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(1) Calculation of Polymer Quantities
Since a certain layer thickness has to be achieved in film coating, the amount of coating material must be related to the surface area of the substrate. For this reason it is expressed in mg of dry polymer substance per cm2 of surface area. If we divide the surface area of a substrate A (mm2) by its weight w (mg), we immediately obtain the requisite coating quantity in %, i.e. the polymer consumption in kg of dry polymer substance per 100 kg of substrate for a coating of 1 mg of dry polymer substance per cm2. If lower or higher coating weights are specified for certain dosage forms, we must multiply by this factor l = mg polymer per cm2. Coating weight (%) = A(mm2) • l(mg/cm2)
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
Taste-masking coatings: Moisture protection:
Pharma Polymers 01/2005
pellets.(2) Calculation of Surface Area (2. the following values for the surface area of tablets and capsules can be used: Tablets Diameter [mm] 2 3 4 5 6 7 8 Height [mm] 5 70 85 100 6 95 115 130 7 120 145 165 185 8 150 175 200 225 9 210 240 270 300 10 250 280 315 345 12 340 380 415 450 505 14 485 530 570 615 660 Surface area [mm2] Capsules Capsule size Surface area [mm2] 5 175 4 235 3 290 2 350 1 410 0 500 00 610 000 800 Pharma Polymers 01/2005 2/6 2.1) Simplified Calculations The surface areas of some pharmaceutical dosage forms can be calculated according to the following simplified formulas.2e . oblongs: A=π • L • Bw=mm2 Spherical shapes (microtablets. assuming that the tablet has the shape of a circumscribed cylinder: A = surface (mm2). D = diameter (mm). Bw = band width (mm) Tablets: A= π • (D • H + 0. L = length (mm). granules): A= π • D2=mm2 Following the simplified calculations.5 • D2)=mm2 Capsules. H = overall height (mm).
(2. 1988) a) Round Biconvex Tablet (A=2 π • (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 b) Oblong-Shaped Tablets X= 2 π • (rB +r2 + Ch2) Z=2B • (L-2r) A=X+Y+Z 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 Z }H L Top view BW Pharma Polymers 01/2005 3/6 2. al.2e . “Coated Pharmaceutical Dosage Forms”. medpharm GmbH Scientific Publishers.2) Exact Calculations The following formulas can serve for the exact calculation of the tablet surface (Bauer et. Stuttgart.
Pharma Polymers 01/2005 4/6 2. their surface area has to be estimated with sufficient accuracy to permit calculation of the polymer requirement and the requisite layer thickness of the diffusion shell. The apparatus. It is then also easier to obtain a consistent release rate when the particle size distribution and surface texture have changed. It is based on the mathematical model of laminar flow through capillaries arranged in parallel. C 205-55). inversely proportional to the diameter of the equivalent sphere. i.(3) Estimating the Surface Area of Small Particles Where irregularly formed crystals or granules have to be evenly coated.2e . Blaine's method serves for quick routine assessment of the specific surface area (in cm2 or cm2 of core volume) of small particles.e. originally developed by Blaine for measuring micronized ceramic powders. This model states that the time taken by a constant air volume to flow through a defined product bed is proportional to the square of the specific surface area of this powder. as established by Kozeny-Carman. 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]. A fast and simple approach is the permeability method according to Blaine (ASTM Des. whereas both nitrogen adsorption and mercury intrusion are much more complicated and time-consuming. had to be modified for pharmaceutical purposes to serve for larger particles as well.
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.8 0.5 – 1.g. size of the particles and mechanical stability.5 0. Pharma Polymers 01/2005 5/6 2. The vacuum required for the airflow is produced by keeping a fluid of known density (e.8 2 1 3 2 12. which should be kept constant if a particular product is measured several times. quite different amounts may be needed.Of critical importance for accurate measurement is a defined porosity of the core bed. water) out of equilibrium in a U-shaped tube. The following values can be used to estimate the surface for spherical particles: Spherical Particles Diameter [mm] Surface area mm_] / piece 0. For calculation. 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. the measured airflow time has to be corrected by subtracting the no-load value of the apparatus.5 3 30 4 50 5 80 6 120 For spherical particles with diameters in a range of 0.2e . For better reproducibility. This is most easily achieved by tapping the sample in a granulate attachment fastened to a tapping volumeter by means of an adapter. using a rubber bulb or automatic pipette. surface structure. time should be measured electronically with the aid of light barriers activated by the liquid meniscus.
including with regard to existing third party intellectual property rights. especially patent rights.2e . procedures and/or applications which may be subject to license agreements. The customer is not released from the obligation to conduct careful inspection and testing of incoming goods. or guarantee of product properties in the legal sense is intended or implied. Trademark of Röhm GmbH & Co. nor does it imply that similar products could not be used. We reserve the right to make any changes according to technological progress or further developments. Germany Pharma Polymers 01/2005 6/6 2. In particular. procedures and/or applications falling within the claims of patents related to EUDRACOL™ and EUDRAPULSE™ will always require separate license agreements.This information and all further technical advice is based on our present knowledge and experience. ® = registered trademark EUDRAGIT = reg. it implies no liability or other legal responsibility on our part. Reference to trade names used by other companies is neither a recommendation. Performance of the product described herein should be verified by testing. Röhm GmbH & Co. KG. Darmstadt. whether express or implied. Pharma Polymers. Compositions. However. no warranty. which should be carried out only by qualified experts in the sole responsibility of a customer. KG is the owner of patent rights covering the use of EUDRAGIT® polymers in compositions.
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