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API Characterization

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. This is the critical first step in developing 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.

Preformulation Services

We first characterize the API’s physical characteristics and solution behavior, allowing us to rationally select optimal approaches and customize development plans to wholistically evaluate formulations and select leads that balance performance, processability, and stability.

Serán’s team of chemists and engineers characterize API solid state properties and solubilities in workplans that are customized to meet the unique needs of each program. The data we collect can be leveraged with our bio-performance model to identify opportunities and risk 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 
  • Multi-particulates – 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

Ready to get started?

Our experience and background cover a wide range of pharmaceutical manufacturing concepts bringing our world-class expertise to you and your drug product.

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