Almac Group

Early Phase Pharmaceutical Drug Product Development

Early Phase Pharmaceutical Drug Product Development

Almac’s experienced formulation development scientists can develop a range of oral dose formulations to support your early phase clinical trials.

With both non-GMP and GMP facilities, flexible and efficient solutions are provided to develop a fit-for-purpose formulation and manufacture early phase clinical trial materials.

For phase I First-in-Human (FIH) supplies, we offer a range of solid oral dose solutions:

• Drug in Capsule
• Manual hand filling / capsule boards
• Xcelodose 600S precision powder micro-dosing
• Drug in Bottle
• API / powder in bottle
• Co-solvent screening, instruction for reconstitution & in-use stability
• Conventional solid oral dose presentations
• Manufacturing of prototype tablets, capsules & powders

We have a range of technology available to work with APIs with varying properties:

• Dry blending
• Dry granulation / Roller compaction
• Wet granulation (aqueous and solvent capabilities)
• Encapsulation (Xcelodose)
• Compression
• Coating (aqueous and solvent capabilities)
• Potent processing