Customized Pharmaceutical Membranes for Fine Crystal Size Control

用于精细晶体尺寸控制的定制制药膜

• 批准号: 7925394
• 负责人: Praveen Babu Kosaraju
• 金额: $ 19.69万
• 依托单位: COMPACT MEMBRANE SYSTEMS, INC.
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-06-01 至 2012-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7925394
• 关键词: Address; Aspirin; Assimilations; Biological Availability; Characteristics; Coupled; Crystallization; Development; Drug Addiction; Drug Delivery Systems; Drug Formulations; Drug Industry; Ensure; Excision; Filtration; Flufenamic Acid; Gases; Human body; Lead; Liquid substance; Mefenamic Acid; Membrane; Modeling; Molecular; Particle Size; Pharmaceutical Preparations; Pharmacologic Substance; Phase; Precipitation; Process; Production; Small Business Innovation Research Grant; Solid; Solutions; Solvents; Source; Speed; Staging; Stress; Structure; System; Techniques; Technology; Time; United States Food and Drug Administration; Variant; abstracting; base; chemical stability; cost; evaporation; feeding; improved; large scale production; manufacturing process; meetings; neutrophil; novel; operation; physical property; programs; public health relevance; small molecule

DESCRIPTION (provided by applicant): Project Summary/Abstract The objective of this program is to build a platform technology based on developing membrane-crystallization technology to produce crystals of active pharmaceutical ingredients in which the crystal size and crystal form polymorph or pseudo-polymorph are controlled. Control of crystal size within a narrow range is an important part of pharmaceutical crystallization, as is the ability to ensure that the desired crystal form (polymorph) is produced at all times. This proposal addresses this general manufacturing need for control of crystal size and crystal size distribution, employing crystallization of model solids by solvent removal in a membrane permeator. Compact Membrane Systems has a number of projects and established products in removing small molecules from liquids and gases through these membranes. The unique principle of solvent removal proposed herein will lead to the development of a new platform for CMS membrane capabilities. Such a platform would help to advance the technology for the reliable and reproducible production of pharmaceutical crystalline ingredients and, thereby, assist in the overall effort to improve the process analytical technology sought by the Food and Drug Administration. The advanced level of control offered by our membrane technique, coupled with a tailored, narrow crystal size distribution, has the potential to impact the pharmaceutical industry greatly where broad size distributions lead to the need for excessive post-precipitation processing, such as milling and sieving to reject over- and under-sized crystals. The purpose of this SBIR Phase I project is the demonstration of this technology that can be applied successfully to a large number of processes and products that involve crystalline solids. In pharmaceutical manufacturing, control of particle size and size distribution is paramount for uniform drug delivery and assimilation ("bioequivalency") within the human body. PUBLIC HEALTH RELEVANCE: Project Narrative A pharmaceutical product with more consistent drug delivery and with better bio-equivalency will result from the development of the membrane reactor. The drug manufacturing process will also be simplified by eliminating unnecessary process steps related to particle size qualification.

描述（由申请人提供）： 项目摘要/摘要该程序的目的是建立一种基于开发膜结晶技术的平台技术，以生产活跃的药物成分的晶体，其中控制晶体尺寸和晶体形式多晶型或伪型孔形成。在狭窄范围内对晶体大小的控制是药物结晶的重要组成部分，并且能够始终产生所需的晶体形式（多晶型物）。该提案解决了对控制晶体尺寸和晶体尺寸分布的一般制造的需求，并通过在膜渗透器中的溶剂去除对模型固体进行了结晶。紧凑型膜系统有许多项目和已建立的产品，可以通过这些膜从液体和气体中去除小分子。本文提出的溶剂去除的独特原则将导致开发新的CMS膜功能平台。这样的平台将有助于推进该技术的可靠生产药物结晶成分，从而帮助改善食品药品监督管理局所寻求的过程分析技术的总体努力。我们的膜技术提供的高级控制水平，再加上量身定制的狭窄晶体尺寸分布，有可能影响制药行业，在大大尺寸的分布中，需要过多的后沉淀处理，例如铣削和筛分，拒绝过度和尺寸不足的晶体。该SBIR I期项目的目的是该技术的演示，可以成功应用于涉及晶体固体的大量工艺和产品。在药品制造中，控制粒度和尺寸分布对于人体内部药物递送和同化（“生物等效性”）至关重要。 公共卫生相关性： 项目叙事是由膜反应器的发展产生的，具有更一致的药物和更好的生物等效性的药品。药物制造过程还将通过消除与粒度资格有关的不必要的过程步骤来简化。