SPRAY-DRIED DISPERSION (SDD) SERVICES
Poor aqueous solubility remains a major challenge in drug development, often limiting the bioavailability of promising therapeutic candidates. Amorphous solid dispersions (ASDs) offer a proven approach to overcome this hurdle by stabilizing the drug in a high-energy, amorphous state within a polymer matrix—enhancing dissolution and absorption. Among the various technologies available to produce ASDs, spray dried dispersions (SDDs) are one of our preferred techniques. Spray drying enables precise control over particle properties, formulation composition, and scalability, making it ideally suited for developing robust, bioavailable drug products from early-stage development through to commercialization.
Speak with one of our manufacturing experts to develop scalable, bioavailable formulations for your challenging APIs.
Speak With Our ExpertsOver 70% of new chemical entities (NCEs) exhibit low aqueous solubility (BCS Class II/IV)―limiting absorption in the gastrointestinal tract and preventing therapies from reaching systemic circulation. Our team addresses this issue using spray-dried dispersions―a proven technique to enhance dissolution rates and oral bioavailability while meeting critical requirements for physical stability, in vivo performance, and scalable manufacturability.
We offer SDD services to support early feasibility studies through to Phase I/first-in-human trials—under full cGMP oversight. Using state-of-the-art equipment such as the PROCEPT Spray Dryer/Chiller with a modular 4M8-Trix design, we can enhance bioavailability of promising compounds by 3 to 5 times, minimize API use, and provide a scalable commercial drug product even at early development stages.
Our scientists have experience with a variety of SDD polymers and solvents that act as carriers and stabilizers that prevent the drug from recrystallizing and maintain its improved solubility―including those listed below and more.
Applications and Benefits of Spray Drying in Early-Phase Drug Manufacturing
In addition to enhancing solubility and bioavailability, spray drying also supports drug developers in improving the formulation of their APIs in the following ways:
Producing Inhalable Powders: Aqueous spray drying produces inhalable powders for pulmonary drug delivery (via dry powder inhalation), where they can be rapidly absorbed into the bloodstream.
Formulating Controlled Release Drugs: The polymer matrix can release the drug at a controlled rate, providing a sustained therapeutic effect over an extended period.
Providing Taste Masking: With the API encapsulated in a polymer matrix, the typical bitter API taste is not discernable.
Encapsulating APIs: Encapsulating APIs in a protective matrix shields them from environmental factors, enhancing the stability and shelf life of the drug.
Easy Scalability for Later Phases: Suitable for both small-scale and large-scale production, it can be used in various stages of drug development, from preclinical studies to commercial manufacturing.
Higher drug loading: This enables a small tablet or capsule to contain less excipient, and therefore, more API. During early phase development, we can test optimal excipients and maximize drug loads for clinical trials.
Compared to other methods like freeze-drying, spray drying is a cost-effective and scalable method for producing high-quality pharmaceutical powders. It allows for efficient use of materials and energy, reducing overall production costs, making it ideal for early-phase research and final dosage form development.
HOW SPRAY DRYING WORKS
Dissolution: The drug and polymer are dissolved in a suitable solvent, often a volatile organic solvent like ethanol, acetone, or tetrahydrofuran. The choice of solvent is an important consideration; our manufacturing experts will select the most appropriate solvent based on the specifics of your program.
Atomization: The solution is then atomized into a fine mist of droplets using either a rotary atomizer or a nozzle atomizer. This breaks the liquid into tiny droplets, increasing the surface area for efficient drying.
Drying: The fine droplets go into a drying chamber where they are dried with hot air ranging in temperature from 100°C to 200°C, depending on the thermal sensitivity of the API. The hot air rapidly evaporates the solvent, leaving behind solid particles of drug product.
Collection: The dried particles, which are now an amorphous solid dispersion, are collected using a cyclone separator or a bag filter. These particles are further processed or formulated into the final product.
