Abstract: A pharmaceutical gel composition is provided comprising (a) a therapeutically effective amount of one or more active pharmaceutical ingredients comprising one or more macrolide related immunosuppressants or pharmaceutically acceptable salts or esters thereof; (b) one or more gel forming agents; and (c) an effective amount of one or more skin penetration enhancers capable of percutaneous delivery of the macrolide related immunosuppressant through the skin. Also provided is a process for its preparation and methods for delivering a macrolide related immunosuppressant through the skin of a mammal in order to treat conditions situated on and beneath the skin.

Abstract: A pharmaceutical ointment composition is provided comprising (a) a therapeutically effective amount of one or more active pharmaceutical ingredients comprising one or more macrolide related immunosuppressants or pharmaceutically acceptable salts or esters thereof; (b) an ointment base; and (c) an effective amount of one or more skin penetration enhancers capable of percutaneous delivery of the macrolide related immunosuppressant through the skin. Also provided is a process for its preparation and methods for delivering a macrolide related immunosuppressant or a pharmaceutically acceptable salt or ester thereof through the skin of a mammal in order to treat conditions situated on and beneath the skin.

Abstract: A pharmaceutical cream composition is provided comprising (a) a therapeutically effective amount of one or more active pharmaceutical ingredients comprising one or more macrolide related immunosuppressants or pharmaceutically acceptable salts or esters thereof; (b) one or more cream forming agents; and (c) an effective amount of one or more skin penetration enhancers capable of percutaneous delivery of the macrolide related immunosuppressant through the skin. Also provided is a process for its preparation and methods for delivering a macrolide related immunosuppressant through the skin of a mammal in order to treat conditions situated on and beneath the skin.

Abstract: Disclosed is a controlled release modifying complex for solid oral controlled release pharmaceutical compositions suitable for once-a-day administration. The composition comprises an active pharmaceutical ingredient, a release modifying complex and other required pharmaceutically acceptable excipients. The release modifying complex comprises a primary release modifying agent, a secondary release modifying agent and an auxiliary release modifying agent or varying combinations thereof, wherein said primary, secondary and auxiliary release modifying agents are present in amounts that synergistically effect and extend the release of active pharmaceutical ingredient.