Lasmiditan API | 5-HT1F Receptor Agonist API Manufacturer in India

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Lasmiditan API

Lasmiditan is a selective serotonin 5-HT1F receptor agonist developed for the acute treatment of migraine with or without aura. It belongs to the ditan class of antimigraine medicines and differs from triptans because its mechanism does not primarily depend on 5-HT1B-mediated cerebral vasoconstriction.

Lasmiditan acts on 5-HT1F receptors involved in migraine-related trigeminal signaling and helps reduce migraine-associated symptoms.

Lasmiditan API Manufacturer in India

Lasmiditan is a specialized neurology and antimigraine pharmaceutical API manufactured through controlled chemical synthesis, purification and crystallization.

Important quality attributes include identity, assay, related substances, water content, residual solvents, elemental impurities, polymorphic form and stability.

Chemical Information

CAS Number: 439239-90-4
Molecular Formula: C26H19F2N3O2
Molecular Weight: 439.45 g/mol
Drug Class: Antimigraine Agent
Pharmacological Class: Selective 5-HT1F Receptor Agonist
Therapeutic Class: Antimigraine / Neurology
Therapeutic Area: Neurology

Mechanism of Action

Lasmiditan selectively activates 5-HT1F serotonin receptors.

Activation of these receptors is thought to inhibit migraine-associated trigeminal pathways and reduce neuropeptide release involved in migraine signaling.

Its pharmacological activity includes:

  • 5-HT1F receptor activation
  • Modulation of trigeminal signaling
  • Reduction of migraine-associated neuropeptide release
  • Reduction of migraine pain

Unlike triptans, lasmiditan does not rely on 5-HT1B-mediated vasoconstriction for its antimigraine effect.

Pharmaceutical Applications

Lasmiditan is used for the acute treatment of migraine attacks with or without aura in adults.

It is intended for treatment of an acute migraine episode rather than preventive migraine therapy.

Ditan Characteristics

Lasmiditan is the first member of the ditan class of migraine therapies. Its selective 5-HT1F mechanism provides an alternative approach to migraine treatment for patients for whom vasoconstrictive mechanisms associated with some older antimigraine medicines may be a concern.

Manufacturing Process

Typical API manufacturing may involve:

  1. Preparation of substituted heterocyclic intermediates
  2. Controlled chemical synthesis
  3. Formation of the pyridinyl and indazole-containing structure
  4. Functional-group transformations
  5. Purification
  6. Crystallization
  7. Filtration
  8. Drying
  9. Milling where required
  10. Final analytical testing
  11. Controlled packaging

Quality and Analytical Testing

Lasmiditan API quality evaluation may include:

  • Identification by IR
  • Identification by HPLC
  • Assay
  • Related substances
  • Organic impurities
  • Water content
  • Residual solvents
  • Elemental impurities
  • Residue on ignition
  • Polymorphic-form characterization
  • Particle-size distribution where required
  • Stability testing

Storage

Lasmiditan should be stored in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive heat, moisture and direct light. Final storage conditions should be established through validated stability studies.

Pharmaceutical Research and Development

Lasmiditan is relevant to research involving:

  • 5-HT1F receptors
  • Migraine pharmacology
  • Trigeminal signaling
  • Serotonin receptor agonists
  • Ditan-class antimigraine agents
  • Acute migraine treatment
  • Neurology drug development
  • Neuropeptide signaling
  • Non-vasoconstrictive migraine therapies

Lasmiditan API Summary

Lasmiditan is a selective 5-HT1F receptor agonist with CAS Number 439239-90-4, molecular formula C26H19F2N3O2, and molecular weight 439.45 g/mol. It is an orally active ditan-class antimigraine agent used for the acute treatment of migraine with or without aura.

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%
Individual Impurity ≤ 0.5%
Total Impurities ≤ 1.5%
Water Content NMT 1.0%
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