Topical 产品 发展 and Clinical-Stage 制造业

im体育APP is a recognized world leader in the design, development and clinical manufacturing of robust topical drug products with an extensive range of therapeutic indications containing small molecules in addition to peptides, 蛋白质和寡核苷酸.

im体育APP’s deep bench of scientific and regulatory expertise, 专门的实验室, well-equipped clinical trial manufacturing facilities, and deep-rooted commitment to 质量 and compliance support the entire topical drug product development and production process. Our team of highly skilled formulators are experienced in overcoming the challenges and issues unique to the development of complex topical formulations. The successful development of physically and chemically stable topical formulations with optimal penetration requires an in-depth understanding of physiochemical properties, 包括释放特性, 给药系统的组成, 以及药物运载工具的性质.

除了促进患者的依从性, 局部产品提供广泛的好处, including ease of delivery and the ability to avoid the problem of first-pass metabolism. When it’s impractical or too costly to formulate topical products in-house, im体育APP has the advanced instrumentation and skilled team needed to develop and manufacture even the most complicated topical formulations in a variety of dosage forms, 包括凝胶, 面霜, 乳液, 药膏, 栓剂, 乳剂, 液体和其他半固体形式.

im体育APP’s Quality by Design (QbD) approach to topical product development

im体育APP’s topical product development laboratory offers comprehensive support for various regulatory pathways, 包括在研新药(IND), 新药申请(NDA), 和简略新药申请(ANDA), 建立在设计质量(QbD)原则之上. The use of a QbD approach is strongly encouraged by the FDA, and the Agency now looks for QbD components in regulatory submissions. Using a QbD approach to create a Design of Experiments (DoE) determines the design space for manufacturing a product. Having a wider design space for process parameters allows for more robust manufacturing that can potentially decrease manufacturing time, 延长产品保质期, 或者提高批次产量.

当采用QbD方法时, an understanding of production processes and manufacturing instrumentation that will be used to develop the final product is brought into the analytical research and development process, 从而获得更高质量的成品. QbD使产品设计形式化, 自动化测试, 简化了故障排除, as an alternative to solely relying on finished product testing. Our consultative team of regulatory and scientific experts help clients not only understand and implement QbD, 同时也加快了上市速度, 帮助公司推出有价值的产品, 安全, and 有效的 topical products in the most reliable and cost-efficient manner.

QbD组件包括:

• 质量目标产品概要(TPP)
• 关键质量属性(cqa)
• 关键工艺参数(CPPs)
• Critical material attributes of drug and excipients
• 控制策略
• Define the 有效的 design space of testing methods as well as manufacturing processes

Topical drug development and clinical manufacturing services

• Target product profile (TPP) development and support
• Pre-formulation studies (excipient compatibility, solubility, pH profile)
• 铅配方选择
• 原型配方设计与开发
• Topical product design and formulation development
• Novel formulation development or existing formulation optimization
• Process development, including identification and optimization of critical process parameters (CPPs)
• Process validation and process performance qualification (PPQ) batches
• 分析和微生物学的发展
• 在制品和成品放行测试
• R&D和ICH稳定性研究
• 包装 and container/closure compatibility and integrity testing
• IVRT (in vitro release testing) and IVPT (in vitro permeation) studies
• Lab-scale, pilot, and clinical trial material manufacturing
• 新产品的试运行
• 包装和标签
• 技术转让和扩大规模支持
• 发展 of technical and regulatory documentation

加工生产能力

• 受管制物质(附表I-V)
• 高低剪切均质化
• 半自动小瓶，瓶子和管子灌装
• 温度控制
• 变速混合
• 双面搅拌
• 混合和造粒
• cGMP批量(1 ~ 20l)

im体育APP优势

im体育APP’s industry-leading team of formulators continually tackle highly complex and challenging projects, 包括外用凝胶的配方, 面霜, 乳剂, 泡沫和喷雾剂. A multitude of factors can influence the stability and efficacy of semisolid and topical formulations, 包括混合方法, 温度, time, 热和冷却速率. Our laboratories are outfitted with equipment that enables us to exercise precise control over these factors, allowing us to develop optimal manufacturing processes. 另外, some active pharmaceutical ingredients (APIs) can be compromised by environmental factors, 包括紫外线和氧气. im体育APP’s scientists have the technical expertise to develop 安全, 有效的, and stable topical formulations that circumvent potential degradation challenges.

Whether you plan to formulate an entirely new topical product or just need to streamline your current production process, 元件具有较深的台架强度, 技术广度, 和经验的帮助. For more information about im体育APP’s topical product development services or to request a quote, im体育APP 今天.