We are a product-focused formulation company and use a range of approaches to address challenges in classic injectable formulations. In addition to experience with formulation, analysis, and stabilization of traditional aqueous solutions, CMC has the expertise for:
We have specialized strength in NCE and repurposed drugs with high potency, low solubility, poor stability, or that may require segregation from other manufacturing operations such as beta-lactams, cytotoxics, and hormones.
Biodegradable polymers are well known in drug delivery, particularly in microspheres. CMC uses these materials as an additive to our stable drug-organic vehicle formulations. The polymer gels upon injection and drug release is prolonged by diffusion from the in-situ gel followed by polymer degradation. We have experience in vehicle and polymer selection to tailor release kinetics from days to months.
For aqueous formulations, prolonged release can be accomplished by the addition of an appropriate polymer. Often these are relatively high viscosity but undergo significant shear thinning. They can be injected with standard syringes and need to accomplish delivery from days to weeks.
CMC utilizes, when possible, excipients in the FDA inactive ingredient database that are found in both commercial and FDA-approved products. They are widely accepted in the pharma and biotech industries. These include excipients to solubilize such as complexing agents, surfactants, and solvents. They also include excipients to stabilize such as antioxidants and buffers. Finally, they can provide a formulation or drug delivery. Examples of this include polymers, lipids, carriers, binders, and disintegrants.
We use our stable organic vehicle formulations and add very hydrophobic low molecular weight materials to obtain delivery from days to weeks.
We can match drug properties to appropriate hydrophobic injection vehicles for a widely accepted long acting injectable approach.
CMC scientists also have experience with fabricating and testing non-degradable polymeric implants for controlled release applications.