NANOMILLING AND SPRAY DRYING: THE EFFEcTS OF A COMBINED APPROACH
Our industry-leading expertise in formulation development and nanomilling (a particle reduction technique) can help to overcome further challenges of complex API development. Nanomilling and spray drying technologies, when integrated, offer a scalable solution to overcome dissolution difficulties and further improve therapeutic efficacy.
This combined approach eliminates the need to dissolve APIs (particularly advantageous for poorly soluble drugs), preserves nanocrystal size post-drying when properly formulated, and enhances dispersion, dissolution rate, and bioavailability of the final powder.
Benefits include:
Enhanced Bioavailability―Nanosizing improves the dissolution rate of poorly soluble APIs, while spray drying creates a physically stable solid state that maintains the high surface area advantage.
Improved Stability―The combined approach transitions liquid nanosuspensions into stable, free flowing powders with preserved nanoscale properties and enhanced physical stability.
Scalability and Versatility―Both processes are industry-validated and can be scaled for commercial production, enabling either reconstitution for suspension dosing or direct compaction into solid forms.
The Nanocrystal Advantage―Retains high surface area and fast dissolution in a final dosage form.
Reconstitution or Direct Use―The spray-dried powder can be redispersed in a liquid medium just before use (ideal for parenteral formulations, suspensions, or inhalables), while the powder can be used as-is, directly processed into capsules, tablets, or other solid dosage forms.
TECHNICAL EXPERTISE YOU CAN TRUST
When you partner with us, you gain a team of dedicated professionals with over 30 years of experience, focused on your success. From biotech startups to mid-sized innovators to global pharmaceutical leaders, our proven expertise and unwavering commitment to quality make us the partner of choice for your manufacturing needs.
Altasciences’ fully qualified, FDA-inspected cGMP manufacturing facility features in-house analytical and R&D laboratories that deliver:
- Characterization methods for particle size, morphology, and dispersibility.
- Stability assessments and analytical method development.
- Quality by design and predictive modeling for faster scale-up.
We have specific analytical equipment that can be used to assess and fully characterize your SDDs, a unique offering in the industry. These instruments include:
- Differential Scanning Calorimeter (DSC)
- Thermal Gravimetric Analyzer (TGA)
- Powder X-Ray Diffraction (PXRD) machine
We have several manufacturing suites, including Grade C cleanrooms for the handling of potent APIs. Using advanced manufacturing processes, we have formulated, tested, and manufactured all pharmaceutical dosage forms on the market, including tablets, liquid- and powder-filled capsules, over-encapsulated capsules, nanomilled suspensions, creams, gels, powders, and terminally sterilized injectables.
Our cross-functional preclinical and clinical teams enable concurrent development activities, ensuring seamless transfer and efficient scale-up, while our regulatory experts—well-versed in global requirements—guide you through your IND/CTA submissions. This fully integrated CRO/CDMO model helps streamline timelines and reduce costs from preclinical to commercial manufacturing.
- Proven bioavailability improvements.
- Expertise in formulating drug products into liquid and solid oral dosage forms.
- Accelerated timelines from feasibility to commercial production.
- Integrated CDMO/CRO expertise, reducing complexity and risk.
- End-to-end project management, single point of contact for seamless communication.
STRUGGLING WITH API SOLUBILITY OR BIOAVAILABILITY?
Connect with our experts to explore how our manufacturing solutions can align with your drug development needs.
OUR FULL SPECTRUM OF DRUG MANUFACTURING SERVICES
Dive deeper into Altasciences' extensive range of pharmaceutical development and manufacturing services. From discovery to commercialization, our comprehensive offering ensures a seamless transition through each stage of drug development.
Related Resources
Learn about our combined nanomilling and spray drying approach that improves drug dissolution, stability, and scalability by reducing particle size and converting nanosuspensions into solid forms.
Discover the benefits of having in-house drug formulation experts to support your first-in-human trials and the cutting-edge methodologies used to accelerate your drug development timelines and enhance patient outcomes.
Explore the benefits of nanomilling, a game-changing process that can maximize your formulations, in this issue of The Altascientist. Case study included!
