Dose Form Development
The amount of work that goes into the development of a dosage form is typically determined by the molecule’s physio-chemical needs, the phase of development, and a company’s corporate goals and objectives. In the earliest phase, it may not be wise to invest a lot of effort. Powder in a bottle or a capsule may be a suitable option, especially when looking for speed to the clinic. However, for poorly soluble molecules and late phase clinical testing, formulation development and more sophisticated dosage forms are often required to ensure scalability, targeted delivery, patient compliance or product differentiation. Every project is unique and requires experience to know which path to take, this is where AustinPx, Pharmaceutics and Manufacturing, comes in. We partner with you to gather and interpret the data needed to make confident decisions at each stage of your molecule’s development.
AustinPx’s dose form development capabilities include:
- Tablets and Capsules
- Bioavailability Enhancement Technologies
- Extended and Targeted Release
- Patient Compliance Strategies (Reduction in Pill Burden)
- Process Development and Optimization
- Scale Up and Validation
Scalability and Process Optimization
As projects approach commercialization, scalability and process optimization are of increasing importance, we can work with you to reduce downstream risk and overcome technical challenges, such as:
- Blend and content uniformity issues
- Cosmetic coating challenges
- Tablet sticking, picking, cracking, etc.
- Scale up of complex formulation processes
- Unexpected or unidentified impurities
Partner with AustinPx to gather and interpret the data needed to make confident decisions. Contact us to discuss your Dosage Form Development needs.