Solid compositions comprising a glp-1 agonist and a salt of n-(8-(2-hydroxybenzoyl) amino) caprylic acid
US-2018360918-A1 · Dec 20, 2018 · US
US10335369B2 · US · B2
| Field | Value |
|---|---|
| Publication number | US-10335369-B2 |
| Application number | US-201314386218-A |
| Country | US |
| Kind code | B2 |
| Filing date | Mar 15, 2013 |
| Priority date | Mar 22, 2012 |
| Publication date | Jul 2, 2019 |
| Grant date | Jul 2, 2019 |
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The invention relates to granules and pharmaceutical compositions comprising a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid and a lubricant obtained by mixing hereof for more than 5 minutes prior to granulation as well as processes for their preparation and use thereof in medicine.
Opening claim text (preview).
The invention claimed is: 1. A process of producing by dry granulation a granule comprising a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid and a lubricant, wherein said process comprises the steps: a) mixing said salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid and said lubricant for more than 5 minutes; and b) optionally roller compacting the mixture of step a, wherein the granule produced by said process does not contain a pharmaceutically active agent. 2. A process according to claim 1 , wherein the duration of said mixing in step a is at least 20 minutes. 3. A process according to claim 1 , wherein the amount of said lubricant is at least 0.25% (w/w) of said composition. 4. The process according to claim 3 , wherein the amount of said lubricant is at least 2.0% (w/w) of said composition. 5. The process according to claim 4 , wherein the amount of said lubricant is less than 10.0% (w/w) of said composition. 6. The process according to claim 5 , wherein the lubricant is magnesium stearate.
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