Green Chemistry in Drug Substance Synthesis

The concept of Green Chemistry accepted by the scientific community, the technical Green Chemistry evolution is yet to achieve with the appropriate attention and effort which only possible through education and awareness. Green Chemistry has the potential to transform the pharmaceutical industry and drug manufacturing in the future. It provides benefit both environmentally and economically. It will result in transforming the traditional pharmaceutical industries into sustainable ones and sustainability of the environment.

So in this article we will try to understand the green chemistry for its concept, definition and the green solvent.

What is GREEN CHEMISTRY?

Green Chemistry is a concept, which is focused on environment safety in order to ensure that the surrounding environment is free from hazards. Under this concept / branch of chemistry we are able to develop chemical processes and earth-friendly products that will prevent pollution in the first place.

It is nothing but an approach to chemical research & production; which targets to design products and processes. It minimize the use and generation of hazardous substances, also known as sustainable chemistry.

Green Chemistry in Drug Substance Synthesis


Definition of green chemistry; 

It is defined by EPA (United States of Environmental Protection Agency) as “Green chemistry is the design of chemical products and processes that reduce or eliminate the use or generation of hazardous substances. Green chemistry applies across the life cycle of a chemical product, including its design, manufacture, use, and ultimate disposal”.

Paul Anastas and John Warner; also known as father green chemistry, they nicely described the shift of the role of chemists in their 1998 book on green chemistry along with the 12 principles of green chemistry.

Pharmaceutical industry is no exception, the principles of Green Chemistry are applicable to various industries, including pharmaceuticals. When applied to drug substance synthesis, Green Chemistry focuses on developing environmentally friendly and economically viable methods for producing pharmaceutical compounds.

What is GREEN SOLVENT?

Solvents are categorized as “Green solvent” based on the generation / from the source by which it derives. Green solvents are called as environmentally friendly solvents or bio solvents. Those are not derived from the chemical process like petrochemical solvents, they are derived from the processing of agricultural crops.

Example of green solvents: Ethyl lactate, for example, is a green solvent derived from processing corn.

 

Types of Green Solvents:

  • Supercritical Fluids: like Supercritical Carbon dioxide (ScCO2): A compound that exists above its critical pressure (Pc) and above its critical temperature (Tc) is known as supercritical fluid or SCF.
  • Water: Water is a great solvent for most of the organic reactions. It is called green or universal solvent.
  • Ionic liquids: An ionic liquid (IL) or ionic liquid is a molten salt in liquid state or we can say salts whose melting point is below some arbitrary temperature like 100 C is called ionic liquid (IL).
  • Fluorous biphasic solventFluorous biphasic means fully fluorinated hydrocarbon solvents that are immiscible with organic solvents at ambient conditions.
  • PEG (Polyethylene Glycol):Polyethylene glycol (PEG) is a special type of green and inexpensive solvent used in various chemical synthesis

Pharmaceutical Drug substance manufacturing aspects with the green chemistry

Pharmaceutical drug substance / Drug Product design seeks to optimize the pharmaceutical effects for a certain target while minimizing toxicological effects of the drug molecule. The goal of pharmaceutical process development is to provide efficient manufacturing conditions that avoid and minimize impurities with toxicological actions.

Avoiding the use of toxic solvents and process conditions that form impurities aligns with the green chemistry principle ‘choose synthetic routes using nontoxic compounds’ as well as with regulatory requirements such as those expressed in the ICH guidelines on residual solvents (ICH Q3C) and impurities in drug substances (ICH Q3/B).

The ICH Q3C guideline for residual solvents in pharmaceuticals classifies solvents into three classes from class-1 to class-2.

  • Class 1 solvents; are toxic or carcinogenic solvents to be avoided
  • Class 2 solvents; solvents to be limited
  • Class 3 solvents; with low toxicologic potential.

Considering the aspects of green chemistry in Drug substance manufacturing; The goal of every pharma company has always been an assurance to deliver revolutionary drugs to enhance the standard of living across the world. Now this is the time to take revolutionary steps to accomplish this goal in an environmentally friendly way, the companies need to progress from the traditional synthetic processes to a present-day innovative mechanism

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Learn More……..

Drug Substance and Drug Product Manufacturing Flow: Discovery to Delivery

Drug Substance in Pharmaceuticals!! Unveiling Its Vital Role

The Evolution of Drug Substance Development

New Chemical Entities (NCEs) in Pharmaceutical Drug Development

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