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US 12,582,717 B2Granted
Protein based excipient for active pharmaceutical ingredients
AssigneeDispersome IP APS
InventorsBjorn Vergauwen, Guy Van De Mooter
Life of this patent
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Abstract
Provided herein is a pharmaceutical formulation comprising a protein based excipient in combination with an active pharmaceutical ingredient (API) wherein said formulation is substantially amorphous and form a substantially homogenous mixture; and further a method for producing said pharmaceutical formulation; and said pharmaceutical formulation for use as a medicament.
Claims20
A formulation comprising:
- a whey protein based excipient obtained from a whey protein composition or a hydrolysate thereof which comprises whey protein monomers of at least 100 amino acids in length;
- and
- a Class II or Class IV active pharmaceutical ingredient (API) according to the biopharmaceutics classification system;
- wherein said whey protein based excipient and said API form a homogenous and amorphous solid dispersion wherein said whey protein based excipient and said API are both completely amorphous, as verified by X-ray powder diffraction (XRD) and form a completely homogenous mixture, as verified by differential scanning calorimetry (DSC), and
- wherein the mass ratio (w/w) of said API to said whey protein based excipient is between at least 10% API and at most 90% whey protein based excipient (10/90) to at most 40% API and at least 60% whey protein based excipient (40/60).
2 more elements
Dependencies are inferred from the claim text.