维达列汀内标法测定二甲双胍片溶出度及含量均匀性

H. Younes, Sandi Saad Ali Adib, Mohamed Izham Mohamed Ibrahim, Ala’ Ahmad Shalash
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引用次数: 0

摘要

劣质药品,品牌或仿制药,不符合可接受的标准。必须进一步研究卡塔尔和该地区的仿制药状况,特别是在海湾合作委员会危机期间。研究目标是评估在卡塔尔和其他选定的全球地点销售的多来源抗糖尿病药物盐酸二甲双胍(MH)片是否符合药典质量控制参数和体外生物等效性/互换性要求。我们能否在不损害患者利益的情况下,用通用MH安全地取代品牌Glucoaphage®?本实验室实验研究根据美国药典(USP 34)指南建议,评估了来自11个国家的16种上市MH片剂产品以及来自卡塔尔市场的33种MH产品的质量控制参数和体外生物等效性/互换性要求。含量分析测试表明,来自国际样品的产品S10的最低含量为96.9%,来自卡塔尔样品的Neomet(Q-N.m-1)和Glucoaphage(Q-G.Ph-2)的最低含量均为97.1%,而来自国际市场的产品S4(Formit 500)的最高含量为103.3%,来自卡塔尔市场的产品Q-Di-4(Dimet-500)的最高限量为101.8%。在产品(S2-S6-S8-S9-S10-S12-S13-s15-S16-(Q-N.m-1。然而,释放最慢的产物是(S4-S11-S14-(Q-D.Ph-3))。但最终,在45分钟时,所有产物都通过了溶解测试。相似因子结果显示,葡糖噬菌体(S15)和(Q-G.Ph-5)是与创新品牌Glucoaphage®(法国)最相似的产品,相似因子分别最高(f2=91.1%)和(f2=90.0%)。这项研究已经证实,并非所有的仿制药都可以与参考产品Glucoaphage®互换。
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Dissolution Testing and Content Uniformity Analysis for Metformin Tablets Using Vildagliptin as an Internal Standard
Poor-quality medicines, brand or generic, do not meet acceptable standards. Further studies must explore the status of generic medicines in Qatar and the region, especially during the GCC crisis. The research goal is to assess whether the multi-sourced antidiabetic medication, Metformin Hydrochloride (MH) tablets marketed in Qatar and other selected worldwide locations fulfill the compendial quality control parameters and in vitro bioequivalence/interchangeability requirements. Could we safely replace branded Glucophage® with generic MH without compromising the patient’s interest? This laboratory experimental study assessed the quality control parameters and in vitro bioequivalence/interchangeability requirements of sixteen marketed products of MH tablets from 11 countries in addition to 33 MH products from Qatar’s market based on the US Pharmacopeia (USP 34) guideline recommendations. Content analysis test showed that the minimum amount was 96.9% in product S10 from the International samples and 97.1% for both Neomet (Q-N.m-1) and Glucophage (Q-G.Ph-2) from Qatar’s samples, while the maximum amount was 103.3% in product S4 (Formit 500) from the international market and 101.8% in product Q-Di-4, which is Dimet -500 from Qatar’s market. The rapid increase in the percentage of the drug release is noticed in products (S2-S6-S8-S9-S10-S12-S13-s15-S16–(Q-N.m-1)-(Q-Di-1)-(Q-Di-3)-(Q-D.ph-1)-(Q-D.ph-3)-(Q-M.ph-1)-(Q-M.ph-2)-(Q-G.m-3)) as they achieved the acceptance limit at the first time point (15 min). However, the products that showed the slowest release are (S4-S11-S14-(Q-D.Ph-3)). But, eventually, at 45 min, all the products passed the dissolution test. similarity factor results revealed that the Glucophage (S15) and (Q- G.Ph-5) were found to be the most similar products to the innovator brand Glucophage® (France) with the highest similarity factors (f2= 91.1%) and (f2 = 90.0%) respectively. This research has confirmed that not all the generics are exchangeable with the reference product Glucophage®.
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