Hendeles L, Dorf A, Stecenko A, Weinberger M
College of Pharmacy, University of Florida, Gainesville 32610-0486.
JAMA. 1990 May 9;263(18):2459-61.
Pancreatic enzyme products are formulated, manufactured, and sold without submitting efficacy or bioavailability data to the Food and Drug Administration because of a quirk in the law. We documented therapeutic failures in three patients with cystic fibrosis after pharmacists substituted generic pancrelipase capsules for the Pancrease brand. Gastrointestinal symptoms and fat malabsorption rapidly resolved after therapy was reinstituted with brand name products. In vitro analysis indicated that after 1 hour of exposure to simulated gastric fluid, lipase activity was less than 200 U per capsule from all three generic capsules dispensed to the patients compared with 6820 U per capsule from Pancrease. These data indicate that the enteric coating of the generic product was defective and that the substituted product was not bioequivalent to the prescribed brand. We conclude that the Food and Drug Administration should institute regulations over this group of products.
由于法律上的一个特殊情况，胰腺酶产品在未向食品药品监督管理局提交疗效或生物利用度数据的情况下就进行了配方、生产和销售。我们记录了3例囊性纤维化患者在用药剂师将通用型胰脂肪酶胶囊替换为Pancrease品牌后治疗失败的情况。在用品牌产品重新治疗后，胃肠道症状和脂肪吸收不良迅速得到缓解。体外分析表明，在暴露于模拟胃液1小时后，分发给患者的所有三种通用胶囊每粒的脂肪酶活性均低于200 U，而Pancrease品牌每粒的脂肪酶活性为6820 U。这些数据表明通用产品的肠溶衣有缺陷，替换产品与处方品牌产品不等效。我们得出结论，食品药品监督管理局应该对这类产品制定相关规定。
