The University of Lahore, Faculty of Pharmacy, Department of Pharmaceutics, Lahore, Pakistan.
University of Central Punjab, Faculty of Pharmacy, Department of Pharmaceutics, Lahore, Pakistan.
J Appl Biomed. 2020 Dec;18(4):115-125. doi: 10.32725/jab.2020.015. Epub 2020 Oct 27.
Rosuvastatin Calcium and Ezetimibe are used to control cholesterol level while Perindopril Erbumine is used to treat hypertension. Hepatic metabolism reduces the therapeutic effect of these drugs.
Instant release buccal films (IRBFs) could possibly be a solution to this issue. The objective of the study was to formulate IRBFs of Rosuvastatin Calcium, Perindopril Erbumine and Ezetimibe using solvent casting technique.
Polymers used to prepare IRBFs included hydroxypropyl methylcellulose (HPMC E5), PEG 400 (as plasticizer) and Tween 80 (as surfactant). Solvent casting technique was used to fabricate the films, followed by their in-vitro analysis including high performance liquid chromatography (HPLC), X-ray diffraction (XRD), fourier transform infrared evaluation (FTIR), In-vitro dissolution, In-vitro disintegration, stability tests, scanning electron microscopy (SEM), folding fortitude, thickness evaluation, surface pH, tensile strength, weight variation and percentage moisture content.
Optical microscopy as well as SEM analysis displayed that the surfaces of IRBFs were smooth with uniform mixing of ingredients. IRBFs disintegrated within 15 seconds while on dissolution they exhibited instant drug release i.e. 100% release in 2 minutes.
The results show promising potential of IRBFs in drug delivery.
瑞舒伐他汀钙和依折麦布用于控制胆固醇水平，培哚普利厄贝沙坦用于治疗高血压。肝脏代谢会降低这些药物的治疗效果。
速释口腔膜（IRBF）可能是解决这个问题的一种方法。本研究的目的是采用溶剂浇铸法制备瑞舒伐他汀钙、培哚普利厄贝沙坦和依折麦布的 IRBF。
用于制备 IRBF 的聚合物包括羟丙甲纤维素（HPMC E5）、聚乙二醇 400（作为增塑剂）和聚山梨酯 80（作为表面活性剂）。采用溶剂浇铸法制备薄膜，然后进行包括高效液相色谱（HPLC）、X 射线衍射（XRD）、傅里叶变换红外评估（FTIR）、体外溶解、体外崩解、稳定性测试、扫描电子显微镜（SEM）、折叠强度、厚度评估、表面 pH 值、拉伸强度、重量变化和水分含量百分比在内的体外分析。
光学显微镜和 SEM 分析表明，IRBF 的表面光滑，成分混合均匀。IRBF 在 15 秒内崩解，而在溶解时，它们表现出即时药物释放，即 2 分钟内达到 100%释放。
结果表明 IRBF 在药物传递方面具有有前景的潜力。
