Back to results
US 2010/0168035 A1Published application
Subcutaneous implants containing a degradation-resistant polylactide polymer
AssigneeHexal AG
InventorsAnna Sendl-Lang, Kai-Thomas Kramer, Gregor Schütz
Life of this patent
Estimating the term…
Abstract
The present invention refers to compositions comprising a LH-RH-analogue and/or pharmaceutically acceptable salts thereof in a low-dose and a degradation-resistant polylactide suitable for the preparation of subcutaneous implants. Sterilisation of the polylactide via gamma-radiation as well as temperature stress result in a negligible decomposition of less than 1000 Dalton.
Claims19
A monolithic implant comprising;
- (i) a luteinizing hormone releasing hormone analogue or a pharmaceutically acceptable salt thereof in an amount of less than 25% per weight of the total composition;
- and
- (ii) a homogenous polylactide polymer that is resistant to degradation caused by gamma-radiation and/or temperature stress, wherein the degradation-resistant polylactide polymer shows a degree of decomposition of less than 1000 Dalton relative to the weight-average molecular weight of the polymer after gamma-irradiation is performed with an irradiation dose of between about 25 and 40 kGy of ionizing gamma-radiation and/or wherein the degradation-resistant polylactide polymer shows a degree of decomposition of less than 1000 Dalton relative to the weight-average molecular weight of the polymer after temperature stress, at a temperature of about 30° C. over a period of at least 24 months.
Dependencies are inferred from the claim text.