Long Acting Injectable Formulations
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United States of America Patent
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Issued Date -
Jul 13, 2017
app pub date -
Oct 24, 2016
filing date -
Jan 8, 2016
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Abstract
The invention relates to extended-release formulations comprising: (i) a poorly water-soluble active pharmaceutical ingredient; and (ii) a non-aqueous liquid vehicle comprising (a) a hydrophobic lipid comprising a glyceryl ester of a C6-C24 fatty acid, or (b) a hydrophilic organic compound selected from the group consisting of polyethylene glycol, propylene glycol, glycerin, and dimethylsulfoxide, or (c) a combination of (a) and (b), and (iii) an amphiphilic agent wherein the active pharmaceutical ingredient is dispersed as discrete particles having a D90 particle size of about 0.5 μm to about 25 μm in the formulation, and wherein the formulation is non-gelling and thixotropic with a viscosity of less than 10 poise at a shear rate of 10/s at 25° C.
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