API's
Active Pharmaceutical Ingredients
Active Pharmaceutical Ingredients
Itopride HCl is a prokinetic agent combining dopamine D₂ receptor antagonism and acetylcholinesterase inhibition, used to treat gastrointestinal (GI) motility disorders such as functional dyspepsia, gastroparesis, nausea, bloating, heartburn, and regurgitation.
| Component | Function |
|---|---|
| Itopride 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 |
| Ethylcellulose (EC) | Sustained-release polymer (controls drug release) |
| Triethyl Citrate / PEG 6000 | Plasticizer (for coating flexibility) |
| 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.
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They are used in the treatment of gastrointestinal motility disorders such as functional dyspepsia, bloating, nausea, heartburn, and gastroparesis.
Yes, by adjusting polymer concentration, coating thickness, and solvent system, the release kinetics can be tailored to specific therapeutic requirements.
Studies show no significant drug–excipient interactions with common polymers like HPMC, EC, or MCC spheres, making them safe for formulation.
We provide COA (Certificate of Analysis), MSDS (Material Safety Data Sheet), Stability Data, and necessary regulatory support documents.