CROSS-LINKED HIGH AMYLOSE STARCH FOR USE IN CONTROLLED-RELEASE PHARMACEUTICAL FORMULATIONS AND PROCESSES FOR ITS MANUFACTURE

THE PRESENT INVENTION RELATES TO A NOVEL FORM OF CROSS-LINKED HIGH AMYLOSE STARCH AND PROCESSES FOR ITS MANUFACTURE. SUCH CROSS-LINKED HIGH AMYLOSE STARCH IS USEFUL AS AN EXCIPIENT IN A CONTROLLED-RELEASE PHARMACEUTICAL FORMULATION WHEN COMPRESSED WITH PHARMACEUTICAL AGENT(S) IN A TABLET. SUCH CROSS-LINKED HIGH AMYLOSE STARCH IS PREPARED BY (A) CROSS-LINKING AND CHEMICAL MODIFICATION OF HIGH AMYLOSE STARCH, (B) GELATINIZATION, AND (C) DRYING TO OBTAIN A POWDER OF SAID CONTROLLED RELEASE EXCIPIENT. IN A PREFERRED EMBODIMENT, SUCH CROSS-LINKED HIGH AMYLOSE STARCH IS PREPARED IN THE FOLLOWING STEPS: (1) GRANULAR CROSS-LINKING AND ADDITIONAL CHEMICAL MODIFICATION (E.G., HYDROXYPROPYLATION) OF HIGH-AMYLOSE.STARCH; (2) THERMAL GELATINIZATION OF THE STARCH FROM STEP (1); AND (3) DRYING THE STARCH FROM STEP (2) TO YIELD A POWDER CAPABLE OF BEING USED AS A CONTROLLED RELEASE EXCIPIENT. (FIGURE 1)