Pharmaceutical-Grade Duloxetine HCl EC Pellets for Enteric-Coated Oral Formulations
Duloxetine HCl EC Pellets are multiparticulate pharmaceutical formulations designed for enteric-coated oral dosage applications. The active ingredient is Duloxetine Hydrochloride, also known as Duloxetine HCl, with CAS Number 136434-34-9, molecular formula C₁₈H₂₀ClNOS, and molecular weight 333.9 g/mol. PubChem identifies Duloxetine Hydrochloride as the hydrochloride salt of the S-enantiomer of duloxetine.
The SDP product portfolio includes Duloxetine HCl EC Pellets in 14.85%, 17%, 20% and 22.5% strengths, providing multiple active-loading options for pharmaceutical formulation development.
The enteric-coated pellet format uses a functional coating system designed to provide delayed release until the pellets encounter the intended gastrointestinal environment. This multiparticulate approach can be used for formulation development involving capsule filling and other suitable oral dosage forms.
Duloxetine Hydrochloride has the molecular formula C₁₈H₂₀ClNOS and molecular weight 333.9 g/mol. Its primary CAS Number is 136434-34-9.
Duloxetine HCl EC Pellets are formulated as multiparticulate pellets with an enteric coating system. The coating is designed to protect the pellet formulation during the intended stage of gastrointestinal transit and provide release according to the specified formulation profile.
The 14.85%, 17%, 20% and 22.5% values represent available pellet strengths, rather than the purity assay of Duloxetine Hydrochloride API.
These four strengths are listed for Duloxetine HCl EC Pellets in the referenced pharmaceutical pellet product portfolio.
Duloxetine HCl EC Pellets can be considered for:
Enteric-coated oral formulation development
Multiparticulate pharmaceutical formulations
Capsule-filling applications
Delayed-release formulation development
pH-dependent release formulations
Oral dosage-form development
Pharmaceutical formulation development
Commercial pharmaceutical manufacturing
Pharmaceutical-Grade Pellets: Designed for pharmaceutical formulation applications.
Multiple Strength Options: Available in 14.85%, 17%, 20% and 22.5% strengths.
Enteric-Coated Format: Designed for formulations requiring an enteric-coated multiparticulate platform.
Multiparticulate Formulation: Suitable for pellet-based oral dosage-form development.
Flexible Active Loading: Multiple strengths support different formulation requirements.
Product-Specific Quality Control: Finished pellets can be evaluated against applicable product specifications.
Capsule-Filling Applications: Suitable for multiparticulate capsule formulation approaches.
Bulk Pharmaceutical Supply: Suitable for formulation and manufacturing requirements.
Duloxetine HCl EC Pellets can be supplied in suitable bulk packaging according to customer requirements. Strength, batch quantity, packaging configuration and applicable technical documentation can be specified according to the intended pharmaceutical formulation.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 95.0% – 105.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.2% |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 0.5% |