Ahmady Amina, Anuar Nor Khaizan, Ariffin Siti Alwani, Abu Samah Nor Hayati
Faculty of Pharmacy, Universiti Teknologi MARA, Selangor Branch, Puncak Alam Campus, Puncak Alam, Selangor, Malaysia.
Faculty of Pharmacy, Kabul University, Kabul, Afghanistan.
Biopolymers. 2025 Jan;116(1):e23646. doi: 10.1002/bip.23646.
This study aims to evaluate the impact of formulation parameters on tannic acid-crosslinked gelatine (GelTA) films, intended as a mucoadhesive matrix for extended buccal drug delivery. GelTA films were prepared using the solvent evaporation technique and screened based on their mucoadhesive and dissolution characteristics. The formulation variables included the source of gelatine (bovine and fish), tannic acid concentration, pH of the film-forming solutions, and the type and concentration of plasticisers. Subsequently, selected films underwent further characterisation (e.g., crosslinking density, stability) to elucidate their features as a drug delivery matrix. GelTA films exhibited a significantly improved dissolution time compared to the non-crosslinked film (BG-GLY20), while maintaining a substantial water uptake capacity conducive to a matrix system with extended action. The bovine GelTA film containing 5% w/w tannic acid and 20% w/w glycerine, prepared at pH 7 (BG-GLY20-7), exhibited a 1.6-fold increase in mucoadhesivity and an extended dissolution time of up to 6 h compared to BG-GLY20 (control), along with superior antioxidant and antimicrobial properties. However, stability studies indicate the need for an oxygen-free environment for film storage. In conclusion, GelTA films show promise as a buccal film matrix, offering extended dissolution times, substantial water uptake, and enhanced adhesive strength.
本研究旨在评估制剂参数对鞣酸交联明胶(GelTA)薄膜的影响,该薄膜旨在作为一种用于延长口腔给药的粘膜粘附基质。采用溶剂蒸发技术制备GelTA薄膜,并根据其粘膜粘附和溶解特性进行筛选。制剂变量包括明胶来源(牛和鱼)、鞣酸浓度、成膜溶液的pH值以及增塑剂的类型和浓度。随后,对选定的薄膜进行进一步表征(如交联密度、稳定性),以阐明其作为药物递送基质的特性。与未交联薄膜(BG-GLY20)相比,GelTA薄膜的溶解时间显著延长,同时保持了较高的吸水能力,有利于形成具有长效作用的基质系统。在pH值为7时制备的含有5%w/w鞣酸和20%w/w甘油的牛GelTA薄膜(BG-GLY20-7),与BG-GLY20(对照)相比,粘膜粘附性提高了1.6倍,溶解时间延长至6小时,同时具有优异的抗氧化和抗菌性能。然而,稳定性研究表明薄膜储存需要无氧环境。总之,GelTA薄膜有望成为一种口腔薄膜基质,具有延长的溶解时间、大量的吸水能力和增强的粘附强度。