Purpose: Prepare a compounded medication using a salt form and properly labeling it according to the USP Salt Policy so that the patient receives the actual dose of drug ordered by the physician or practitioner.
Methods: A patient with gastrointestinal acute graft-versus-host disease (GVHD) required treatment with oral beclomethasone. Since beclomethasone is not commercially available in a commercial dosage form, an oral suspension needed to be compounded. The compounding pharmacist was provided with formulas from a couple of pharmacy department website; however, the formulas did not follow USP Salt Policy. The compounding pharmacist sourced and ordered the beclomethasone dipropionate (USP-grade) API powder and created a master formula for beclomethasone 1 mg/mL oral suspension with the appropriate adjusted weight for the salt so that the patient actually received the dose (active moiety) that the physician ordered. The beclomethasone (as dipropionate) 1 mg/mL oral suspension was prepared with beclomethasone dipropionate 0.127 gm and a non-aqueous vehicle to a total of 100 mL. A beyond-use date (BUD) of 90 days at room temperature was assigned to the formula according to USP standards.
Results: A smooth, homogenous suspension was prepared by the compounding pharmacist. The master formula was written according to current official USP <795> standards and it was properly labeled according to the USP Salt Policy and USP standards. The patient received the correct dose ordered by the physician.
Conclusion: When preparing a compounded dosage form, the weight of the salt form must be adjusted so that it is equivalent to the active moiety. The compound should be labeled according to the USP Salt Policy and USP standards so that the patient will receive the accurate dose prescribed or ordered by the physician or practitioner. Not adjusting for the salt form can result in the patient receiving a subtherapeutic or supratherapeutic dose.
Learning Objectives:
Describe the weight adjustment of an Active Pharmaceutical Ingredient (API) salt powder to the equivalent weight of the API base powder.
List USP label standards for compounded medications with the proper strength when a specific salt form is used.
Describe the impact of different salt forms of API on properly dosing the medication.
.jpg "Sarah M. Gaffney, PharmD, MBA, BCPS photo")