Abstract: The present invention relates to pharmaceutical formulations of highly active drugs with limited shelf-life in aqueous media, suitable to be administered by a caregiver person to a patient avoiding or minimizing the risk of exposure, contact or contamination of the caregiver person with the active product ingredient (API), preferably an EGFR-TKI such as afatinib dimaleate.

Abstract: The present invention relates to pharmaceutical formulations of highly active drugs with limited shelf-life in aqueous media, suitable to be administered by a caregiver person to a patient avoiding or minimizing the risk of exposure, contact or contamination of the caregiver person with the active product ingredient (API), preferably an EGFR-TKI such as afatinib dimaleate.

Abstract: The present invention provides pharmaceutical release systems comprising an therapeutically effective amount of flibanserin and at least one pharmaceutically acceptable excipient, characterized in that said pharmaceutical release systems exhibit a pharmacokinetic profile that is characterized by an average maximum flibanserin plasma concentration Cmax lower than 300 ng/mL, preferably lower than 200 ng/mL after administration of a single dose to healthy volunteers in fasted state or directly after a meal.

Abstract: The invention is directed to a pharmaceutical controlled release system for administration, particularly oral administration, of active substances with pH-dependent solubilities, comprising a) a core material containing or consisting of one or more pharmaceutically acceptable pH modifiers; b) optionally an insulating layer, c) a first layer containing or consisting of one or more pharmaceutically acceptable water-insoluble polymers; d) a second layer containing or consisting of at least one active substance having a pH-dependent solubility; e) a third layer containing or consisting of one or more pharmaceutically acceptable polymers having anionic or no ionic groups; and f) optionally a fourth layer, preferably in form of an outer coating layer. It is provided a pH-independent release profile of active substances having pH-dependent solubilities in vitro and vivo.

Abstract: The invention is directed to a pharmaceutical controlled release system for administration, particularly oral administration, of active substances with pH-dependent solubilities, comprising a) a core material containing or consisting of one or more pharmaceutically acceptable pH modifiers; b) optionally an insulating layer, c) a first layer containing or consisting of one or more pharmaceutically acceptable water-insoluble polymers; d) a second layer containing or consisting of at least one active substance having a pH-dependent solubility; e) a third layer containing or consisting of one or more pharmaceutically acceptable polymers having anionic or no ionic groups; and f) optionally a fourth layer, preferably in form of an outer coating layer. It is provided a pH-independent release profile of active substances having pH-dependent solubilities in vitro and vivo.

Abstract: The present invention provides pharmaceutical release systems comprising an therapeutically effective amount of flibanserin and at least one pharmaceutically acceptable excipient, characterized in that said pharmaceutical release systems exhibit a pharmacokinetic profile that is characterized by an average maximum flibanserin plasma concentration Cmax lower than 300 ng/mL, preferably lower than 200 ng/mL after administration of a single dose to healthy volunteers in fasted state or directly after a meal.