Active Pharmaceutical Ingredients
Dabigatran Etexilate Mesylate IR (Immediate Release) Pellets are an oral anticoagulant formulation designed for rapid drug release and absorption. Dabigatran is a prodrug that, once converted to its active form (dabigatran), acts as a direct thrombin inhibitor, preventing clot formation. The IR pellet form ensures fast onset of action, making it suitable for customized formulations, capsules, or sachets.
| Component | Function |
|---|---|
| Dabigatran Etexilate Mesylate | Active Pharmaceutical Ingredient (API) |
| Sugar Spheres / MCC Spheres | Inert core or starter pellets |
| Hydroxypropyl Methylcellulose (HPMC) / Povidone | Binder / Film former during layering |
| Talc / Colloidal Silicon Dioxide | Anti-adherent / Glidant |
| Hypromellose Phthalate (HPMCP) or similar polymer | Coating polymer for immediate release |
| Polyethylene Glycol (PEG) / Triethyl Citrate | Plasticizer to enhance film 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.
We ensure prompt and reliable shipping worldwide. Delivery times may vary depending on destination, order volume, and regulatory requirements.
Looking to source Dabigatran Etexilate Mesylate IR 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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Dabigatran itself has poor oral bioavailability. Converting it into the prodrug (Dabigatran Etexilate Mesylate) enhances lipophilicity, allowing efficient absorption from the gastrointestinal tract.
Co-formulation is challenging due to potential drug–drug interactions and pH-dependent solubility. However, fixed-dose combinations may be possible with careful compatibility and stability studies.
Uniform pellet size ensures consistent coating, reproducible drug release, and improved filling efficiency into capsules. Irregular pellet sizes may cause dose variability.
We provide COA (Certificate of Analysis), MSDS (Material Safety Data Sheet), Stability Data, and necessary regulatory support documents.