SPI Pharma Announces Actimask® Ibuprofen Taste-Masked Active
WILMINGTON, Del., Feb. 14, 2013 /PRNewswire/ — SPI Pharma, Inc. (Wilmington, DE), a global leader in providing pharmaceutical ingredients and technologies for patient-friendly dosage forms, announces the launch of Actimask® Ibuprofen 92S, a taste-masked Ibuprofen. It joins Actimask Acetaminophen 92M in SPI’s line of taste-masked actives specifically designed for making patient-friendly orally dispersible dosage forms economically in conventional equipment.
Actimask Ibuprofen 92S is manufactured via a 100% aqueous hydrogel coating system that provides 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 releases rapidly in the GI tract, far exceeding the compendial requirement of releasing no less than 80% in 60 minutes. However, the dissolution rate of Ibuprofen dosage forms does not always predict bioequivalence to reference drugs, so SPI conducted a 3-way cross-over pilot pharmacokinetic (PK) study comparing SPI’s oral dispersible tablets (ODT) and powder (ODP) containing Actimask Ibuprofen 92S against a leading brand of Ibuprofen chewable tablet as the reference. 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.
For more information about Actimask and the pilot biostudy, please contact your local SPI Pharma sales representative, call our regional offices for the Americas (800) 789-9755 ext. 8600; Europe, Middle East, Africa +33 4 91 96 36 10; or Asia-Pacific +91 80 3027 0005 or visit our website, www.spipharma.com.
About SPI Pharma
SPI Pharma serves Pharmaceutical Formulators in over 55 countries supplying antacid actives, taste-masked APIs, excipients, and drug delivery systems for oral dose applications including: quick-dissolve technologies, chewables, lozenges, powders and other patient-friendly dosage forms. SPI also provides drug development services tailored to customers’ specific needs.
SPI’s mission is to partner with customers and engineer functional materials that enable pharmaceutical formulators to solve formulation problems, achieve differentiation, and gain speed to market.
SOURCE SPI Pharma, Inc.