Abstract
It was evaluated if coprocessing via spray drying can be used as a formulation platform to improve the compactability of formulations containing drug substance (acetaminophen, ibuprofen, cimetidine) and excipients (carbohydrates, disintegrant, glidant, surfactant). Experimental design was applied to optimise the drug concentration and solid content of the feed suspension. In addition, scaling-up of acetaminophen- and ibuprofen-containing formulations was performed on a production-scale spray dryer. Optimised acetaminophen (drug concentration: 70% w/w), ibuprofen (drug concentration: 75% w/w) and cimetidine (drug concentration: 70% w/w) powders were obtained via co-spray drying of aqueous suspensions with a high solid content of the feed (35% w/w) and the resulting powders were directly compressed. Scaling-up of optimised acetaminophen and ibuprofen formulations was performed successfully, resulting in a robust and reproducible manufacturing process. It can be concluded that a combination of mannitol, erythritol, Glucidex ® 9, Kollidon ® CL, colloidal silicon dioxide and polyoxyethylene 20 sorbitan monooleate allowed the spray drying of highly dosed drug substances (acetaminophen, ibuprofen, cimetidine) in order to obtain ‘ready-to-compress’ powder mixtures on lab-scale and production-scale equipment.
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