Active ingredient containing stabilised solid forms and method for the production thereof
AssigneeLosan Pharma GmbH
InventorsPeter Gruber, Dirk Spickermann
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Abstract
The invention relates to solid medicinal forms containing at least one active ingredient and at least one pharmaceutically compatible, water soluble drying agent which is selected from the group consisting of trimagnesium dicitrate and/or calcium chloride, the solid medicinal form having a drying loss of at most 6% and a relative equilibrium moisture content of 25% or less. The invention also relates to solid medicinal forms containing a moisture-sensitive active ingredient and trimagnesium dicitrate.
Claims8
A non-effervescent solid medicinal form comprising a hydroxypropylmethylcellulose (HPMC) capsule filled with a capsule filling comprising:
- a. 30 to 40% by weight of a moisture-sensitive active ingredient, wherein said active ingredient is not trimagnesium dicitrate;
- b. 20 to 50% by weight of trimagnesium dicitrate acting as a drying agent that stabilizes the moisture sensitive agent against hydrolysis during storage;
- and
- c. 5 to 30% by weight of a microcrystalline cellulose;
- wherein said medicinal form exhibits a drying loss, measured at 120° C./30 min, of 0.5 to 2.5% and a relative equilibrium moisture, measured at 25° C., of at most 15%.
Dependencies are inferred from the claim text.