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    NOVEL COPOLYMERS AND THEIR USE IN PHARMACEUTICAL DOSAGE FORMS
    3.
    发明公开
    NOVEL COPOLYMERS AND THEIR USE IN PHARMACEUTICAL DOSAGE FORMS 审中-公开

    公开(公告)号：US20230257501A1

    公开(公告)日：2023-08-17

    申请号：US18014508

    申请日：2021-07-02

    Applicant: BASF SE

    Inventor： Theo Smit ,  Ferdinand Paul Brandl ,  Felicitas Guth ,  Karl Kolter ,  Frank Schmidt

    IPC: C08F226/10 ,  C08F2/06 ,  A61K9/16

    CPC classification number: C08F226/10 ,  C08F2/06 ,  A61K9/1635

    Abstract: Copolymer, wherein structural units are derived from: i) an acrylic carboxylic acid monomer (4 to 18% by weight), selected from the group consisting of acrylic acid and methacrylic acid, ii) a 5 hydrophobic methacrylate (more than 8% by weight), selected from a group consisting of isopropyl methacrylate, tert-butyl methacrylate and cyclohexyl methacrylate, iii) a N-vinyl lactam, selected from a group consisting of N-vinyl pyrrolidone and N-vinylcaprolactam and optionally iv) 2-hydroxyethyl methacrylate, with the proviso that the total amount of structural units derived from the monomer groups adds up to 100% by weight, and the calculated solubility parameter SP of 10 the copolymer is between 22.0 and 25.0 MPa1/2, and the use of the copolymers as crystallization inhibitors in pharmaceutical dosage forms for inhibiting the recrystallization of an active ingredient in an aqueous environment of a human or animal body.

    DIGITAL ASSISTANT TO SUPPORT PRODUCT DEVELOPMENT
    4.
    发明申请
    DIGITAL ASSISTANT TO SUPPORT PRODUCT DEVELOPMENT 有权

    公开(公告)号：US20220367012A1

    公开(公告)日：2022-11-17

    申请号：US17624417

    申请日：2020-07-16

    Applicant: BASF SE

    Inventor： Ferdinand Paul Brandl ,  Thorsten Cech ,  Verena Geiselhart ,  Johann Philipp Hebestreit ,  Brett R. Burns ,  Andres Christian Orthofer ,  Christian Herbert Rueckold ,  Kai Sievert ,  Ulrike Hees ,  Felix Klug

    IPC: G16C20/50 ,  G16C20/30 ,  G16H70/40 ,  G16C20/20

    Abstract: In order to facilitate product development, such as pharmaceutical product development, a computer implemented method and an apparatus are proposed that enable formulators to develop robust drug formulations in a cost- and time-efficient manner. To start the development process, the user selects the preferred dosage form (e.g., granules, pellets, capsules, tablets etc.), defines a target profile (e.g., amount of active ingredient per unit, size of dosage form, mechanical strength of dosage form, desired release behaviour etc.) and enters key characteristics of the active ingredient (e.g., true density, particle size distribution data, bulk and tapped density, angle of repose, compressibility and compactibility profile etc.). The identity (e.g., chemical name or structure) of the active ingredient is not necessarily disclosed. The apparatus processes the provided data and calculates key parameters of the AI (e.g., particle size, powder density, powder flow and tabletability) Similar key parameters are calculated for common pharmaceutical excipients and stored in the apparatus. The apparatus then selects all relevant excipients and suggests a suitable manufacturing process. Combinations of active ingredients and excipients qualify as drug formulation if the predicted properties comply with the defined target profile. The following aspects can be considered: solubility and permeability of the active ingredient, dissolution of the active ingredient, probability to pass the content uniformity criteria, flowability of the powder blend, tabletability of the powder blend, mechanical strength and size of the tablet, compatibility of active ingredients and excipients etc.

    NOVEL TERPOLYMERS AND THEIR USE IN PHARMACEUTICAL DOSAGE FORMS
    5.
    发明申请
    NOVEL TERPOLYMERS AND THEIR USE IN PHARMACEUTICAL DOSAGE FORMS 有权

    公开(公告)号：US20210069112A1

    公开(公告)日：2021-03-11

    申请号：US16772273

    申请日：2018-12-07

    Applicant: BASF SE

    Inventor： Ferdinand Paul Brandl ,  Theo Smit ,  Felicitas Guth ,  Karl Kolter ,  Maximilian Angel ,  Frank Schmidt

    IPC: A61K9/16 ,  C08F220/18 ,  A61K47/32 ,  A61K31/635 ,  A61K31/58 ,  A61K31/216 ,  A61K31/5377

    Abstract: Terpolymer, wherein 20 to 35% by weight of the structural units are derived from acrylic acid, 45 to 60% by weight of the structural units from a hydrophobic methacrylate selected from a group consisting of isopropyl methacrylate, tert-butyl methacrylate and cyclohexyl methacrylate and 15 to 40% by weight of the structural units from a third olefinic monomer selected from the group consisting of N-vinyl lactam, hydroxy ethyl methacrylate and phenoxyethyl acrylate with the proviso that the total amount of structural units derived from the three monomer groups adds up to 100% by weight, and the use of the terpolymers as crystallization inhibitors in pharmaceutical dosage forms for inhibiting the recrystallization in an aqueous environment of a human or animal body of an active ingredient.

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