Solid Oral Dosage

Early solid dose evaluation, GJC 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.

GJC produces smaller early-phase clinical supplies, and can scale up to larger later-phase trials, and eventual commercial-scale production. GJC 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 Activity

• 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