Enhanced Solubility and Engineered Particle Solutions
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 3 separate spray drying systems that can produce material for a wide variety of drug delivery requirements.
Our custom spray dryers are designed to work across a broad range of development scales. For early development (e.g. discovery), we utilize a custom-designed spray dryer that can produce material for testing using as little as 10 mg of API. We have also developed a novel spray drying system that can produce precise particle size distributions for pulmonary or multiparticlulate applications. GMP manufacturing scale ranges from 100 g up to 50 kg. We can engineer particle sizes ranging from a few microns to several hundred microns with a variety of controlled morphologies. All of our spray dryers are aqueous and solvent capable and can utilize 2-fluid, pressure, and ultrasonic nozzles.
A large percentage of new chemical entities exhibit poor aqueous solubility which results in poor bioavailability. Serán utilizes a wide variety of approaches to overcome these bioavailability challenges, including amorphous formulations. When relatively simple techniques (such as salt forms and particle size reduction) fail to provide adequate exposure, preparation in an amorphous state can improve compound solubility resulting in improved bioavailability.
Serán’s personnel have many decades of experience in amorphous formulation development and our leadership team was instrumental in introducing amorphous spray dried dispersions into the pharmaceutical industry. We have a fundamental understanding of the chemistry and physics of amorphous materials and particle formation and leverage this knowledge to develop optimized formulations for our clients. Serán primarily uses spray drying to produce amorphous solid dispersions as this process has extremely broad applicability to diverse chemical space. With over 10 commercial products so far, spray dried dispersions are highly precedented and use standard pharmaceutical excipients.
Control of particle size and morphology is critical to delivery of the optimum dose to the optimum location within the lung. Serán uses multiple approaches to produce the desired particle size and particle density needed for the specific target for pulmonary delivery. We use a variety of particle formation methods, including jet milling and spray drying. Delivery of soluble and insoluble compounds are feasible with our engineered approaches. Serán can engineer particles that are designed for your target.
If you require solid formulations of your biological molecule, we can help. Solid particle formation requires careful control of processing parameters to maintain function and stability of the active pharmaceutical molecule.
Our custom spray dryers can process aqueous solutions at much lower temperatures than standard spray dryers- below 50 °C inlet temperatures, with extrememly low outlet temperatures. These temperatures enable particle formation of temperature sensitive materials.
Particle size and morphology is carefully optimized for the application and formulation that is needed using a wide variety of droplet formation approaches and drying chamber designs. We use a variety of particle collection technologies, including cyclones and filter systems. We use extensive solid-state and chemical analytical methods to ensure successful formulation.
Your drug is your future, but the path to a successful product is daunting. You need a CMC partner that’s as committed to your success as you are. Seràn offers a comprehensive set of drug-development services that begins with a detailed understanding of your project and goals. We deploy a science-based methodology that rapidly identifies a preferred approach that will enable an efficient advancement of your drug to the clinic and beyond. Our science, quality systems, regulatory expertise, and customer service are second to none.All Services