Jadach Barbara, Misek Martyna, Ferlak Jan
Chair and Department of Pharmaceutical Technology, Poznan University of Medical Sciences, 60-780 Poznan, Poland.
Gels. 2023 Aug 25;9(9):687. doi: 10.3390/gels9090687.
The aim of the study was the preparation and comparison of two types of orodispersible gel films (ODF) by the solvent casting method. Natural polymers: sodium alginate (ALG) or hydroxypropyl methylcellulose (HPMC) were used as the gel film formers, and Kollidon or microcrystalline cellulose was used as the disintegrant. Meloxicam (MLX), the drug used to treat rheumatic diseases for children and adults, was proposed as the active pharmaceutical ingredient (API). The influence of the polymer and disintegrant on the properties of ODF was investigated. The evaluation of prepared gel films was based on appearance description, mass uniformity measurement, disintegration time, API content, film wettability, and water content. Also, the dissolution test was prepared in a basket apparatus using artificial salvia (pH = 6.8) as the medium. The obtained API release profiles were analyzed for the similarity factors (f) with the DDSolver software. The results showed that independently of the polymer or disintegrant, using the solvent casting method, gel films have a similar appearance and active substance content close to the theoretical value and water content of less than 10%. Only the type of polymer influences the release profiles of MLX. However, the disintegration time was longer than 30 s, which makes the films non-fast-dissolving drug delivery systems. This means that for the ODF system, further evaluation is required, and some changes in the composition of the film have to be done.
本研究的目的是通过溶剂浇铸法制备并比较两种类型的口腔崩解凝胶膜(ODF)。天然聚合物:海藻酸钠(ALG)或羟丙基甲基纤维素(HPMC)用作凝胶膜形成剂,聚乙烯吡咯烷酮或微晶纤维素用作崩解剂。用于治疗儿童和成人风湿性疾病的药物美洛昔康(MLX)被用作活性药物成分(API)。研究了聚合物和崩解剂对ODF性能的影响。对制备的凝胶膜的评估基于外观描述、质量均匀性测量、崩解时间、API含量、膜润湿性和含水量。此外,使用人工唾液(pH = 6.8)作为介质,在篮式装置中进行溶出度试验。使用DDSolver软件分析获得的API释放曲线的相似因子(f)。结果表明,无论使用何种聚合物或崩解剂,采用溶剂浇铸法制备的凝胶膜外观相似,活性物质含量接近理论值,含水量小于10%。只有聚合物类型会影响MLX的释放曲线。然而,崩解时间超过30秒,这使得这些膜不是速溶药物递送系统。这意味着对于ODF系统,需要进一步评估,并且必须对膜的组成进行一些改变。