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Ketamine

Ketamine is a general dissociative anaesthetic for human and veterinary use. Its hydrochloride salt is sold as Ketanest®, Ketaset®, and Ketalar®. Pharmacologically it is very similar to other dissociative anesthetics such as tiletamine and phencyclidine (PCP). more...

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History

Ketamine was first synthesized in 1962 in an attempt to find a safer anaesthetic alternative to PCP, which was more likely to cause hallucinations and seizures. The drug was first used on American soldiers during the Vietnam War, but is often avoided now because it can cause unpleasant out-of-body experiences. It is still used widely in veterinary medicine, and for select human applications.

Ketamine's "unpleasant" side effects prompted its first psychedelic use in 1965. The drug was used in psychiatric and other academic research through the 1970s, culminating in 1978 with the publishing of John Lilly's The Scientist, a book documenting the author's ketamine, LSD, and isolation tank experiments. The incidence of recreational ketamine use increased through the end of the century, especially in the context of raves and other parties. The increase in illicit use prompted ketamine's placement in Schedule III of the United States Controlled Substance Act in August 1999. In the United Kingdom, it became outlawed and labelled a Class C drug on January 1, 2006.

Medical use

Given that it suppresses breathing much less so than most other available anaesthetics, ketamine is still used in human medicine as a first-choice anaesthetic for victims with unknown medical history (e.g. from traffic accidents), in podiatry and other minor surgery, and occasionally for the treatment of migraine. There is ongoing research into the drug's usefulness in pain therapy and for the treatment of alcoholism and heroin addiction.

In veterinary medicine, ketamine is often used for its anaesthetic and analgesic effects on cats, dogs, rabbits, rats, and other small animals. Veterinarians often use ketamine with sedative drugs to produce balanced anaesthesia and analgesia, and as a constant rate infusion to help prevent pain wind-up. Ketamine is used to manage pain among horses and other large animals, though it has less effect on bovines.

Ketamine may be used in small doses (0.1–0.5 mg/kg/hr) as an analgesic, particularly for the treatment of pain associated with movement and neuropathic pain. It has the added benefit of counter-acting spinal sensitization or wind-up phenomena experienced with chronic pain. At these doses, the psychotropic side effects are less apparent and well managed with benzodiazepines. Ketamine is a co-analgesic, requiring a concomitant low-dose opioid to be effective.

The effect of Ketamine as a depressant on the respiratory and circulatory systems is less than that of other anaesthetics. When used at anaesthetic doses, it will sometimes stimulate rather than depress the circulatory system. It is sometimes possible to perform ketamine anaesthesia without protective measures to the airways. Ketamine is also a potent analgesic and can be used in sub-anaesthetic doses to relieve acute pain; however, its psychotropic properties must be taken into account. Patients have reported going into other worlds or seeing God while anaesthetized, and these unwanted psychological side-effects have marginalized the use of ketamine in human medicine.

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Ketamine 25-mg/mL Nasal Spray
From International Journal of Pharmaceutical Compounding, 11/1/04

METHOD OF PREPARATION

Note: This preparation should be done in a laminar airflow hood in a cleanroom or via isolation barrier technology by a validated aseptic compounding pharmacist using strict aseptic technique.

1. Calculate the required quantity of each ingredient for the total amount to be prepared.

2. Accurately weigh and/or measure each ingredient.

3. Heat about 90 mL of purified water to about 90°C, add the methylparaben and propylparaben and stir until dissolved.

4. Cool to room temperature and add the ketamine hydrochloride and sodium chloride and mix until dissolved.

5. Add sufficient purified water to volume and mix well.

6. Filter through an appropriate sterile 0.2-µm filter into sterile containers.

7. Package and label.

PACKAGING

Package in tight, light-resistant containers.1

LABELING

Keep out of reach of children. Use only as directed. For nasal use only.

STABILITY

A beyond-use date of 48 hours at room temperature, 14 days at refrigerated temperature or 45 days at

USE

Ketamine nasal spray is used in the treatment of pain. The dose can be measured by calibrating the spray bottle that is used.

