Perindopril Production Cost Reports

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

Perindopril is an ACE (Angiotensin-Converting Enzyme) inhibitor. It is used in the pharmaceutical industry for the treatment of mild to moderate essential hypertension and congestive heart failure. It is utilised in the reduction of cardiovascular risks, including strokes, heart attacks, and kidney issues. Additionally, it is often supplied as perindopril erbumine for oral prodrug delivery, lowering blood pressure effectively.

The market demand for Perindopril is driven by the rising global burden occurrence of hypertension, cardiovascular diseases, and renal conditions, coupled with the increasing demand for affordable, long-acting ACE inhibitors like perindopril and its erbumine or tert-butylamine salt forms. The growing ageing population worldwide also contributes to the demand, as older adults have a higher risk of cardiovascular conditions requiring ACE inhibitors like perindopril. Additionally, government health policies promoting the use of essential medicines and chronic disease management programs facilitate greater accessibility and affordability of perindopril, especially in emerging markets.

Technological advancements in drug formulation, enabling longer-acting and better-tolerated versions, improve patient compliance and support the market expansion. The rising adoption of combination therapies involving perindopril with other cardiovascular drugs also propels market expansion. Furthermore, increasing awareness about cardiovascular health and early diagnosis initiatives drives prescriptions and uptake of perindopril-based treatments. However, fluctuations in the costs and availability of the major raw materials such as (2S,3aS,7aS)-octahydroindole-2-carboxylic acid benzyl ester and N-[(S)-1-ethoxycarbonylbutyl]-(S)-alanine impact industrial perindopril procurement.

Raw Material for Perindopril Production

According to the Perindopril production plant project report, the various raw materials for Perindopril production include (2S,3aS,7aS)-octahydroindole-2-carboxylic acid benzyl ester and N-[(S)-1-ethoxycarbonylbutyl]-(S)-alanine.

Production Process of Perindopril

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

1. Production via a peptide coupling reaction: The production process of perindopril involves a peptide coupling step where (2S,3aS,7aS)-octahydroindole-2-carboxylic acid benzyl ester condenses with N-[(S)-1-ethoxycarbonylbutyl]-(S)-alanine. The reaction occurs using coupling agents like dicyclohexylcarbodiimide (DCC) and 1-hydroxybenzotriazole (HOBt) at 15-20 degree Celsius to form the benzyl ester intermediate, followed by filtration of dicyclohexylurea byproduct and purification via extraction and vacuum distillation. In the next step, debenzylation proceeds through catalytic hydrogenolysis under 20-60 bars of hydrogen at ambient temperature to liberate the free perindopril acid, which is then crystallised as the stable erbumine (tert-butylamine) salt in solvents such as acetone for pharmaceutical use.

Properties of Perindopril

Perindopril (C19H32N2O5) has a molecular weight of 368.47-368.5 g/mol, and an exact mass of 368.23112213 g/mol. It has 2 hydrogen bond donors, 6 acceptors, 9 rotatable bonds, and a topological polar surface area of 95.9 Ų, contributing to its moderate lipophilicity (XLogP3: 0.9) and complexity (524) suitable for oral bioavailability as an ACE inhibitor prodrug. It appears as a white to off-white solid with a melting point of 100-101 degree Celsius, and an estimated boiling point of 537.4±45.0 degree Celsius. It has a density of 1.150±0.06 g/cm³, and slight solubility in chloroform and methanol, requiring storage at -20 degree Celsius freezer conditions for stability. It has a pKa of 3.15±0.20, undergoes hydrolysis to active perindoprilat, and is prone to degradation, forming impurities like diketopiperazine (impurity F), necessitating strict control in pharmaceutical formulations.