壳聚糖海藻酸钠生物胶阴道片。

AAPS PharmSci Pub Date : 2002-01-01 DOI:10.1208/ps040444
Amal El-Kamel, Magda Sokar, Viviane Naggar, Safaa Al Gamal
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引用次数: 133

摘要

采用与戊二醛松散交联的天然阳离子聚合物壳聚糖与海藻酸钠(含或不含微晶纤维素)直接压缩制成甲硝唑黏附阴道片。在部分配方中加入羧甲基纤维素钠(CMC)。片剂中药物含量为20%。在pH为4.8的缓冲液和蒸馏水中对片剂进行药物溶出度研究。同时测定了所有配方的溶胀指数和附着力。该配方(FIII)含6%壳聚糖、24%海藻酸钠、30% CMC钠和20% MCC,在两种介质中均具有良好的释放性能,且溶胀指数较低。FIII也被证明具有良好的粘附性能,最小的施加重量。在pH为4.8的缓冲液中,其释放特性(%溶解效率,DE)和释放机制(n值)受老化的影响可忽略不计。因此,该配方可被认为是阴道黏液剂型的良好候选剂型。
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Chitosan and sodium alginate-based bioadhesive vaginal tablets.

Metronidazole was formulated in mucoadhesive vaginal tablets by directly compressing the natural cationic polymer chitosan, loosely cross-linked with glutaraldehyde, together with sodium alginate with or without microcrystalline cellulose (MCC). Sodium carboxymethylcellulose (CMC) was added to some of the formulations. The drug content in tablets was 20%. Drug dissolution rate studies from tablets were carried out in buffer pH 4.8 and distilled water. Swelling indices and adhesion forces were also measured for all formulations. The formula (FIII) containing 6% chitosan, 24% sodium alginate, 30% sodium CMC, and 20% MCC showed adequate release properties in both media and gave lower values of swelling index compared with the other examined formulations. FIII also proved to have good adhesion properties with minimum applied weights. Moreover, its release properties (% dissolution efficiency, DE) in buffer pH 4.8, as well as release mechanism (n values), were negligibly affected by aging. Thus, this formula may be considered a good candidate for vaginal mucoadhesive dosage forms.

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