3个月稳定口服粘性布地奈德凝胶的制备及指示稳定性高效液相色谱法的建立

M. Bonnet, M. Dermu, Clara Roessle, M. Bellaiche, T. Abarou, V. Vasseur, Samira Benakouche, T. Storme
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引用次数: 4

摘要

背景嗜酸性粒细胞性食管炎是一种日益增多的病理,可引起吞咽困难、呕吐、食物阻塞等胃部症状。治疗包括饮食治疗和局部皮质类固醇治疗,以避免口服皮质类固醇的重要副作用。目前还没有适合治疗食道病理的可用外用形式。方法研制布地奈德口服粘稠凝胶(OVBG)。为了在儿童中使用OVBG,对适口性进行了关注。我们建立了一种稳定性指示高阶pc方法,能够定量我们OVBG中所含的布地奈德。结果Hefner等先前的研究表明黄原胶与食道粘膜的接触时间比三氯蔗糖长。这鼓励了黄原胶基配方的发展。由于其口感和令人愉悦的质地,这种OVBG还具有促进依从性的优势。制剂的稳定长度可延长至3个月以上,在2-8°C的冰箱中保存。结论:开发了一种具有3个月稳定性的儿童配方。此外,该配方易于在社区药房复制。关于越来越多的患者关注OVBG是一个很好的答案,一个真正的临床需要。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Formulation of a 3-months Stability Oral Viscous Budesonide Gel and Development of an Indicating Stability HPLC Method
Abstract Background Eosinophilic Esophagitis is an increasing pathology which can cause stomach symptom like dysphagia, vomiting, food blockage. The treatment consists in dietary therapy and topical corticosteroid therapy to avoid the important number of side effects of the oral corticosteroids. There is presently no available topical form adapted for treating esophageal pathology. Methods The aim of this work was to develop an oral viscous budesonide gel (OVBG). A focus on palatability was made in order to use OVBG in children. A stability indicating HLPC method able to quantify budesonide contained in our OVBG has been developed. Results Previous work of Hefner and Al. showed that xanthan gum had a longer esophageal mucosal contact time than sucralose. This encouraged the development of a xanthan gum-based formulation. This OVBG has also the advantage to facilitate compliance thanks to its taste and pleasant texture. The stability length of the preparation can be extended over a 3-months period, stored in a refrigerator at 2–8 °C. Conclusions An adapted pediatric formulation with a 3-months stability was developed. Furthermore, the formulation can be easily reproduced in community pharmacy. Regarding the increasing number of patients concerned OVBG is a good answer to a real clinical need.
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