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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. We provide robust, manufacturable and scalable drug products early in development to accelerate and de-risk your path to market.
Tackling Even the Most Complex Formulation Challenges
Serán develops oral solid dosage forms 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) principles, allows 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 a 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.
BEGINNING WITH THE END IN MIND
Our experienced formulation team will work with you to identify an appropriate technology and formulation strategy to meet your program’s unique needs, right from the start. 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
- Multiparticulates – 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
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