Stable orally disintegrating pharmaceutical compositions
AssigneeDexcel Pharma Technologies Ltd.
InventorsVictor PEVZNER, Sheera MOSES-HELLER
Life of this patent
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Abstract
Described herein are stable orally disintegrating tablets containing a proton pump inhibitor, methods for making the same, and methods for treating subjects in need thereof. In particular, the orally disintegrating tablets are composed of a plurality of coated units admixed with a disintegrant that demonstrate decreased friability and increased hardness.
Claims25
A compressed orally disintegrating tablet comprising a disintegrant and a plurality of units comprising:
- i) a plurality of cores comprising a therapeutically effective amount of a proton pump inhibitor;
- ii) an enteric coating over the cores;
- and
- iii) a coating comprising a reverse enteric polymer over the enteric coating;
- wherein a friability of the compressed tablet is 0.75% or less when 10 kN to 50 kN of a compression force is applied during manufacturing of the tablet.
A compressed orally disintegrating tablet prepared by a process comprising the following steps:
- a) generating a plurality of cores comprising a therapeutically effective amount of a proton pump inhibitor;
- b) applying a solution or dispersion comprising an enteric polymer to the plurality of cores of step (a) thereby obtaining a plurality of enteric coated cores;
- c) applying a solution or dispersion comprising a reverse enteric polymer to the enteric coated cores of step (b) thereby obtaining a plurality of units;
- d) mixing the plurality of units of step (c) with at least one tablet excipient comprising a disintegrant thereby obtaining a blend;
- and
- e) compressing the blend of step (d) using a compression force of from 10 kN to 50 kN thereby obtaining the compressed orally disintegrating tablet having a friability of 0.75% or less.
A method for increasing a compressibility of a compressed orally disintegrating tablet comprising a disintegrant and a plurality of units comprising:
- i) a plurality of cores comprising a therapeutically effective amount of a proton pump inhibitor;
- and
- ii) an enteric coating over the cores;
- the method comprising the step of applying a coating comprising a reverse enteric polymer to the enteric coated cores,
- wherein the increased compressibility comprises one or more of a decreased friability or an increased hardness compared to a compressed orally disintegrating tablet not comprising a coating comprising a reverse enteric polymer when a substantially identical compression force is applied during manufacturing of the tablet.
Dependencies are inferred from the claim text.