丁丙诺啡透皮给药系统:两种贴片配方的生物等效性评估和粘附性能。

IF 4.9 3区 医学 Q1 PHARMACOLOGY & PHARMACY Pharmaceutics Pub Date : 2024-09-26 DOI:10.3390/pharmaceutics16101249
Marcelo Gomes Davanço, Miguel Fortuny, Alejandro Scasso, Jessica Meulman, Fernando Costa, Thalita Martins da Silva, Débora Renz Barreto Vianna, Leonardo de Souza Teixeira, Karini Bruno Bellorio, Ana Carolina Costa Sampaio, Celso Francisco Pimentel Vespasiano
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引用次数: 0

摘要

背景和目的:丁丙诺啡是一种阿片类药物,适用于治疗严重和持续性疼痛。丁丙诺啡透皮贴片提供了一种非侵入性的药物释放速率控制方法,可确保在较长时间内保持稳定和可预测的药物血浆水平。本研究旨在评估两种丁丙诺啡透皮贴剂的生物等效性、皮肤粘附性和耐受性,以满足巴西仿制药注册的监管要求。研究方法对健康的男女受试者进行了随机、单剂量、两阶段、两序列交叉试验。受试者单剂量服用试验制剂或参比制剂(Restiva®),中间有 29 天的冲洗期。为了进行药代动力学分析,在用药后 12 天内采集了血液样本,并采用经过验证的生物分析方法进行了定量。在贴敷后的 7 天内(用药间隔)对皮肤粘附性进行评估。研究共招募了 76 名受试者,其中 52 人完成了研究。结果与结论Cmax、AUC0-t 和部分 AUC 的 90% 置信区间在 80% 至 125% 的可接受生物等效性范围内。粘附性比较显示试验制剂无劣效。根据 ANVISA 的监管要求,试验制剂和参比制剂被认为具有生物等效性,在临床实践中可以互换。
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Buprenorphine Transdermal Delivery System: Bioequivalence Assessment and Adhesion Performance of Two Patch Formulations.

Background and Objective: Buprenorphine is an opioid drug indicated for the management of severe and persistent pain. The buprenorphine transdermal patch provides a non-invasive method of rate-controlled drug release, ensuring constant and predictable drug plasma levels over an extended period. This study aimed to assess the bioequivalence, skin adhesion non-inferiority, and tolerability of two buprenorphine transdermal patches to meet the regulatory requirements for the registration of a generic product in Brazil. Methods: A randomized, single-dose, two-period, two-sequence crossover trial was performed involving healthy subjects of both genders. The subjects received a single dose of either the test formulation or the reference formulation (Restiva®), separated by a 29-day washout period. For pharmacokinetic analysis, blood samples were collected up to 12 days post-dose and quantified using a validated bioanalytical method. Skin adhesion was assessed over a 7-day period (dosing interval) following patch application. Seventy-six subjects were enrolled and fifty-two completed the study. Results and Conclusion: The 90% confidence intervals for Cmax, AUC0-t, and partial AUCs were within the acceptable bioequivalence limits of 80 to 125%. Adhesion comparison showed the non-inferiority of the test formulation. Based on ANVISA's regulatory requirements, the test and reference formulations were considered bioequivalent and could be interchangeable in clinical practice.

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来源期刊
Pharmaceutics
Pharmaceutics Pharmacology, Toxicology and Pharmaceutics-Pharmaceutical Science
CiteScore
7.90
自引率
11.10%
发文量
2379
审稿时长
16.41 days
期刊介绍: Pharmaceutics (ISSN 1999-4923) is an open access journal which provides an advanced forum for the science and technology of pharmaceutics and biopharmaceutics. It publishes reviews, regular research papers, communications,  and short notes. Covered topics include pharmacokinetics, toxicokinetics, pharmacodynamics, pharmacogenetics and pharmacogenomics, and pharmaceutical formulation. Our aim is to encourage scientists to publish their experimental and theoretical details in as much detail as possible. There is no restriction on the length of the papers. The full experimental details must be provided so that the results can be reproduced.
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