Oral thin films (OTFs) are innovative dosage forms that have gained tremendous attention for the delivery of nutraceuticals. They are ultra-thin, flexible sheets that can be easily placed on the tongue, sublingual or buccal mucosa (inner lining of the cheek). These thin films possess several advantages for nutraceutical delivery including ease of administration, rapid disintegration, fast absorption, rapid onset of action, bypass first-pass hepatic metabolism, accurate dosing, enhanced stability, portability, discreetness, dose flexibility and most importantly consumer acceptance. This review highlights the utilization OTFs for nutraceutical delivery, their composition, criteria for excipient selection, methods of development and quality-based design (QbD) approach to achieve quality product. We have also provided recent case studies representing OTFs as promising platform in delivery of nutraceuticals (plant extracts, bioactive molecules, vitamins, minerals and protein/peptides) and probiotics. Finally, we provided advancement in technologies, recent patents, market analysis, challenges and future perspectives associated with this unique dosage form.

中文翻译：

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用于营养药物输送的口腔薄膜的黎明时代：从实验室到临床


口服薄膜（OTF）是一种创新剂型，在营养保健品的输送方面受到了极大的关注。它们是超薄、柔韧的薄片，可以轻松放置在舌头、舌下或颊粘膜（脸颊的内衬）上。这些薄膜在营养药物输送方面具有多种优势，包括易于给药、快速崩解、快速吸收、快速起效、绕过肝脏首过代谢、准确剂量、增强稳定性、便携性、谨慎性、剂量灵活性以及最重要的是消费者接受度。本综述重点介绍了 OTF 在营养保健品输送中的应用、其组成、赋形剂选择标准、开发方法以及实现优质产品的基于质量的设计 (QbD) 方法。我们还提供了最近的案例研究，表明 OTF 作为营养保健品（植物提取物、生物活性分子、维生素、矿物质和蛋白质/肽）和益生菌输送的有前途的平台。最后，我们提供了与这种独特剂型相关的技术进步、最新专利、市场分析、挑战和未来前景。