The report provides a detailed analysis essential for establishing a Pinacidil production plant. It encompasses all critical aspects necessary for Pinacidil production, including the cost of Pinacidil production, Pinacidil plant cost, Pinacidil production costs, and the overall Pinacidil production plant cost. Additionally, the study covers specific expenditures associated with setting up and operating a Pinacidil production plant. These encompass production processes, raw material requirements, utility requirements, infrastructure needs, machinery and technology requirements, manpower requirements, packaging requirements, transportation requirements, and more.
Pinacidil is a cyanoguanidine medication classified as a potassium channel opener that activates ATP-sensitive potassium channels in vascular smooth muscle cells. This causes hyperpolarisation, reduced intracellular calcium, and direct peripheral vasodilation of arterioles to lower blood pressure and vascular resistance without major cardiac effects. It is used as an oral antihypertensive agent for mild to moderate essential hypertension, often combined with diuretics like thiazides or beta-blockers to counter fluid retention and edema, showing efficacy comparable to hydralazine, prazosin, or nifedipine in trials. Its common side effects are headache, edema, palpitations, tachycardia (fast heartbeat), dizziness, nausea, fatigue, abdominal pain, and somnolence.
The market for Pinacidil is driven by its growing demand in pharmaceutical research and cardiovascular studies. Its utilisation as a potassium channel opener for novel applications like anticonvulsants or anxiolytics in epilepsy and neurological models contributes to its market growth. The need for hypertension management in different regions makes it a popular option. Its sourcing from specialised API suppliers and custom synthesis requirements for high-purity research-grade material affect industrial Pinacidil procurement. The regulatory requirements for investigational use (e.g., non-FDA approved for therapy), global supply chain variations influenced by economic and geopolitical shifts, and competition from superior antihypertensives like calcium channel blockers or ACE inhibitors impact its sourcing strategies.
Raw Material for Pinacidil Production
According to the Pinacidil production plant project report, the key raw materials used in the production of Pinacidil include N-(4-pyridyl)-N-(1,2,2-trimethylpropyl)thiourea, Cyanamide, Dicyclohexylcarbodiimide, and Ethyldiisopropylamine.
Production Process of Pinacidil
The extensive Pinacidil production cost report consists of the following major industrial production process:
- By Condensation Reaction: The production process of Pinacidil involves the condensation method. First, N-(4-pyridyl)-N-(1,2,2-trimethylpropyl)thiourea goes through condensation with cyanamide. This takes place in the presence of dicyclohexylcarbodiimide (DCC) and ethyldiisopropylamine in ether. This reaction leads to the formation of Pinacidil, which is separated and purified to get pure Pinacidil as the final product.
Pinacidil is a cyanoguanidine potassium channel opener with molecular formula C13H19N5 (anhydrous) and an average molecular weight of 245.33 Da. It appears as a white crystalline solid or powder with a melting point of 164-165 degree Celsius. It exhibits moderate water solubility and good solubility in ethanol. It shows low lipophilicity with a logP value in the range 1.94-2.3 and a pKa value of the strongest basic ~8.16 and the strongest acidic ~16.28. It has two hydrogen bond donors and 5 acceptors, a polar surface area of 73.1 Ų, 3 rotatable bonds, 1 ring, and collision cross sections around 163-175 Ų for protonated and alkali adducts. It is stable at room temperature as a solid and shows high bioavailability, refractivity 73.04 m³·mol?¹, and polarizability 27.31 ų.
