发明申请
- 专利标题: Stability Drying
- 专利标题(中): 稳定性干燥
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申请号: US12462855申请日: 2009-08-10
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公开(公告)号: US20100120014A1公开(公告)日: 2010-05-13
- 发明人: Victor Bronshtein
- 申请人: Victor Bronshtein
- 主分类号: C12N9/96
- IPC分类号: C12N9/96 ; C12N1/04 ; C12N5/02 ; A01N1/00
摘要:
A method of formulating high ambient temperature (room temperature and above) stable biologics (biologically active macromolecules, enzymes, serums, vaccines, viruses, pesticides, drug delivery systems, liposomes, cells suspensions, sperm, erythrocytes, other blood cells, stem cells, multicellular tissues, skin, heart valves) including secondary drying comprising at least two steps of stability drying at elevated temperature: 35° C., 40° C., 45° C., 50° C., and higher temperatures. The method could be applied to stabilize biologics encapsulated in alginate gel microspheres for better oral delivery. The method encompasses the following: microspheres are formulated using a cryo-encapsulation procedure comprised of mixing drops of frozen preservation mixture (To form the preservation mixture, biologics are mixed with preservation solutions containing sodium alginate.) with frozen drops of a calcium solution (i.e. calcium gluconate) and subsequent warming to form the gel particles.