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Heat Effect on Generic Transdermal Drug Delivery Systems

Heat Effect on Generic Transdermal Drug Delivery Systems
热效应对普通透皮给药系统的影响
批准号:
9340991
负责人:
Audra L. Stinchcomb
金额:
$50.0万
依托单位国家:
美国
项目类别:
财政年份:
2013
资助国家:
美国
项目状态:
已结题
起止时间:
2013-09-15 至 2021-06-30

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ABSTRACT Drug release from different transdermal drug delivery systems (TDDS) is governed by a number of factors including: skin condition, occlusion, exposure to heat, different inactive ingredients, sweat, age and patch design (reservoir vs. matrix). In particular, exposure to heat has been well documented to increase the peak plasma concentration and area-under the plasma concentration curve for many drugs including nicotine, fentanyl, nitroglycerine, clonidine, methyl salicylate, estradiol and testosterone, imposing critical safety issues. Most of the reported studies are limited as they focused on studying heat effect on reference or generic TDDS and almost none, according to the literature, provided direct comparison of the influence of heat effect on reference and generic products in vivo. When a reference product has a warning against applying heat, the generic product will have the same warning regardless of the dissimilarity that may exist between them (i.e., differences in inactive ingredients or type of TDDS). It is likely that the release rate of the same drug differs from different TDDS products in response to heat, as well as the skin permeation being modified due to different release rates of enhancers and cosolvents. There is an unmet need to characterize heat effects on generic vs. reference products in vitro and in vivo to develop in vitro/in vivo correlation which can be used by ANDA sponsors to predict the performance of their generic products upon heat application. This will ensure that generic products are no different than reference products with respect to their performance upon heat application and will ensure that there are no additional critical safety issues for users of generic TDDS. The objective of this proposal is to determine the best in vitro test conditions that identify the influence of heat on the permeation properties of reservoir and matrix nicotine and fentanyl patches. Nicotine and fentanyl patches are available without and with prescriptions, respectively. They are among the most used patches worldwide and they are available in both matrix and reservoir forms from different manufacturers. This project will: investigate the influence of heat effects on reference and generic nicotine and fentanyl TDDS in healthy human volunteers, investigate the influence of variable test conditions in vitro on FDA approved nicotine and fentanyl TDDS at normal and elevated temperatures, develop in vitro/in vivo correlation, and evaluate the influence of heat on FDA-approved generic products (with no available heat effect studies) and their respective reference products using our optimized in vitro test conditions. Results from these studies will help the FDA decide on which in vitro test conditions and study design ANDA sponsors will have to consider in evaluating the performance of their generic product to ensure that heat effect on their products is equivalent to that on the respective reference product. Future years of this project could include examination of the heat effect on additional drug patches, on special patient populations, and on skin with compromised barrier.
期刊论文(7)
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科研奖励(0)
会议论文
LC-MS determination of fentanyl in human serum and application to a fentanyl transdermal delivery pharmacokinetic study.
LC-MS 测定人血清中的芬太尼及其在芬太尼透皮给药药代动力学研究中的应用。
DOI: 10.4155/bio-2017-0174
发表时间: 2017
期刊: Bioanalysis
影响因子: 1.8
作者: [Yu,Mingming, Abdallah,InasA, Shin,SooHyeon, Hammell,DanaC, Stinchcomb,AudraL, Hassan,HazemE]
通讯作者: Hassan,HazemE
Effect of Controlled Heat Application on Topical Diclofenac Formulations Evaluated by In Vitro Permeation Tests (IVPT) Using Porcine and Human Skin.
通过猪和人皮肤的体外渗透试验 (IVPT) 评估控制加热对局部双氯芬酸制剂的影响。
DOI: 10.1007/s11095-019-2741-1
发表时间: 2020
期刊: Pharmaceutical research
影响因子: 3.7
作者: [Thomas,Sherin, Shin,SooHyeon, Hammell,DanaC, Hassan,HazemE, Stinchcomb,AudraL]
通讯作者: Stinchcomb,AudraL
Norelgestromin/ethinyl estradiol intravenous infusion formulation optimization, stability and compatibility testing: A case study to overcome polysorbate 80 interference in chromatographic analysis.
诺孕曲明/乙炔雌二醇静脉输液配方优化、稳定性和相容性测试:克服聚山梨酯 80 色谱分析干扰的案例研究。
DOI: 10.1016/j.jpba.2016.03.024
发表时间: 2016
期刊: Journal of pharmaceutical and biomedical analysis
影响因子: 3.4
作者: [Abdallah,InasA, Hammell,DanaC, Hassan,HazemE, Stinchcomb,AudraL]
通讯作者: Stinchcomb,AudraL
Evaluation of in vitro/in vivo correlations for three fentanyl transdermal delivery systems using in vitro skin permeation testing and human pharmacokinetic studies under the influence of transient heat application.
使用体外皮肤渗透测试和瞬态热影响下的人体药代动力学研究评估三种芬太尼透皮给药系统的体外/体内相关性。
DOI: 10.1016/j.jconrel.2021.11.030
发表时间: 2022
期刊: Journal of controlled release : official journal of the Controlled Release Society
影响因子: --
作者: [Shin,SooHyeon, Yu,Mingming, Hammell,DanaC, Ghosh,Priyanka, Raney,SamG, Hassan,HazemE, Stinchcomb,AudraL]
通讯作者: Stinchcomb,AudraL
Transdermal Naltrexone for Opiate Addiction and Alcoholism
  • 批准号:
    8253142
  • 项目类别:
  • 资助金额:
    $53.78万
  • 财政年份:
    2012
  • 负责人:
    Audra L. Stinchcomb
  • 依托单位:
Microneedle-enhanced codrug delivery for smoking cessation and appetite suppressi
  • 批准号:
    8508902
  • 项目类别:
  • 资助金额:
    $23.01万
  • 财政年份:
    2012
  • 负责人:
    Audra L. Stinchcomb
  • 依托单位:
Transdermal Naltrexone for Opiate Addiction and Alcoholism
  • 批准号:
    8519709
  • 项目类别:
  • 资助金额:
    $69.6万
  • 财政年份:
    2012
  • 负责人:
    Audra L. Stinchcomb
  • 依托单位:
Microneedle-enhanced codrug delivery for smoking cessation and appetite suppressi
  • 批准号:
    8303925
  • 项目类别:
  • 资助金额:
    $20.36万
  • 财政年份:
    2012
  • 负责人:
    Audra L. Stinchcomb
  • 依托单位:
国内基金
海外基金
LINC00673调控HIF-1α促进Warburg effect在子宫内膜蜕膜化中的作用和机制研究
  • 批准号:
    82060281
  • 项目类别:
    地区科学基金项目
  • 资助金额:
    34.0万元
  • 批准年份:
    2020
  • 负责人:
    朱元昌
  • 依托单位:
(宫颈)癌前病变的Warburg-like effect与糖代谢重编程机制研究
  • 批准号:
    31670788
  • 项目类别:
    面上项目
  • 资助金额:
    60.0万元
  • 批准年份:
    2016
  • 负责人:
    陈尚武
  • 依托单位: