Abstract: A method is described for preparing a mixture for quality control of 0.1 g glycine tablets for sublingual application. The mixture for quality control includes a 100:0.5 ratio of ethanol to porphyrized tablets, each tablet containing 0.1 g microcapsules of non-agglomerated crystals of amino-acetic acid covered with a polymeric film of water-soluble methylcellulose, each tablet further containing 0.001 g of magnesium stearate. The process for preparing the mixture includes dissolution of the tablet in ethanol for 20 minutes and is carried out at a temperature of 40° C. in an apparatus using a paddle rotation speed of 200 revolutions per minute. After the mixture is dissolved, it is allowed to stand for 10 minutes at room temperature, and then a light transmission coefficient is measured at 700±2 nm for a 10 mm thick layer of the mixture. A transmission value within the limits of 90% to 100% compared with 50% ethanol corresponds to the proper quality.
Type:
Grant
Filed:
June 23, 2010
Date of Patent:
October 25, 2011
Assignee:
Nekommercheskoe Uchrezhdenie “Nauchno-Issledovateljskiyj Institut Citokhimii I Molekulyarnoyj Farmakologii”
Abstract: A method is described for preparing a mixture for quality control of 0.1 g glycine tablets for sublingual application. The mixture for quality control includes a 100:1 ratio of water to porphyrized tablets, each tablet containing 0.101 g microcapsules of non-agglomerated crystals of amino-acetic acid covered with polymeric film of water-soluble methylcellulose, each tablet further comprising 0.001 g magnesium stearate. The process of dissolution takes 20 minutes and is carried out at a temperature of 37° C. in an apparatus using a paddle rotation speed of 150 revolutions per minute. After the mixture is dissolved, it is allowed to stand for 10 minutes, then a light transmission coefficient is measured at 700±2 nm for a 10 mm thick layer of the mixture. A transmission value within the range of 50% to 70% compared to purified water corresponds to the proper quality.
Type:
Grant
Filed:
December 15, 2006
Date of Patent:
December 28, 2010
Assignee:
Nekommercheskoe Uchrezhdenie “Nauchno-Issledovateljskiyj Institut Citokhimii I Molekulyarnoyj Farmakologii”