Bacitracin

METHOD OF PREPARATION

Note: This preparation should be prepared in a laminar airflow hood (LAH) in a cleanroom or via isolation barrier technology by a validated aseptic compounding pharmacist using strict aseptic technique.

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

Note: It is important to use the activity of the bacitracin powder in determining the weight that will be required to provide 50,000 U of activity.

2. Accurately weigh and/or measure each ingredient.

Method A

3. Dissolve the bacitracin in a small amount of ethyl alcohol.

4. Using aseptic technique, filter the solution through an appropriate 0.2-µm filter onto a sterile glass pill tile or other sterile working surface inside an LAH or isolation barrier chamber.

5. Allow the alcohol to evaporate.

6. Dry-heat sterilize the white petrolatum at 150°C for at least 1 hour.

7. Incorporate the sterile bacitracin powder into the sterile white petrolatum using aseptic technique and mix well.

8. Package and label.

Method B

Note: This method uses sterile bacitracin powder from bacitracin for injection as the source of the drug.

3. Dry-heat sterilize the white petrolatum at 150°C for at least 1 hour.

4. Aseptically, remove the seal and septa from the bacitracin for injection vial.

5. Remove the required quantity of bacitracin powder, making allowances for any other excipients in the product, and place on a sterile working surface.

6. Aseptically, reduce the particle size of the bacitracin powder.

7. Aseptically, incorporate the sterile white petrolatum into the sterile bacitracin powder and mix well.

8. Package and label.

PACKAGING

Package in sterile, collapsible ophthalmic ointment tubes.1

LABELING

For the eye. Keep out of reach of children. Use only as directed.

STABILITY

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

USE

Bacitracin is used alone or in combination with other drugs in the short-term topical treatment of superficial infections of the eye involving the conjunctiva and cornea.2

QUALITY CONTROL

Sterile ophthalmic ointment quality-control assessment can include comparison of theoretical weight with actual weight, specific gravity, active-drug assay, color, texture-surface, texture-spatula spread, appearance, feel, rheological properties, physical observations, paniculate matter and sterility.3-5

DISCUSSION

Bacitracin Ophthalmic Ointment USP is a sterile preparation of bacitracin in an anhydrous ointment base containing not less than 90.0% and not more than 140.0% of the labeled amount of bacitracin. It is packaged in collapsible ophthalmic tubes.1

Bacitracin ophthalmic ointment was formerly available under the brand name AK-tracin 500 U/g by Akorn but was discontinued in 2001. Bacitracin is active against many gram-positive organisms such as staphylococci, streptococci, anaerobic cocci, corynebacteria and clostridia. It is also effective against gonococci, meningococci and fusobacteria and other microorganisms.2

Bacitracin is a polypeptide produced by the growth of an organism of the licheniformis group of Bacillus subtilis (Fam. Bacillacaea). It has a potency of not less than 40 bacitracin U/mg. It occurs as a white to pale buff hygroscopic powder that is odorless or has a slight odor. Its solutions deteriorate rapidly at room temperature. It is freely soluble in water and soluble in alcohol. It is precipitated from solution and is inactivated by salts of many of the heavy metals.1

White petrolatum (white petroleum jelly, white soft paraffin) is a white-colored, translucent, soft, unctuous mass that is inert, odorless and tasteless. It is a mixture of semisolid saturated hydrocarbons obtained from petroleum. It has a specific gravity of about 0.815 to 0.880 and melts at from 38 to 60°C. It is practically insoluble in ethanol, glycerin and water but is soluble in chloroform and most fixed and volatile oils. Heating above its melting range (about 70°C) for extended times should be avoided, but it can be sterilized by dry heat.6

REFERENCES

1. US Pharmacopeial Convention, Inc. United States Pharmacopeia 26-National Formulary 21. Rockville, MD:US Pharmacopeial Convention, Inc.; 2003: 204-205, 2197-2201, 2549.

2. McEvoy GK. AHFS Drug Information-2003. Bethesda, MD:American Society of Health-System Pharmacists; 2003:2595-2596.

3. Allen LV Jr. Standard operating procedure for performing physical quality assessment of ointments/creams/gels. IJPC 1998;2:308-309.

4. Allen LV Jr. Standard operating procedure for particulate testing for sterile products. IJPC 1998;2:78.

5. Allen LV Jr. Standard operating procedure: Quality assessment for injectable solutions. IJPC 1999;3:406-407.

6. Weller PJ. Petrolatum: In: Rowe RC, Sheskey PJ, Weller PJ, eds. Handbook of Pharmaceutical Excipients. 4th ed. London:Pharmaceutical Press; 2003:421-423.

Copyright International Journal of Pharmaceutical Compounding Nov/Dec 2003
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