Active Pharmaceutical Ingredients
Duloxetine Hydrochloride Delayed Release (DR) Pellets are designed to ensure targeted release of the active ingredient in the small intestine, thereby preventing degradation in the acidic environment of the stomach. Duloxetine is a serotonin-norepinephrine reuptake inhibitor (SNRI) widely used for the treatment of major depressive disorder, generalized anxiety disorder, neuropathic pain, fibromyalgia, and chronic musculoskeletal pain.
| Component | Function |
|---|---|
| Duloxetine Hydrochloride | Active Pharmaceutical Ingredient (API) |
| Sugar Spheres / MCC Spheres | Inert core or starter pellets |
| Hydroxypropyl Methylcellulose (HPMC) | Binder / Film former during layering |
| Talc / Colloidal Silicon Dioxide | Anti-adherent / Glidant |
| Eudragit L100-55 / Eudragit S100 | Enteric coating polymer – Delayed release |
| Triethyl Citrate / PEG 6000 | Plasticizer (for polymer coating) |
| Purified Water | Solvent (removed after processing) |
Outsourcing pellets through a trusted partner like Salius Pharma can be a strategic decision to save both time and resources, without compromising on quality or compliance. Instead, partnering with Salius Pharma—a leading distributor aligned with USFDA-approved and WHO-GMP-certified manufacturers in India—allows you to leverage high-quality products, seamless logistics, and professional support under one roof.
We ensure prompt and reliable shipping worldwide. Delivery times may vary depending on destination, order volume, and regulatory requirements.
Looking to source Duloxetine HCl DR Pellets or other high-quality pharmaceutical pellet formulations?
Whether you need Active Pharmaceutical Ingredients (APIs), excipients, or regulatory support, our team is ready to provide reliable, compliant, and cost-effective solutions tailored to your market needs.
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Any patented products are excluded from our offerings in regions where such patents are currently in force.
Pelletized formulations allow multiarticulate drug delivery, which improves GI distribution, reduces dose dumping risk, and offers more consistent plasma concentrations compared to monolithic capsules or tablets.
Regulatory variations across regions (e.g., US-FDA, EMA, CDSCO) require tailored documentation on stability, bioequivalence, and excipient safety. Customs clearance for APIs with CNS action may also need additional approvals.
Key tests include dissolution profiling at multiple pH levels, particle size distribution, assay by HPLC, coating integrity, and stability under accelerated conditions.
We provide COA (Certificate of Analysis), MSDS (Material Safety Data Sheet), Stability Data, and necessary regulatory support documents.