Foslevodopa API | Pharmaceutical API Manufacturer in India

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Foslevodopa API

Foslevodopa is a phosphate prodrug of levodopa developed to improve the delivery of levodopa for the treatment of Parkinson's disease. It is converted to levodopa in the body and is used in combination with foscarbidopa for continuous subcutaneous administration in patients with advanced Parkinson's disease.

Foslevodopa API Manufacturer in India

Foslevodopa is a specialized pharmaceutical active ingredient belonging to the antiparkinsonian drug class. It is a water-soluble phosphate ester prodrug of levodopa and is designed for continuous delivery through subcutaneous infusion.

Chemical Information

CAS Number: 85821-19-8
Molecular Formula: C9H12NO6P
Molecular Weight: 261.17 g/mol
Drug Class: Antiparkinsonian Agent
Chemical Class: Phosphate Prodrug of Levodopa
Active Drug: Levodopa
Therapeutic Area: Neurology / Parkinson's Disease

Mechanism of Action

Foslevodopa is converted to levodopa after administration. Levodopa crosses the blood-brain barrier and is subsequently converted to dopamine in the brain. Increasing dopamine availability in the striatum helps compensate for the dopamine deficiency associated with Parkinson's disease and improves motor symptoms.

Pharmaceutical Applications

Foslevodopa is used as part of continuous dopaminergic therapy for patients with advanced Parkinson's disease who experience motor fluctuations despite conventional oral levodopa treatment. The pharmaceutical combination of foslevodopa and foscarbidopa provides continuous subcutaneous delivery of levodopa and carbidopa.

Foslevodopa and Foscarbidopa

Foslevodopa is formulated together with foscarbidopa, the phosphate prodrug of carbidopa. Foscarbidopa inhibits peripheral conversion of levodopa to dopamine, allowing more levodopa to reach the brain. The combination is administered by continuous subcutaneous infusion.

Physical and Chemical Properties

Foslevodopa is a phosphate-containing levodopa prodrug designed to provide substantially improved aqueous solubility compared with levodopa. Its phosphate ester structure enables formulation at concentrations suitable for continuous subcutaneous administration.

Quality and Analytical Testing

Foslevodopa API quality assessment can include identification, assay, related substances, water content, residual solvents, elemental impurities and other appropriate pharmaceutical quality-control tests. HPLC and other validated analytical techniques may be used for assay and impurity determination.

Storage

Foslevodopa should be stored in accordance with the applicable pharmaceutical specification and validated stability conditions. The material should be protected from unsuitable temperature, moisture and light conditions and handled according to appropriate pharmaceutical procedures.

Pharmaceutical Development

Foslevodopa represents a prodrug-based approach to improving the pharmaceutical delivery of levodopa. Its increased aqueous solubility supports concentrated aqueous formulations for continuous subcutaneous administration, providing an alternative to intermittent oral dosing in advanced Parkinson's disease.

Foslevodopa API Summary

Foslevodopa is a phosphate prodrug of levodopa developed for continuous subcutaneous dopaminergic therapy. It has the CAS Number 85821-19-8, molecular formula C9H12NO6P, and molecular weight 261.17 g/mol. It is used together with foscarbidopa for continuous treatment of motor fluctuations in adults with advanced Parkinson's disease.

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 1.0%
pH (1% Solution) 5.0 – 7.0
Individual Impurity NMT 0.5%
Total Impurities NMT 2.0%
Water Content NMT 2.0%
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