Kołodziejczyk Michał Krzysztof, Kołodziejska Justyna, Zgoda Marian Mikołaj
Zakład Technologii Postaci Leku, Katedra Farmacji Stosowanej, Uniwersytet Medyczny w Łodzi.
Polim Med. 2010;40(4):19-26.
On pharmaceutical market, beside technological variability of the forms of a drug with ibuprofen, there also occurs variability of chemical and crystallographic forms of ibuprofen itself. The above allows to use ibuprofen not only in the form of pure acid, but also forms of ibuprofen sodium salts or hydrophilic solubilized complexes of very good solubility in water. The above influences changeability of technological parameters measured with the use of methods of quality control being the pharmacopeal standard. On the basis of information collected in pharmacies, it can be also considered that pharmacological effect of identical forms of drugs with ibuprofen in the same dose is differently perceived by patients expecting comfort of the process of treatment, the result of which is to be effective. The above arguments induce undertaking studies on the estimation of differences occurring between particular market versions of the forms of a drug with ibuprofen.
在药品市场上,除了含布洛芬药物剂型的技术变异性外,布洛芬本身的化学和晶体形式也存在变异性。上述情况使得布洛芬不仅可以以纯酸形式使用,还可以以布洛芬钠盐形式或在水中溶解度非常好的亲水性增溶复合物形式使用。上述情况影响了采用作为药典标准的质量控制方法所测量的技术参数的可变性。根据在药房收集的信息,还可以认为,相同剂量的含布洛芬药物相同剂型的药理作用,对于期望治疗过程舒适且治疗结果有效的患者来说,其感受是不同的。上述观点促使人们开展研究,以评估含布洛芬药物各市场版本剂型之间存在的差异。