US 2026/0263349 A1 · DELAYED TIMED RELEASE PHARMACEUTICAL COMPOSITION, PREPARATION METHOD THEREFOR, AND USE THEREOF

Abstract

A delayed timed release pharmaceutical composition, a preparation method therefor, and use thereof. The pharmaceutical composition comprises a tablet core. The tablet core comprises a drug-containing layer and a boosting layer stacked on the drug-containing layer. The drug-containing layer comprises a drug active ingredient. The drug active ingredient is levodopa or a derivative thereof, or a mixture of levodopa or a derivative thereof and a DOPA decarboxylase inhibitor, and accounts for 5-72.5 wt % of the content of the drug-containing layer. The pharmaceutical composition is a capsule-shaped tablet, can realize the effects of 1-3 h delayed release of the drug active ingredient and reaching a peak concentration at 6-10 h, can be used for reducing morning stiffness in patients with Parkinson's disease, and has good application prospects.

Claims23

Dependent claims

A delayed timed release pharmaceutical composition, wherein the dosage form of the pharmaceutical composition is a controlled-release tablet;

the pharmaceutical composition comprises an active pharmaceutical ingredient, and the active pharmaceutical ingredient is levodopa or a derivative thereof, or a mixture of “levodopa or a derivative thereof” and a dopa decarboxylase inhibitor;
the release characteristics of the composition are:
before starting to release, the active pharmaceutical ingredient has a time lag of 1-3 hours;
after starting to release, the active pharmaceutical ingredient has a cumulative release rate of 85% or more in 6-10 hours;
when the active pharmaceutical ingredient is a mixture of “levodopa or a derivative thereof” and a dopa decarboxylase inhibitor, the content of the dopa decarboxylase inhibitor is ≤7.5 wt %, but not 0, and the content is the weight percentage of this component in a drug-containing layer.

2 more elements

A pharmaceutical composition, wherein the pharmaceutical composition comprises a tablet core, and the tablet core comprises a drug-containing layer and a push layer stacked on the drug-containing layer;

the drug-containing layer comprises an active pharmaceutical ingredient;
in the drug-containing layer, the content of the active pharmaceutical ingredient is 5-72.5 wt %, and the content is the weight percentage of the active pharmaceutical ingredient in the drug-containing layer;
in the drug-containing layer, the active pharmaceutical ingredient is levodopa or a derivative thereof, or a mixture of “levodopa or a derivative thereof” and a dopa decarboxylase inhibitor;
when the active pharmaceutical ingredient is a mixture of “levodopa or a derivative thereof” and a dopa decarboxylase inhibitor, the content of the dopa decarboxylase inhibitor is ≤7.5 wt % but not 0, and the content is the weight percentage of this component in the drug-containing layer;
the dosage form of the pharmaceutical composition is a capsule-shaped tablet.

2 more elements

Dependencies are inferred from the claim text.

Delayed timed release pharmaceutical composition, preparation method therefor, and use thereof

Life of this patent

Delayed timed release pharmaceutical composition, preparation method therefor, and use thereof

Life of this patent

Abstract

Claims23