Product Formulation and Development
Precise development services for oral solid dosage forms
Oral Solid Dosage Form Development Services
Our formulation development capabilities are sharply focused on NDA and ANDA oral solid dosage products. Our team will collaborate with you to achieve optimal formulation for your process. We are committed to creating robust processes that provide seamless transition to commercial manufacturing and ultimately to market.
Supporting Clients with:
- Non-clinical safety and pharmacological assessments
- ADME Testing
- Clinical Trials
- NDA/ANDA filing support addition to formulation & process development support
We support clients with a proposal based approach which comes from CMIC’s solid expertise and well established experiences/know-hows to introduce high quality products. We have small non-GMP equipment in R&D suite for development work, and our experienced formulation scientists support your formulation design and process development. We believe analysis is an essential ingredient for success as a part of development works and tech transfer activities. CMIC offers a full range of testing services and expertise from development of test methods during the early phases through validation support for product release. We also offer a full spectrum of stability studies.
Capabilities
- Formulation design and process design for oral solid dosage forms such as powders, granules, tablets, coated tablets, and double-layered tablets
- Design of functional formulations such as sustained-release formulations, taste-masking and OD tablets through the drug layering, particle size control and coating
Our Approach
- Fit-for-Purpose Early Phase Formulation: GMP Supply for an API-in-Bottle formulation (Suspension) and matching placebo with a validated standard procedure for reconstitution at clinic
- Development of generic products: Support formulation development, scale up, and tech-transfer for generic products with in-vitro equivalency
- Best formulation/process composition through DOE
Case Studies
- Contributed to the development work of investigational drugs, product launch in the United States, and stable commercial operation through well designed formulation and process development works for double-layer tablet formulations.
- Formulation design projects including the early stage to the late stage by our clients, and we are happy to navigate smooth product launch
- Establishment of cross-functional teams, assigning well experienced project managers to lead projects for each customer’s projects and timelines
Your Molecule. Our Mission
