Formulation Development
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FORMULATION DEVELOPMENT: FROM CONCEPT TO PRECLINIC
Customized Pathways for Topical and Transdermal Success
Tioga Research offers end-to-end formulation development services tailored to each API and project objective. Whether your goal is rapid prototype generation, lifecycle management, or IND-enabling formulations, our team applies a science-first, data-rich approach grounded in both creativity and control.
Our Development Workflow Includes:
Concept Assessment:
Evaluation of commercial and technical feasibility
Target Product Profile:
Development of a detailed description of a prospective new drug product, in terms of indication, API nature and strength, formulation format, delivery requirements, development and regulatory paths, competitive products, differentiating benefits, etc.
Preformulation Assessment:
Comprehensive solubility, stability, rheology, and excipient compatibility studies with your molecule
Exploratory Screening:
Rapid testing of penetration enhancers, surfactants, and vehicle systems
Prototype Formulation:
Design and manufacture of semi-solids, foams, and patches
QbD Optimization:
Iterative formulation refinement through design of experiments (DoE) and testing via HTE platforms
Scale-Up Consideration:
Selection of excipients and formats with downstream manufacturing readiness in mind
Specialized Capabilities:
- Enhanced delivery systems
- Stabilization of challenging actives
- Rheological tailoring to meet patient experience or brand aesthetic goals
- Lifecycle optimization for existing products
Regulatory Readiness:
Our formulations are designed with regulatory agencies expectations in mind. We have supported:
- New Chemical Entities (NCEs)
- 505(b)(2) submissions with novel formulation IP
- ANDAs with complex formulation attributes
Our few benefits
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