About: Industrial microfluidization of liposomal and hydrophobic drug formulations     Goto   Sponge   NotDistinct   Permalink

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Description
  • We will focus gathered opinion of partners to develop industrial microfludization to prepare liposomal gel form drug formulation for hydrophobic hydroxy-aluminum phthalocyanine, already patented in its laboratory form for photodynamic therapy of tumors in dermatology, head and neck cancer and for colorectal carcinoma. In the first stage semi-industrial scale of first non=sterile and later sterile production will be developed and resulting preparations will be tested by experimental photodynamic therapy of human tumors xenotransplanted to nude mice while in the later stage full mature industrial professional production based on the Good Manufacture Practice procedures and quality controls will be developed. Resulting formulations will be not only tested but also described in Drug Master File for application of clinical testing in the National authority. (en)
  • Navrhovaný projekt bude soustředit dosavadní znalosti a zkušenosti partnerů do experimentálního vývoje průmyslové přípravy gelové liposomální lékové formy ftalocyaninu hydroxyhlinitého pro fotodynamickou terapii zhoubných nádorů, a to v zařízeních firmy Wake, spol. s r.o., pobočce v Rokycanech, kde byly zbudovány nové čisté prostory splňující všechny příslušné normy a akreditace Státního ústavu pro kontrolu léčiv (SÚKL). Po optimalizovaném experimentálním vývoji bude sepsán tzv. Drug Master File a bude podána žádost u SÚKL o klinická testování a registraci účinné látky a její lékové formy jako léčiva.
Title
  • Industrial microfluidization of liposomal and hydrophobic drug formulations (en)
  • Průmyslová mikrofludizace liposomálních a hydrofóbních lékových forem
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  • TA01010781
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  • Drug formulation development Photodynamic therapy of tumors Liposomal gel drug formulations Industrial microfludization (en)
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