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Spray Drying and Particle Engineering
Bioavailability Enhancement
Serán has decades of experience in particle engineering, including spray drying. Our deep scientific expertise, formulation and dosage form experience, and technical knowledge form the bedrock of our particle engineering leadership. Our technology enables delivery of drugs to a wide variety of biological targets, including the small intestine to enhance bioavailability, colonic, and pulmonary delivery.
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Enhancing Solubility, Bioavailability, and Therapeutic Performance
Serán has extensive spray drying capabilities. Our team has decades of experience developing spray drying processes, related formulations, and analytical methods and techniques. We have leveraged our core knowledge of particle engineering and formulation requirements to design and build optimum spray drying systems for pharmaceutical applications. At present, Serán has 6 separate spray drying systems that can produce material for a wide variety of drug delivery requirements.
ROBUST PHASE-APPROPRIATE PARTICLE ENGINEERING
Particles with controllable size and structure are highly desired for their physical properties (e.g., for manufacturing ease) or because they exhibit enabling performance (e.g., improved pharmacokinetics). Serán has extensive expertise in designing and manufacturing of particles ranging from a few tens of nanometers to several hundred microns in size. Particle architectures can be either homogeneous or structured on micron or nanometer length scales, as needed to enhance product performance.
Serán takes a holistic approach to process and product design to enable pre-clinical studies with minimal quantities of API while simultaneously developing knowledge to facilitate rapid scale-up as the program progresses through clinical trials toward commercialization. This goal is achieved through a combination of fundamental process modeling, material-sparing benchtop techniques, and custom-designed manufacturing equipment that preserves the essential process elements across scales and connects them to the models and bench experiments. The end result is a data-driven, risk-based collaboration tailored to meet client's needs.
Capabilities
- Decades of experience in spray drying, numerous cited patents for spray drying and formulation technologies
- Scalable approach to spray drying, with a variety of atomization techniques that produce particles representative of commercial products early in the program life cycle
- Custom spray dryers capable of adapting to unique product and process needs
- Expertise in colloidal science for manufacturing of micro- and nanoparticles with enhanced performance characteristics
- Spray drying of biologically active ingredients and temperature-sensitive products
- Seamless integration into a variety of dosage forms, including tablets, capsules, suspensions, inhalation devices, and vials and syringes.
Technologies
Bioavailability enhancement using amorphous solid dispersions, produced by spray drying or hot-melt extrusion
- Dissolution-rate-enhancement using API micronization or wet bead nano milling for particle suspensions
- High-concentration micro- or nano-particle suspensions of biologics or small molecules for subcutaneous delivery.
- Turbulent micro-mixing as a scalable way to produce nanoparticles for emerging drug delivery strategies
- Spray drying with low-volatility organic solvents for compounds with poor aqueous AND organic solubility
- Tunable particle size for pulmonary targets in the lung
- Fluid bed coating for multilayered particle architectures
- Granule production either by (dry) roller compaction or wet methods
- Variety of finished dosage forms, tablets, capsules, and bulk powder
CUSTOM SPRAY DRYERS SCALE APPROPRIATE FOR ALL CLINICAL PHASES
- Formulation screening & pre-clinical supplies (< 50 mg – 200 g)
- Pre-clinical supplies to support PK and GLP tox studies (100 g – 10 kg)
- Phase I/II clinical supplies (100 g – 20 kg)
- Late-stage clinical supplies (10 kg – 100+ kg)
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