Anyuan fully understands that preformulation and formulation development activities are critical to the success of your drug candidate. We provide full range of service modules of formulation/product development services to meet your needs at various R&D stages. The service modules include drug discovery support, preformulation, formulation and process development, analytical development, stability testing and IND/CTA filings. The integration of these services helps to move your drug candidates quickly and seamlessly from concept to regulatory filings.

Our preformulation group is skilled in a wide range of analytical approaches to choose the correct form of your drug substance, evaluate its physical properties, and generate a thorough understanding of the material's stability under various conditions, leading to the optimal downstream formulation and product development.

Our formulation group is highly experienced in developing most conventional solid and liquid dosage forms and novel formulations, drug delivery systems (e.g. sustained/controlled release, water insoluble drug formulations, etc.).

Drug discovery support
• Physical-chemical evaluation of selected chemical leads to enable the selection of optimal development candidates;
• Microscale drug characterization and evaluation;
• Exposure-enhancing formulations for activity/efficacy, pharmacokinetics and toxicology evaluations;
• Drug developability assessment.

Preformulation study
• Physical pharmacy profiling: pH-solubility, pH-stability, solubility in lipids, surfactants/polymers, partition coefficient (logP, logD), solid state characterization, solid state stability, solution stability;
• Dissolution and intrinsic dissolution rate;
• Polymorph form screening and selection;
• Salt form screening and selection;
• Early formulations for PK, PD and toxicological evaluation;
• Powder characterization: compactability, process induced form conversion, flow, particle size evaluation and specification recommendation;
• Drug excipient compatibility.

Formulation and product development
• Formulation screening using stability, dissolution and animal PK;
• Process selection based on physicochemical and physical properties of the drug candidate;
• Scale up process design and optimization;
• Establish product specifications based on pre-formulation and formulation data;
• Multimedia dissolution testing and dissolution method development;
• Packaging, storage and shipping conditions evaluation and selection;
• Technology transfer of formulation and manufacturing process to clinical supply manufacturing sites;
• CMC package for IND/NDA/ANDA filing documents;