Formulation and Characterization of Fast Dissolving films of Etoricoxib

Km. Roshani, Mangla Nand Singh, D. Sasmal, P. Panda, J. Mishra, Reena Singh
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Abstract

Etoricoxib belongs to a class of drugs called non-steroidal anti-inflammatory drugs (NSAIDs). Etoricoxib acts by reducing the pain and swelling (inflammation) in the joints and muscles of people older than 16 years of age and older patients with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and gout. The present study was aimed to formulate fast dissolving oral films to enhance bioavailability, avoid presystemic metabolism and fast onset of action. The Preformulation studies such as Micromeritics, melting point, partition coefficients, UV spectroscopy, thin layer chromatography, loss on drying were carried out. The fast dissolving oral film was successfully fabricated by solvent casting method. Oral film was fabricated using PVA and PVP polymer. The prepared films were evaluated for Organoleptic evaluations, film weight, thickness, folding endurance, tensile strength, drug content uniformity of films, surface pH, disintegration time and in-vitro dissolution studies and SEM study. The formulation F8 has shown disintegration time of 22±1 seconds and is more promising, showed drug release in phosphate buffer 6.8 pH 86.33% in 10 min. Hence formulation F8 was selected as best formulation. In the stability testing all films stored at elevated temperature showed slight change in pH, other parameters were found to be unchanged.
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依托昔布快溶膜的制备及表征
依托昔布属于非甾体类抗炎药(NSAIDs)。依托妥昔布的作用是减轻16岁以上人群和老年骨关节炎、类风湿关节炎、强直性脊柱炎和痛风患者关节和肌肉的疼痛和肿胀(炎症)。本研究旨在制备快速溶解的口服膜,以提高生物利用度,避免全身前代谢和快速起效。对配制前进行了显微分析、熔点、分配系数、紫外光谱、薄层色谱、干燥损失等研究。采用溶剂铸造法制备了快速溶解口腔薄膜。采用PVA和PVP聚合物制备口腔膜。对制备的膜进行感官评价、膜的重量、厚度、折叠耐力、拉伸强度、膜的药物含量均匀性、表面pH、崩解时间、体外溶出研究和扫描电镜研究。F8的崩解时间为22±1秒,较有前景,在6.8 pH的磷酸盐缓冲液中10 min内释药率为86.33%,优选F8为最佳处方。在稳定性测试中,所有薄膜在高温下保存时pH值变化不大,其他参数不变。
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