Fausett H, Gayser C, Dash A K
Department of Pharmaceutical & Administrative Sciences, School of Pharmacy & AHP, Creighton University, Omaha, NE 68178, USA.
AAPS PharmSciTech. 2000 Jul 2;1(3):E20. doi: 10.1208/pt010320.
The purpose of this investigation was to develop a rapidly disintegrating calcium carbonate (CC) tablet by direct compression and compare it with commercially available calcium tablets. CC tablets were formulated on a Carver press using 3 different forms of CC direct compressed granules (Cal-Carb 4450, Cal-Carb 4457, and Cal-Carb 4462). The breaking strength was measured using a Stokes-Monsanto hardness tester. The disintegration and dissolution properties of the tablets were studied using USP methodology. The calcium concentration was determined by an atomic absorption spectrophotometer. Scanning electron microscopy was used to evaluate the surface topography of the granules and tablets. Breaking strength of Cal-Carb 4450, Cal-Carb 4457, and Cal-Carb 4462 tablets was in the range of 7.2 to 7.7 kg, as compared with a hardness of 6.2 kg and 10 kg for the commercially available calcium tablets Citracal and Tums, respectively. The disintegration time for the tablets presented in the order earlier was 4.1, 2.1, 1.9, 2.9, and 9.7 minutes, respectively. The dissolution studies showed that all formulations released 100% of the elemental calcium in simulated gastric fluid in less than 20 minutes. In summary, this study clearly demonstrated that quick disintegrating CC tablets can be formulated without expensive effervescence technology.
本研究的目的是通过直接压片法研制一种快速崩解的碳酸钙(CC)片剂,并将其与市售钙片进行比较。使用3种不同形式的CC直接压缩颗粒(Cal-Carb 4450、Cal-Carb 4457和Cal-Carb 4462)在卡弗压力机上制备CC片剂。使用斯托克斯-孟山都硬度测试仪测量抗压强度。采用美国药典方法研究片剂的崩解和溶出特性。通过原子吸收分光光度计测定钙浓度。使用扫描电子显微镜评估颗粒和片剂的表面形貌。Cal-Carb 4450、Cal-Carb 4457和Cal-Carb 4462片剂的抗压强度在7.2至7.7千克范围内,相比之下,市售钙片Citracal和Tums的硬度分别为6.2千克和10千克。上述片剂的崩解时间分别为4.1、2.1、1.9、2.9和9.7分钟。溶出度研究表明,所有制剂在模拟胃液中均能在不到20分钟的时间内释放100%的元素钙。总之,本研究清楚地表明,无需昂贵的泡腾技术即可制备快速崩解的CC片剂。