Formulation and Clinical Evaluation Of Ultradeformable Liposomes in the Topical Treatment of Psoriasis

K. Vanaja, R. H. Shobha Rani, S. Sacchidananda
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引用次数: 23

Abstract

Ultradeformable liposomes of Methotrexate (MTX) were formulated to enhance its transdermal delivery in the treatment of psoriasis. Formulations were characterized for particle size, polydispersity index, morphology employing TEM and residual solvent analysis. The efficacy of topical liposomal MTX gel was compared with the commercially available plain MTX gel by clinically investigating the reduction in PASI score in psoriasis patients. Allergic contact sensitization potential of placebo ultradeformable liposomal gel was evaluated which showed that the placebo gel did not produce any reaction in the induction as well as challenge phase in 12 human volunteers. Open label, randomized parallel study was conducted in 25 patients. Baseline PASI score in the group receiving liposomal gel (0.25%) was 5.3 ± 1.027 and at the 10th week was reduced to 2.4 ± 0.625. In the case of the group applying plain MTX gel (1%), the baseline PASI score was 6.2 ± 0.17, reduced to 2.9 ± 0.79 at the 10th week. It was observed that liposomal MTX gel of 0.25% improved palmoplantar psoriasis in comparison with 1% plain MTX gel. Therefore, reducing the dose by entrapping MTX in liposomes improved the efficacy and patient compliance.
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超成形脂质体局部治疗银屑病的配方及临床评价
甲氨蝶呤(MTX)的超成型脂质体,以提高其透皮输送治疗牛皮癣。用透射电镜和残余溶剂分析对配方的粒径、多分散性指数、形貌进行了表征。通过临床研究银屑病患者PASI评分的降低,比较外用脂质体MTX凝胶与市售普通MTX凝胶的疗效。对安慰剂超成形脂质体凝胶的过敏接触致敏潜力进行了评估,结果表明,在12名人类志愿者的诱导和激发阶段,安慰剂凝胶没有产生任何反应。在25例患者中进行了开放标签,随机平行研究。脂质体凝胶(0.25%)组PASI基线评分为5.3±1.027,第10周降至2.4±0.625。在使用普通MTX凝胶(1%)的组中,基线PASI评分为6.2±0.17,在第10周降至2.9±0.79。我们观察到0.25%的MTX脂质体凝胶与1%的普通MTX凝胶相比,能改善掌跖牛皮癣。因此,通过脂质体包埋MTX减少剂量可以提高疗效和患者依从性。
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