FORMULATION OF MUCOADHESIVE BUCCAL FILMS USING PREGELATINIZED CASSAVA STARCH PHTHALATE AS A FILM-FORMING POLYMER
FORMULATION OF MUCOADHESIVE BUCCAL FILMS USING PREGELATINIZED CASSAVA STARCH PHTHALATE AS A FILM-FORMING POLYMER
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使用预胶化木薯淀粉邻苯二甲酸酯作为成膜聚合物配制粘膜粘附性颊膜
DOI：
10.22159/ijap.2018.v10s1.50
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发表时间：
2018
影响因子：
--
通讯作者：
K. Putri
中科院分区：
文献类型：
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作者：
Silvia Surini;Fungi Gotalia;K. Putri
目的：本研究旨在比较用邻苯二甲酰化木薯淀粉配制的四种颊膜的特性及其药物递送潜力。方法：传统（口服）给药的替代方法是在颊膜中给药；然而，所需剂量必须溶解在具有适当机械和粘膜粘附特性的成膜聚合物中。先前的研究通过物理和化学改性淀粉来生产赋形剂，例如在碱性条件（pH 8-10）的水介质中完全预糊化和邻苯二甲酰化。由此产生了具有高取代度 (0.0541±0.0019) 的预胶化木薯淀粉邻苯二甲酸酯 (PCSPh) 粉末，从而赋予其与未邻苯二甲酸酯 PCS 不同的物理、化学和功能特性。结果：4.5% 和 6% (w/w) 浓度的 PCSPh 用作赋形剂，生产四种配方的颊膜。其中一种薄膜具有最合适的特性，其离体粘膜粘附时间为 57.1±20.3 分钟，拉伸强度为 0.84±0.02 N/mm2，并且比其他两种薄膜类型具有更快的药物释放曲线。我们的测试还表明，最好的薄膜在潮湿时往往不会发生物理变化（吸湿百分比为 139%，水分损失为 65%）。结论：因此，我们预测 PCSPh 可以适当配制，以提供具有适当药物释放曲线的粘膜粘附颊膜。
Objective: This study aimed to compare the characteristics of four buccal films formulated with phthalylated cassava starch and their drug deliverypotentials.Methods: An alternative to conventional (oral) drug administration is to administer drugs in a buccal film; however, the required dosage mustbe dissolved in a film-forming polymer with suitable mechanical and mucoadhesive characteristics. Previous studies have produced excipientsby physically and chemically modifying starch, such as by completely pregelatinization and phthalylation it in an aqueous medium under alkalineconditions (pH 8–10). This produced a pregelatinized cassava starch phthalate (PCSPh) powder with a high degree of substitution (0.0541±0.0019),thus giving it different physical, chemical, and functional characteristics than unphthalated PCS.Results: PCSPh in 4.5% and 6% (w/w) concentrations was used as excipients for producing four formulations of buccal film. One film had themost suitable characteristics, with an ex vivo mucoadhesion time of 57.1±20.3 min, tensile strength of 0.84±0.02 N/mm2, and a more rapid drugrelease profile than two of the other film types produced. Our tests also revealed that the best film tended to not change physically when moistened(percentage moisture absorption was 139% and moisture loss was 65%).Conclusion: Thus, we predict that PCSPh could be adequately formulated to provide mucoadhesive buccal films with an appropriate drug release profile.