SPI Pharma launches Actimask Ibuprofen taste-masked active

SPI Pharma, a US developer of patient-friendly dosage forms, has added Actimask Ibuprofen 92S, a taste-masked Ibuprofen, to its series of taste-masked actives for orally dispersible dosage forms.

Actimask Ibuprofen 92S is manufactured through a 100% aqueous hydrogel coating system that is said to provide excellent taste masking and rapid dissolution without the concern of residual solvents. The coating is readily wettable, while effectively masking unpleasant taste and preventing the characteristic ‘burning’ sensation many patients experience with some Ibuprofen products. The wetting characteristics and a small particle size give Actimask both the smooth mouth feel and the superior organoleptic properties that are essential to formulating superior dispersible dosage forms.

While Actimask Ibuprofen 92S releases very little Ibuprofen in the mouth and throat, it disperses rapidly in the GI tract, exceeding the compendial requirement of releasing no less than 80% in 60 minutes. However, because the dissolution rate of Ibuprofen dosage forms does not always predict bioequivalence to reference drugs, Wilmington, DE-based SPI conducted a three-way cross-over pilot pharmacokinetic (PK) study comparing its oral dispersible tablets (ODT) and powder (ODP) containing Actimask Ibuprofen 92S against a leading brand of Ibuprofen chewable tablet. Tablets were made with SPI's Pharmaburst 500 and the powder with Pharmasperse 416 delivery systems. The PK parameters for the Actimask dosage forms are similar to the reference product, which provides assurance to developers/marketers that they can formulate bioequivalent Ibuprofen products.