| 摘要 |
A method of producing an extruded, powdered/granulated composition comprising an active pharmaceutical ingredient (API) is provided wherein the method comprises the steps of: (a) providing an API; (b) providing a porous and particulate inorganic excipient; and (c) processing (a) and (b) by a twin screw granulation process to directly produce an extruded, powdered/granulated composition wherein the API is absorbed within the pores of the carrier particles. Preferably the inorganic excipient is a metal aluminasilicate, in particular magnesium alumino-metasilicate (Al2O3.MgO.1.7SiO2.xH2O). The method may further include the steps of (d) blending the extruded, powdered/granulated composition with one or more pharmaceutically acceptable excipients to produce a composition blend; and (e) directly compressing the composition blend into a direct compression tablet. The API is preferably ibuprofen or indomethacin. Preferably the API is melted or solubilised in a solubiliser. A powdered/granulated composition comprising an API absorbed within the pores of a porous and particulate inorganic excipients is also outlined. |
