Early formulation development is a critical stage in the drug development process, bridging the gap between the discovery of small molecule candidates and the development of a final drug product. Creative Bioarray offers end-to-end formulation development services that tackle challenges related to solubility, stability, and bioavailability at the earliest stages of development. Our services are customized to suit the specific needs of each project, ensuring a smooth transition from discovery to clinical stages.
Supported Formulation Types
We provide formulation design and optimization across a wide range of dosage forms and delivery systems, including:
Oral Formulations:
- Tablets
- Capsules
- Beads
- Amorphous solid dispersions
- Self-emulsifying systems
- Cyclodextrin complexes
Parenteral Formulations:
- Aqueous and non-aqueous solutions
- Lyophilized powders
- Emulsions
- Long-acting depots
- Microspheres
Specialty Formulations:
- Combination products
- Controlled-release systems
- Nanoparticle and lipid-based formulations…
Formulation Development Services
Our services are designed to provide a holistic approach to early formulation development, covering every aspect from initial design to stability assessment. Key services include:
Formulation Design
We create innovative and effective formulations tailored to your drug's specific properties and therapeutic goals.
Preclinical formulation Development
Extensive solubility, stability and solid state profiling to inform formulation decision-making.
Formulation Optimization
- Solubility Enhancement: Optimization of solubility vehicles/formulations (particle size reduction, surfactants, co-solvents, etc.) to improve absorption.
- Release Kinetic Tuning: Optimization of matrices, coatings, or carriers to achieve desired immediate, sustained, or targeted release profiles.
Stability and Robustness Studies
- Accelerated and Real-Time Stability: Comprehensive storage studies under various temperature/humidity conditions to determine shelf-life and degradation pathways.
- Forced Degradation Studies: Stress testing (light, heat, oxidation, hydrolysis) to characterize the intrinsic stability of the drug product.
- In-Use Stability: Evaluating the stability of the product after reconstitution or preparation for administration.
Analytical Capabilities
Our analytical platform supports the full lifecycle of early formulation development:
- Physicochemical characterization (pKa, LogP, hygroscopicity, polymorphism)
- Solubility and dissolution profiling
- Particle size and morphology analysis
- Content uniformity and assay testing
- Degradation pathway and impurity identification
- Stability-indicating method development and validation
Why Partner with Us
Accelerated Time to Clinic: Quickly and efficiently deliver robust, preclinical-ready formulations, dramatically reducing your time to First-in-Human (FIH).
Expert Risk Mitigation: Using minimum API we screen for and solve difficult bioavailability/stability issues in the preclinical setting.
Integrated Expertise: Connect with an interdisciplinary team and advanced analytical infrastructure to fully characterize your product.
Our customer service representatives are available 24 hours a day, 7 days a week.
Inquiry
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