Dyclonine

METHOD OF PREPARATION

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

2. Accurately weigh and/or measure each ingredient.

3. Blend the clohetasol propionate and dyclonine hydrochloride powders together.

4. Incorporate the powders into the Ora-hesive Base or Orabase Plain until uniform.

5. Package and label.

PACKAGING

Package in tight, light-resistant containers.1

LABELING

Keep out of reach of children. Use only as directed.

STABILITY

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

USE

Clobetasol and dyclonine oral paste is used to treat painful disorders of the oral mucosa.

QUALITY CONTROL

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

DISCUSSION

Clobetasol propionate (C^sub 25^H^sub 32^ClFO^sub 5^, MW 466.97) occurs as a white- to cream-colored crystalline powder. It is practically insoluble in water, slightly soluble in diethyl ether, sparingly soluble in ethanol and soluble in acetone and dimethyl sulfoxide. It should be stored in tight, light-resistant containers. Clobetasol Propionate Topical Solution USP is preserved in tight containers and at controlled room temperature; it is not to be refrigerated. Clobetasol propionate is a synthetic fluorinated corticosteroid classified as an anti-inflammatory agent used in the relief of inflammation of moderate-to-severe corticosteroid-responsive dermatoses. It appears to stimulate the synthesis of enzymes needed to decrease inflammation, suppress mitotic activity and cause vasoconstriction.1

Dyclonine hydrochloride (C^sub 18^H^sub 27^NO^sub 2^.HCl, MW 325.87) occurs as white crystals or as a white crystalline powder that may have a slight odor. It exhibits local anesthetic properties when placed upon the tongue. It is soluble in water, acetone and alcohol. It has a melting range between 173° and 178°C, and the pH of a 1% aqueous solution is between 4.0 and 7.0. It is stored in tight, light-resistant containers.1

Ora-hesive is a topical oral paste containing a combination of bioadhesive ingredients in an anhydrous, hydrophobic base designed to repel water and adhere to mucosal surfaces. It is a protective paste that can be used as a professionally acceptable base for elegant extemporaneously compounded formulations.3

Orabase Plain contains pectin, gelatin, carboxymethylcellulose, polyethylene, mineral oil and tragacanth.4

REFERENCES

1. US Pharmacopeial Convention, Inc. United States Pharmacopeia 27-National Formulary22. Rockville, MD: US Pharmacopeial Convention, Inc.; 2004: 676-677, 2345-2349, 2756, 2760.

2. Allen LV Jr. Standard operating procedure for performing physical quality assessment of ointments/creams/gels. IJPC1998; 2(4): 308-309.

3. Ora-hesive [product information]. St. Paul, MN: Gallipot.

4. Orabase Plain [product information]. Canton, MA: Colgate Oral Pharmaceuticals.

Copyright International Journal of Pharmaceutical Compounding Mar/Apr 2005
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