Stable pharmaceutical compositions comprising duloxetine hydrochloride
Enteric-coated duloxetine hydrochloride compositions with a pellet core and HPMCAS-MF polymer, combined with neutralization, address nitrosamine impurity concerns, ensuring stability and effective drug release for treating major depressive disorder, diabetic neuropathy, and stress urinary incontinence.
Patent Information
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- SANTA FARMA ILAC SANAYII ANONIM SIRKETI
- Filing Date
- 2024-12-11
- Publication Date
- 2026-06-18
AI Technical Summary
Existing pharmaceutical compositions of duloxetine hydrochloride do not adequately address nitrosamine impurity levels, which are a concern due to their potential formation under acidic conditions, and there is a need for stable, delayed-release enteric-coated formulations that meet stringent international guidelines.
The development of enteric-coated pharmaceutical compositions with a pellet core, drug layer, separating layer, and enteric layer, using HPMCAS-MF as the enteric polymer, and employing neutralization with ammonium hydroxide to control acidic conditions, ensuring the composition remains stable and minimizes nitrosamine impurities.
The solution achieves a suitable nitrosamine impurity profile within acceptable limits, maintaining stability and ensuring complete drug release in gastrointestinal pH conditions, thereby addressing the challenge of nitrosamine formation and providing effective treatment for conditions like major depressive disorder, diabetic neuropathy, and stress urinary incontinence.
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