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Pitfalls in Formulation Development and How to Overcome Them 

There are several potential pitfalls in finished product development that, through extensive experience, SGS Quay Pharma have generated a robust risk mitigation strategy that is imbedded in our development, manufacturing and quality processes.

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

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

Risk 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, formulation design, 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. Without this knowledge, there 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 here.

Risk 2: Failure to consider the intended route of administration

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

Risk Mitigation: Carefully consider the intended route of administration and its effects on the API’s stability and solubility and select appropriate excipients accordingly. SGS Quay Pharma provide cost-effective screening platforms using solvents, surfactants, 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.

Risk 3: Inadequate testing of the API’s stability and compatibility with other ingredients

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

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

Risk 4: Lack of regulatory compliance

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

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

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

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

Risk 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 clinical manufacturing beyond phase I. During the development stages, we will work to assess an appropriate scale for clinical manufacturing 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.

Risk 6: Inadequate packaging and storage conditions

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

Risk Mitigation: Selecting appropriate packaging that considers the end patient population, trial location logistics, and the commercial product goal is key. Appropriate selection of storage conditions ensures representative stability 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, robust testing and documentation, and a proactive approach to problem-solving.

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