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w(mg)
Note that A in this formula refers to the surface area and mg per cm2 to the amount of film former. Both quantities are linked by the factor 100, which leads to the result in percent. Depending on the desired function of a coating, the following values can be used for the calculation of the required amount of polymer: Enteric coatings: 4 6 mg for round tablets 5 10 mg for oblong-shaped tablets 5 20 mg for gelatin or HPMC capsules 1 2 mg for round tablets 1 4 mg for oblong-shaped tablets 1 6 mg for round tablets 2 10 mg for oblong-shaped tablets 5 10 mg for gelatin or HPMC capsules
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Capsules Capsule size Surface area [mm2] 5 175 4 235 3 290 2 350 1 410 0 500 00 610 000 800
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Round Biconvex Tablet (A=2 (rB+r2+Ch2) CH can be calculated by means of the following formula: Ch = H B 2 Side view A = Surface area D = Diameter Ch r = Radius H B Ch = Curvature height B = Band height H = Overall height Top view WR = Curvature radius BW = Band width r D
The individual calculation steps are based on the hatched areas in the schematic drawing: X = round ends Y = 2x top-hat segment Z = band (2x faces)
Y X X Y
Side view Side view
Ch B
}H
L Top view
BW
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Air volume (Friedrich manometer) and powder bed (granulate attachment according to Gupte) were increased to extend the measuring range to specific surface areas up to about 100 [cm2/cm3].
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Of critical importance for accurate measurement is a defined porosity of the core bed, which should be kept constant if a particular product is measured several times. This is most easily achieved by tapping the sample in a granulate attachment fastened to a tapping volumeter by means of an adapter. The vacuum required for the airflow is produced by keeping a fluid of known density (e.g. water) out of equilibrium in a U-shaped tube, using a rubber bulb or automatic pipette. For calculation, the measured airflow time has to be corrected by subtracting the no-load value of the apparatus. For better reproducibility, time should be measured electronically with the aid of light barriers activated by the liquid meniscus. The following values can be used to estimate the surface for spherical particles: Spherical Particles Diameter [mm] Surface area mm_] / piece 0.5 0.8 0.8 2 1 3 2 12.5 3 30 4 50 5 80 6 120
For spherical particles with diameters in a range of 0.5 1.2 mm the following % polymer weight gains can be used as a guideline: Enteric coatings: Sustained-release coatings: Taste-masking coatings: Moisture protection: 10 30% 5 20% 5 10% 10 30%
Depending on the solubility of the active, surface structure, size of the particles and mechanical stability, quite different amounts may be needed. Therefore it is recommended to start with a coating trial in which samples at different polymer weight gains should be taken and tested in order to determine the required amount of polymer.
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This information and all further technical advice is based on our present knowledge and experience. However, it implies no liability or other legal responsibility on our part, including with regard to existing third party intellectual property rights, especially patent rights. In particular, no warranty, whether express or implied, or guarantee of product properties in the legal sense is intended or implied. We reserve the right to make any changes according to technological progress or further developments. The customer is not released from the obligation to conduct careful inspection and testing of incoming goods. Performance of the product described herein should be verified by testing, which should be carried out only by qualified experts in the sole responsibility of a customer. Reference to trade names used by other companies is neither a recommendation, nor does it imply that similar products could not be used. Rhm GmbH & Co. KG is the owner of patent rights covering the use of EUDRAGIT polymers in compositions, procedures and/or applications which may be subject to license agreements. Compositions, procedures and/or applications falling within the claims of patents related to EUDRACOL and EUDRAPULSE will always require separate license agreements. = registered trademark EUDRAGIT = reg. Trademark of Rhm GmbH & Co. KG, Pharma Polymers, Darmstadt, Germany
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