Inoue Yutaka, Mitsumori Akiho, Shinohara Itsuka, Narumi Sachie, Murata Isamu, Kanamoto Ikuo
Laboratory of Drug Safety Management, Faculty of Pharmacy and Pharmaceutical Sciences, Josai University, 1-1 Keyakidai, Sakado-shi, Saitama 3500295, Japan.
J Pharm (Cairo). 2018 Aug 1;2018:8761394. doi: 10.1155/2018/8761394. eCollection 2018.
A lot of prescription medicines have become switch over-the-counter (OTC) medicines. However, additives in brand-name drugs, generic drugs, and switch OTC drugs differ; therefore, the feelings associated with the use of these medicines vary for patients. The aim of this study was to compare the physicochemical properties and the feeling of use (assuming skin as an index of usability) of acyclovir (ACV) ointments. Five ACV ointments were used: ACV-A, a brand-name drug, ACV-B and ACV-C, generic drugs, and ACV-D and ACV-E, switch OTC drugs. The physicochemical properties were evaluated by determining the content uniformity, water content, flattening, viscosity and viscoelasticity, and near-infrared (NIR) absorption spectroscopy. Skin friction was measured to evaluate the feeling associated with use. Results of the content uniformity test indicated that the ACV content was uniform, and equivalence was observed. Measurement of moisture content indicated that this parameter differed in each ointment preparation. The yield value, which was calculated by measuring flattening, was 4416.7 dyne/cm for ACV-A, 1175.7 dyne/cm for ACV-B, 2114.9 dyne/cm for ACV-C, 4234.5 dyne/cm for ACV-D, and 3620.7 dyne/cm for ACV-E. Measurement of viscosity and viscoelasticity revealed that viscosity increased with time and the viscoelasticity of each ointment. The second derivative of the NIR spectrum revealed that ACV-B and ACV-C had a wider spectrum of absorption than the other ointments. ACV-B had lesser friction than other ointments. These findings suggest that differences in the type and content of additives (macrogol) result in differences in the physicochemical properties of individual ointments.
许多处方药已转为非处方药(OTC)。然而,品牌药、仿制药和转换后的非处方药中的添加剂有所不同;因此,患者使用这些药物时的感受也有所不同。本研究的目的是比较阿昔洛韦(ACV)软膏的物理化学性质和使用感受(以皮肤作为 usability 的指标)。使用了五种 ACV 软膏:品牌药 ACV-A、仿制药 ACV-B 和 ACV-C,以及转换后的非处方药 ACV-D 和 ACV-E。通过测定含量均匀度、水分含量、铺展性、粘度和粘弹性以及近红外(NIR)吸收光谱来评估物理化学性质。测量皮肤摩擦力以评估使用感受。含量均匀度测试结果表明 ACV 含量均匀,观察到等效性。水分含量测量表明该参数在每种软膏制剂中有所不同。通过测量铺展性计算得出的屈服值,ACV-A 为 4416.7 达因/厘米,ACV-B 为 1175.7 达因/厘米,ACV-C 为 2114.9 达因/厘米,ACV-D 为 4234.5 达因/厘米,ACV-E 为 3620.7 达因/厘米。粘度和粘弹性测量表明粘度随时间增加,且每种软膏的粘弹性也不同。NIR 光谱的二阶导数显示 ACV-B 和 ACV-C 的吸收光谱比其他软膏更宽。ACV-B 的摩擦力比其他软膏小。这些发现表明添加剂(聚乙二醇)的类型和含量差异导致各软膏物理化学性质的差异。