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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 Hydrochloride 5% and Ketoprofen 5% in Pluronic Lecithin Organogel
From International Journal of Pharmaceutical Compounding, 9/1/04

METHOD OF PREPARATION

Note: The lecithin:isopropyl palmitate solution can be prepared by mixing 0.2 g sorbic acid, 50 g of soy lecithin and 50 g of isopropyl palmitate. The Pluronic F127 solution can be prepared by mixing 0.2 g sorbic acid, 30 g of Pluronic F127 and sufficient purified water to make 100 mL.

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

2. Accurately weigh and/or measure each ingredient.

3. Mix the ketamine hydrochloride and the ketoprofen with the propylene glycol to form a smooth paste.

4. Incorporate this paste into the lecithin:isopropyl palmitate solution and mix well.

5. Add sufficient Pluronic F127 20% gel to volume and mix using a shear-mixing technique until thoroughly mixed.

6. Package and label.

PACKAGING

Package in tight, light-resistant containers.1

LABELING

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

STABILITY

A beyond-use date of up to 30 days can be used for this preparation.1

USE

Ketamine and ketoprofen Pluronic lecithin organogel have been used in the treatment of mild-to-moderate musculoskeletal pain.

QUALITY CONTROL

Quality-control assessment can include theoretical weight compared to actual weight, pH, specific gravity, active drug assay, color, clarity, texture-surface, texture-spatula spread, appearance, feel, rheological properties and physical observations.2

DISCUSSION

Ketamine hydrochloride (C^sub 13^H^sub 16^CINO.HCl, MW 274.2) is used as an anesthetic and analgesic. It 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, in 14 mL of alcohol and in 60 mL of absolute alcohol.1,3

Ketoprofen (C^sub 16^H^sub 14^O^sub 3^, MW 254.28) occurs as a white or almost-white, odorless or almost-odorless crystalline powder. It is practically insoluble in water but freely soluble in alcohol and ether. It has a melting range between 92.0°C and 97.0°C. Ketoprofen has analgesic, anti-inflammatory and antipyretic properties and is an inhibitor of cyclo-oxygcnase.1,3

Propylene glycol (C^sub 3^H^sub 8^O^sub 2^, MW 76.09) occurs as a clear, colorless, viscous, practically odorless liquid with a sweet taste, somewhat resembling glycerin. It is miscible with acetone, 95% ethanol, glycerin and water.4

Lecithin (egg lecithin, soybean lecithin, vegetable lecithin) is a complex mixture of acetone-insoluble phosphatides; the composition and physical properties vary depending upon the source and the degree of purification. Physically, lecithin ranges from a viscous semiliquid to a powder. It is practically insoluble in water; when mixed with water, though, it hydrates to form emulsions. It should be stored in well-closed containers and be protected from light.5

Isopropyl palmitate (C^sub 19^H^sub 38^O^sub 2^, MW 298.51) is a colorless, mobile liquid with a very slight odor that is used as an emollient, oleaginous vehicle and a solvent. It is soluble in acetone, castor oil, cottonseed oil, alcohol and mineral oil. It is insoluble in water, glycerin and propylene glycol.6

Pluronic F127, a poloxamer, is a series of closely related block copolymers of ethylene oxide and propylene oxide. Poloxamers are available in different grades, either liquids or solids with average molecular weights ranging from 2,090 to 14,600. Poloxamers generally are white-colored, waxy, free-flowing granules or cast solids that are practically odorless and tasteless. Poloxamer 407 (Pluronic F-127) is generally available in powdered form. It is either odorless or may have a very mild odor. It is freely soluble in water, alcohol and isopropyl alcohol.7

REFERENCES

1. US Pharmacopeial Convention, Inc. United States Pharmacopeia 27-National Formulary 22. Rockville, MD: US Pharmacopeial Convention, Inc.; 2004: 978, 1054-1056, 2345-2349, 2768.

2. Allen LV Jr. Standard operating procedure for performing physical quality assessment of ointments/creams/gels. IJPC 1998; 2: 308-309.

3. Sweetman SC, ed. MARTINDALE: The Complete Drug Reference. 33rd ed. London: Pharmaceutical Press; 2002: 210-222, 1262-1263.

4. Weller PJ. Propylene glycol. In: Rowe RC, Sheskey PJ, Weller PJ, eds. Handbook of Pharmaceutical Excipients. 4th ed. Washington, DC: American Pharmaceutical Association; 2003: 521-523.

5. Fowler K. Lecithin. In: Rowe RC, Sheskey PJ, Weller PJ, eds. Handbook of Pharmaceutical Excipients. 4th ed. Washington, DC: American Pharmaceutical Association; 2003: 340-342.

6. Taylor AK. Isopropyl palmitate. In: Rowe RC, Sheskey PJ, Weller PJ, eds. Handbook of Pharmaceutical Excipients. 4th ed. Washington, DC: American Pharmaceutical Association; 2003: 314-315.

7. Collett JH. Poloxamer. In: Rowe RC, Sheskey PJ, Weller PJ, eds. Handbook of Pharmaceutical Excipients. 4th ed. Washington, DC: American Pharmaceutical Association; 2003: 447-450.

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