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

项目总结/摘要 该项目的主要目的是调查局部产品成分差异对 物理、结构和功能特性。另一个目标是开发额外的、特定的产品 表征工具和方法，以探索结构和热力学变化，发生在 局部产品的变态。由于BE的失效模式风险相对较高， 不同的产品，有必要系统地调查潜在的故障模式和方法， 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 系统的成分变化，对显微结构特征，变态，和性能 局部产品的属性。发展一个理论框架来描述支配 局部剂型性能。将制定不同的案例研究，以考虑各种产品， 复杂程度不同。不同的产品类型，如溶液，胶体产品，凝胶，悬浮液， 乳膏、微乳液、泡沫和纳米技术产品将被考虑。在每种情况下， 将通过系统地改变产品成分来制备产品。一些方法（不限于 a）改变一种或多种成分的量，或B）通过 用相同化学类别/药物的成分替换一种或多种成分 c）使用不同等级/质量/来源的成分。化学表征 将是拟议实验的重点。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。之一 目的是修改标准的传统方法，并验证它们在广泛的应用。 局部产品的类别。还将开发新的方法来了解 不同成分产物的微观结构和热力学特性。目标3： 识别非Q1和/或非Q2产品中的潜在失效模式，并研究 降低风险。潜在的故障模式将在本项目提出的个别案例研究中进行评估， 还将探讨减轻风险的可能办法。 据信，拟议研究的成功完成将产生可用于以下方面的信息： 制定一个理论框架来描述管理主题性能的基本原则， 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.