Pharmaceutical-Grade Dexlansoprazole Dual Delayed-Release Pellets for Oral Multiparticulate Formulations
Dexlansoprazole DDR Pellets are pharmaceutical multiparticulate pellets containing Dexlansoprazole and designed for dual delayed-release oral formulations. Dexlansoprazole is the R-enantiomer of lansoprazole and has the molecular formula C₁₆H₁₄F₃N₃O₂S, CAS Number 138530-94-6, and molecular weight 369.36 g/mol.
The DDR pellet system is different from a conventional single delayed-release pellet. The dual delayed-release concept uses pellet populations or coating systems designed to provide release at different stages after oral administration. Official product information describes Dexlansoprazole as being supplied in capsules containing enteric-coated pellets in a dual delayed-release formulation.
Dexlansoprazole is practically insoluble in water, while its pharmaceutical formulation uses specialized pellet coating technology to protect the active ingredient from acidic conditions and achieve the intended release profile.
As a Dexlansoprazole DDR Pellets Manufacturer in India, Swapnroop can position this product for pharmaceutical formulation development, multiparticulate capsule filling and dual delayed-release applications. The final active loading, coating parameters, particle size and dissolution requirements should always be controlled against the applicable product specification.
Dexlansoprazole is particularly associated with a dual delayed-release formulation approach. The finished capsule dosage form contains enteric-coated pellets designed to provide two delayed-release phases rather than a conventional single release event.
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Public manufacturer listings show several Dexlansoprazole DDR pellet strengths. One pharmaceutical pellet manufacturer lists 22.5%, while another lists 17%, 20% and 22.5%. A broader commercial listing reports strengths ranging from 15% to 30%.
For SDP: do not publish all of these strengths as SDP-available strengths unless they are confirmed by SDP's current product specification or COA.
A commercially documented 22.5% w/w Dexlansoprazole DDR pellet strength is therefore a reasonable industry reference, but it should not be presented as an SDP strength without confirmation.
Dexlansoprazole DDR Pellets can be used for:
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 95.0% – 105.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | NMT 0.5% |
| Water Content | NMT 1.0% |