Relationship-based Processes Lead to Enhanced Risk Reduction for Smaller to Mid-size Projects
Unsurprisingly, advancing new and efficacious pharmaceutical compounds to clinical trials is highly competitive and often challenging. Given that the ultimate goal is to bring them to market in a reasonable dosage form, nearly every new project requires the optimization and stability of amorphous powders obtained from crystalline drugs.
The term "crystalline drugs" refers to pharmaceutical compounds that exist in a highly organized and repeating three-dimensional lattice structure. In this solid state, the particles exhibit a distinct and repeating geometric pattern, providing a clear and well-defined crystalline structure.
However, the crystallinity of a drug can exert an influence on its physical and chemical properties, including solubility, stability, and bioavailability.
Drug Delivery and Effectiveness: The Increasing Usefulness of Spray Drying
Understanding the crystalline nature of a drug is crucial in pharmaceutical development. The specific configuration can impact formulation strategies, drug delivery mechanisms, and overall therapeutic efficacies.
As such, many pharmaceutical companies turn to spray drying in their efforts to bring a new chemical entity to clinical trials. Spray drying is a widely used - process for converting crystalline drugs into amorphous powders, a form that often exhibits enhanced solubility and bioavailability.
This technique involves atomizing a liquid drug formulation into fine droplets, which are then rapidly dried using hot air or other gases. The resulting amorphous powder consists of small, spherical particles with a large surface area, promoting faster dissolution rates when compared to their crystalline API counterparts.
How Spray Drying Works in Drug Development Settings
The process of spray drying pharmaceuticals typically begins by creating a liquid "feedstock." Usually, this includes the drug of interest dissolved or dispersed in a suitable solvent or mixture.
The feedstock is pumped through a nozzle where it is atomized into small droplets. These atomized droplets are then exposed to heated gas in a drying chamber. This process causes the solvent to evaporate rapidly and the droplets form solid particles. The resultant powder is then collected at the bottom of the drying chamber.
One advantage of spray drying is the ability to produce homogeneous and reproducible powder particles in an amorphous state with controlled size distribution. This is a crucial factor in pharmaceutical applications, as it allows precise control over the drug's dissolution properties. As a result, process parameters such as inlet temperature, feed rate, and drying gas flow velocity must be carefully optimized to ensure the desired product characteristics are obtained. If not set properly, spray drying parameters can often lead to a delay in the development process.
The Frequent Need for Customizing the Spray Drying Process
Despite its popularity, pharmaceutical spray drying is not without its unique set of challenges. Among these is the potential for degradation of heat-sensitive drugs due to high temperatures during processing.
Additionally, the selection of an appropriate solvent is critical. Post-process residual solvents can easily impact the stability and safety of the final product.
Overall, spray drying is a versatile and widely used technique for the production of amorphous drug powders that offers several advantages in terms of solubility, bioavailability, and ease of manufacturing. However, the need for an attentive, customized approach quickly becomes evident. Simply stated, the stakes are incredibly high once a pharmaceutical company scales up to clinical batch production. Investors are understandably keen to head off as many risks as possible prior to the initiation of a clinical trial.
Consider the Ascendia Advantage for Your Development Project
Staffed with world-class expertise, Ascendia® Pharmaceuticals leverages its smaller organizational size to take a more nimble and flexible approach to development. Without sacrificing any of the quality controls clients would expect from larger companies, Ascendia allows for a more amenable and collaborative relationship from start to finish for small-batch projects.
The Ascendia facilities produce high quality spray dried compounds and utilize the same techniques and machinery deployed by larger companies. The key difference is that Ascendia often takes on spray drying projects that larger CDMOs would likely turn away. At Ascendia, smaller batch sizes and finely tuned processes get a green light that might not get traction elsewhere.
Do you have a pipeline candidate, but the available API is quite limited for formulation development? Has your current pharmaceutical project not yet scaled up or not been able to garner interest elsewhere due to its small batch size? If either is applicable, please spend some time talking to Ascendia. Our team takes pride in taking on spray-drying projects that have not previously been considered. We are here to solve problems that others have failed.
Find out - if Ascendia can help your organization remove unnecessary risk from your pharmaceutical projects. We believe Ascendia is correctly sized for both early development and transitioning smoothly to the manufacture of clinical trial materials.