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微晶纤维素II和市售崩解剂的崩解性能评估。

Evaluation of the disintegration properties of microcrystalline cellulose II and commercial disintegrants.

作者信息

Rojas J, Kumar V

机构信息

Department of Pharmacy, School of Pharmaceutical Chemistry, The University of Antioquia, Medellin, Colombia.

出版信息

Pharmazie. 2012 Jun;67(6):500-6.

Abstract

This study was conducted to assess the disintegration properties of cellulose II excipients named as spray-dried cellulose II (SDCII) and non spray-dried cellulose II (MCCII) in comparison with commercial disintegrants. Swelling and water sorption characteristics were determined by conventional methods. The swelling values, water uptake and percentage of compact volume expansion all suggested that SDCII and MCCII compacts disintegrate by a wicking mechanism similar to that of Polyplasdone-XL, whereas a swelling mechanism dominates for Primojel and Ac-Di-Sol. With commercial binders, SDCII, MCCII and Polyplasdone-XL produced strong, but fast disintegrating tablets. At high levels, their performance as a disintegrant was superior compared to Primojel and Ac-Di-Sol. Disintegration times of the pure excipients revealed SDCII and MCCII to be comparable to Polyplasdone-XL, but faster than Primojel and Ac-Di-Sol. Ibuprofen tablets prepared using disintegrants at all levels released 80% of the drug within 60 min. SDCII and MCCII offer potential for use as a disintegrant in the design and development of solid dosage forms.

摘要

本研究旨在评估名为喷雾干燥纤维素II(SDCII)和非喷雾干燥纤维素II(MCCII)的纤维素II辅料与市售崩解剂相比的崩解性能。通过常规方法测定膨胀和吸水特性。膨胀值、吸水量和紧密体积膨胀百分比均表明,SDCII和MCCII片芯通过类似于聚维酮XL的毛细管作用机制崩解,而对于Primojel和Ac-Di-Sol,膨胀机制起主导作用。使用市售粘合剂时,SDCII、MCCII和聚维酮XL制成的片剂强度高,但崩解快。在高用量时,它们作为崩解剂的性能优于Primojel和Ac-Di-Sol。纯辅料的崩解时间表明,SDCII和MCCII与聚维酮XL相当,但比Primojel和Ac-Di-Sol快。使用各级崩解剂制备的布洛芬片在60分钟内释放了80%的药物。SDCII和MCCII在固体剂型的设计和开发中具有用作崩解剂的潜力。

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