Mirodenafil Hydrochloride

Mirodenafil Hydrochloride is a selective phosphodiesterase type 5 (PDE5) inhibitor active pharmaceutical ingredient (API) supplied for the formulation and commercial manufacturing of male health oral solid dosage forms.

Structural Properties
• Molecular Formula: C26H37N5O5S · 2HCl
• Molecular Weight: 604.59 g/mol
• CAS Registry Number: 862189-96-6

Mechanism of Action
• Target Selectivity: Selectively inhibits cGMP-specific phosphodiesterase type 5 (PDE5) in cavernous smooth muscle tissues.
• Hemodynamic Pathway: Facilitates endogenous nitric oxide signaling to promote smooth muscle relaxation and local blood flow.

Solubility Characteristics
• Aqueous Profile: Freely soluble in acidic media, with solubility of ≥ 50 mg/mL at pH 1.2.
• Organic Profile: Moderately soluble in methanol and practically insoluble in non-polar organic solvents.

Polymorphic Stability: Maintains a controlled crystal phase across commercial manufacturing batches through optimized crystallization and solvent-processing conditions.

Moisture Mitigation: Controlled vacuum thermal drying at temperatures ≤ 40°C is used to minimize surface moisture adsorption.

Intermediate Purge: Multi-stage recrystallization is used to reduce trace process-related impurities.

Metal Scavenging: Resin-based filtration is used to control residual palladium and nickel catalyst levels to below 1 ppm.

Binder Interaction: Demonstrates chemical stability when processed with commonly used excipients such as microcrystalline cellulose, lactose monohydrate, and croscarmellose sodium.

Degradation Control: Designed for stable handling under standard ambient processing conditions.

Powder Flowability: Typical Carr's Index is controlled within the range of 15% to 20% to support downstream powder processing.

In-Vitro Release: Micronized grades can achieve more than 85% active dissolution within 15 minutes in simulated gastric fluid at pH 1.2, subject to formulation and test conditions.

Core Tablets: Suitable for direct compression and wet granulation development for oral tablet formulations.

Orally Disintegrating Films: Fine particle grades can be evaluated for rapid dispersion applications where particle size and mouthfeel are critical formulation parameters.

Reference Standards: Qualified material can be supplied for in-vitro permeability studies, analytical method development, and comparative dissolution testing.

Testing Protocol: Analytical testing can include validated UPLC methods with photodiode array detection and mass spectrometric confirmation where required.

Scope: A lot-specific Certificate of Analysis (CoA) can be provided covering identity, assay, water content, residual solvents, and impurity profiles.

Protocol: Stability evaluation can be conducted under long-term and accelerated conditions in accordance with applicable ICH guidelines.

DMF Support: Regulatory and technical documentation can be provided to support customer registration and submission requirements, subject to product and market requirements.

Compliance Statements: TSE/BSE statements, elemental impurity information, and other compliance documents can be supplied upon request.

Traceability: Raw material and production records can be maintained to support traceability from manufacturing through final packaging.

Recommended Storage: Store according to the product-specific stability and packaging requirements.

Temperature Control: Avoid prolonged exposure to excessive heat during storage and transportation.

Sealed Integrity: Keep the material in its original sealed packaging and protect it from light, moisture, and contamination.

Liner Specifications: Double polyethylene liners can be used to provide additional protection against moisture and contamination.

Outer Protection: Rigid fiber drums or other suitable pharmaceutical-grade outer packaging can be used according to order requirements.

Standard Sizes: 1 kg, 5 kg, and 25 kg packaging configurations can be available depending on customer requirements.

Shipping Conditions: Transportation conditions are selected according to product stability requirements, destination regulations, and agreed customer specifications.

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