Controlled release dosage forms

  • US 8,323,692 B2
  • Filed: 12/05/2008
  • Issued: 12/04/2012
  • Est. Priority Date: 02/21/2002
  • Status: Active Grant
First Claim
Patent Images

1. A controlled release oral dosage form comprising:

  • a) a core, wherein said core comprises;

    i) an effective amount of metformin hydrochloride, andii) at least one first pharmaceutically acceptable excipients, andb) a stable controlled release monolithic coating surrounding the core,wherein said dosage form provides a Tmax of said metformin hydrochloride of from about 6 hours to about 12 hours after administration to a patient; and

    /or provides an in-vitro release rate of the metformin hydrochloride when tested by the USP Apparatus I (Basket Apparatus) method at 100 rpm, in 900 mL simulated gastric fluid and at about 37°

    C., such that not more than 37% of the metformin hydrochloride is released after about 2 hours and not more than 61% of the metformin hydrochloride is released after about 4 hours,wherein the stable controlled release coating hydrates when placed into water, and wherein the at least one first pharmaceutically acceptable excipient comprises cross-linked polyvinylpyrrolidone, andwherein the stable controlled release coating is formed by a process comprising;

    coating the core with a coating composition to form a coated core, and curing the coated core to form the stable controlled release coating, wherein the coating composition comprisesi) an aqueous dispersion of a neutral ester copolymer without any functional groups;

    ii) a poly glycol having a melting point of at least about 55°

    C., andiii) one or more second pharmaceutically acceptable excipients; and

    wherein the curing is conducted at a temperature at least equal to or greater than the melting point of the poly glycol.

View all claims
    ×
    ×

    Thank you for your feedback

    ×
    ×