直接压缩法制备甲氧胺酸盐酸二环胺口腔崩解片及评价

T RanjithaM, C. Somashekhar
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摘要

一种新的剂型,口服崩解片(ODT’s)作为传统口服剂型的替代品。与口服液相比,ODT是一种可在口腔中分解的剂型,具有各种优点,如更好的口感、剂量准确性、更好的稳定性和方便的给药。因此,有必要设计口服崩解片,以提高药物的释放速度。甲氧胺酸是抗炎药,盐酸双环胺是抗胆碱能药。甲氧胺酸和盐酸双环明的组合能有效地控制疼痛,也能缓解月经期间常见的身体痉挛或肠绞痛痉挛。这种组合比传统剂型起效快,缓解快。为制备口腔崩解片,设计了以不同浓度的交联棉糖钠和交联维酮为超崩解剂的9种剂型。所有配方均采用直接压缩法制备。为此,对甲非那酸盐酸双环明口腔崩解片的处方进行了考察,并对F9的处方进行了优化。F9批口腔崩解片在18 min内释放甲非那酸含量为96.98%,盐酸双环霉素含量为94.02%,崩解时间为40秒,湿润时间为25秒。
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PREPARATION AND EVALUATION OF MEFENAMIC ACID AND DICYCLOMINE HYDROCHLORIDE AS ORAL DISINTEGRATING TABLET BY DIRECT COMPRESSION METHOD
A new dosage form, Oral disintegrating tablets (ODT’s) as a replacement to conventional oral dosage forms. ODT’s are dosage forms they disintegrate in mouth offering various advantages such as better mouth feel, dose accuracy, improved stability and convenient dosing as compared to oral liquids. So, there is need to designed oral disintegrating tablet to release the medicaments with an enhanced rate. Mefenamic acid is an anti- inflammatory drug while Dicyclomine HCl is anti-cholinergic drug. The combination of Mefenamic acid & Dicyclomine HCl controls pain very effectively, also relaxes bodily spasm which commonly arises during menstruation or intestinal colic spasm. This combination gives the quick onset of action and fast relief than conventional dosage form. For preparation of oral disintegrating tablet nine formulations were designed using Croscarmellose sodium and Crospovidone as superdisintegrants in varying concentration. All the formulations were prepared by direct compression method. Thus, all the formulations of Mefenamic acid and Dicyclomine HCl oral disintegrating tablets were investigated, in which F9 formulation was optimized. The % drug release of, Oral disintegrating tablet batch F9 has shown 96.98% of Mefenamic acid and 94.02 % of Dicyclomine HCl in 18 min, disintegration time in 40 sec and wetting time in 25sec.
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