QUALITY CONTROL

Quality-control assessment can include weight/volume, physical observation, pH, specific gravity, osmolality, assay, clarity and sterility.2,3

DISCUSSION

Ketamine hydrochloride (C^sub 13^H^sub 16^ClNO.HCl, MW 274.2) is used as an anesthetic and analgesic. It is usually administered parenterally but is also used as a nasal spray in patients where the patenterai route is not convenient. Ketamine hydrochloride occurs as a white crystalline powder with a slight characteristic odor. Approximately 1.15 mg is equivalent to 1 mg of ketamine base. It is soluble 1 g in 4 mL of water, 14 mL of alcohol and in 60 mL of absolute alcohol. Ketamine hydrochloride injection is a sterile solution of ketamine hydrochloride in water for injection. It contains an amount of ketamine hydrochloride equivalent to not less than 95.0% and not more than 105.0% of the labeled amount of ketamine. The injection has a pH of 3.5-5.5 and it contains not more than 0.4 USP endotoxin units per mg of ketamine hydroehloride. It should be stored at controlled room temperature and protected from light.1,4

Sodium chloride (NaCl, MW 58.44) is available as a white crystalline powder or as colorless crystals. In parenteral, ophthalmic and nasal preparations, it is used to prepare isotonic solutions. It is soluble in water (1 g in 2.8 mL), glycerin (1 g in 10 mL) and 95% ethanol (1 g in 250 mL). A 0.9% w/v aqueous solution is iso-osmotic with serum and its solutions are stable.1

Methylparaben (C^sub 8^H^sub 8^O^sub 3^, MW 152.15, methyl hydroxybenzoate, methyl parahydroxybenzoate) is available as colorless crystals or as a white, crystalline powder that is odorless or almost odorless, and has a slight burning taste. One gram is soluble in 400 mL of water, 3 mL of 95% ethanol, 60 mL glycerin, 200 mL peanut oil and 5 mL propylene glycol.6

Propylparaben (C^sub 10^H^sub 12^O^sub 3^, MW 18.20, propyl hydroxybenzoate, propyl parahydroxybenzoate) is available as a white, crystalline, odorless and tasteless powder. One gram is soluble in 2500 mL of water, 1.1 mL ethanol, 250 mL glycerin, 70 mL peanut oil and 3.9 mL propylene glycol.7

Purified water is water that is obtained by distillation, ion exchange, reverse osmosis or some other suitable process.8

REFERENCES

1. US Pharmacopeial Convention, Inc. United States Pharmacopeia 27-National Formulary 22. Rockville, MD: US Pharmacopeial Convention, Inc.; 2004: 1262-1263, 2345-2349.

2. Allen LV Jr. Standard operating procedure for particulate testing for sterile products. IJPC 1998; 2: 78.

3. Allen LV Jr. Standard operating procedure: Quality assessment for injectable solutions. IJPC 1999; 3: 406-407.

4. Sweetman SC, ed. MARTINDALE: The Complete Drug Reference. 33rd ed. London: Pharmaceutical Press; 2002: 1262-1263.

5. Cable CG. Sodium chloride. In: Kibbe AH, ed. Handbook of Pharmaceutical Excipients. 3rd ed. Washington, DC: American Pharmaceutical Association; 2000: 478-481.

6. Reiger MM. Methylparaben. In: Rowe RC, Sheskey PJ, Weller PJ, eds. Handbook of Pharmaceutical Excipients. 4th ed. Washington, DC: American Pharmaceutical Association; 2003: 390-394.

7. Rieger MM. Propylparaben. In: Kibbe AH, ed. Handbook of Pharmaceutical Excipients. 3rd ed. Washington, DC: American Pharmaceutical Association; 2000: 450-453.

8. Ellison A, Nash RA, Wilkin MJ. Water. In: Rowe RC, Sheskey PJ, Weller PJ, eds. Handbook of Pharmaceutical Excipients. 4th ed. Washington, DC: American Pharmaceutical Association; 2003: 672-676.

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