Newsletter | October 29, 2020

10.29.20 -- Avoiding API Challenges That Can Slow Your Drug's Development

 
The Physical Properties Of An API And Drug Product Performance
 

It is well known that the physical properties of an API are important in selecting the dosage form and designing its formulation to meet the drug product requirements. An integrated approach to product development can help address issues that exist as a result of a mismatch between the API properties and the requirements placed upon the formulated product.

Six API Challenges And How To Avoid Them
 
The challenges for new drugs looking to enter the market are numerous and varied. But many are self-inflicted — especially in small molecule development. A dangerous perception persists that, aside from highly potent APIs, small molecule medications have simple process requirements. Having a solid understanding of the most common API challenges can help to avoid development delays, rework, or outright failure.
Optimize Chemical Synthesis, Formulation In Complex Molecule Development
 

Finding a balance between a complex API, its formulation, and its synthesis requires equipment, knowledge, and processes more extensive than those typically required for traditional drug development. It also calls for collaboration across several teams in order to break down the silos that can interrupt the flow of open and clear communication.

Solutions