Storage-stable dust-free homogeneous particulate formulation
AssigneeBASF SE
InventorsFelicitas Guth, Karl Kolter, Michael Schönherr, Michael Klemens Müller
Life of this patent
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Abstract
Described is a storage-stable dust-free homogeneous particulate formulation. The formulation consists of (a) at least one water-soluble Vitamin E-derivative, (b) at least one hydrophilic polymer, (c) optionally additional surface-active substances, and (d) optionally additional pharmaceutical additives. The sum of (a), (b), (c) and (d) equals 100% by weight of the formulation. The fines fraction with particle diameters of less than 100 μm is less than 10% by weight. Describe also is a process for manufacturing the formulation, and use of the formulation as a solubilizing composition in pharmaceutical formulations.
Claims21
A storage-stable dust-free homogeneous spray-dried agglomerated formulation, consisting of:
- (a) at least one water-soluble Vitamin E-derivative;
- and
- (b) at least one hydrophilic polymer;
- with the proviso, that the sum of (a) and (b) equals 100% by weight of the formulation,
- wherein a fines fraction of the agglomerated formulation is less than 10% by weight with a particle diameter of less than 100 μm,
- wherein the agglomerated formulation is free of organic solvents, and
- wherein the agglomerated formulation is an agglomerate produced by a spray drying agglomeration process.
A storage-stable dust-free homogeneous spray-dried agglomerated formulation, consisting of:
- (a) at least one water-soluble Vitamin E-derivative;
- (b) at least one hydrophilic polymer;
- and
- (c) at least one surface-active substance selected from the group consisting of polyalkylene glycol fatty acid esters, polyalkylene glycol fatty alcohol ethers, polyalkylene glycols, poloxamers, polyalkylene glycol glycerides, and alkylene glycol fatty acid mono- and diesters;
- with the proviso, that the sum of (a), (b), and (c) equals 100% by weight of the formulation,
- wherein the at least one surface-active substance is present in the formulation in an amount up to 15% by weight of the formulation,
- wherein a fines fraction of the agglomerated formulation is less than 10% by weight with a particle diameter of less than 100 μm,
- wherein the agglomerated formulation is free of organic solvents, and
- wherein the agglomerated formulation is an agglomerate produced by a spray drying agglomeration process.
A storage-stable dust-free homogeneous spray-dried agglomerated formulation, consisting of:
- (a) at least one water-soluble Vitamin E-derivative;
- (b) at least one hydrophilic polymer;
- (c) at least one surface-active substance selected from the group consisting of polyalkylene glycol fatty acid esters, polyalkylene glycol fatty alcohol ethers, polyalkylene glycols, poloxamers, polyalkylene glycol glycerides, and alkylene glycol fatty acid mono- and diesters;
- and
- (d) at least one pharmaceutical additive selected from the group consisting of antioxidants, chelating agents, colorants, flavors, fillers, stabilizers, preservatives, and biocides;
- with the proviso, that the sum of (a), (b), (c), and (d) equals 100% by weight of the formulation,
- wherein the at least one surface-active substance is present in the formulation in an amount up to 15% by weight of the formulation,
- wherein the at least one pharmaceutical additive is present in the formulation in an amount up to 15% by weight of the formulation,
- wherein a fines fraction of the agglomerated formulation is less than 10% by weight with a particle diameter of less than 100 μm,
- wherein the agglomerated formulation is free of organic solvents, and
- wherein the agglomerated formulation is an agglomerate produced by a spray drying agglomeration process.
Dependencies are inferred from the claim text.