Controlled release systems for polymers
OwnerSidney Pestkainventor
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Abstract
The present invention relates to controlled release delivery of biologically active molecules from a solid composition prepared by exposure of the molecules to an organic compound. For instance, the organic compound is an organic solvent, such as an alcohol (e.g., preferably a lower alcohol, such as methanol, ethanol, isopropanol, n-propanol, n-butanol, isobutanol, t-butanol, etc.), a mixture of alcohols, an aldehyde, a ketone, a hydrocarbon (saturated or unsaturated), or an aromatic hydrocarbon. The solvent can be a mixture of different organic solvents, or the resulting formulation can be a mixture of, e.g., different lyophilized preparations, such as may be used to control the release profile of the resulting admixture.
Claims25
A slow release formulation comprising one or more biologically active molecules from a solid composition prepared by exposure of the biologically active molecules to an organic solvent under conditions wherein a precipitate, lyophilate or crystal is formed.
A slow release formulation comprising precipitate, lyophilate or crystals of a polypeptide prepared by exposure of the polypeptide to an organic solvent, which polypeptide is released from the formulation in aqueous solution for a period of at least 7 days.
A formulation comprising precipitate, lyophilate or crystals of a biologically active polypeptide prepared by exposure of the polypeptide to a polar protic organic solvent, which formulation, when administered to a patient, releases said polypeptide at a rate providing an average steady state dosage of at least the ED50 for the polypeptide for a period of at least 7 days.
A formulation comprising a precipitate or lyophilate of a polypeptide, which precipitate or lyophilate includes at least 50 percent (molar) polar protic organic solvent(s), and which formulation, when administered to a patient, releases said polypeptide at a rate providing an average steady state dosage of at least the ED50 for the polypeptide for a period of at least 7 days.
A method method for manufacturing a slow release formulation of a biologically active molecule, comprising (a) exposing said biologically active molecules to an organic solvent, and (b) forming a precipitate, lyophilate or crystal.
Dependencies are inferred from the claim text.