Nahata Milap C, Morosco Richard S, Brady Michael T
The Ohio State University, Columbus, OH 43210, USA.
Am J Health Syst Pharm. 2006 Feb 1;63(3):254-7. doi: 10.2146/ajhp050208.
The stability of sildenafil citrate 2.5 mg/mL in two extemporaneously prepared oral suspensions stored at 4 and 25 degrees C was studied.
Thirty 25-mg tablets of sildenafil citrate were ground to powder, and the powder was combined with a 1:1 mixture of Ora-Sweet and Ora-Plus or a 1:1 mixture of methylcellulose 1% and Simple Syrup, NF, to produce two 2.5-mg/mL suspensions. Five plastic bottles of each suspension were stored in amber plastic prescription bottles at 4 or 25 degrees C. Samples were collected on days 0, 7, 14, 28, 42, 56, 70, and 91 for analysis of sildenafil content by high-performance liquid chromatography; pH was also measured. Samples were visually observed against black and white backgrounds.
The mean concentration of sildenafil citrate exceeded 98% of the initial concentration in all samples at both temperatures throughout the 91-day study period. No changes in pH, odor, or physical appearance were observed.
Sildenafil citrate 2.5 mg/mL in two extemporaneously compounded oral suspensions was stable for 91 days in plastic prescription bottles at 4 and 25 degrees C.
研究枸橼酸西地那非2.5毫克/毫升在两种临时配制的口服混悬液中于4℃和25℃储存时的稳定性。
将30片25毫克的枸橼酸西地那非片剂研磨成粉末，然后将该粉末与Ora - Sweet和Ora - Plus的1:1混合物或1%甲基纤维素与NF级单糖浆的1:1混合物混合，制成两种2.5毫克/毫升的混悬液。每种混悬液的五个塑料瓶分别储存在琥珀色塑料处方瓶中，于4℃或25℃保存。在第0、7、14、28、42、56、70和91天采集样品，用高效液相色谱法分析西地那非含量；同时测量pH值。样品分别在黑色和白色背景下进行目视观察。
在整个91天的研究期间，两种温度下所有样品中枸橼酸西地那非的平均浓度均超过初始浓度的98%。未观察到pH值、气味或外观的变化。
两种临时配制的含2.5毫克/毫升枸橼酸西地那非的口服混悬液在塑料处方瓶中于4℃和25℃下91天内稳定。
