Modified release orally administered amino acid formulations
AssigneeAPR Applied Pharma Research S.A.
InventorsAlberto Reiner, Giorgio Reiner
Life of this patent
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Abstract
Methods and formulations of modified release amino acids are provided for the treatment or management of diseases defined by impaired amino acid metabolism, with improved pharmacokinetics, metabolism and utilization.
Claims21
An orally administered amino acid formulation comprising:
- a) one or more modified release amino acids;
- b) hydroxymethylpropyl cellulose or ethylcellulose or a combination thereof integrally mixed with said amino acids;
- or
- c) a coating on said modified release amino acids comprising ethylcellulose or a combination of ethylcellulose and glyceryl dibehenate;
- wherein the formulation comprising 2 g of the modified release amino acids comprises a release profile releasing no more than 70% of the modified release amino acids in 30 minutes of dissolution testing performed in a <711> USP 39 NF 34, paddle apparatus, at 37° C., in 450 or 500 mL, 0.1 N hydrochloric acid (pH 1.2), paddle speed 50 rpm, and said modified release is defined by said release profile.
An orally administered amino acid formulation comprising one or more modified release amino acids wherein the formulation comprising 2 g of the modified release amino acids comprises a release rate releasing no more than 70% of the modified release amino acids in 30 minutes of dissolution testing performed in a <711> USP 39 NF 34, paddle apparatus, at 37° C., in 450 or 500 mL, 0.1 N hydrochloric acid (pH 1.2), paddle speed 50 rpm, wherein said modified release is defined by said release profile, wherein the modified release amino acids are granulates coated by from 5 wt % to 25 wt % of one or more release modifying excipients based on the weight of the amino acids, wherein each of the granulates comprise a plurality of modified release amino acids, and wherein said formulation comprises:
- a) hydroxymethylpropyl cellulose or ethylcellulose or a combination thereof integrally mixed with said amino acids;
- or
- b) a coating on said modified release amino acids comprising ethylcellulose or a combination of ethylcellulose and glyceryl dibehenate.
An orally administered amino acid formulation comprising one or more modified release amino acids wherein the formulation comprising 2 g of the modified release amino acids comprises a release profile releasing no more than 70% of the modified release amino acids in 30 minutes of dissolution testing performed in a <711> USP 39 NF 34, paddle apparatus, at 37° C., in 450 or 500 mL, 0.1 N hydrochloric acid (pH 1.2), paddle speed 50 rpm, wherein said modified release is defined by said release profile, wherein the modified release amino acids are granulates coated by from 5 wt % to 25 wt % of one or more release modifying excipients based on the weight of the amino acids, and wherein each of the granulates comprise a plurality of modified release amino acids, further comprising one or more release modifying excipients selected from ethylcellulose and a combination of ethylcellulose and glyceryl dibehenate.
Dependencies are inferred from the claim text.