Sustained-released material prepared by dispersing a lyophilized polypeptide in an oil phase
AssigneeTakeda Chemical Industries, Ltd.
InventorsShigeyuki Takada, Tomofumi Kurokawa, Susumu Iwasa
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Abstract
A sustained-release preparation containing a bioactive polypeptide is prepared using a starting material containing a lyophilized product of an aqueous solution or suspension of the bioactive polypeptide in a non-ionic surfactant. The lyophilized product is dispersed in an oil phase, which further contains a biocompatible, biodegradable polymer.
Claims33
A method of producing a sustained-release preparation, which comprises the steps of:
- lyophilizing an admixture of a bioactive polypeptide and a non-ionic surfactant to obtain a lyophilized product, wherein said bioactive polypeptide is hormone or cytokine, and the hydrophile/lipophile balance of said non-ionic surfactant is not less than 10;
- dispersing said lyophilized product as a solid phase in an oil in water-type emulsion;
- and
- thereafter shaping the resulting dispersion.
An oil in water-type emulsion having an oil phase comprising a lyophilized product of an admixture of a non-ionic surfactant and a bioactive polypeptide selected from the group consisting of hormones and cytokines, said lyophilized product being dispersed in said oil phase, wherein
- the hydrophile/lipophile balance of said non-ionic surfactant is not less than 10.
A composition which is useful as a starting material for preparing a sustained-release preparation, said composition comprising an oil in water-type emulsion having an oil phase comprising a biocompatible polymer, and a lyophilized product of an aqueous solution or suspension comprising an admixture of a non-ionic surfactant and a bioactive polypeptide selected from the group consisting of hormones and cytokines, wherein said lyophilized product is dispersed in said oil phase and the hydrophile/lipophile balance of said non-ionic surfactant is not less than 10.
Dependencies are inferred from the claim text.