Speed and Simplicity – A Formulator’s Best Friend in Development
From core to coating, there is a lot to consider when it comes to developing and optimizing a solid dosage formulation. Simple best practices can offer an edge that allows formulators to reduce potential problems that could occur in later stage commercial manufacturing.
Jayesh Parmar |
sponsored by Colorcon
Formulators are faced with many choices during the early phase of development, and they must focus on the project milestones they need to deliver. Examining formulation strategy early can deliver key benefits and having an end goal in mind early on leads to greater efficiency, as everyone will understand what they are working towards. Understanding the molecule is the first step, then exploring the needs and options for formulation enables development to progress faster and smoother.
Solubility is one issue that is often encountered with new molecules in development. Many technologies are available to help solubilize an API; however, if a robust formulation and process is not developed then it can impact the subsequent manufacturing of a consistent product. Using the right technology and choice of excipients, it’s possible to develop a stable formulation with reduced complexity. Partnership with key suppliers of ingredients and equipment is critical during development phase. For example, formulators need to ensure that the process parameters for equipment used during development are transferrable to commercial-scale equipment. Similarly, formulators should partner with suppliers before putting in place any particular specifications for ingredients; thus avoiding future supply issues.
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