Pharmaceutical Formulation Development
Unmatched formulation development expertise to accelerate
your drug development program.
Formulation development is at the heart of drug development
Formulation development is the science of developing a stable pharmaceutical product or dosage form that delivers the drug or active pharmaceutical ingredient (API) at the right concentration to the site of action in the human body. To achieve this, the formulation scientist can develop the drug as an oral solid dosage form (OSD), oral liquid formulation, topical formulation, ophthalmic formulation, or an injectable formulation, which are suitable for either cGMP clinical trial manufacturing or commercial manufacturing.
Why is it important to choose the right formulation development team?
To avoid costly delays and failure.
Formulation development encompasses many disciplines within pharmaceutical sciences:
- Chemical and material properties of the drug molecule and drug delivery systems must be considered to ensure regulatory compliance, stability, and proper drug release kinetics. Suitable inactive ingredients (excipients) and manufacturing process are then carefully considered and developed to ensure successful formulation development.
- Clinical pharmacokinetic requirements and drug delivery system mechanisms are crucial to achieve the required clinical goal. Drug molecules often have poor solubility, poor permeability, undergo first pass metabolism, or are unstable in gastrointestinal environments leading to poor bioavailability. The formulation scientist must be knowledgeable in bioavailability enhancement techniques to ensure that the drug successfully reaches the site of action to provide clinical benefit to the patient.
- When developing drugs for regulated markets, understanding regulatory requirements is important to avoid costly delays in both clinical and commercial drug development programs. At Vici, we are well-versed in FDA requirements and are able to work with the Agency to ensure that your clinical program is not hampered by FDA compliance related delays.
Dosage Form Development & Manufacturing
Our expertise across dosage forms includes capabilities for:
