Pharmaceutical Sciences | Research and Development
Formulation of Drug Product
MRIGlobal offers a complete array of capabilities including analytical, pre-formulation, formulation development, and drug product manufacturing services.
Good formulation development focuses on delivering sound clinical trial material to the customer. It starts in the pre-formulation phase with physical and chemical characterization of the API. Once formulation development is underway, stability testing and repository services are key. MRIGlobal offers robust capabilities in this area, including ICH stability testing; full-service controlled, validated, GMP-compliant, and monitored storage environments; and supply chain management.
MRIGlobal’s pre-formulation testing of API typically includes the determination of solid-state and physical properties using analysis by polarized light microscopy and morphology by microscope or particle sizing. We also offer extensive chemical analysis techniques, such as mass spectrometry (MS, AA, ICP, IR, UV, and NMR), chromatography (TLC, GC, , HPLC, CE, HPLC/GPC, GC/MS, and LC/MS), and electrochemical and colorimetric titrations. Physical testing includes a range of assessments:
- Weight variation
- Fill volume
- Tablet friability
MRIGlobal tests the intrinsic stability of formulations in pharmaceutical solvents. We check dissolution as a function of particle size, solubility, and stability in solvents commonly used in formulation and analytical testing.
MRIGlobal maintains a repository management GMP facility with 10,000 ft2 dedicated to pharmaceuticals storage. Our full repository services (receipt, test, store, aliquot, ship) include on-site licensed drug distribution, analytical support (such as ICH stability testing), worldwide distribution, and cold chain management. We also offer packaging, labeling, storage, shipment, and tracking services, and provide CoA, synthesis material, and FDA submission support for government and commercial clients.
MRIGlobal’s drug product development team includes accomplished PhD scientists who present their published research at scientific meetings.
Learn more about our scientist, Jon White, PhD, and his work through his poster on Formulation Development, cGMP Manufacturing and Characterization of a Novel
Transdermal Formulation for E/Z-Endoxifen.
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MRIGlobal looks forward to contributing our expertise where it matters most.
Use our Project Quote Tool to see if MRIGlobal can help advance your next project.