Duloxetine
Enteric-coated pellets formulated for serotonin-norepinephrine reuptake inhibitor therapies addressing depression, neuropathic pain, and generalized anxiety disorders.
Product overview
Duloxetine Pellets – Precision-Crafted for Reliable SNRI Performance. Rraynex’s duloxetine pellets are formulated to deliver consistent serotonin-norepinephrine reuptake inhibition (SNRI) through advanced enteric protection and precision-engineered layering. Designed for stability, uniformity, and optimal bioavailability, these pellets ensure predictable release profiles in the intestinal tract—empowering manufacturers to build high-performance antidepressant and neuropathic pain formulations. Overview: Duloxetine hydrochloride is a dual-action antidepressant that modulates both serotonin and norepinephrine pathways to treat major depressive disorder, generalized anxiety disorder, and neuropathic pain. Our pelletised form enhances stability, reduces gastric degradation, and delivers reliable absorption—ideal for controlled-release capsule and tablet applications. Key Features & Benefits: • Controlled Release Design: Enteric coatings delay release until intestinal pH levels, ensuring gastric protection and steady absorption. • Uniform Pellet Density: Precision spheronisation and solvent layering guarantee consistent pellet morphology and low friability. • Real-Time Process Analytics: Continuous monitoring of moisture, assay, and coating thickness ensures batch-to-batch reproducibility. • High Purity & Low Impurities: Pharmacopeial-grade duloxetine hydrochloride processed under stringent GMP and PAT frameworks. • Versatile Applications: Compatible with capsule filling, multiparticulate tablets, or film-coated dosage forms. • Data-Driven Validation: Comparative dissolution, impurity profiles, and accelerated stability data across climatic zones included. Technical Specifications: • API: Duloxetine Hydrochloride • Assay: 98.0–102.0% • Pellet Size Range: 500–1000 μm (customizable) • Enteric Polymer: Methacrylic Acid Copolymers or HPMC-based systems • Loss on Drying: ≤1.5% • Packaging: 25 kg HDPE drum with inner liner or nitrogen-flushed bags for clinical batches • Storage: Store below 25°C, protected from moisture and direct sunlight. Applications: • Pharmaceutical manufacturers producing antidepressant or neuropathic pain formulations. • Contract development and manufacturing organizations (CDMOs) seeking SNRI pellet solutions. • R&D teams developing controlled-release or enteric-coated psychiatric formulations. Educational Insight: Duloxetine works by inhibiting the reuptake of serotonin and norepinephrine, enhancing neurotransmitter balance in the brain. Its enteric-protected pellet form prevents early degradation in gastric acid, allowing targeted release in the small intestine for improved therapeutic consistency and reduced side effects. SEO Keywords: duloxetine pellets, duloxetine hydrochloride pellets, SNRI pellets, antidepressant pellets, neuropathic pain pellets, enteric coated duloxetine, controlled release duloxetine, duloxetine API pellets, pharmaceutical pellets manufacturer, antidepressant raw material supplier Usage Note: For pharmaceutical manufacturing and educational reference only. End-use medications containing duloxetine should be used strictly under medical supervision. Manufacturers are advised to validate formulation performance according to pharmacopeial standards before commercialization.
Technical specifications
- Grade
- IP / BP / USP / EP
- Type
- Pellets
- Category
- SNRI
- Pack size
- 25/50 kg
- Available strengths
- 20 mg, 30 mg, 60 mg
- Certifications
- WHO-GMP, ISO 9001, ISO 14001
