Parenteral Formulation Platform

Some of the factors our platform will consider are:

Dosage Form Selection

The parenteral formulation platform encompasses various dosage forms, including solutions, suspensions, emulsions, lyophilized powders for reconstitution, and lipid-based formulations (e.g., liposomes, nanoemulsions). The selection of the dosage form depends on factors such as drug properties, route of administration, stability requirements, and intended therapeutic effect.

Sterility Assurance

Parenteral formulations are typically manufactured under aseptic conditions. Ensuring sterility is paramount in parenteral formulation development to prevent microbial contamination and minimize the risk of infection in patients.

pH and Buffering

Parenteral formulations often require adjustment of pH and buffering to maintain drug stability and compatibility with physiological pH. Buffer systems such as phosphate buffers, citrate buffers, or acetate buffers may be used to maintain the desired pH range and prevent pH changes during storage.

Container Closure Systems

Selection of appropriate container closure systems is critical in parenteral formulation development to maintain product sterility, stability, and compatibility with the intended route of administration. Container closure systems may include vials, ampoules, prefilled syringes, infusion bags, or dual-chamber systems.

Regulatory Compliance

Parenteral formulations must comply with regulatory requirements set forth by government agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), or other relevant regulatory authorities.