ISSUE NO. 46 – SPRAY DRIED DISPERSIONS
Spray-dried dispersions (SDDs) are an effective method to improve solubility and bioavailability of your active pharmaceutical ingredient (API) in early-phase drug development. The spray drying process involves converting a liquid into a dry powder, with the resulting SDDs benefiting from improved characteristics for further developments. Spray drying can also be combined with nanomilling for further improve the bioavailability and for flexible downstream processing.
In Issue 46 of The Altascientist, explore:
- how SDDs improve efficiency of early-phase drug development
- applications and benefits of spray drying in early-phase drug manufacturing
- advances in spray drying technology for pharmaceutical development
- the use of spray dry technology in early-phase development of proteins and peptides
- key considerations for the development of spray-dry pharmaceuticals
APPLICATIONS AND BENEFITS OF SPRAY DRYING IN EARLY-PHASE DRUG MANUFACTURING
Spray drying can convert APIs into amorphous forms with enhanced dissolution properties, making this technology ideal for APIs with poor aqueous solubility. With spray drying, drug developers can improve their API’s formulation in a number of ways, depending on the specifics of each individual program, such as solubility and bioavailability, producing inhalable powders, formulating controlled release drugs, encapsulating APIs, providing taste masking, and facilitating scalability for later phases.
Spray drying technology offers a versatile and efficient approach for formulating low-dose, high-potency APIs, particularly when uniform API distribution within a carrier matrix is critical. The rapid solvent evaporation characteristic of spray drying minimizes thermal and moisture exposure, making it especially suitable for APIs that are sensitive to heat or humidity.
KEY CONSIDERATIONS FOR THE DEVELOPMENT OF SPRAY-DRY PHARMACEUTICALS
There are currently no specific, prescriptive regulations solely for spray drying processes. However, spray drying is a manufacturing process that should follow broader regulations, particularly good manufacturing practices (GMP) and quality control. Documentation and record keeping, microbiological controls, and other standards outlined in the regulations apply to spray-dried materials.
Important parameters that relate directly to the spray drying process itself include solvent selection, process parameters, polymer selection, and product characterization. The type of solvents used largely depend on the type of API and the overall chemical stability of the API—it is important to choose a solvent that can dissolve the pharmaceutical compound and be easily removed during the drying process.
Optimization of the spray drying process parameters, such as inlet temperature, feed rate, and atomization method, ensures the formation of high-quality spray-dried powders. It is critical to use a polymer that is compatible with the drug and enhances its solubility. Commonly used polymers include hydroxypropyl methylcellulose (HPMC), polyvinylpyrrolidone (PVP), and ethyl cellulose. Thorough characterization of the spray-dried powder to ensure it meets the desired specifications is another crucial step, for which we, as your CDMO partner, will evaluate the particle size distribution, morphology, solid-state properties, and dissolution rate.
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