tailored release profiles that can address individual patient needs.
Areas covered: This comprehensive review provides an in-depth look into the several 3D printing technologies currently utilized in pharmaceutical research. Additionally, the review delves into vaginal anatomy and physiology, 3D-printed drug delivery systems for vaginal applications, the latest research studies, and the challenges of 3D printing technology and future possibilities.
Expert opinion: 3D printing technology can produce drug-delivery devices or implants optimized for vaginal applications, including vaginal rings, intra-vaginal inserts, or biodegradable microdevices loaded with drugs, all custom-tailored to deliver specific medications with controlled release profiles. However, though the potential of 3D printing in vaginal drug delivery is promising, there are still challenges and regulatory hurdles to overcome before these technologies can be widely adopted and approved for clinical use. Extensive research and testing are necessary to ensure safety, effectiveness, and biocompatibility.