Duloxetine enteric-coated pellet and compound formulation and preparation method therefor
By optimizing the structure and materials of the double-layer enteric coating, the problem of dose dumping of duloxetine enteric-coated formulations in the presence of ethanol was solved, achieving stable drug release and low impurity generation, thereby improving bioavailability and therapeutic efficacy.
WO2025242110A1PCT designated stage Publication Date: 2025-11-27AC PHARMA CO LTD
Patent Information
- Application Number
- PCT/CN2025/096173
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2025-05-14
- Filing Date
- 2025-05-21
- Publication Date
- 2025-11-27
Smart Images
Figure PCTCN2025096173-FTAPPB-I100001 
Figure PCTCN2025096173-FTAPPB-I100002 
Figure PCTCN2025096173-FTAPPB-I100003
Abstract
A duloxetine enteric-coated pellet and a compound formulation and a preparation method therefor. The enteric-coated pellet contains a drug-loaded pellet core, an enteric inner layer, and an enteric outer layer. The enteric outer layer contains hydroxypropyl methylcellulose phthalate (HPMCP), wherein the HPMCP constitutes 55.6-90.9% of the mass of the enteric outer layer; and the HPMCP is soluble in a medium with a pH value of 5.0 or more, or 5.5 or more. By means of optimizing the types of ethanol-dumping resistant materials and the weight gain of the enteric layers, the duloxetine enteric-coated pellet and the compound formulation thereof achieve a balance between an ethanol-dumping resistance effect and a desirable dissolution rate, and exhibit low impurity levels generated within 2 hours in a weakly acidic dissolution medium with a pH of 5.0 or less.
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Citation Information
Patent Citations
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