Hydrocortisone

METHOD OF PREPARATION

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

2. Accurately weigh and/or measure each ingredient.

3. Make a smooth paste of the hydrocortisone and glycerin.

4. Slowly incorporate the Ora-Plus and mix until uniform.

5. Incorporate sufficient Ora-Sweet or Ora-Sweet SF to volume and mix well.

6. Package and label.

PACKAGING

Package in tight, light-resistant containers.1

LABELING

Keep out of reach of children. Use only as directed. Shake well. Keep in refrigerator.

STABILITY

A beyond-usc date of 30 days should be appropriate for this preparation.1

USE

Hydrocortisone is a curticostcroiU widely used lur its anti-inflammatory properties.

QUALITY CONTROL

Quality-control assessment can include weight/volume, pH, specific gravity, active-drug assay, color, rheological propertics/pourability, physical observation and physical stability (discoloration, foreign materials, gas formation, mold growth).2

DISCUSSION

Hydrocortisone (C^sub 21^H^sub 30^O^sub 5^, MW 362.46, Cortisol, Compound F) is a corticosteroid secreted by the adrenal cortex. It is very widely used in oral and topical preparations for its anti-inflammatory properties. It occurs as a white to practically white, odorless, crystalline powder. It is very slightly soluble in water and sparingly soluble in alcohol. Hydrocortisone is mostly stable in a pH range of 3.S to 4.S. The vehicles used here have a pH of approximately 4.2.3 The original Cortef Oral Suspension (hydrocortisone cypionate, Upjohn) has been discontinued by the manufacturer. Since that time, numerous formulations have appeared in the literature using various suspending vehicles.

Glycerin (C^sub 3^H^sub 8^O^sub 3^, MW 92.10, glycerol, 1,2,3-propane triol) occurs as a clear, colorless, odorless, viscous, hygroscopic liquid with a sweet taste, about two thirds as sweet as that of sucrose. It has a specific gravity of about 1.25 and a melting point of 17.8°C; if cooled to crystallization, it will need to be heated to about 20°C to melt. It is miscible with water, methanol and 95% ethanol; practically insoluble in oils and chloroform; and slightly soluble in acetone. It is hygroscopic and should be stored in airtight containers in a cool place. It is not prone to oxidation but will decompose on heating. When mixed with water, ethanol and propylene glycol, the mixtures arc chemically stable.4

Ora-Plus is an oral suspending vehicle that accepts dilution of up to 50% or more with water, flavoring agents or syrups and still retains its suspending properties. Tt has a p H of approximately 4.2 and an osmolality of about 230 mOsm/kg. It is a thixotropic vehicle with a viscosity of approximately 1000 cps at 25°C. It contains purified water, microcrystalline cellulose, sodium carboxymethylcellulose, xanthan gum, carrageenan, sodium phosphate and citric acid as buffering agents; simethicone as an antifoaming agent; and potassium sorbatc and methylparaben as preservatives.5

Ora-Sweet syrup vehicle is a flavoring vehicle for oral extemporaneous preparations. It is flavored with a citrus-berry flavor blend and contains glycerin and sorbitol to prevent "cap-lock," a problem associated with many syrups. It is buffered to a pH of approximately 4.2 and has an osmolality of about 3240 mOsm/kg. It contains purified water, sucrose, glycerin, sorbitol (5%), flavoring, sodium phosphate and citric acid as buffering agents and potassium sorbate and methylparaben as preservatives.5

Ora-Sweet SF is a flavoring vehicle for oral extemporaneous preparations. It is a sugar-free, alcohol-free syrup flavored with a citrus-berry flavor blend. It is buffered to a pH of approximately 4.2 and may be used alone or in combination with other vehicles. It will tolerate a dilution to 50% with dissolved actives in water or suspending agents and still retain an acceptable taste. It has an osmolality of 2150 mOsm/kg. It contains water, sodium saccharin, xanthan gum, glycerin, sorbitol, citric acid and sodium citrate as buffers; methylparaben, propylparaben and potassium sorbate as preservatives; and flavoring agents.5

REFERENCES

1. US Pharmacopeial Convention, Inc. United States Pharmacopeia 26-National Formulary 21. Rockville, MD:US Pharmacopeial Convention, Inc.; 2003:2197-2201.

2. Alien LV Jr. Standard operating procedure for performing physical quality assessment of oral and topical liquids. IJPC 1999)3:146-147.

3. McEvoy GK. XlWFS Drug Information-2000. Bethesda, MD:American Society of Health-System Pharmacists; 2000:2428-2429.

4. Price JC. Glycerin. In: Kibbe AH, ed. Handbook of Pharmaceutics! Excipients. 3rd ed. Washington, DC:American Pharmaceutical Association; 2000:220-222.

5. Ora-Plus, Ora-Sweet, Ora-Sweet SF [product information]. Minneapolis, MN:Paddock Laboratories, Inc.

Copyright International Journal of Pharmaceutical Compounding Jan/Feb 2004
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