ORAL DOSAGE FORMS

Ascendia manufactures cGMP clinical batches of both tablet and capsule dosage forms for early-stage clinical studies. For solid dosage formulation, we have the capability to granulate, blend, and roller compact to make tablet batches for immediate release and modified release applications. We have a R&D-scale tablet press suitable for small batch sizes, and can fill capsules if required. All manufacturing operations are conducted in a qualified ISO 7 cleanroom.

Our equipment for manufacturing solid dosage forms includes:

• Glatt GPCG1 Fluid Bed
• Qualicap Liquid Capsule Filling Machine F-40
• Qualicap Capsule Banding Machine: S-100
• Netzsch Wet Milling Machine: DeltaVita 300 and DeltaVita 60,000
• Buchi 295 Spray Dryer
• Freund-Vector Fluid Bed Granulators (4 liter and 45 liter)
• Vector & O’Hara Labcoat IIX Coating Pans
• Manesty 16-station Betapress and BB4 bi-layer Tablet Presses
• Piccola Tablet Press
• Glatt-Powrex High Shear Granulation
• Key & Niro High Shear Granulation
• Quadro Comils
• V-shaped blending (8 quart, 16 quart, 1 cubic foot, and 3 cubic foot)
• Bench-top and Floor-scale electronic balances