Diltiazem HCl SR Pellets are pharmaceutical-grade sustained-release multiparticulate pellets containing Diltiazem Hydrochloride as the active ingredient. These pellets are designed for oral multiparticulate formulations where a controlled release profile is required.
Diltiazem Hydrochloride is the hydrochloride salt of diltiazem. Its CAS Number is 33286-22-5, molecular formula is C₂₂H₂₆N₂O₄S·HCl, and molecular weight is 450.98 g/mol. The USP monograph defines Diltiazem Hydrochloride as containing 98.0%–102.0% of diltiazem hydrochloride on the dried basis. This is an API specification and should not be used directly as the finished-pellet assay specification.
Diltiazem HCl SR Pellets provide a multiparticulate platform in which the active ingredient is incorporated into individual pellets and the release characteristics are controlled through the formulation and release-controlling system. Depending on the formulation, sustained release may be achieved through polymeric matrix systems, functional coatings or combinations of pellet-processing technologies.
Commercial pellet manufacturers report Diltiazem HCl SR Pellets at different loadings, including 40%, 44%, 48%, 50%, 55%, 60% and 66%, while several manufacturers specifically list 50%, 55% or 60% products. These are market references and should not be presented as SDP strengths unless confirmed by the applicable SDP product specification.
Diltiazem HCl SR Pellets are designed for multiparticulate oral formulations requiring a sustained-release profile. Pellet-based systems can provide multiple discrete units within a dosage form, allowing formulation developers to control pellet size, active loading, coating characteristics and release behavior.
The finished pellet should be evaluated for assay, content uniformity, particle-size distribution, moisture, density, friability and dissolution/release performance. For an SR product, dissolution testing is particularly important because the release profile is a critical finished-product quality attribute.
Published formulation research demonstrates the use of Diltiazem Hydrochloride sustained-release pellets with controlled-release polymer systems and evaluates different release profiles. This supports the use of coating/polymer systems as formulation-specific approaches for sustained-release Diltiazem pellets.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Water Content | NMT 0.5% |