Active Pharmaceutical Ingredients
Venlafaxine Hydrochloride Sustained-Release (SR) Pellets are multiparticulate oral dosage forms engineered for the gradual and controlled release of Venlafaxine HCl, a serotonin-norepinephrine reuptake inhibitor (SNRI) used in the treatment of major depressive disorder (MDD), generalized anxiety disorder (GAD), and panic disorder. These SR pellets maintain consistent plasma drug levels, reduce dosing frequency (once or twice daily), and minimize peak-related side effects such as nausea, dizziness, and hypertension.
| Component | Function |
|---|---|
| Venlafaxine Hydrochloride (USP/BP/EP) | Active Pharmaceutical Ingredient (API) |
| Microcrystalline Cellulose (MCC) (USP/EP) | Pellet core former / spheronization agent |
| Lactose Monohydrate (USP/EP) | Filler / Diluent for weight uniformity |
| Hydroxypropyl Methylcellulose (HPMC) | Matrix polymer to regulate release |
| Ethyl Cellulose Aqueous Dispersion (USP) | Sustained-release coating agent (e.g., Surelease®) |
| Glycerol Monostearate (USP) | Lipophilic release modifier |
| Magnesium Stearate (USP / EP) | Lubricant / anti-adherent during processing |
| Talc (USP / EP) | Anti-adherent during coating |
| Colloidal Silicon Dioxide (USP / EP) | Glidant and moisture scavenger |
| Purified Water (USP / EP) | Processing solvent (evaporated during drying) |
Salius Pharma manufactures Venlafaxine HCl SR Pellets using advanced extrusion-spheronization and fluid-bed coating technologies in USFDA-approved, WHO-GMP, and ISO-certified facilities. Our pellets exhibit:
• Excellent content uniformity
• Customizable drug release profiles
• Robust mechanical strength for capsule or tablet formulation
• Low intra- and inter-batch variability
With an established regulatory footprint in Africa, LATAM, MENA, and South/Southeast Asia, Salius provides:
• CTD dossiers
• CoA, COPP, and GMP certifications
• Stability data (Zone IVB compliant)
making us a trusted CDMO or formulation partner for global SR antidepressant products.
We ensure prompt and reliable shipping worldwide. Delivery times may vary depending on destination, order volume, and regulatory requirements.
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Venlafaxine HCl SR Pellets are used in the treatment of major depressive disorder, generalized anxiety disorder, panic disorder, and social anxiety disorder, where sustained drug delivery is required.
The sustained-release design helps reduce peak plasma fluctuations, minimizes side effects, and improves patient adherence by allowing once-daily dosing.
Yes. They are manufactured under GMP-compliant systems, tested for dissolution, content uniformity, and stability, and meet international quality standards required for export.