Orlistat Pellets Manufacturer India

Orlistat Pellets (CAS No: 96829-58-2) — Pharmaceutical Multiparticulates

Orlistat Pellets are pharmaceutical pellets manufactured from Orlistat (C₂₉H₅₃NO₅, MW ≈495.7), a gastrointestinal/pancreatic lipase inhibitor used in weight-management formulations. The drug substance is a white to almost-white powder or crystalline solid with a melting point of 43°C–47°C, is insoluble in water, and is soluble in chloroform and readily soluble in ethanol — properties that make particle-size control and moisture protection especially important during pellet manufacture. Swapnroop Drugs and Pharmaceuticals manufactures Orlistat Pellets at its WHO-GMP certified Aurangabad, Maharashtra facility for pharmaceutical formulators across India and export markets.

Formulation Approach
Given Orlistat's low melting point (43–47°C) and water-insolubility, pellet manufacturing typically involves controlled-temperature processing (drug-layering or granulation) to avoid softening/agglomeration of the API during coating, along with lipophilic-drug-appropriate dissolution-enhancement strategies where needed.

Key Features

• Multiparticulate pellet form of a low-melting-point lipase-inhibitor API
• Requires temperature-controlled manufacturing due to the 43–47°C melting range
• Suitable for hard-gelatin capsule filling and multiparticulate dosage-form development
• WHO-GMP manufactured with full batch documentation

Applications

• Weight-management / anti-obesity capsule formulations
• Multiparticulate oral dosage-form development for lipophilic, low-melting-point actives
• Generic ANDA/CTD dossier programs

Why Choose Swapnroop for Orlistat Pellets?

• WHO-GMP certified facility experienced with temperature-sensitive/low-melting-point API processing
• Full CoA, MSDS, DMF-grade documentation for USFDA, EMA, and CDSCO submissions

FAQs

• Why does Orlistat's low melting point matter for pellet manufacturing? At 43–47°C, Orlistat can soften well below typical fluid-bed drying/coating temperatures, so process temperature control is critical to avoid pellet agglomeration or drug migration.
• Is Orlistat water-soluble? No — it is insoluble in water, soluble in chloroform, and easily soluble in ethanol.

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