Drug Product R&D and Manufacturing

Avista Pharma Solutions has an experienced and reliable, full-service drug product team that can support preformulation, formulation and early- to late-phase Drug Product manufacturing. We have extensive experience in selecting the appropriate formulation technology based on physiochemical properties, drug metabolism and pharmacokinetic data.

 

Avista Pharma has a core strength in improving oral bioavailability of poorly soluble compounds through solubility and/or rate of diffusion using particle size reduction, cyclodextrins, pH adjustments, solvents, emulsions, microemulsions, spray dried dispersions and combinations of these technologies. Our experience includes preformulation, GLP toxicology studies and First-in-Human (FIH) formulation selection/manufacturing for over 21 compounds that have progressed into human clinical trials. We have successfully formulated compounds with particular challenges such as food effects, pH solubility dependence (e.g. proton pump inhibitors in humans) and poor solubility. The best-in-class pharmaceutics groups is also experienced in pharmacy compounding and pediatric formulation development. Our current GMP capabilities allow us to Support Phase I/II manufacturing & packaging of clinical supplies and pilot-scale support of technology transfer for tablets, capsules and parenteral formulations to Qualified Commercial Manufacturers for later stage products.