Dabigatran IR Pellets are pharmaceutical-grade immediate-release multiparticulate pellets containing Dabigatran Etexilate Mesylate as the active ingredient. The pellet format is designed for oral multiparticulate formulation applications, including capsule filling and pharmaceutical formulation development.
The active ingredient should be correctly identified as Dabigatran Etexilate Mesylate, rather than simply Dabigatran. Dabigatran is the active moiety, while dabigatran etexilate is the orally administered prodrug. Current regulatory information identifies Dabigatran Etexilate Mesylate with molecular formula C₃₄H₄₁N₇O₅ · CH₄O₃S and molecular weight 723.86 g/mol for the mesylate salt; the corresponding free-base molecular weight is 627.75 g/mol.
Dabigatran Etexilate Mesylate is described as a yellow-white to yellow powder. It is freely soluble in methanol, slightly soluble in ethanol and sparingly soluble in isopropanol. Its saturated solution in pure water has a reported solubility of approximately 1.8 mg/mL.
The immediate-release pellet format provides a multiparticulate system in which the active ingredient is distributed across individual pellets. This format can be suitable for capsule filling, multiparticulate oral formulations and formulation development.
Commercial pharmaceutical pellet portfolios report Dabigatran Etexilate Mesylate IR Pellets in 35% and 40% w/w, while other published portfolios report 35%, 40%, 43% and 50% strengths. A separate commercial listing specifically reports 40% Dabigatran Etexilate Mesylate pellets.
For an SDP product page, however, the available SDP strength should be taken from the current SDP product specification or COA. A market strength should not automatically be represented as an SDP-approved strength.
Dabigatran IR Pellets can be manufactured as a controlled multiparticulate system with defined active loading and physical characteristics.
Important finished-pellet attributes can include:
The exact acceptance limits should be established for the finished pellet product. API specifications should not be copied directly into the finished-pellet specification.
Current FDA labeling for Dabigatran Etexilate Oral Pellets describes packets containing 20 mg, 30 mg, 40 mg, 50 mg, 110 mg or 150 mg dabigatran etexilate. The label also lists acacia, dimethicone, hydroxypropyl cellulose, hypromellose, talc and tartaric acid as inactive ingredients.
These mg amounts are finished-presentation doses, not pellet percentage strengths. Therefore, they should not be converted into 20%, 30%, 40%, etc. pellet loading without knowing the total pellet mass.
Designed for immediate-release multiparticulate formulation development.
Suitable for pellet-based capsule filling where the required formulation and specifications are met.
Individual pellets provide a multiparticulate dosage format.
Can be used during development and scale-up of pellet-based oral formulations.
Suitable for pharmaceutical manufacturers requiring bulk pellet material according to defined specifications.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | NLT 98.0% by HPLC |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 10 ppm |
| Water Content | NMT 0.5% |