Laporte Carine M, Cruz-Espindola Crisanta, Thungrat Kamoltip, Schick Anthea E, Lewis Thomas P, Boothe Dawn M
Am J Vet Res. 2017 Apr;78(4):421-432. doi: 10.2460/ajvr.78.4.421.
OBJECTIVE To evaluate pharmaceutical characteristics (strength or concentration, accuracy, and precision), physical properties, and bacterial contamination of fluconazole compounded products. SAMPLE Fluconazole compounded products (30- and 240-mg capsules; 30- and 100-mg/mL oral suspensions) from 4 US veterinary compounding pharmacies. PROCEDURES Fluconazole compounded products were ordered 3 times from each of 4 pharmacies at 7- or 10-day intervals. Generic fluconazole products (50- and 200-mg tablets; 10- and 40-mg/mL oral suspensions) served as references. Compounded products were evaluated at the time of receipt; suspensions also were evaluated 3 months later and at beyond-use dates. Evaluations included assessments of strength (concentration), accuracy, precision, physical properties, and bacterial contamination. Acceptable accuracy was defined as within ± 10% of the labeled strength (concentration) and acceptable precision as within ± 10%. Fluconazole was quantified by use of high-performance liquid chromatography. RESULTS Physical characteristics of compounded products differed among pharmacies. Aerobic bacterial cultures yielded negative results. Capsules (30 and 240 mg) had acceptable accuracy (median, 96.3%; range, 87.3% to 135.2%) and precision (mean ± SD, 7.4 ± 6.0%). Suspensions (30 and 100 mg/mL) had poor accuracy (median, 73.8%; range, 53.9% to 95.2%) and precision (mean ± SD, 15.0 ± 6.9%). Accuracy and precision were significantly better for capsules than for suspensions. CONCLUSIONS AND CLINICAL RELEVANCE Fluconazole compounded products, particularly suspensions, differed in pharmaceutical and physical qualities. Studies to evaluate the impact of inconsistent quality on bioavailability or clinical efficacy of compounded fluconazole products are indicated, and each study should include data on the quality of the compounded product evaluated.
目的 评估氟康唑复方制剂的药学特性（规格或浓度、准确度和精密度）、物理性质及细菌污染情况。样本 来自美国4家兽用复方药房的氟康唑复方制剂（30毫克和240毫克胶囊；30毫克/毫升和100毫克/毫升口服混悬液）。方法 从4家药房各订购3次氟康唑复方制剂，间隔7天或10天。通用型氟康唑产品（50毫克和200毫克片剂；10毫克/毫升和40毫克/毫升口服混悬液）作为对照。收到复方制剂时进行评估；混悬液在3个月后及超过有效期时也进行评估。评估内容包括规格（浓度）、准确度、精密度、物理性质及细菌污染情况。可接受的准确度定义为在标示规格（浓度）的±10%以内，可接受的精密度定义为在±10%以内。采用高效液相色谱法定量氟康唑。结果 不同药房的复方制剂物理特性存在差异。需氧菌培养结果均为阴性。胶囊（30毫克和240毫克）的准确度（中位数为96.3%；范围为87.3%至135.2%）和精密度（均值±标准差为7.4±6.0%）可接受。混悬液（30毫克/毫升和100毫克/毫升）的准确度（中位数为73.8%；范围为53.9%至95.2%）和精密度（均值±标准差为15.0±6.9%）较差。胶囊的准确度和精密度显著优于混悬液。结论及临床意义 氟康唑复方制剂，尤其是混悬液，在药学和物理性质方面存在差异。有必要开展研究以评估质量不一致对复方氟康唑产品生物利用度或临床疗效的影响，且每项研究均应包含所评估复方制剂质量的数据。
