Latanoprostene Bunod API | Nitric Oxide-Releasing Prostaglandin Analog API Manufacturer in India

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Latanoprostene Bunod API

Latanoprostene Bunod is a nitric oxide (NO)-donating prostaglandin F2α analogue used in ophthalmology to reduce elevated intraocular pressure. It is a prodrug that is metabolized to latanoprost acid and a nitric oxide-donating moiety.

Its dual mechanism increases aqueous humor outflow through both the uveoscleral pathway and the trabecular meshwork/Schlemm's canal pathway, helping lower intraocular pressure.

Latanoprostene Bunod API Manufacturer in India

Latanoprostene Bunod is a specialized ophthalmic pharmaceutical API requiring controlled synthesis, purification and stereochemical characterization.

Important quality attributes include identity, assay, related substances, stereochemical purity, water content, residual solvents, elemental impurities, impurity profile and stability.

Chemical Information

CAS Number: 860005-32-5
Molecular Formula: C27H39NO6
Molecular Weight: 473.61 g/mol
Drug Class: Prostaglandin Analogue
Pharmacological Class: Prostaglandin F2α Analogue / Nitric Oxide Donor
Therapeutic Class: Antiglaucoma Agent
Therapeutic Area: Ophthalmology

Mechanism of Action

Latanoprostene Bunod is hydrolyzed to latanoprost acid, which activates FP prostanoid receptors and increases uveoscleral outflow.

It also releases nitric oxide, which contributes to relaxation of the trabecular meshwork and increases conventional aqueous humor outflow.

The combined mechanism results in:

  • Increased uveoscleral outflow
  • Increased trabecular outflow
  • Reduced aqueous humor resistance
  • Lower intraocular pressure
  • Improved control of ocular hypertension

Pharmaceutical Applications

Latanoprostene Bunod is used for the reduction of elevated intraocular pressure in patients with:

  • Open-angle glaucoma
  • Ocular hypertension

The specific approved indications depend on the applicable regulatory labeling.

Dual-Mechanism Characteristics

Latanoprostene Bunod is distinctive among prostaglandin analogues because it combines:

Prostaglandin pathway → increased uveoscleral outflow

Nitric oxide pathway → increased conventional/trabecular outflow

This dual activity provides a pharmacological approach to lowering intraocular pressure through multiple aqueous humor drainage pathways.

Manufacturing Process

Typical manufacture may involve:

  1. Preparation of protected prostaglandin intermediates
  2. Controlled stereoselective synthesis
  3. Construction of the prostaglandin analogue
  4. Introduction of the nitric oxide-donating group
  5. Purification
  6. Chromatographic separation where required
  7. Isolation and drying
  8. Stereochemical characterization
  9. Final analytical testing
  10. Controlled packaging

Quality and Analytical Testing

Latanoprostene Bunod API quality evaluation may include:

  • Identification by HPLC
  • Mass spectrometry
  • Assay
  • Related substances
  • Stereochemical purity
  • Diastereomeric impurities
  • Water content
  • Residual solvents
  • Elemental impurities
  • Chromatographic purity
  • Nitric oxide-donor related testing where applicable
  • Stability testing

Storage

Latanoprostene Bunod should be stored according to validated stability data and approved product requirements, with appropriate protection from heat, moisture, oxygen and light.

Pharmaceutical Research and Development

Latanoprostene Bunod is relevant to research involving:

  • Prostaglandin F2α receptors
  • Nitric oxide signaling
  • Glaucoma
  • Ocular hypertension
  • Trabecular meshwork
  • Schlemm's canal
  • Uveoscleral outflow
  • Intraocular pressure regulation
  • Ophthalmic drug delivery
  • Antiglaucoma drug development

Latanoprostene Bunod API Summary

Latanoprostene Bunod is a nitric oxide-donating prostaglandin analogue with CAS Number 860005-32-5, molecular formula C27H39NO6, and molecular weight 473.61 g/mol. It reduces intraocular pressure through a dual mechanism involving increased uveoscleral and conventional aqueous humor outflow.

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 2.0%
Residue on Ignition NMT 0.5%
Individual Impurity ≤ 0.5%
Total Impurities ≤ 1.5%
Water Content NMT 1.0%
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