CMC Pharma uses proven approaches to develop long acting drug product formulations. We are specialists with extensive experience in formulation and analytical development of competing technologies that are appropriate for drug compounds with varying characteristics. CMC Pharma selects the best approaches to evaluate in vitro and in vivo.
Biodegradable polymers are well known in drug delivery, particularly in microspheres. CMC Pharma 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 and can be injected with standard syringes and needs to accomplish delivery from days to weeks.
We use our stable organic vehicle formulations and add very hydrophobic low molecular weight materials to obtain delivery from days to weeks.
CMC Pharma scientists also have experience with fabricating and testing non-degradable polymeric implants for controlled release applications.
We can match drug properties to appropriate hydrophobic injection vehicles for a widely accepted long acting injectable approach.
CMC Pharma utilizes, when possible, excipients in the FDA inactive ingredient database that are found in commercial, FDA-approved products and are widely accepted in the pharma and biotech industries. These include excipients to solubilize (complexing agents, surfactants, solvents, etc.), stabilize (antioxidants, buffers etc.), or provide a formulation or drug delivery function (polymers, lipids, carriers, binders & disintegrants, etc.)
