We have assisted many of our clients in the development of both immediate and modified release formulations, for their late stage clinical trials, registration batch manufacturing and commercial launches. Our expertise covers the development of the following dosage forms:
- Immediate and modified release capsules
- Immediate and modified release tablets
- Fixed dose combinations
- Powder / granule filled sachets
When developing modified release dosage forms, we often employ one of the following approaches to achieve the desired release profile:
- Insoluble / swellable
- Eroding matrix
- Coated pellets
- Coated tablets
- pH Sensitive coatings
Our manufacturing technologies and processing scales range from hundreds of grams for small-scale process investigation studies to hundreds of kilograms for phase III/IV and registration batches.
We understand that the best way to ensure a smooth regulatory review process for an NDA or MAA is to clearly present the results from a well-defined series of experiments. By understanding the parameters that are critical to the quality of the product and the safety of the patient, we build quality into the product from the start, implementing effective control strategies.