Muzíková J, Horácek J
Katedra farmaceutické technologie Farmaceutické fakulty Univerzity Karlovy, Hradec Králové.
Ceska Slov Farm. 2003 Jul;52(4):176-80.
Vivapur is microcrystalline cellulose manufactured by the German firm J. Rettenmeier & Söhne GmbH + Co. The types Vivapur 102 and 12 enjoy priority use as dry binders for direct tablet compression. The present paper evaluates tensile strength of tablets made from these substances and the effect of an addition of the lubricant magnesium stearate in connection with its concentration and the conditions of the process of mixing, particularly the period and intensity of mixing. The tested concentrations of stearate were 0.4 and 0.8%, the tested periods of mixing being 2.5, 5, 10, and 20 minutes, intensities of mixing 17 and 34 rot./min. Sensitivity of dry binders to added stearate was evaluated by means of the LSR (lubricant sensitivity ratio) values. The results demonstrated higher sensitivity to an addition of the lubricant in Vivapur 12 than in Vivapur 102. In the first part of the paper focused on the effect of stearate concentration on tensile strength of tablets, Vivapur 102 was also compared with Avicel PH-102. Tablets from Vivapur 102 alone were stronger than those from Avicel PH-102. A concentration of stearate of 0.8% decreased the binding capacity of Vivapur 102 more than that of Avicel PH-102. With a prolonged period of mixing and increased intensity of mixing with stearate, tensile strength of tablets from both Vivapur types was decresed, and a prolonged period of mixing exerted a more marked effect on Vivapur 12 and increased intensity of mixing, on Vivapur 102.
维瓦普尔是德国J. Rettenmeier & Söhne GmbH + Co.公司生产的微晶纤维素。维瓦普尔102型和12型作为直接压片的干黏合剂优先使用。本文评估了用这些物质制成的片剂的抗张强度,以及添加润滑剂硬脂酸镁的效果,这与硬脂酸镁的浓度以及混合过程的条件有关,特别是混合时间和强度。硬脂酸酯的测试浓度为0.4%和0.8%,测试的混合时间为2.5、5、10和20分钟,混合强度为17和34转/分钟。通过LSR(润滑剂敏感度比)值评估干黏合剂对添加硬脂酸酯的敏感度。结果表明,维瓦普尔12型对添加润滑剂的敏感度高于维瓦普尔102型。在本文第一部分关注硬脂酸酯浓度对片剂抗张强度的影响时,还将维瓦普尔102型与艾维素PH - 102进行了比较。仅由维瓦普尔102制成的片剂比由艾维素PH - 102制成的片剂更强。0.8%的硬脂酸酯浓度对维瓦普尔102型结合能力的降低幅度大于对艾维素PH - 102型的降低幅度。随着与硬脂酸酯混合时间的延长和混合强度的增加,两种维瓦普尔类型片剂的抗张强度均降低,且混合时间延长对维瓦普尔12型的影响更显著,混合强度增加对维瓦普尔102型的影响更显著。