Griseofulvin

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. Mix the griseofulvin and docusate sodium with the alcohol and the Ora-Plus, added in portions, with thorough mixing after each addition.

4. Add sufficient Ora-Sweet or Ora-Sweet SF to about 90 mL, and mix well.

5. Check the pH and adjust to the range of pH 5.5 to 7.5 using sodium hydroxide.

6. Add sufficient Ora-Sweet or Ora-Sweet SF to volume and mix well.

7. Package and label.

PACKAGING

Package in tight, light-resistant containers.1

LABELING

Keep out of reach of children. Take only as directed. Shake well.

STABILITY

A beyond-use date of up to 6 months would be appropriate for this preparation.1

USE

Griseofulvin is indicated in the treatment of infections caused by lrichophyton, Microsporum and Epidermophyton genera of fungi.

QUALITY CONTROL

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

DISCUSSION

Griseofulvin oral suspension has recently become unavailable. The suspension contained griseofulvin, alcohol, docusate sodium, FD&C Red No. 40, FD&C Yellow No. 6, flavors, magnesium aluminum silicate, menthol, methylparaben, propylene glycol, propylparaben, saccharin sodium, simethicone emulsion, sodium alginate, sucrose and purified water.

Griseofulvin (C^sub 17^H^sub 17^ClO^sub 6^, MW 352.77) occurs as a white-tocreamy-white odorless powder, in which particles of the order of 4 µm in diameter predominate. It is very slightly soluble in water. Griseofulvin Oral Suspension USP contains not less than 90.0% and not more than 115.0% of the labeled amount of griseofulvin. The pH of the suspension is between 5.5 and 7.5. It contains one or more suitable colors, diluents, flavors, preservatives and wetting agents.1

Alcohol 95% (C^sub 2^H^sub 5^OH, MW 46.01, ethyl alcohol, cthanol and grain alcohol) is a clear, colorless, mobile and volatile liquid with a slight, characteristic odor and a burning taste. It is miscible with glycerin and water. Tt should be stored in a cool place.3

Docusate sodium (C^sub 20^H^sub 37^NaO^sub 7^S, MW 444.56, dioctyl sodium sulfosuccinate) is an anionic surfactant, therapeutic agent and wetting agent. It occurs as a white or almost white, wax-like, bitter tasting, plastic solid with a characteristic octanol-like odor. It is hygroscopic and is soluble l g in 70 mL of water. It is also freely soluble in glycerin, soluble in vegetable oils and acetone and soluble 1 g in 3 mL of 95% ethanol.4

Sodium hydroxide (NaOH, MW 40.00, caustic soda, soda lye) occurs as dry, very deliquescent, white or almost white sticks, pellets or fused masses that are hard and brittle. It is soluble 1 g in 1 mL of water and is freely soluble in alcohol.5

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. It has a pH of approximately 4.2. 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 sorbate and methylparaben as preservatives.6

Ora-Sweet syrup is a flavoring vehicle for oral extemporaneous preparations. It is buffered to a pH of approximately 4.2. It contains purified water, sucrose, glycerin, sorbitol (5%), flavoring, sodium phosphate and citric acid as buffering agents; and potassium sorbate and methylparaben as preservatives.6

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 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.6

REFERENCES

1. US Pharmacopeial Convention, Inc. United States Pharmacopeia 28National Formulary 21. Rockville, MD:US Pharmacopeial Convention, lnc.;2003:875-877, 2197-2201, 2563.

2. Alien LV Jr. Standard operating procedure for performing physical quality assessment of oral and to picalliquids. /JPC1999;3:146-147.

3. Owen SC. Alcohol. In: Rowe RC, Sheskey PJ, Weller PJ, eds. Handbook of Pharmaceutical Excipients. 4th ed. Washington, DC:American Pharmaceutical Association;2003:13-15.

4. Malick AW. Docusate sodium. In:Rowe RC, Sheskey PJ, Weller PJ, eds. Handbook of Pharmaceutical Excipients. 4th ed. Washington, DC:American Pharmaceutical Association;2003:222-224.

5. Reynolds JEF, ed. MARTINDALE:The Extra Pharmacopeia. 30th ed. LondoniPharmaceutical Press; 1993:1415.

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

Copyright International Journal of Pharmaceutical Compounding Mar/Apr 2004
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