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Preformulation Services
API Characterization
Serán’s pre-formulation assessment begins with an in-depth understanding of our client's API and project goals and timelines, right from the start. We use a science-first approach to conduct detailed research into your molecule and state-of-the-art technologies enable us to develop optimized formulations, processes, and analytical methods for your project. We leverage a full suite of analytical capabilities and modeling tools to assess your API with a drug product mindset.
Early-Phase Formulation Optimization Accelerates and De-Risks Development Right from the Start
We first characterize the API’s physical characteristics and solution behavior, allowing us to rationally select optimal approaches and customize development plans to holistically evaluate formulations and select leads that balance performance, processability, and stability.
Serán’s team of chemists and engineers characterizes API solid-state properties and solubilities in work plans customized to meet each program's unique needs. Our Analytical team collects data that can be leveraged with our bio-performance model to identify opportunities and risks for drug product development using only milligram quantities of API.
Capabilities
- Experts in formulation science for pre-clinical and clinical products
- API Characterization
- mDSC, PXRD, SEM
- Particle size and morphology
- Solubility screening
- Dissolution studies (biorelevant dissolution, IDR)
- Multifactorial stability screening
- Preclinical formulation development (discovery, efficacy, toxicology)
- GLP toxicology formulation development & supplies
- Material sparing, rapid prototype screening for drug product intermediate and drug product
- Technology selection for enabled formulations (spray drying, hot melt extrusion, lipid/SEDDS, particle size reduction)
- Pediatric formulation development
- Modified release / Controlled release formulation development
- Fit for purpose analytical method development
- Oral solid dosage form development
- Tablets – IR, MR/CR, cosmetic or functional coatings, bilayer, fixed-dose combinations
- Capsules
- Multiparticulates – fluid bed coating
Technologies
- Oral solid dosage forms (tablets, mini-tablets, capsules, multiparticulates)
- Oral solutions / suspensions (pre-clinical & clinical)
- Spray drying
- Hot Melt Extrusion
- Tablet compression
- Direct blend, dry granulation / roller compaction, wet granulation
- Film coating (cosmetic or functional)
- Fluid bed coating
- Capsule filling
- Pediatric dose forms
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