Babu R J, Pandit J K
Department of Pharmaceutics, Banaras Hindu University, Varanasi, India.
Drug Dev Ind Pharm. 1999 Nov;25(11):1215-9. doi: 10.1081/ddc-100102291.
The effect of aging on the physicochemical stability of glibenclamide (GB)/beta-cyclodextrin (CD) systems and tablets made with CD-complexed GB was studied. Infrared (IR) spectrometry and X-ray diffraction analyses showed that the properties of the products were unaffected even after a storage period of 4 years, except that the crystallinity of GB/CD physical mixture was decreased with aging. The dissolution rate of the kneaded mixture, inclusion complex, and tablets made with the inclusion complex were unaffected on storage for 4 years. Thus, the age-related dissolution problems of GB can be overcome by utilizing the GB/CD complex in the tablet dosage form.
研究了老化对格列本脲（GB）/β-环糊精（CD）体系以及由CD包合的GB制成的片剂的物理化学稳定性的影响。红外光谱（IR）和X射线衍射分析表明，即使经过4年的储存期，产品的性质也未受影响，只是GB/CD物理混合物的结晶度随老化而降低。捏合混合物、包合物以及由包合物制成的片剂在储存4年后的溶出速率未受影响。因此，通过在片剂剂型中使用GB/CD包合物，可以克服GB与年龄相关的溶出问题。
