Department of Pharmaceutical Sciences, College of Clinical Pharmacy, King Faisal University, Al-Ahsa, Saudi Arabia.
J Control Release. 2013 Feb 28;166(1):10-21. doi: 10.1016/j.jconrel.2012.11.019. Epub 2012 Dec 5.
Extensive research on transmucosal drug delivery in the past few decades has resulted in the clinical application of several drug molecules through the buccal route. Interestingly, most of the new chemical moieties under clinical trials are being screened for their potential to deliver through the buccal cavity. In this context, buccal film offers several advantages including convenient dosing and better patient compliance. However, the greatest challenge is to develop a high quality buccal film which also necessitates constant evaluation and understanding the performance of the dosage form, the critical steps to achieve a successful product development. Despite the intense focus on buccal film based drug delivery system, there are no official standardized methods for its evaluation. Significant efforts have been made to demonstrate and improve the efficacy, potency and safety of buccal film using in vitro, ex vivo and in vivo assessments. Besides the physical properties of the film, several other parameters such as residence time, mucoadhesion, drug release, in vitro and in vivo buccal permeation profiles and absorption kinetics of the drug are examined while characterizing the prepared buccal films. However, various research groups have employed different methods and experimental conditions to evaluate the formulation, which has limited the comparison of data between the research groups. This review provides an overview about the various parameters that are considered and assessed as a part of formulation development to ensure quality product with desired characteristics.
在过去几十年中，对经粘膜给药的广泛研究导致了几种药物分子通过颊部途径的临床应用。有趣的是，大多数正在临床试验中的新化学物质都在筛选其通过颊腔给药的潜力。在这种情况下，颊膜具有许多优点，包括方便给药和更好的患者依从性。然而，最大的挑战是开发高质量的颊膜，这也需要不断评估和了解剂型的性能，这是成功产品开发的关键步骤。尽管人们强烈关注基于颊膜的药物传递系统，但对于其评估还没有官方的标准化方法。已经做出了重大努力，使用体外、离体和体内评估来证明和提高颊膜的功效、效力和安全性。除了膜的物理性质外，在表征制备的颊膜时，还检查了其他几个参数，如停留时间、粘膜粘附性、药物释放、体外和体内颊部渗透曲线以及药物的吸收动力学。然而，不同的研究小组采用了不同的方法和实验条件来评估制剂，这限制了研究小组之间数据的比较。本综述概述了作为制剂开发的一部分需要考虑和评估的各种参数，以确保具有所需特性的高质量产品。
