A retrospective study of oral and dermatological formulations compounded via dosage form modifications at Kenyatta National Hospital from January 2020 to December 2021

Sharon W Wanyeki; Lucy J Tirop

Sharon W Wanyeki Department of Pharmaceutical Chemistry, Pharmaceutics & Pharmacognosy, Faculty of Health Sciences, University of Nairobi, P.O. Box 19676-00202, Nairobi, Kenya
Lucy J Tirop Department of Pharmaceutical Chemistry, Pharmaceutics & Pharmacognosy, Faculty of Health Sciences, University of Nairobi, P.O. Box 19676-00202, Nairobi, Kenya

Keywords: Compounding, beyond-use date, dosage form modification, oral, dermatological

Abstract

The current study aimed to elucidate the extent of compounding involving dosage form modifications at Kenyatta National hospital from 2020-2021. A total of 2205 oral formulations, containing one out of thirty-eight active pharmaceutical ingredients, were compounded from commercially available tablets or capsules during the study period. The most frequently compounded oral formulations were furosemide (34.40%), spironolactone (25.72%), and sildenafil (9.40%) suspensions, which also accounted for the highest volumes produced. The study revealed that the total volume of oral formulations compounded was 161.4L, a marked rise from 38.4L compounded in the 2012-2013 period. Oral formulations were all prepared using 40% dextrose as diluent, packaged in amber colored plastic bottles and recommended for storage at 4-8°C. The majority of the formulations (71.29%) were assigned a beyond-use date of 14 days, in compliance to the United States Pharmacopeia (USP)recommendation. A total of 17 dermatological formulations, comprising either single-entity or dual combination of three active pharmaceutical ingredients, were prepared from commercially available powders or tablets during the two-year study period. The dermatologicals were reformulated as either ointments (with emulsifying ointment as diluent) or pastes (with white soft paraffin as base), packaged in white translucent plastic jars and recommended for storage at room temperature. Nifedipine paste accounted for the highest percentage by weight and frequency of the dermatological formulations. About 75.76% of the dermatological formulation were assigned a beyond-use date of 30 days, in compliance with the USP recommendation. The study revealed that extensive compounding, involving dosage form modifications, was carried out during the study period.