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Formulation Development

Formulation Development

Whether you need a simple immediate-release, an enabled formulation with enhanced bioavailability, or a highly engineered controlled-release tablet, Serán has the experience and knowledge to find the best solution for your project.

Formulation Development

Serán develops oral solid dosage forms that are engineered to meet solubility and release challenges. The comprehensive understanding of the physicochemical properties of your drug gained during development, along with a tactical deployment of QbD (Quality by Design) and DoE (Design of Experiment) principals allow us to design an optimal dosage form, even in Phase 1. This increases the chances of your clinical success and scalability in later Phases, without significant impact to costs or timelines.

For early discovery and toxicology studies, we utilize a variety of suspension and solution approaches to obtain desired in vivo exposure, especially at high doses. As you advance to the clinic, our solid dosage form approaches are designed to achieve your preferred performance and are engineered for scalability.

Our experienced formulation team will work with you to identify an appropriate technology and formulation strategy to meet your program’s unique needs. Our comprehensive approach to formulation design considers the physiochemical properties of the API, the target product profile, and your program’s objectives and constraints to develop scalable formulations using efficient and material-sparing approaches. We take a technology agnostic approach to formulation development and will consider all viable options for your program based on molecular properties and clinical or preclinical objectives. Whether considering enabling technologies (amorphous solid dispersions, lipid formulations, particle size reduction techniques) or conventional approaches, we comprehensively assess technology options to consider bio-performance, stability, manufacturability, and drug product design – aiming to deliver you the simplest approach that meets your program’s needs. 

Capabilities

  • Rapid, flexible, science-based formulation development or optimization
  • Integrated solutions for preclinical – Phase III studies
  • Tailored and customized approaches
  • Material sparing prototype screening for scalable drug product intermediate and drug product
  • Excipient compatibility studies
  • Multifactorial stability screening
  • Dissolution (biorelevant, IDR, release testing)
  • PK/PD study design support and data analysis
  • Pediatric formulation development
  • Modified release / controlled release formulation development
  • Drug product intermediate development
  • Spray dried dispersions
  • Hot melt extrusion
  • Micronization
  • Nanocrystals
  • Oral solid dosage form development
  • Tablets – IR, MR/CR, cosmetic or functional coatings, bilayer, fixed dose combinations
  • Capsules 
  • Multi-particulates – fluid-bed coating
  • Analytical method development
  • Manufacturing process design & engineering

Technologies

  • Oral solid dosage forms (tablets, mini-tablets, capsules, multiparticulates)
  • Oral solutions / suspensions (pre-clinical & clinical)
  • Inhalable particulates
  • Spray drying
  • Hot melt extrusion
  • Particle size reduction: Jet and nano- milling
  • Tableting (conventional, mini, bilayer)
  • Direct blend, dry granulation / roller compaction, wet granulation
  • Coating (cosmetic or function, pan and fluid bed)
  • Capsule filling
  • Pediatric dose forms
  • Multiparticulates

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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