Formulation and evaluation of amoxapine mucoadhesive buccal films

Mahaboob Ali Sk., S. Kv, Gautham Chakra R
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Abstract

Among innovative drug delivery methods, buccal mucoadhesive systems have been attracting much interest recently because of their capacity to stick to the oral mucosa, stay there, and gradually release their drug content. By improving medication absorption through the oral mucosa and reducing the hepatic first-pass impact, buccal mucoadhesive films can increase the drug's bioavailability and enhance its therapeutic effect. The current study aimed to synthesize the medicine as a buccal bioadhesive film, which reduces the frequency of dosage form administration by releasing the drug at a sufficient concentration over time. Because this formulation is simple to administer and requires no water to swallow, improved patient compliance is one of its benefits. Dissolving profile as investigated in USP dissolving apparatus type 1 using saliva at pH 6.8. The impact of factors such as polymer type, concentration, and release profile of Amoxapine was investigated. The formulation was optimized Based on several evaluation criteria, including drug content and in-vitro drug release. Formulation F6 successfully releases the drug in 7 hours. The stability studies followed ICH recommendations, and the results showed that the optimized formulation was stable. The IR spectra demonstrated the stable qualities of Amoxapine in a mixture of polymers utilized and revealed the absence of interaction between the drug and the selected polymer.
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阿莫沙平粘合剂口腔胶片的配制与评估
在创新给药方法中,颊黏膜黏附系统因其能够黏附在口腔黏膜上,并在口腔黏膜上停留和逐渐释放药物成分而受到广泛关注。颊黏膜可以提高药物通过口腔黏膜的吸收率,减少肝脏的首过效应,从而提高药物的生物利用度,增强治疗效果。本研究旨在将药物合成为一种口腔生物黏附膜,通过在一段时间内释放足够浓度的药物,减少剂型给药次数。由于这种制剂给药简单,无需用水吞服,因此能提高患者的依从性,这也是它的优点之一。在 pH 值为 6.8 的美国药典 1 型溶解器中使用唾液对溶解曲线进行了研究。研究了聚合物类型、浓度和阿莫沙平释放曲线等因素的影响。根据药物含量和体外药物释放等多项评估标准,对配方进行了优化。配方 F6 成功地在 7 小时内释放了药物。稳定性研究遵循了 ICH 建议,结果表明优化后的制剂是稳定的。红外光谱显示了阿莫沙平在聚合物混合物中的稳定性,并表明药物与所选聚合物之间不存在相互作用。
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