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Preparation of a powdery pharmaceutical composition by means of cryo-milling

  • US 10,449,547 B2
  • Filed: 05/25/2016
  • Issued: 10/22/2019
  • Est. Priority Date: 11/26/2013
  • Status: Active Grant
First Claim
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1. A method for preparing a powdery pharmaceutical composition comprising a pharmaceutical excipient and a pharmaceutical component, wherein the pharmaceutical excipient is polyethylene glycol having a molecular weight of up to 50,000 g/mol;

  • the method comprising the steps of;

    (a)(i) mixing the pharmaceutical excipient with the pharmaceutical component outside an extruder and then feeding the pharmaceutical excipient and the pharmaceutical component as mixed into the extruder;

    or(ii) feeding the pharmaceutical excipient and the pharmaceutical component into the extruder at different feeding points, where either (1) the feeding point for the pharmaceutical excipient is located upstream with respect to the feeding point for the pharmaceutical component, or (2) the feeding point for the pharmaceutical component is located upstream with respect to the feeding point for the pharmaceutical excipient;

    (b) extruding a mixture of the pharmaceutical excipient and the pharmaceutical component in the extruder at a temperature profile allowing a liquid melt of the mixture to congeal in the extruder and to exit the extruder in form of a powder extrudate; and

    (c) grinding the powder extrudate at a temperature below ambient temperature, wherein the temperature below ambient temperature is at most −

    10°

    C.

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