Tizanidine SR Pellets Manufacturer India

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

Tizanidineb SR Pellets (CAS No: 64461-82-1) — Sustained Release Multiparticulates

Tizanidine HCl SR Pellets are sustained-release pharmaceutical pellets manufactured from Tizanidine Hydrochloride (C₉H₈ClN₅S·HCl, MW ≈290.2), a centrally-acting α2-adrenergic agonist used to manage spasticity from conditions such as multiple sclerosis and spinal cord injury. Swapnroop Drugs and Pharmaceuticals manufactures Tizanidine HCl SR Pellets at its WHO-GMP certified Aurangabad, Maharashtra facility for pharmaceutical formulators across India and export markets.

Formulation Approach
Tizanidine HCl is highly water-soluble (>20 mg/mL), which is a relevant formulation consideration when designing the rate-controlling functional coat needed to achieve a genuine extended-release profile rather than rapid dose-dumping; SR pellet systems for this molecule are typically built by drug-layering followed by a calibrated polymer coat.

Key Features

  • Sustained-release multiparticulate formulation for a highly water-soluble drug substance
  • Centrally-acting α2-adrenergic agonist muscle relaxant
  • Suitable for hard-gelatin capsule filling and multiparticulate tablet compression
  • WHO-GMP manufactured with full batch documentation

Applications

  • Spasticity management (multiple sclerosis, spinal cord injury, and related conditions)
  • Extended-duration muscle-relaxant capsule/tablet formulations
  • Generic ANDA/CTD dossier programs requiring dissolution-matched SR profiles

Why Choose Swapnroop for Tizanidine SR Pellets?

  • WHO-GMP certified facility with drug-layering and functional-coating expertise, including for highly water-soluble actives
  • Full CoA, MSDS, DMF-grade documentation for regulated-market submissions

FAQs

  • Why is sustained release important for Tizanidine? Tizanidine's immediate-release form has a short duration of action and pronounced sedative side effects at peak plasma levels; an SR profile is used to smooth the plasma curve for better tolerability.
  • Is Tizanidine HCl water-soluble? Yes — it is soluble in water at concentrations greater than 20 mg/mL, which is an important consideration for coating-system design.

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 1.0%
Residue on Ignition NMT 0.5%
Heavy Metals NMT 20 ppm
Individual Impurity NMT 0.5%
Total Impurities NMT 1.0%
Water Content NMT 2.0%
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