Jagotec Ag

Biogram Ab

Stratosphere Pharma Ab

Monica Jönsson

Timo Laakso

Mats Reslow

Nils Ove Gustavsson

Nils-Ove Gustafsson

Nils Ove Gustafsson

Per Berdén

Sören Björn

Jörn Drustrup

Karin Larsson

Process for producing parenterally administrable cores. The cores are intermediates suitable for manufacturing sustained release preparations. Microcapsules incorporating a core and a shell and pharmaceutical compositions incorporating such cores and microcapsules are also provided.

Cores and microcapsules suitable for parenteral administration as well as process for their manufacture

Production of purified, parenterally administrable starch by washing starch containing more than 85% amylopectin in order to remove surface-localized proteins, lipids and endotoxins, dissolving the starch in aqueous medium, molecular weight reduction by shearing, and optionally removal of residual water-soluble proteins, preferably by anion exchange chromatography. Purified starch and microparticles based on such starch.

Pharmaceutically acceptable starch

A process for producing parenterally administrable microparticles, in which an at least 20% by weight aqueous solution of purified amylopectin-based starch of reduced molecular weight is prepared, the solution is combined with biologically active substance, an emulsion of starch droplets is formed in an outer phase of polymer solution, the starch droplets are made to gel, and the gelled starch particles are dried. A release-controlling shell is optionally also applied to the particles. Microparticles which essentially consist of said starch, have an amino acid content of less than 50 &#x3bc;g and have no covalent chemical cross-linking.

Microparticles

A parenterally administrable, biodegradable microparticle preparation containing a biologically active substance which, during the first 24 hours after injection, exhibits a release of the active substance that is less than 25% of the total release, determined from a concentration-time curve in the form of the ratio between the area under the curve during the said first 24 hours and the total area under the curve in question

Microparticle preparation

A process for producing microparticles, in which an aqueous solution of purified amylopectin-based starch of reduced molecular weight is prepared, the solution is combined with biologically active substance, an emulsion of starch droplets is formed in an outer phase of polymer solution, the starch droplets are made to gel, the gelled starch particles are dried, and a release-controlling shell is optionally applied to the particles, wherein at least one buffer substance having the ability of keeping the pH of the produced microparticles above 3 if exposing the microparticles to an aqueous evironment is added at any stage during the process. Microparticles which essentially consist of said starch, have an amino acid content of less than 50 &#x3bc;g and have no covalent chemical cross-linking and which have the aktivity of keeping the pH above 3 if exposed to a aqueous environment.

Growing community of inventors

Bara, Sweden

Monica Jönsson