Assessment of the physical properties and stability of mixtures of tetracycline hydrochloride ointment and acyclovir cream

被引:5
作者
Inoue, Yutaka [1 ]
Furuya, Kayoko [1 ]
Maeda, Rikimaru [1 ]
Murata, Isamu [1 ]
Kanamoto, Ikuo [1 ]
机构
[1] Josai Univ, Lab Drug Safety Management, Fac Pharmaceut Sci, Sakado, Saitama 3500295, Japan
关键词
Tetracycline hydrochloride; Acyclovir; Mixture; Ointment; Generic drug;
D O I
10.1016/j.ijpharm.2013.02.047
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
In dermatology, ointments are often mixed as part of drug therapy, but mixing often leads to incompatibility. Three combinations of tetracycline ointment (TC-o) and acyclovir cream (ACV-cr) were prepared at a TC-o:ACV-cr ratio of 1:1 using a brand-name ACV-cr and two generic ACV-cr (samples TC-o + ACV-A, TC-o + ACV-B, and TC-o + ACV-C). Microscopic examination revealed separation in TC-o + ACV-C. Viscosity and elasticity measurement indicated that the storage modulus (G '') and loss modulus (G '') of each of the TC-o + ACV-cr mixtures behaved similarly to those of an ACV-cr and the loss tangent (tan i) behaved similarly to that of a TC ointment. In addition, differences in the storage modulus (G') and loss modulus (G '') of the TC-o + ACV-cr mixtures were noted. To assess stability, each TC-o + ACV-cr mixture was stored away from direct sunlight at 25 degrees C and an RH of 84% and at 4 degrees C (in a refrigerator). HPLC revealed that the ACV content in each TC-o + ACV-cr mixture remained at 95-105% for up to 14 days under both sets of storage conditions. A decline in TC content in each TC-o + ACV-cr mixture was not noted with storage at 4 degrees C but was noted over time with storage at 25 degrees C and an RH of 84%. In addition, significant differences in the percent decline in TC content in each TC-o + ACV-cr mixture occurred with storage at 25 degrees C and an RH of 84%. Thus, differences in physical properties and stability may occur when combining brand-name and generic drugs, and temperature and humidity may be the cause of the TC-o's incompatibility. Crown Copyright (C) 2013 Published by Elsevier B. V. All rights reserved.
引用
收藏
页码:158 / 164
页数:7
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