Poorly soluble molecules in the pipeline can have a negative effect on your active pharmaceutical ingredient (API). From wasting the active or even having to double the API for the necessary patient absorption to take place, creating a formulation with a high solubility tolerance and the ability to reach the patient’s body is a crucial aspect of getting your drug to market faster.
To determine the type of solubility for each particle, the Biopharmaceutics Classification System (BCS) typifies a drug with its corresponding absorption rate. However, many belong to Class II, which translates to a formulation that exhibits poor solubility and high permeability. Poorly soluble drugs are less bioavailable and often need to be doctored during the formulation manufacturing process.
According to a Capsugel ebook, Perspectives on Overcoming Bioavailability Challenges, the company’s Head of Biotherapeutics, David Lyon, states: “Candidate molecules are increasingly complex, and target product profiles [are] increasingly specialised, leading to the need for enabling delivery technologies.”1 As such, for molecules to become more bioavailable, they often need to be modified. The process of increasing bioavailability, from the technology employed to the process and methods, is often dependent on outsourcing. This outsourcing will wind up with a contract development and manufacturing organisation (CDMO), although these organisations vary tremendously both in capability, size, structure, capacity and internal values.
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