Stomatitis

METHODOFPREPARATION

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

2. Accurately weigh and/or measure each ingredient.

3. Blend the powders together and make a paste using the glycerin.

4. Add the Ora-Plus with mixing until the consistency is uniform.

5. Add 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. Store in a refrigerator.

STABILITY

A beyond-use date of 14 days is appropriate for this preparation when stored in a refrigerator.'

USE

This preparation is used to treat mucositis resulting from chemotherapy and other conditions.

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

Tetracycline (C^sub 22^H^sub 24^N2O^sub 8^, MW 444.43) occurs as a yellow, odorless, crystalline powder. It is stable in air, but exposure to strong sunlight causes it to darken. It loses potency in solutions that have a pH less than 2 and is rapidly destroyed by alkali hydroxide solutions. It is very slightly soluble in water and sparingly soluble in alcohol.1 It should be preserved in tight, light-resistant containers.

Diphenhydramine hydrochloride (C^sub i7^H^sub 21^NO-HCl, MW 291.82) occurs as a white, odorless, crystalline powder. It slowly darkens on exposure to light. It is freely soluble in water and in alcohol.1

Nystatin is a substance, or a mixture of two or more substances, produced by the growth of Streptomyces noursei (Fam. Streptomycetaceae). It has a potency of not less than 4400 USP Nystatin u/mg or, when intended for use in the extemporaneous preparation of oral suspensions of not less than 5000 USP Nystatin u/mg. Nystatin occurs as a yellow to light tan powder with an odor suggestive of cereals. It is hygroscopic and is affected by long exposure to light, heat and air. It is practically insoluble in water and in alcohol.'

Hydrocortisone (C^sub n^H^sub so^Os, MW 362.46, Cortisol, Compound F) is a corticosteroid secreted by the adrenal cortex. It occurs as a white to practically white, odorless, crystalline powder. It is very slightly soluble in water and sparingly soluble in alcohol.3

Glycerin (C^sub s^H^sub g^C^sub h^, MW 92.1, glycerol, 1,2,3-propane triol) occurs as a clear, colorless, odorless, viscous, hygroscopic liquid with a sweet taste. It has a specific gravity of about 1.25. It is miscible with water and 95% ethanol. It should be stored in airtight containers in a cool place.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. It has a pH 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 sorbate and methylparaben as preservatives.5

Ora-Sweet syrup is a flavoring vehicle for oral extemporaneous preparations. It is flavored with a citrus-berry flavor blend and contains glycerin and sorbitol. 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 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 26NationalFormulary21. Rockville, MD:US Pharmacopeial Convention, lnc.;2003:1341, 1790, 2197-2201, 2558, 2572, 2583.

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

3. McEvoy GK. XlWf5 Drug Information-2000. Bethesda, MD:American Society of Health-System Pharmacists;2000:2428-2429.

4. Price JC. Glycerin. In: Rowe RC, Sheskey PJ, Weller PJ, eds. Handbook of Pharmaceutical Excipients. 4th ed. Washington, DC:American Pharmaceutical Association;2003:257-259.

5. 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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