[Effect of admixture of betamethasone butyrate propionate ointment on preservative efficacy].
Twenty percent of dermatologists have experienced a separation of water or deterioration of topical corticosteroids mixed with commercially available ointments and/or creams. However, few investigations of this deterioration of admixtures have been reported. To assess the effects of preservatives in preventing microbial contamination of these admixtures, we attempted to investigate the concentration of preservative agents in admixtures and the microbial contamination of these admixtures with a topical corticosteroid ointment (Antebate). The concentration of parabens was reduced by half using an admixture of corticosteroid ointment with four types of moisturizing creams, Urepearl, Pastaronsoft, Hirudoid, and Hirudoidsoft. After a further 3 months, no decrease in parabens was seen. No microbial contamination was found in any admixture stored at room temperature for 1 week and touched two times daily with a finger. The concentration and ratio of the parabens in the aqueous phase and oil phase were entirely different in the admixtures before being centrifuged. The aqueous phase of the admixtures of the oil/water (O/W)-type emulsions of Urepearl and Hirudoid was not found to have microbial contamination immediately after being centrifuged. All aqueous phases stored at room temperature or in a refrigerator for 1 week and touched with a finger twice daily exhibited microbial contamination. These experiments demonstrated that O/W-type emulsions, in which the water easily separates from the bases, should be thoroughly mixed to prevent microbial contamination.
Ohtani
Michiteru
M
Department of Hospital Pharmacy, Tokyo Postal Services Agency Hospital, 2-14-23 Fujimi, Chiyoda-ku, Tokyo 102-8798, Japan. mootani@tpth.go.jp
Nakai
Tatsurou
T
Ohsawa
Kouji
K
Kim
Soan
S
Matsumoto
Mika
M
Etoh
Takafumi
T
Kariya
Satoru
S
Kanou
Syoujirou
S
Uchino
Katsuyoshi
K
D001623:Betamethasone / Q000031:analogs & derivatives*; D004340:Drug Contamination / Q000517:prevention & control*; D004355:Drug Stability; D004356:Drug Storage; D004655:Emulsions; D009824:Ointments; D010226:Parabens / Q000032:analysis; D011310:Preservatives, Pharmaceutical / Q000032:analysis
D004655:Emulsions; D009824:Ointments; D010226:Parabens; D011310:Preservatives, Pharmaceutical; C000612965:betamethasone butyrate propionate; C011175:betamethasone-17,21-dipropionate; D001623:Betamethasone