Pharmaceutical Development - Late Phase

Source: Almac Group
Pharmaceutical Development - Late Phase

Specialising in solid oral dosage forms, Almac has the technical experience and knowledge to develop robust formulations and manufacturing processes.

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:

Matrix Systems

  • Insoluble / swellable
  • Eroding matrix
  • Hydrogels

Coating Systems

  • 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.