title: Pharmaceutical design of a new lactose-free coprocessed excipient: application of hydrochlorothiazide as a low solubility drug model.
abstract: Most co-processed excipients used in direct-compression tablets contain lactose, which prevents lactose-intolerant patients from taking such tablets. Therefore, a novel lactose-free co-processed excipient for direct compression tablets has been prepared. Microcrystalline cellulose and dicalcium phosphate dehydrate were used as primary excipients which underwent a wet granulation process and factorial experiment in order to ascertain the best prototype. Finally, the best two prototypes were added to hydrochlorothiazide, which has chosen as the model drug because of its low solubility. An extensive characterization of the new excipient as well as the drug loaded tablets is reported. Our results show adequate parameters (rheological and compression behavior, uniformity of weight, disintegration, friability, crushing force and cohesion index). Moreover, the biopharmaceutical profile was evaluated; the tablets exhibits a Weibull kinetic function and fast drug release.
authors.affiliation: Pharmaceutical Technology Unit, Department of Pharmacy and Pharmaceutical Technology, School of Pharmacy, University of Barcelona, Barcelona, Spain.
authors.forename: Anna
authors.initials: A
authors.lastname: Viscasillas Clerch
authors.forename: Francisco
authors.initials: F
authors.lastname: Fernandez Campos
authors.forename: Alfonso
authors.initials: A
authors.lastname: Del Pozo
authors.forename: Ana Cristina
authors.initials: AC
authors.lastname: Calpena Campmany
mesh_terms: D015195:Drug Design; D005079:Excipients / Q000737:chemistry*; D006852:Hydrochlorothiazide / Q000008:administration & dosage / Q000737:chemistry*; D012995:Solubility; D013607:Tablets
chemical_list: D005079:Excipients; D013607:Tablets; D006852:Hydrochlorothiazide