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- Lindberg, N.-O., et al.
(author)
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Optimization of disintegration time and crushing strength of a tablet formulation
- 1985
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In: Drug Development and Industrial Pharmacy. - : Informa UK Limited. - 0363-9045 .- 1520-5762. ; 11:4, s. 931-944
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Journal article (peer-reviewed)abstract
- In an experiment with a factorial design, the following aspects were scrutinized: the impact on disintegration time and crushing strength caused by the loss-on-drying of the granulation; the granule-size distribution; the lubricant concentration; the compression force; and the pre-compression. Both with regard to disintegration time and crushing strength, these factors were found to have a significant influence: the loss-on-drying of the granulation; the fraction less than 0.150 mm; the concentration of magnesium stearate; and the compression force. A reduction of the tablet disintegration time was obtained by means of an increase of the granulation moisture; by an increase of the fine fraction; or by a reduction of the lubricant concentration or the compression force. The tablet crushing strength was increased by reducing the deviation of the granulation loss-on-drying from approximately 4.6 %; by a reduction of the fine fraction; by decreasing the lubricant concentration; or by increasing the compression force. The fraction larger than 0.300 mm had no significant influence; nor did the pre-compression. Further, there were no significant interactions. By means of superimposing contour plots of disintegration time and crushing strength, a region was obtained where the requirements of disintegration time and crushing strength could be satisfied by controlling the processing variables.
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- Lindberg, N.-O., et al.
(author)
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The granulation of a tablet formulation in a high-speed mixer, Diosna P 25
- 1985
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In: Drug Development and Industrial Pharmacy. - : Informa UK Limited. - 0363-9045 .- 1520-5762. ; 11:4, s. 917-930
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Journal article (peer-reviewed)abstract
- The impeller speed, the loss-on-drying of starch, and the added amount of water significantly influenced these response variables: granule fractions of less than 0.150 mm and more than 2.00 mm; and granule median diameter. The influence of the drug concentration on the response variables was less important. All the response variables showed significant interactions. At a fixed impeller speed, the fine fraction was reduced when the loss-on-drying of starch increased, and when water was added in increasing amounts. The coarse fraction and granule median diameter increased along with an increasing moisture content in the starch. Increasing amounts of added water had the same effect. The response surface contours of a fraction less than 0.150 mm, and a fraction exceeding 2.00 mm, were plotted. So was the granule median diameter. Suitable levels for the processing variables involved in obtaining a granulation of the desired proportions - fine or coarse fraction - can be read from the contour plots. Heat was generated in the mixer during kneading, which caused some evaporation of water. The change in the rotation rate of the impeller during the addition of the granulating liquid can be used as an indication of the fraction percentages below 0.150 mm and above 2.00 mm, but not of the median diameter.
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