The development of a spray-dried dispersion formulation begins with the choice of excipients. Depending on these and the solubility of the drug compound, spray drying can be performed from aqueous or solvent solutions. The composition of the spray-drying feed solution, including drug loading and total solids content, and selection of appropriate spray-drying parameters are designed to produce a uniform powder with physical properties aligned with the intended final dosage form.
Commonly used excipients for spray-dried dispersions include polymers such as PVP, HPMC-AS and copovidone. The possible drug loading levels in these polymers depend mainly on the solubility of the drug compound in common solvents and are typically between 20-30% w/w but can be as high as 60% w/w. Polymer selection and drug:polymer ratios have the potential to affect clinical performance and thus require careful selection.
After selecting the excipients, the formulator can move on to the spray dryer configuration. The choice of nozzles and cyclones, combined with key process parameters such as atomization pressure and airflow, solution feed rate and temperature profile, enables formulators to design a process at laboratory scale to produce Properties of products that are safe in the knowledge that the process can be scaled to industrial volumes.
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