Bacitracin 500-U/g Ophthalmic Ointment From International Journal of Pharmaceutical Compounding, 11/1/03 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-m 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 150C 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 150C 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, texturespatula 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 60C. 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 70C) for extended times should be avoided, but it can be sterilized by dry heat.6 ###Upon introduction into clinical use in man, bacitracin was found to be nephrotoxic, and preparations for systemic use were soon withdrawn. However, it continued to be used topically, and is still used for the treatment of infected dermatoses and other skin infections, for infected wounds and the prevention of infection in dirty wounds, although to a diminished extent now other more effective agents have taken its place. The products containing bacitracin are ointments (including ophthalmic preparations) and various antibiotic sprays, in which it is mixed with such antibiotics as polymyxin and neomycin. The antibiotic sprays have rarely been favoured by microbiologists since they have been associated with both bacitracin and neomycin resistance, even though only the latter is of great clinical importance.