Alaei Samaneh, Omidian Hamid
College of Pharmacy, Nova Southeastern University, Fort Lauderdale, FL 33328, United States.
College of Pharmacy, Nova Southeastern University, Fort Lauderdale, FL 33328, United States.
Eur J Pharm Sci. 2021 Apr 1;159:105727. doi: 10.1016/j.ejps.2021.105727. Epub 2021 Jan 21.
Aligned with efforts to overcome shortcomings of conventional oral dosage forms, mucoadhesive oral thin films have been the focus of drug development. Transmucosal drug delivery through oral cavity is a popular alternative to deliver many drugs due to several advantages over conventional oral delivery including greater bioavailability due to bypassing the first-pass effect and avoiding enzymatic or acid-related degradation in the gastrointestinal tract, faster onset of action, and better patient compliance particularly in geriatric and pediatric patients. Furthermore, among solid transmucosal delivery platforms, buccal and sublingual strips or patches are more attractive due to their flexibility, ease of administration, high patient compliance, and fast dissolution. They are also more stable compared to oral gels making them a desirable candidate to deliver many small and large molecules locally or systemically. Mucoadhesion and mechanical properties of oral films are crucial in their performance, and therefore ways to measure these properties are also similarly important. Since they are relatively new to the pharmaceutical market, there are currently no FDA-recommended or USP standard methods available to characterize such dosage forms. This review intends to cover and discuss various methods cited in the literature to measure and evaluate mucoadhesive and mechanical properties of oral films.
为克服传统口服剂型的缺点,粘膜粘附性口腔薄膜一直是药物研发的重点。通过口腔进行粘膜给药是一种常用的给药方式,可用于递送多种药物,因为它相对于传统口服给药具有多种优势,包括绕过首过效应提高生物利用度、避免胃肠道中的酶促或酸相关降解、起效更快,以及在老年和儿科患者中具有更好的患者依从性。此外,在固体粘膜给药平台中,颊部和舌下条带或贴片因其灵活性、易于给药、高患者依从性和快速溶解而更具吸引力。与口服凝胶相比,它们也更稳定,使其成为局部或全身递送许多小分子和大分子的理想候选者。口腔薄膜的粘膜粘附性和机械性能对其性能至关重要,因此测量这些性能的方法同样重要。由于它们在制药市场上相对较新,目前尚无FDA推荐或USP标准方法来表征此类剂型。本综述旨在涵盖和讨论文献中引用的各种测量和评估口腔薄膜粘膜粘附性和机械性能的方法。