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Pharmaceutical formulation

  • US 7,842,308 B2
  • Filed: 01/30/2002
  • Issued: 11/30/2010
  • Est. Priority Date: 01/30/2001
  • Status: Expired due to Fees
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Product Citations
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Petitions
2
Forward Citations
6
Assignments
First Claim
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1. A process for making a pharmaceutical dosage form comprising the steps of:

  • a) introducing Aminoalkyl Methacrylate Copolymer E present in an amount of about 50 to 90% w/w and an excipient composition comprising at least one dissolution-modifying excipient which is polyethylene oxide present in an amount of about 5 to about 30% w/w; and

    optionally a second dissolution modifying excipient selected from the group consisting ofi) a swellable solid present in an amount from about 5% to about 60% w/w;

    ii) a disintegrant present in an amount of about 5 to 50% w/w;

    iii) a non-reducing sugar present in an amount of about 2.5 to 15% w/w;

    iv) a water soluble filler present in the amount of about 5 to 20% w/w;

    v) a wicking agent present in the amount of about 2.5% to about 70% w/w;

    vi) an inorganic salt present in an amount of 5 to 10% w/w;

    or a combination or mixture thereof;

    and a lubricant present in an amount from 10 to about 25% w/w and optionally a plasticizer from about 0 to 5% w/w and/or a processing agent from about 0 to about 10% w/w; and

    /or a surfactant present in an amount of about 0.25 to 5% w/w;

    simultaneously into a first location of an elongated hot melt extruder, the first location having a temperature of about 50°

    C.;

    b) mixing said Aminoalkyl Methacrylate Copolymer E and said excipient composition in the hot melt extruder at a temperature ranging from about 50°

    C. to about 125°

    C. to form a homogeneous composition therein and substantially without thermal degradation of the Aminoalkyl Methacrylate Copolymer E and the excipient composition;

    (c) extruding the homogeneous composition in the form of a strand from the hot melt extruder though a die at a second location distal from said first location, said second location having a temperature not greater than about 125°

    C.;

    c) cutting the strand into pellets; and

    d) introducing said pellets into an injection molder and forming a thin-walled capsule shell compartments from said pellets by injection molding, and wherein the shell between and including the inner and outer surfaces of said shell is composed of the extruded and injection molded capsule shell composition.

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