Impact of Formulation Composition on the Structure and Performance Attributes of Topical Products

项目摘要/摘要 该项目的主要目标是调查局部产品的成分差异对 物理、结构和功能特性。另一个目标是开发额外的、特定于产品的 探索结构和热力学变化的表征工具和方法 局部产品的变形。由于BE的故障模式的风险在成分上相对较高 不同的产品，需要系统地研究潜在的失效模式和方法，以 缓解它们。我们在这个项目中提出了三个具体目标。在目标1中，我们建议调查 系统性成分变化，对显微结构特征、变形和性能的影响 专题产品的属性。开发一个理论框架来描述支配的基本因素 外用剂型性能。将制定不同的案例研究，以考虑具有 不同程度的复杂性。不同的产品类型，如溶液、胶体产品、凝胶、悬浮液、 将考虑乳霜、微乳液、泡沫和纳米技术产品。在每种情况下，都有一个序列 将通过系统地改变产品组成来准备产品。一些方式(不限于 到)改变成分将包括：a)改变一种或多种配料的量或b)通过 用相同化学类别/药物的配料替换一种或多种配料 C)使用不同等级/质量/来源的配料。热力学表征 将是拟议实验中的主要重点。最后，提出了一个理论框架来描述 将制定管理局部产品性能的基本原则。在目标2中，我们建议 开发新的工具和方法来表征局部产品的微观结构属性。其中一个 目标是修改标准的传统方法，并验证它们在广泛的应用中的应用 特效药的种类。还将开发新的方法来理解 不同成分产品之间的微观结构和热力学特性。在目标3中， 确定非第一季度和/或第二季度产品的潜在故障模式，并调查 降低风险。将在本项目建议的个别案例研究中评估潜在的故障模式， 此外，还将探讨减轻风险的潜在方法。 成功完成拟议的研究，据信将产生将被用来 建立一个理论框架来描述支配主题表现的基本原则 产品。

Project Summary/Abstract The main objective of the project is to investigate the effect of compositional differences in topical products on the physical, structural and functional properties. The other objective is to It develop additional, product specific characterization tools and methodologies to explore the structural and thermodynamic changes that occur during metamorphosis of topical products. As the risk of failure modes for BE is relatively higher in compositionally different products, there is need to systematically investigate the potential failure modes and approaches to mitigate them.We propose three specific aims in this project. In aim 1 we propose to investigate the influence of systematic compositional alterations, on the microstructural characteristics, metamorphosis, and performance attributes of topical products. To develop a theoretical framework to describe the fundamental factors that govern topical dosage form performance. Different case studies will be formulated to consider various products with different levels of complexities. Different product types, such as solutions, colloidal products, gels, suspensions, creams, microemulsions, foams, and nanotechnology products, will be considered. In each case, a sequence of products will be prepared by systematic alteration in the product composition. Some of the ways (not limited to) of changing the composition would include: a) changing the amount of one or more ingredients or b) by replacing one or more of the ingredients with an ingredient that is of same chemical class/ pharmaceutical category and c) by using an ingredient of different grades/quality/source. The thermodynamical characterization would be of major emphasis in the proposed experiments. Finally, a theoretical framework to describe the fundamental principles that govern the performance of topical products will be developed. In aim 2, we propose to develop novel tools and methods to characterize the microstructural attributes of topical products. One of the objectives is to modify the standard conventional methods and validate them for application across broad categories of topical products. Novel methods will also be developed to understand the differences in microstructure and thermodynamic characteristic between products of different compositions. In aim 3, To identify the potential failure modes in nonQ1 and/or non-Q2 products and to investigate the approaches to mitigate the risk. Potential failure modes would be assessed in individual case studies, proposed in this project, and potential approaches to mitigate the risk would be explored as well. The successful completion of the proposed studies, is believed to generate information that would be used to develop a theoretical framework to describe the fundamental principles that govern the performance of topical products.