DETAILS DESCRIPTION
Formulation R&D
- Position :
Gear Pharma’s Formulation research and development services include pre-formulation research, technical transfer, formulation development, and product registration. Through full-range formulation and product development platforms, our team works seamlessly with the Process Development, and Analytical teams to help accelerate your drug candidates quickly from the pre-clinical stage to IND/NDA/ANDA filings.
PRE-FORMULATION AND DISCOVERY SUPPORT
• Solubility, stability, compatibility, logP testing
• Solid form screening and selection
• Physicochemical profiling, drug ability assessment
FORMULATION AND PROCESS DEVELOPMENT
• Formulation screening using stability, dissolution and animal PK
• Process development based on physicochemical and physical properties of drug candidates
• Storage and shipping conditions assessment of drug candidates
• Technology transfer of formulation and manufacturing process to clinical manufacturing sites
• CMC document preparation for IND/NDA/ANDA submission
GENERIC FORMULATION AND PRODUCT DEVELOPMENT
• Patent analyses and bypassing strategies
• Reverse engineering of branded drugs
• Innovative formulation and process development
• Key platform technologies:
• Conventional dosage forms
• Modified release dosage forms
• Poorly soluble drug formulations
FILING DOCUMENT PREPARATION
• CMC document preparation and regulatory support
• CFDA/FDA/EMA/TFDA dossier filling support
• CTD format IND/NDA/ANDA filing support
EQUIPMENT
Rotary tablet press (8 stations, 19 stations)
Bilayer rotary tablet press (14 stations, B/D turret)
High shear vertical granulators (1L ~ 25L)
Fluid bed granulator, dryer and coater (1L ~ 10L)
Extruder and spheronizor
Spray dryer, with solvent recovery unit
Lyophilizer, 0.4 m2 with auto capping
Roller compactor
Quadro Comil
Perforated pan coater (1.5L ~ 8L)
Automatic capsule filler (for solids, liquids and semi-solids) and capsule sealer
Powder X-Ray diffraction (Powder XRD)
Differential Scanning Calorimetry (DSC)
Thermal Gravimetric Analysis (TGA)
Dynamic moisture vapor sorption (DVS)
Polarized microscopy
Dissolution stations with online UV detector, auto-sampler
Ultrasonic Homogenizer
High shear dispersing emulsifier
Moisture analyzer
High speed freezing centrifuge
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