Bioresorbable controlled-release composition
AssigneeLidds AB
InventorsHans Lennernäs, Niklas Axén
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Abstract
A novel method for the preparation of a highly densified and at least partly, preferably fully or almost fully hydrated ceramic for use in the preparation of a pharmaceutical composition notably for controlled-release of one or more therapeutically, prophylactically and/or diagnostically active substance. The method involves a concomitant step of hydrating and densifying a bioresorbable and hydratable ceramic such as calcium sulphate. The invention also relates to compositions comprising such a highly densified ceramic. The pharmaceutical composition is useful for targeted and controlled local prolonged release of active substances, e.g. anti-cancer agents, whereby the spectrum and severity of side effects are minimized due to an optimized local concentration-time profile.
Claims46
A method for preparing a ceramic composition for controlled release of a pharmaceutically active substance, comprising the steps of:
- i) mixing one or more hydratable and bioresorbable ceramics with one or more pharmaceutically active substances,
- ii) densifying the mixture obtained in i) by applying an external pressure, and
- iii) hydrating the ceramic during the densification in step ii) by adding water to the resulting mixture from step i) in an amount corresponding to from about 20% to about 120% of the stoichiometric amount necessary to fully hydrate the one or more ceramics,
- whereby a highly densified and at least partly hydrated ceramic is obtained with a porosity of below 7%,
- wherein the applied external pressure in step ii) is of at least 20 MPa for at least 10 minutes.
Dependencies are inferred from the claim text.