How is Ketamine Made?

Contact Us

You might have heard of ketamine referred to as a party drug or a horse tranquiliser. It’s true that ketamine is commonly misused for recreational purposes and it also has legitimate uses in the veterinary field.

It was, though, developed for use as a human anaesthetic in the 1960s. It is still used for that purpose, as well as for the treatment of severe or chronic pain in certain circumstances. Ketamine is also increasingly being used as a therapeutic to help people who are experiencing mental health issues including treatment-resistant depression, anxiety, PTSD and alcohol addiction.

Understanding ketamine’s origin is important because patients and legitimate users need to have trust in the efficacy and safety of the drug. Street drugs can often vary in potency or be cut with other substances, whereas clinical ketamine is made to the most rigorous of standards.

What is Ketamine?

Ketamine is a dissociative anaesthetic that has some hallucinogenic effects. In more technical terms, it is an NMDA receptor antagonist, meaning it blocks the N-methyl-D-aspartate neurotransmitter in the brain. It can have a number of effects, including sedation, relaxation, pain relief and antidepressant effects.

Ketamine hydrochloride is a cyclohexane derivative closely related chemically and pharmacologically to the veterinary drug phencyclidine. Ketamine exists as its two enantiomers, S- (esketamine) and R- (arketamine). Enantiomers are pairs of molecules that are non-superimposable mirror images of each other, like a chemical version of left and right hands. These enantiomers possess distinct pharmacological and therapeutic properties.

Illegal or ‘street’ ketamine generally comes as a clear liquid or white or off-white crystalline powder. Clinical ketamine is usually liquid and can come in a variety of forms, including oral suspension, oral solution, solution for injection and spray.

Synthesis of Ketamine: Overview

The history of ketamine started in the 1950s as researchers investigated a drug group known as cyclohexylamines for an ‘ideal’ anaesthetic agent with analgesic properties. Unlike some drugs, ketamine is entirely synthetic, meaning it doesn’t occur naturally like opioids.

The clinical ketamine used today is made in the laboratory via rigorous and exacting chemical processes. It is a complex overall process but can be broken down into a number of key steps.

First the organic chemical compound cyclohexanone (which is also used to make nylon) goes through a series of chemical reactions, including a condensation reaction with hydroxylamine hydrochloride to make intermediate products needed to synthesise ketamine. These intermediate compounds are reduced and undergo purification techniques that may include distillation, recrystallisation and filtration, among others.

The goal is to produce incredibly pure ketamine hydrochloride that is free of any contaminants.

Crucially, the whole process involves exacting procedures carried out in a controlled and sterile laboratory environment. This allows for the safe and consistent production of ketamine for clinical use. Quality control checks are carried out at various stages, including checks of the raw material, monitoring of the chemical processes as they are carried out and testing the final product using advanced analytical techniques such as high-performance liquid chromatography (HPLC) and mass spectrometry.

 

 

Formulations Used in Clinical Settings

The ketamine used in clinical settings comes in various formulations.

These can include:

  • Injectable formulations: These include both IV (intravenous) injections, which deliver the drug directly into a vein for the fastest absorption, and IM (intramuscular) injections that  deliver medication into a muscle.
  • Oral preparations: These can take the form of a tablet, capsule or liquid.
  • Nasal sprays: The best-known product is an antidepressant nasal spray known as esketamine, which is not exactly the same drug but is very similar to ketamine.

All formulations of ketamine for clinical use are thoroughly and rigorously checked for safety and consistency, including for sterility, pH and concentration standards.

Some of these formulations are available ‘off label’, which means ketamine is being used for a purpose other than the one it is currently licensed for. This does not mean it is unsafe or unregulated though.

How is Ketamine Made? Regulations, Licensing, and Pharmacopoeia Standards

The production of any medication or drug for clinical use is rigorously regulated. The primary regulations include the Medicines Act 1968, the Human Medicines Regulations 2012, and the directives set forth by the Medicines and Healthcare Products Regulatory Agency (MHRA), particularly concerning Good Manufacturing Practices (GMP). These regulations relate not only to the manufacture but also the storage, distribution and labelling of the medicines.

There are a number of reasons why a medication may be used off-label. Licensing is a very involved and expensive process and evidence may still show that a certain medication can provide benefits it has not yet been licensed for. The UK government says that there are clinical situations when the use of unlicensed or off-label medicines ‘may be judged by the prescriber to be in the best interest of the patient on the basis of available evidence’.

The Risks of Non-Pharmaceutical Ketamine

Some ketamine that enters the streets for illicit use is stolen from the legitimate supply chain, often involving veterinary supplies. Other sources are illegally diverted using shell companies, with a lot of the ketamine seized in Europe originating in India, Pakistan and China. Some ketamine is made in illegal factories.

All these sources can have risks. Ketamine made in illegal labs is not subject to the same rigorous standards and even stolen ketamine from legitimate sources may be ‘cut’ or adulterated with other substances. There is no way to know before taking it if illicit ketamine is pure or safe. Using it in an uncontrolled or unsupervised manner can also be very dangerous.

 

Why Clinical Grade Ketamine is Safer and More Reliable

As mentioned, ketamine for clinical use is manufactured under extremely controlled settings and the process and finished product is monitored at every step.

Clinical oversight, monitoring and quality assurance systems all help ensure that the ketamine used in legitimate clinical settings has known purity, sterility and safety.

Safe and Professional Administration of Ketamine is Essential

It’s important that people who could benefit from ketamine’s legitimate uses have confidence that the drug is produced to the highest standards and administered safely. Eulas Clinics only uses high-quality, certified ketamine under all appropriate regulations.

Curious about how medical ketamine is safely produced? Contact Eulas Clinics for reassurance and transparency about our sourcing and protocols.