发明申请
- 专利标题: PROCESS FOR PREPARING FORMULATIONS FOR GASTROINTESTINAL-TARGETED THERAPIES
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申请号: US15768044申请日: 2016-10-11
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公开(公告)号: US20180311172A1公开(公告)日: 2018-11-01
- 发明人: Akhilesh Bhambhani , Robert K. Evans , Pranav Gupta , Ronald L. Smith , Donna M. Williams
- 申请人: Merck Sharp & Dohme Corp.
- 申请人地址: US NJ Rahway
- 专利权人: Merck Sharp & Dohme Corp.
- 当前专利权人: Merck Sharp & Dohme Corp.
- 当前专利权人地址: US NJ Rahway
- 国际申请: PCT/US16/56322 WO 20161011
- 主分类号: A61K9/50
- IPC分类号: A61K9/50 ; A61K9/00
摘要:
The present invention provides a process for preparing enterically-coated lyospheres comprising a therapeutic agent comprising: a.) providing lyospheres comprising the therapeutic agent; b.) coating said lyospheres with an enteric polymer coating composition; and c.) isolating said enterically-coated lyospheres. In other embodiments, the invention provides dosage forms comprising a lyosphere comprising an effective amount of a therapeutic agent and an enteric polymer coating. In some embodiments, the therapeutic agent in the process or dosage form is a polypeptide, a protein, a peptide, a lipopeptide, a glycoprotein, a fusion protein, a protein conjugate, a cytokine, an enzyme, an antibody, an oligonucleotide, a vaccine vector, small molecule, a live virus, an inactivated virus, a virus-like particle, a viral protein subunit, an adjuvant, microbiome, a prebiotic, a probiotic, or an ectobiotic. In some embodiments of the present invention, after oral administration the dosage forms containing the enterically-coated lyospheres provide a method of delivering a therapeutic agent to the ileum, ileo-caecal junction, colon or a combination thereof in a subject.
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