EUDRAGIT RL 100 and/or RS 100 Organic Sustained Release

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Technical Information – Quickstart
EUDRAGIT® RL 100 and/or RS 100
Organic sustained-release coating
Formulation
The following formulation is calculated for a standard quantity of 1 kg spray suspension. The quantity for film coating of your substrate depends on
the application and surface area of the substrate. Please contact us if you need assistance to calculate your individual formulation.
Quantity based on
dry polymer [%]
Quantity to be
weighed [g]
Function
Ingredient
Polymer
EUDRAGIT® RL 100 and/or RS 100
Dry substance [g]
Plasticizer
Triethyl citrate
10.0
6.25
6.25
Anti-tacking
Talc
50.0
31.25
31.25
Diluent
Acetone
342.90
Diluent
Isopropanol
514.20
Diluent
Water
62.50
62.50
42.90
Total
1000.00
100.00
Attention: Please follow the respective regulations for explosion protection when working with organic solvents.
EUDRAGIT® solution
Add the EUDRAGIT® powder slowly into 50 % of the diluent mixture and
stir until the polymer is completely dissolved (approx. 30–60 minutes).
EUDRAGIT® RL 100 and/or RS 100
55
0
50
10
45
40
35
5
15
30
20
25
½ Diluent mixture
(acetone, isopropanol, and water)
Spray suspension
Pour the excipient suspension slowly into
the EUDRAGIT® solution while stirring with
a conventional stirrer.
Add talc and triethyl citrate in the remaining
diluent mixture and stir for 10 minutes with
a high shear mixer (e.g. Ultra Turrax).
Triethyl citrate
Pass the spray suspension
through a 0.5 mm sieve.
Talc
55
0
50
10
45
40
35
½ Diluent mixture
( acetone, isopropanol, and water)
5
15
30
20
25
EUDRAGIT® solution
Spray suspension
(should be stirred continuously)
Evonik Industries AG | EUDRAGIT | Quickstart Page 1/2
Coating parameters:
The tables below give examples of process parameters for film coating. Please do not hesitate to contact us if you need
assistance to find the right parameters for your specific equipment, batch size, and substrate combination.
EUDRAGIT® RL 100 and/or RS 100 on particles (1 kg) in Glatt GPCG 1.1, top spray
Equipment setup
Nozzle bore
mm
1.2
Distance nozzle/product
cm
7–10
Internal silicone tube diameter
mm
2
Process parameter setup
Atomizing air pressure
bar
1.5–2
Filter rattling time
s
5
Filter rattling interval
s
30
Drying air volume
m³/h
42–84
Drying air capacity
m³/min/kg
0.7–1.4
Process data
Inlet air temperature
°C
25–40
Exhaust air temperature
°C
20–25
Product temperature
°C
20–25
Spray rate
g/min/kg
15–25
Final drying at 40 °C (circulating air oven)
h
2
EUDRAGIT® RL 100 and/or RS 100 on tablets (10 kg) in Accela Cota 10
Equipment setup
Drum speed
rpm
8 –10
mm
1.2
No. of spray guns
Nozzle bore
1
Distance tablet bed/spray gun
cm
10–15
Internal silicone tube diameter
mm
2
Process parameter setup
Atomizing air pressure
bar
0.8 –1.5
Flat pattern pressure
bar
0.8 –1.5
Drying air volume
m3/h
180 –300
Drying air capacity
m3/min/kg
0.3 –0.5
Exhaust air volume
m3/h
> 180 –300
Process data
Inlet air temperature
°C
40 –50
Exhaust air temperature
°C
25 –30
Product temperature
°C
25 –30
Difference pressure
Pa
– 98
Spray rate
g/min/kg
3–6
Final drying at 40 °C (circulating air oven)
h
2
® = registered trademark EUDRAGIT is a registered trademark of Evonik Röhm GmbH, Darmstadt, Germany.
Evonik Industries AG
Kirschenallee, 64293 Darmstadt, Germany
[email protected] www.eudragit.com www.eudragit.com/e-lab www.evonik.com
Dec 2011, V 3.0
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, also 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.
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