Oral sustained release nystatin tablets for the treatment of oral candidiasis: formulation development and validation of UV spectrophotometric analytical methodology for content determination.

IF 2.4 4区 医学 Q3 CHEMISTRY, MEDICINAL
Michelle Maria Gonçalves Barão de Aguiar, Raphael Pereira de Albuquerque, Daniel Savignon Marinho, Bárbara Regina Souza Braga, Camila Braga Dornelas, Anderson Oliveira, Valéria Pereira de Sousa, Sandra Regina Torres, Daniela Sales Alviano, Celuta Sales Alviano, Lúcio Mendes Cabral, Carla Holandino
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引用次数: 32

Abstract

Objective: In this study, oral sustained release mucoadhesive nystatin tablets were developed to increase nystatin contact time with the oral cavity and mask its unpleasant taste.

Methods: The best formulation studied included sustained release agents and it was submitted to physical-mechanical characterization, taste assessment and clinical test in twelve patients. The ultraviolet-visible nystatin methodology was also developed and validated in parallel as an alternative to the pharmacopoeial microbiological dosage method.

Results: The best formulation developed in this study included sustained release agents. The efficacy of this formulation was verified through a clinical assessment, showing that this formulation is more effective (100%) than the commercial oral nystatin suspension used traditionally (50%). Moreover, the UV absorption spectrophotometry method developed to validate the methodology for nystatin content analysis for new oral tablets was shown to be specific, linear, exact and reproducible, as recommended by the ICH regulations.

Conclusion: The oral nystatin tablets developed showed to present faster therapeutic response than the oral aqueous solution through the preliminary clinical assays. The UV absorption spectrophotometry method showed to be an attractive test for the usual routine in the pharmaceutical industry.

治疗口腔念珠菌病的口服制霉菌素缓释片:配方开发及紫外分光光度法含量测定方法的验证。
目的:研制口腔制霉菌素黏附缓释片,增加制霉菌素与口腔的接触时间,掩盖制霉菌素的不良味道。方法:采用缓释剂作为优选处方,对12例患者进行物理力学表征、口感评价和临床试验。紫外可见制霉菌素方法学也被开发和验证,作为药典微生物剂量法的替代方法。结果:本研究开发的最佳处方为缓释剂。通过临床评估验证了该配方的有效性,表明该配方比传统的商业口服制霉菌素悬浮液(50%)更有效(100%)。此外,为验证新口服片剂制霉菌素含量分析方法而开发的紫外吸收分光光度法具有特异性、线性性、准确性和可重复性,符合ICH法规的建议。结论:经初步临床试验,所研制的制霉菌素口服片剂的治疗效果快于口服制霉菌素水溶液。紫外吸收分光光度法是一种很有吸引力的检测方法,适用于制药行业的常规检测。
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来源期刊
CiteScore
6.80
自引率
0.00%
发文量
82
审稿时长
4.5 months
期刊介绍: The aim of Drug Development and Industrial Pharmacy is to publish novel, original, peer-reviewed research manuscripts within relevant topics and research methods related to pharmaceutical research and development, and industrial pharmacy. Research papers must be hypothesis driven and emphasize innovative breakthrough topics in pharmaceutics and drug delivery. The journal will also consider timely critical review papers.
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