East Mediterr Health J. 2013 Jun;19(6):542-6.
The objective of this study was to evaluate the quality of 10 commercial paracetamol products available on the Palestinian market. We carried out a survey on the price of all paracetamol tablet products and assessed their quality. To assess quality, all products were examined visually for their organoleptic properties, tested for weight uniformity, friability, disintegration, and dissolution profile, and assayed for paracetamol content. All imported products were 2 to 3 times more expensive than the locally produced generic products. Based on our testing procedure, all paracetamol products were equivalent to the innovator product except for 1 imported product which fell below the approved specifications developed for the innovator product. Although the majority of generic products met the dissolution specification requirement that 80% of the drug must dissolve in 30 minutes, 1 generic product failed. These results demonstrate that generic paracetamol tablets produced by local manufacturers are often comparable in vitro to the innovator product and have lower costs.
本研究旨在评估巴勒斯坦市场上 10 种市售扑热息痛产品的质量。我们对所有扑热息痛片剂产品的价格进行了调查，并评估了它们的质量。为了评估质量，我们对所有产品进行了外观感官特性检查、重量均匀性、易碎性、崩解度和溶出度测试，并对扑热息痛含量进行了测定。所有进口产品的价格是本地生产仿制药的 2 至 3 倍。根据我们的测试程序，除了 1 种不符合为创新产品制定的批准规格的进口产品外，所有扑热息痛产品均与创新产品等效。尽管大多数仿制药产品符合 80%药物必须在 30 分钟内溶解的溶出度规范要求，但有 1 种仿制药产品未能达标。这些结果表明，本地制造商生产的仿制药通常在体外与创新产品相当，且成本更低。
