Oral Formulations For Delivery of Catecholic Butanes Including Ndga Compounds
AssigneeErimos Pharmaceuticals LLC
InventorsRocio Alejandra Lopez, Jessica Andrea LoDuca Blomberg, Melissa Claire Rhodes, Jonathan Daniel Heller, Amanda Beth Goodman
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Abstract
The present invention provides for compositions, kits and methods for treatment of diseases, where the compositions contain catecholic butanes, including NDGA compounds, such as NDGA derivatives, for example tetra-O-methyl NDGA. The present invention also provides for solubilizing agents and excipients that are suitable for administration of the present compounds into animals via an oral route, whether in a liquid, semi-solid or solid form.
Claims91
A composition for oral administration to an animal comprising an active pharmaceutical ingredient and a pharmaceutically acceptable carrier, wherein the active pharmaceutical ingredient comprises a catecholic butane, and the carrier comprises at least one of a solubilizing agent and an excipient selected from the group consisting of:
- (a) a water-soluble organic solvent other;
- provided that when the water-soluble organic solvent is propylene glycol, the propylene glycol is in the absence of white petrolatum, in the absence of xanthan gum and in the absence of at least one of glycerine or glycine, when the water-soluble organic solvent is polyethylene glycol, the polyethylene glycol is present in the absence of ascorbic acid or butylated hydroxytoluene, and when the polyethylene glycol is polyethylene glycol 400, the polyethylene glycol 400 is present in the absence of polyethylene glycol 8000;
- (b) a cyclodextrin;
- (c) an ionic, non-ionic or amphipathic surfactant, provided that when the surfactant is a non-ionic surfactant, the non-ionic surfactant is present in the absence of xanthan gum;
- (d) a modified cellulose;
- (e) a water-insoluble lipid, provided that when the water-insoluble lipid is castor oil, the castor oil is present in the absence of beeswax or carnuba wax;
- and a combination of any of the carriers (a)-(e).
The method of claim 76, wherein the disease is obesity.
Dependencies are inferred from the claim text.