Wegmans School of Pharmacy, St John Fisher College, Rochester, New York 14618, USA.
J Pharm Sci. 2012 Jan;101(1):1-6. doi: 10.1002/jps.22735. Epub 2011 Sep 8.
Many ionizable drugs are developed and marketed as salt forms. However, there are no clear US regulatory guidelines on drug strength labeling for salts. The strengths of some drugs are expressed as salts and some as free acids/bases. This study surveyed the top 200 US drugs to assess the common practice in industry. The top 200 drugs prescribed in the United States were included in this survey. The drugs containing active pharmaceutical ingredient (API) salts were selected for analysis. Generic or combination products with redundant API salts were excluded. The package insert of each selected drug was reviewed, and the information on drug strength expression was extracted and categorized. Out of the top 200 drugs, 59 unique API salts were identified. The drug strengths were expressed as salts for 32 drugs (54%) and as free acids/bases for 27 drugs (46%). The survey results revealed the inconsistent practice among the industries regarding the drug strength expression for salts. Non-harmonized labeling practice can lead to confusions, potential calculation/dosing errors, and complications in labeling new products. The authors recommend the US Food and Drug Administration to standardize the labeling format for salts and preferably express the drug strengths based on the free acid/base forms.
许多可电离药物被开发并以盐的形式上市。然而，美国并没有关于盐类药物强度标签的明确监管指南。一些药物的强度以盐的形式表示，而另一些则以游离酸/碱的形式表示。本研究调查了美国前 200 种药物，以评估行业中的常见做法。本调查包括美国处方量最大的 200 种药物。选择含有活性药物成分（API）盐的药物进行分析。排除含有冗余 API 盐的仿制药或复方产品。审查了每个选定药物的说明书，并提取和分类了药物强度表达信息。在这 200 种药物中，确定了 59 种独特的 API 盐。32 种药物（54%）的药物强度以盐的形式表示，27 种药物（46%）以游离酸/碱的形式表示。调查结果显示，行业中盐类药物强度表达的做法不一致。非协调的标签实践可能导致混淆、潜在的计算/给药错误以及新产品标签的并发症。作者建议美国食品和药物管理局（FDA）标准化盐类的标签格式，并最好基于游离酸/碱形式来表示药物强度。
