Nanostructure lipid system
AssigneesUniversidade De Santiago De Compostela, Servizo Galego De SAúDe, FundacióN Instituto De InvestigacióN Sanitaria De Santiago De Compostela (Fidis)
InventorsJosé Víctor Álvarez González, Francisco Javier Otero Espinar, Mª Luz Couce Pico, Asteria Luzardo Álvarez, Cristobal Colón Mejeras, MªRosaura Leis Trabazo
Life of this patent
Estimating the term…
Abstract
The present invention is related to systems of administration of enzymes or other proteins, preferably for use in enzyme replacement therapy (ERT), in particular for the treatment of Lysosomal diseases. In particular, the invention encompasses the preparation of a composition based on nanostructured lipid systems and its use in the manufacture of a therapeutic product.
Claims13
A lipid nanostructured system which comprises nanoparticles which in turn comprise:
- a. a gelled core comprising an aqueous dissolution, solution or dispersion comprising a temperature responsive polymer that becomes a gel as a function of the temperature, and which further comprises one or more enzymes or other proteins immobilized in the core;
- b. a lipid layer coating the inner core comprising a mixture of:
- i. a solid lipid, which is solid or waxy at 25° C. and a pressure of 1 atm, comprising fatty acids, with a fusion process that begins at temperatures above 35° C., as determined by differential scanning calorimetry (DSC), with a hydrophilic-lipophilic balance (HLB) value lower than 10 and densities between 0.8 and 1 g/cm3, or a mixture of the solid lipids, and
- ii. a liquid lipid which behaves as a liquid at 25° C. and a pressure of 1 atm, constituted by fatty acids with a fusion process that begins at temperatures below 30° C., as determined by differential scanning calorimetry (DSC), and densities ranging from 0.88 to 0.97 g/cm3,
- where the mixture of liquid lipid and solid lipid presents a fusion process that begins at temperatures between 20° C. and below 50° C. as determined by differential scanning calorimetry (DSC), wherein the solid lipid and liquid lipid are mixed in a ratio of liquid lipid to solid lipid of 98:2 to 1:99%, wherein the ratio is expressed as a percentage by weight of solid lipid and liquid lipid with respect to the total lipid composition of the lipid layer coating the inner core;
- wherein the lipid layer also comprises lipid soluble or dispersible surfactants;
- wherein the lipid soluble or lipid dispersible surfactants, are selected from molecules surface-active with HLB values lower than 10;
- and
- c. a pegylated coating of the lipid layer that also comprises water soluble or water dispersible surfactants, wherein said pegylated coating comprises polyethylene glycol (PEG), or PEG esters, and the water soluble or water dispersible surfactants have a HLB greater than 10.
Dependencies are inferred from the claim text.