Can you provide a liquid formulation for vancomycin HCl?
Vancomycin HCl, a glycopeptide antibiotic, is used to treat gram-positive bacterial infections, most notably pseudomembranous colitis caused by the anaerobic bacillus Clostridium difficile
. This form of colitis is often seen as an iatrogenic infection following large-dose antibiotic therapy that kills much of normal gut flora, and can in extreme cases lead to toxic megacolon and death.
Vancomycin HCl is administered as a parenteral solution or oral capsule (125 and 250 mg/capsule). Therapeutic compliance can be enhanced by administration of oral liquid preparations in selected cases.
Oral liquid preparations of vancomycin HCl for oral solution formerly were available as 500 mg/6 mL and 250 mg/5 mL (Vancoled, Lederle; Vancocin HCl, Viropharma), but currently are listed in the FDA Orange Book
Several formulations for extemporaneous preparation of vancomycin HCl oral solution have been published. One recent example uses a unique vehicle to compound vancomycin 50 mg/mL (Whaley PA, Voudrie MA II. Stability of vancomycin in SyrSpend SF. Int J Pharm Compounding
Vancomycin HCl 5 g
SyrSpend SF q.s. ad 100 mL
The authors assigned BUD 90 days when refrigerated and protected from light.
Calculate the required quantity of each ingredient for the total amount of formulation to be prepared.
Accurately weigh and/or measure each ingredient; reduce powders to fine consistency with ceramic or Wedgwood mortar and pestle.
Add a small amount of SyrSpend SF to the vancomycin HCl to wet the powder; mix well.
Transfer mixture in (3) to a graduated cylinder of sufficient capacity.
Add sufficient SyrSpend SF to reach desired calculated volume by “washing” the mortar and pestle in (4) with 2 to 3 aliquots of SyrSpend SF into the graduated cylinder to ensure all active ingredient is transferred.
Package and label. Consider “Shake Well” and “Refrigerate” labeling.
Mr. Erickson is quality assurance and regulatory affairs manager at Fagron, Inc. (Fagron US).