Cilazapril Production Cost Reports

The report provides a detailed analysis essential for establishing a Cilazapril production plant. It encompasses all critical aspects necessary for Cilazapril production, including the cost of Cilazapril production, Cilazapril plant cost, Cilazapril production costs, and the overall Cilazapril production plant cost. Additionally, the study covers specific expenditures associated with setting up and operating a Cilazapril 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.

Cilazapril belongs to a class of medicines called ACE inhibitors, which treat hypertension by relaxing blood vessels to lower blood pressure. It helps bring down elevated blood pressure and can be used in combination with diuretics like hydrochlorothiazide. It is also utilised in congestive heart failure as an add-on therapy along with other drugs like digitalis or water pills to strengthen the heart's pumping action.

It is also used after a heart attack to support recovery by protecting the remaining heart muscle, stabilising blood pressure, and preventing further damage. It is taken once daily and provides long-lasting effects similar to other ACE inhibitors. Its common side effects include dry cough, dizziness, headache, fatigue, nausea, diarrhoea, flushing, muscle cramps, rash, and unusual tiredness.

The market for Cilazapril is influenced by increasing cases of hypertension and heart failure. The ageing populations around the world, and stronger healthcare access with generic availability after patent expiry boosts its demand. The industrial Cilazapril procurement is affected by the need for its sourcing from GMP-certified API suppliers offering DMF, CEP, and WC documentation.

Also, high purity levels and full regulatory compliance from agencies like the FDA, EMA, and EDQM to meet formulation quality needs add to its procurement costs. The cost-effective deals, reliable supply from major Indian producers, and flexible minimum order quantities because of generic price pressures influence its sourcing strategies.

Raw Material for Cilazapril Production

According to the Cilazapril production plant project report, the key raw materials used in the production of Cilazapril include tert-butyl (1S,9S)-octahydro-10-oxo-9-amino-6H-pyridazino[1,2-a]diazepine-1-carboxylate | ethyl (R)-2-(4-nitrobenzenesulfonyloxy)-4-phenylbutyrate | N-methylmorpholine.

Production Process of Cilazapril

The extensive Cilazapril production cost report consists of the following major industrial production process:

1. From Nucleophilic Substitution: Cilazapril production starts with coupling the protected bicyclic diamine tert-butyl (1S,9S)-octahydro-10-oxo-9-amino-6H-pyridazino[1,2-a]diazepine-1-carboxylate with ethyl (R)-2-(4-nitrobenzenesulfonyloxy)-4-phenylbutyrate. The reaction takes place using N-methylmorpholine in methylene chloride at elevated temperature to form the tert-butyl ester intermediate via nucleophilic substitution. The reaction is diluted with water, adjusted to a basic with sodium carbonate, separates the organic layer, washed, dried over sodium sulfate, and filtered through celite. The solution cools and is treated with dry hydrogen chloride gas to deprotect the tert-butyl group, forming cilazapril hydrochloride upon stirring and solvent evaporation. The Cilazapril is extracted into aqueous hydrochloric acid, followed by pH adjustment to an acidic with sodium hydroxide to precipitate cilazapril monohydrate as the final product.

Cilazapril appears as a white to off-white crystalline powder with the molecular formula C22H31N3O5 and a molecular weight of 417.5 g/mol. It has a melting point of 98 degree Celsius with decomposition. It shows low water solubility with slight solubility in ethanol, methanol, and chloroform. Its logP value is around 0.8-2.21, making it moderately lipophilic. Its pKa values are 2.285 (carboxylic acid), 3.3, and 6.4, with a topological polar surface area of 99.2 Ų. It contains a bicyclic diazepine ring system with ester and amide functionalities, enabling hydrolysis to cilazaprilat. It has 2 hydrogen bond donors, 9 rotatable bonds, and 608 complexity.