Diltiazem HCl SR Pellets Manufacturer in India

Swapnroop Pharma · WHO-GMP Certified · +91 87670 62101

Diltiazem HCl SR Pellets

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.

Pharmaceutical-Grade Diltiazem HCl SR Pellets

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.

Why Diltiazem HCl SR Pellets from Swapnroop?

  • Pharmaceutical-Grade Pellets – Designed for pharmaceutical formulation applications.
  • Sustained-Release Format – Developed for controlled release over the intended formulation period.
  • Diltiazem HCl-Based System – Uses Diltiazem Hydrochloride as the active ingredient.
  • Controlled Active Loading – Loading can be specified according to the applicable product specification.
  • Multiparticulate Format – Suitable for pellet-based oral formulations.
  • Controlled Pellet Characteristics – Particle size, density and physical properties can be established according to requirements.
  • Release-Profile Development – Coating and formulation parameters can be optimized according to the intended SR profile.
  • Capsule-Filling Applications – Suitable for multiparticulate capsule formulations.
  • Bulk Pharmaceutical Supply – Suitable for commercial formulation requirements.
  • Manufacturer & Supplier Support – Suitable for pharmaceutical formulation and bulk supply requirements.

Detailed Specifications

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%
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