QUALITY CONTROL TESTS & PACKAGING FOR CAPSULES PHAR 2322
Learning OutcomesAt the end of this topic, you should be able to describe: •Relevant QC tests and their significance for capsules •Various types of packaging for capsules •The advantages and disadvantages of each packaging material
1.Bloom Strength•Bloom value is a measurement of the gelling power and the strength of the resulting gel. •The bloom value is determined by measuring the strength of the gel formed by a specified concentration, 6.67% of gelatin, maintained at 10 °C for a specified time period, eighteen hours. •After this period a texture analyzer is used to measure the force or weight required to depress a plunger 4mm into the gel. Should 150g be required, then the bloom value is specified as 150.•Gelatin generally falls between 50 and 300 bloom strength.IMPORTANT SPECIFICATIONS OF GELATIN
2. Gelling power •Is one of the key functions of gelatin. The gelling power varies depending on the grade of gelatin.•It is measured in terms of bloom value. The higher the bloom value, the greater the ability to form gels & the stronger the gel strength.•Less gelatin is required to give the same level of gelling as for a low- or medium bloom gelatin. •Therefore the higher the bloom value, the higher the quality. The higher bloom grades tend to have higher melting points and less odor or color.IMPORTANT SPECIFICATIONS OF GELATIN
IMPORTANT SPECIFICATIONS OF GELATIN63. Viscosity:•Viscosity is another key criterion of gelatin grades. In general the higher the bloom, the greater the viscosity but various combinations of bloom and viscosity are available. Beef bone grades tend to have higher viscosity. •Viscosity is determined by measuring the flow time of a 6.67% solution of gelatin through a U-tube viscosimeter at 60 °C. Viscosity measurement is given in millipoise units and varies between 20 and 70 mill poise4. Iron content:Iron is always present in raw gelatin, and its concentration usually depends on the iron content of the large quantities of water used in its manufacture amount should not exceed 15ppm.
Quality Control of Capsules•Whether capsules are produced on a small scale or large scale all of them are required to pass not only the disintegration test, weight variation test and percentage of medicament test but a visual inspection must be made as they roll off
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- Fall '19