Pramar Yashoda V, Graves Richard A, Ledet Grace A, Phan Kelly V, Bostanian Levon A, Mandal Tarun K
College of Pharmacy, Xavier University of Louisiana, New Orleans, Louisiana.
Int J Pharm Compd. 2016 Sep-Oct;20(5):421-425.
Clindamycin is an effective antibiotic in the treatment of infections caused by certain gram-positive and gram-negative anaerobic microorganisms. While manufactured forms of the drug for pediatric use are available, there are instances when a compounded liquid dosage form is essential to meet unique patient needs. The purpose of this study was to determine the chemical stability of clindamycin hydrochloride in the PCCA base SuspendIt, a sugar-free, paraben- free, dye-free, and gluten-free thixotropic vehicle containing a natural sweetener obtained from the monk fruit. It thickens upon standing to minimize settling of any insoluble drug particles and becomes fluid upon shaking to allow convenient pouring during administration to the patient. A robust stability-indicating high-performance liquid chromatographic assay for the determination of clindamycin hydrochloride in SuspendIt was developed and validated. This assay was used to determine the chemical stability of the drug in SuspendIt. Samples were prepared and stored under three different temperature conditions (5°C, 25°C, and 40°C), and assayed using the high-performance liquid chromatographic assay at pre-determined intervals over an extended period of time as follows: 7, 14, 30, 45, 60, 91, 120, and 182 days at each designated temperature. Physical data such as pH, viscosity, and appearance were also monitored. The study showed that drug concentration did not go below 90% of the label claim (initial drug concentration) at all three temperatures studied, barring isolated experimental errors. Viscosity and pH values also did not change significantly. Some variations in viscosity were attributed to the thixotropic nature of the vehicle. This study demonstrates that clindamycin hydrochloride is physically and chemically stable in SuspendIt for 182 days in the refrigerator and at room temperature, thus providing a viable, compounded alternative for clindamycin hydrochloride in a liquid dosage form, with an extended beyond-use date to meet patient needs.
克林霉素是治疗某些革兰氏阳性和革兰氏阴性厌氧微生物引起的感染的有效抗生素。虽然有用于儿科的成品药，但在某些情况下，配制液体制剂对于满足患者的特殊需求至关重要。本研究的目的是确定盐酸克林霉素在PCCA公司生产的SuspendIt基质中的化学稳定性，SuspendIt是一种无糖、无对羟基苯甲酸酯、无染料、无麸质的触变载体，含有从罗汉果中提取的天然甜味剂。它静置时会变稠，以尽量减少任何不溶性药物颗粒的沉降，摇晃时会变成液体，以便在给患者给药时方便倾倒。开发并验证了一种用于测定SuspendIt中盐酸克林霉素的稳健的稳定性指示高效液相色谱法。该方法用于测定药物在SuspendIt中的化学稳定性。制备样品并在三种不同温度条件（5°C、25°C和40°C）下储存，并在较长时间内按预定间隔使用高效液相色谱法进行分析，具体如下：在每个指定温度下分别于7、14、30、45、60、91、120和182天进行分析。还监测了诸如pH值、粘度和外观等物理数据。研究表明，在所研究的所有三个温度下，除个别实验误差外，药物浓度均未低于标签标示量（初始药物浓度）的90%。粘度和pH值也没有明显变化。粘度的一些变化归因于载体的触变性。本研究表明，盐酸克林霉素在SuspendIt中于冰箱和室温下182天内物理和化学性质稳定，从而为液体制剂的盐酸克林霉素提供了一种可行的配制替代品，延长了使用期限，以满足患者需求。
