Pharmacetucal Development

Formulation development

  1. Tagen pharmaceuticals provide pre-formulation evaluation and formulation development services for conventional oral solids, semi-solids and liquids as well as products requiring dedicated containment such as:
  2. Hormones (oral and topical)
  3. Antibiotics (oral) including penicillins and cephalosporins
  4. Controlled drugs
    1. Pre-formulation evaluation services include:
    2. pKa determination
    3. Partition coefficient
    4. Chemical stability profile
    5. Solubility determination
    6. Crystal properties and polymorphism (DSC, XRPD)
    7. * Particle size, shape and surface area

Formulation development capabilities include:

  1. Clinical Batch Manufacture
  2. Manufacturing of IMPs (solids, semi-solids and liquids) and matching placebos
  3. De-blistering and de-packaging of medication
  4. Blinding / manufacturing of capsules (semi-automatically)
  5. Over-encapsulation (capsule sizes: 5 – 000 and E – AAA)
  6. Single tablet / capsule in a capsule
  7. 1/2 tablet in a capsule
  8. Multiple tablets / capsules in a capsule
  9. Blinding / manufacturing of capsules (automatically) with Modu-C capsule filling machine
  10. Available Modu-C filling stations
  11. Dosator for powder / granules
  12. Pellet dosing by volumetric principle starting at a dosing range of > 50 mg.
  13. Format-free tablet / capsule dosing
  14. Micro tablet dosing with 100 % camera control system on shape, colour of micro tablets
  15. Further filling stations available on request
  16. 100% online and offline weight and tare / gross weight check

Scale up and process validation

Tagen pharmaceuticals offers pharmaceutical formulation development and subsequent scale-up services to ensure safe routine production at commercial scale.

Batch sizes are adapted to meet customers' requirements. For each production step, qualified equipment is available in the relevant dimensions to support the processing across a range of batch sizes, providing customers with a consistent and reliable scale-up service.

Process validation, including complete documentation, is performed on the first product batches and according to customer requirements. Validation will qualify the manufacturing process in respect of product conformity with specifications.

  1. At pilot and commercial scale, dedicated containment areas enable us to handle specific product types, including:
  2. Hormones (oral and topical)
  3. Steroids (oral and topical)
  4. Antibiotics (oral), including penicillins and cephalosporins
  5. Controlled drugs