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Cefadroxil 50 mg/mL Oral Suspension

Loyd V. Allen, Jr., PhD
Professor Emeritus
College of Pharmacy, University of Oklahoma
Oklahoma City, Oklahoma

 



4/18/2014

 

US Pharm. 2014;39(4):80-81.

Method of Preparation: Calculate the quantity of each ingredient for the amount to be prepared. Accurately weigh or measure each ingredient. Obtain the cefadroxil powder or sufficient tablets or capsules to provide the required quantity of cefadroxil (make a weight adjustment for the monohydrate powder as necessary). Pulverize the cefadroxil to a fine powder. Add about 15 to 20 mL of Ora-Plus and mix with the cefadroxil powder to form a smooth paste. Add the remainder of the Ora-Plus and mix well, followed by the Ora-Sweet or Ora-Sweet SF in portions to final volume. Package and label.

Note: Ora-Blend or Ora-Blend SF, as well as similar commercially available vehicles, may be used in place of the vehicles listed here.

Use: Cefadroxil is used in the treatment of susceptible infections.

Packaging: Package in tight, light-resistant containers.

Labeling: Shake well before taking. Keep out of reach of children. Discard after ____ [time period].

Stability: A beyond-use date of 14 days when stored in a refrigerator may be used for this preparation.1

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

Discussion: Cefadroxil is a first-generation cephalosporin used to treat susceptible bacterial infections. Cefadroxil (Duricef, cefadroxil monohydrate, C16H17N3O5S.H2O, MW 381.40) occurs as a white to off-white or yellowish-white, crystalline powder. It is soluble in water and slightly soluble in ethanol. The pH of a 50 mg/mL aqueous suspension is between 4.0 and 6.0. Cefadroxil contains between 4.2% and 6.0% water. Cefadroxil for Oral Suspension contains the equivalent of not less than 90.0% and not more than 120.0% of the labeled amount of C16H17N3O5S. The pH of the suspension is between 4.5 and 6.0. Preserve the powder in tight containers.1

Ora-Plus is an oral suspending vehicle that accepts dilution of up to 50% with water, flavoring agents, or syrups while still retaining its suspending properties. It has a pH of approximately 4.2 and an osmolality of about 230 mOsm/kg. Ora-Plus is a thixotropic vehicle with a viscosity of approximately 1,000 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.3

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. Ora-Sweet is buffered to a pH of approximately 4.2 and has an osmolality of about 3,240 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.4

Ora-Sweet SF sugar-free syrup vehicle is a flavoring vehicle for oral extemporaneous preparations. It is a sugar-free, alcohol-free syrup flavored with a citrus-berry flavor blend. Ora-Sweet SF 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. Ora-Sweet SF has an osmolality of 2,150 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

Ora-Blend is a sweetened oral suspending vehicle used to simplify the process involved in the extemporaneous compounding of oral suspensions. It is an aqueous-based, sweetened vehicle consisting of a synergistic blend of suspending agents that have a high degree of colloidal activity. Ora-Blend is buffered to a slightly acidic pH of approximately 4.2, and it has a viscosity of approximately 700 cps at 25°C and an osmolality of 2,107 mOsm/kg. It occurs as an opaque, pinkish liquid with a sweet citrus-berry flavor. Ora-Blend contains purified water, sucrose, glycerin, sorbitol, flavoring, microcrystalline cellulose, carboxymethylcellulose sodium, xanthan gum, carrageenan, citric acid, and sodium phosphate as buffers and simethicone as an antifoaming agent. It is preserved with methylparaben and potassium sorbate.6

Ora-Blend SF is a flavored oral suspending vehicle used in the extemporaneous compounding of oral suspensions. It is an aqueous-based, sweetened vehicle consisting of a synergistic blend of suspending agents that have a high degree of colloidal activity. The suspending agents form a structured, gel-like matrix that suspends particles and allows for little settling. Ora-Blend SF is buffered to a pH of approximately 4.2, and it has a viscosity of approximately 1,000 cps at 25°C and an osmolality of 1,073 mOsm/kg. It occurs as an opaque, pinkish liquid with a sweet citrus-berry flavor. Ora-Blend SF contains purified water, sorbitol, glycerin, flavoring, microcrystalline cellulose, carboxymethylcellulose sodium, xanthan gum, carrageenan, sodium saccharin, citric acid, and sodium citrate as buffers, and simethicone as an antifoaming agent. It is preserved with methylparaben, propylparaben, and potassium sorbate.7

REFERENCES

1. U.S. Pharmacopeia 36/National Formulary 31. Rockville, MD: U.S. Pharmacopeial Convention, Inc; 2013:355-361,2839-2841.
2. Allen LV Jr. Standard operating procedure for performing physical quality assessment of oral and topical liquids. IJPC. 1999;3:146-147.
3. Ora-Plus product information. Allegan, MI: Perrigo; 2014.
4. Ora-Sweet product information. Allegan, MI: Perrigo; 2014.
5. Ora-Sweet SF product information. Allegan, MI: Perrigo; 2014.
6. Ora-Blend product information. Allegan, MI: Perrigo; 2014.
7. Ora-Blend SF product information. Allegan, MI: Perrigo; 2014.

To comment on this article, contact rdavidson@uspharmacist.com.

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