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Pitfalls in 制定发展 and How to Overcome Them 

T在这里 are several potential pitfalls in finished product development that, 通过丰富的经验, SGS Quay Pharma have generated a robust risk mitigation strategy that is imbedded in our development, manufacturing and quality processes.

风险 1: Insufficient characterisation of the active pharmaceutical ingredient (API)

Potential Impact: Can lead to manufacturing issues, poor 稳定 and bioavailability of the API in the final formulation.

风险 Mitigation: Thoroughly characterising the physicochemical properties of your key starting materials, API, and excipients are vital to ensure effective and efficient decision-making during development. These decisions can impact the route of administration, 配方设计, processing equipment and associated processing parameters, final packaging materials and mitigation of environmental conditions. Adequate quantitative and qualitative testing methods provide characteristic data to inform the drug product development process. 没有这些知识, t在这里 can be a significant impact on dosage form efficacy, long-term drug performance and delays to project timings. If you want to learn more about SGS’s Physical & Spectroscopic Characterisation, such as XRPD, TGA/DSC and PSD, click 在这里.

风险 2: Failure to consider the intended route of administration

Potential Impact: Effects on the API’s solubility, 稳定, and ability to formulate an effective dose form.

风险 Mitigation: Carefully consider the intended route of administration and its effects on the API’s 稳定 and solubility and select appropriate excipients accordingly. SGS Quay Pharma provide cost-effective screening platforms using solvents, 表面活性剂, and other excipients tailored to each API, considering key aspects such as indication, route of administration and intended species. We manufacture small lab-scale batches for supply to PK evaluation for determination of toxicological profile.

风险 3: Inadequate testing of the API’s 稳定 and compatibility with other ingredients

Potential Impact: Can lead to excipient interactions or degradation of the API

风险 Mitigation: Thoroughly testing the API’s 稳定 and compatibility with other formulation ingredients via excipient compatibility, forced degradation studies and accelerated 稳定 testing. Our work is supported by access to the latest technologies, and all prototype formulations are subject to in-depth screening and 稳定 evaluation in a non-GMP environment.

风险 4: 缺乏法规遵从性

Potential Impact: Can lead to delays or rejection of the formulation during the approval process

风险 Mitigation: Ensuring regulatory compliance by following current good manufacturing practices (cGMPs), 配方设计 in compliance with currently available guidelines (e.g., ICH, FDA, EMEA) and consulting with regulatory authorities as needed (FDA, MHRA).

风险 5: Failure to consider manufacture processing and scale-up aspects

Potential Impact: Can lead to variations in the final product and potential safety risks

风险 Mitigation: Using a Quality by Design (QbD) approach during the development stage minimises risk, improves quality and looks to increase efficiency. With advanced facilities and in-house analytics, we provide a framework to enable efficient scale-up of products for 临床生产 第一阶段过后. 在开发阶段, we will work to assess an appropriate scale for 临床生产 and make recommendations on process development strategies. Performing robust process validation to ensure consistency and quality of the final product is vital when reaching the later stages of development before commercialisation.

风险 6: Inadequate packaging and storage conditions

Potential Impact: Can lead to in稳定 and degradation of the API. Failure to consider the packaging suitability can lead to overprocessing during clinical trials and poor patient compliance.

风险 Mitigation: Selecting appropriate packaging that considers the end patient population, 试验地点物流, and the commercial product goal is key. Appropriate selection of storage conditions ensures representative 稳定 data on the product, increasing clinical supplies’ longevity.

To successfully overcome these potential impacts, it’s essential to have a well-structured and iterative formulation development process that involves a multidisciplinary team, 健壮的测试和文档, and a proactive approach to problem-solving.

联系 our experts now to learn more about our formulation development expertise.