Dosage Formulation
- Majority of dosage forms (tablets, powder or liquid-filled capsules, injectables, granules, etc)
- Feasibility studies for the development of dosage forms of an active entity
- Pre-formulation excipients compatibility studies
- Formulation development for new chemical entities, generics, biologics and controlled substances
- Immediate or modified release dosage forms (gastric protection, sublingual, effervescent, delayed release)
- Formulation patent extension
- Evaluation of formulations (content and weight uniformity, dissolution testing, stability, flow, compression, hardness, disintegration and friability testing, bulk and tap density testing)
- Process development (direct compression, dry and wet granulation, encapsulation, coatings)
- Determination of the critical manufacturing steps and parameters
- Creation and justification of the finished product specifications
- Manufacture of R&D batches for reduced development times
- Transfer of products and processes for large scale manufacture
- Manufacture of clinical batches
Please see our Pharmaceutical Development brochure for more details or Contact Us.
