Drug Product

Solid Oral Dosage

Asymchem Drug Product Solid Oral Dosage

Developing and Optimizing Successful Formulations

From initial API characterization and early solid dose evaluation, Asymchem covers all the bases. We use QbD and DOE to develop and optimize formulations and solid dosage forms for robust manufacturing, with an eye towards eventual NDA filing and process validation. Thorough product knowledge and understanding is the goal.

Asymchem produces smaller early-phase clinical supplies, and can scale up to larger later-phase trials, and eventual commercial-scale production. Asymchem offers full validation support, and has much experience with technology transfers, if client decides to transfer commercial production elsewhere.

  • Chemical characterization of dosage forms, including impurities, stability, excipient compatibility
  • Physical characterization/development of solid bulk properties—particle size, density, flowability, compressibility—for robust downstream processing
  • Tablet development, including multiple dosage sizes, sustained release, enteric coatings; and characterization, including hardness, friability, and dissolution profiling
  • Formulation development for poorly soluble APIs, and spray-drying and micronization  capabilities to improve solubility

Production Capacity

  • Dry granulation
  • Wet granulation
  • Spray drying
  • Compression
  • Film coating and enteric coating
  • Encapsulation
  • Sachet package of granule
  • Bottle and blister package of tablet and capsule
  • Secondary packaging and labeling
  • Can handle low OEL compound
  • Up to 1.2M units per batch