Characterization of Critical Quality Attributes for Semisolid Topical Drug Products
Characterization of Critical Quality Attributes for Semisolid Topical Drug Products
批准号:
8924792
负责人:
Michael Roberts
金额:
$24.98万
依托单位国家:
美国
项目类别:
财政年份:
2014
资助国家:
美国
项目状态:
已结题
起止时间:
2014-09-10 至 2019-08-31
中文摘要
摘要
目前,迫切需要建立局部用药的质量目标产品概况(QTPP)。
产品,并确定关键质量属性(CQA),以制定有意义的
基于临床性能的制剂质量标准,并确保等效性
安全性和有效性的参考上市药物(RLD)。大多数半固体制剂
例如药物/化妆品霜剂、软膏剂、洗剂等
流动特性,包括在高剪切、触变性和
粘弹性,其可以通过测量中使用的方法来描述,
这些参数。
大多数半固体系统如软膏、乳膏、糊剂和凝胶是可接受的。
粘弹性的性质,因为它们在相同的温度下显示出液体和固体性质。
材料在这个项目中,我们的目标是改变关键配方和制造
识别和定义影响产品的潜在失效模式的参数
性能
我们将使用有限(使用中)和无限剂量和使用来比较生物利用度
诸如原子力显微镜(AFM)、共焦拉曼和多光子
显微镜检查,以研究辅料和制剂对体外和体内
皮肤除BE外,我们还旨在定义外观等效性(CE)。感官
相似性/外观等同性将被定义为关键质量属性,
这个过程
英文摘要
Abstract
There is an urgent need to establish Quality target product profile (QTPP) for topical
products and identify the Critical Quality Attributes (CQAs) to develop meaningful
drug product specifications based on clinical performance and to ensure equivalent
safety and efficacy to the Reference Listed Drug (RLD). Most semisolid preparations
such as pharmaceutical/ cosmetic creams, ointments, lotions etc. display complex
flow behaviour including breakdown on application of high shear, thixotropy and
viscoelasticity which can be described by the methods used in measurement of
these parameters.
Most of the semisolid systems such as ointments, creams, pastes, and gels are
viscoelastic in nature as they display both liquid and solid properties within the same
material. In this project we aim to vary key formulation and manufacturing
parameters to identify and define potential failure mode that effect a products
performance.
We will compare bioavailability using both finite (in use) and infinite dosing and use
tools such as Atomic Force Microscopy (AFM), Confocal Raman and multiphoton
microscopy to study the effects of excipients and formulation on in vitro and in vivo
skin. Apart from BE we aim to define cosmetic equivalence (CE). Sensorial
similarity/cosmetic equivalence will be defined as a critical quality attribute through
this process.
期刊论文(0)
专著(0)
科研奖励(0)
会议论文
Physiologically Based Biopharmaceutics and Pharmacokinetics of Drug Products for Dermal Absorption in Humans
-
批准号:9132018
-
项目类别:
-
资助金额:$20.0万
-
财政年份:2014
-
负责人:Michael Roberts
-
依托单位:
Physiologically Based Biopharmaceutics and Pharmacokinetics of Drug Products for Dermal Absorption in Humans
-
批准号:8925790
-
项目类别:
-
资助金额:$20.0万
-
财政年份:2014
-
负责人:Michael Roberts
-
依托单位:
Characterization of Critical Quality Attributes for Semisolid Topical Drug Products
-
批准号:9132017
-
项目类别:
-
资助金额:$25.0万
-
财政年份:2014
-
负责人:Michael Roberts
-
依托单位:
Characterization of Critical Quality Attributes for Semisolid Topical Drug Products
-
批准号:8857569
-
项目类别:
-
资助金额:$24.98万
-
财政年份:2014
-
负责人:Michael Roberts
-
依托单位:
海外基金