Pharmaceutical formulation of palbociclib and a preparation method thereof
First Claim
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1. A single amorphous solid dispersion, wherein the single amorphous solid dispersion comprises:
- palbociclib or a pharmaceutically acceptable salt thereof;
tartaric acid; and
a hydrophilic high-molecular weight material, wherein a mass ratio of the tartaric acid to the palbociclib or the pharmaceutically acceptable salt thereof ranges from 0.5;
1 to 5;
1, wherein the palbociclib and the tartaric acid are dispersed within the hydrophilic high-molecular weight material; and
wherein the palbociclib and tartaric acid are in an amorphous state.
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Abstract
The present invention belongs to the pharmaceutical field, and in particular, it relates to a pharmaceutical formulation of palbociclib and a preparation method thereof. The pharmaceutical formulation comprises palbociclib, an acidic auxiliary material, and optionally a hydrophilic high-molecular weight material, which has better solubility and in vitro dissolution property as compared with the conventional formulation and can be used for enhancing in vivo absorption and bioavailability of palbociclib.
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8 Claims
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1. A single amorphous solid dispersion, wherein the single amorphous solid dispersion comprises:
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palbociclib or a pharmaceutically acceptable salt thereof; tartaric acid; and a hydrophilic high-molecular weight material, wherein a mass ratio of the tartaric acid to the palbociclib or the pharmaceutically acceptable salt thereof ranges from 0.5;
1 to 5;
1, wherein the palbociclib and the tartaric acid are dispersed within the hydrophilic high-molecular weight material; and
wherein the palbociclib and tartaric acid are in an amorphous state. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8)
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Specification