Kibwage I O, Nguyo M
Department of Pharmacy, College of Health Sciences, University of Nairobi, Kenya.
East Afr Med J. 1993 Aug;70(8):512-4.
A comparative in-vitro performance of carbamazepine 200mg tablet products available on the Kenyan market was evaluated. The products which include the innovator product, Tegretol, have similar quality consonant with pharmacopoeial specifications. A batch of one of the products had a carbamazepine content of 106.6% label claim which was outside the upper limits of 105%. One product packaged in multiple-unit containers of a 1000, had an unacceptable high friability of 6.82% loss in weight. All products had good dissolution profiles and released at least 70% of the dose within 45 minutes. Drug dissolution from tablets was found to vary between batches for one product. At each sampling time, most generics had wide variations in amount of dissolved drug. The effect of such variations on tablet efficacy cannot be ascertained in the absence of bioavailability data.
对肯尼亚市场上可得的200毫克卡马西平片剂产品进行了体外性能比较评估。这些产品包括创新产品得理多，其质量与药典规格相符。其中一批产品的卡马西平含量为标示量的106.6%，超出了105%的上限。一种包装在1000片多剂量容器中的产品，其脆碎度高达6.82%，失重率不可接受。所有产品的溶出度曲线良好，在45分钟内至少释放70%的剂量。发现一种产品不同批次的片剂药物溶出情况存在差异。在每个取样时间，大多数仿制药的溶出药量差异很大。在缺乏生物利用度数据的情况下，无法确定这种差异对片剂疗效的影响。
