ECOPOL™ S 100
Description:
ECOPOL™ S 100 is a ready-to-mix enteric coating system reconstituted using hydro-alcoholic system as solvent with addition of plasticizer, glidant & colorants.
Recommended Solvent System:
For total batch size of 1.0 Kg., 70.0 gm of ECOPOL™ S 100 is required with 1235.55 gm of Isopropyl alcohol + Purified water (9:1) as total solids content is 8.0 %.
IPA + Purified Water (8:2) can also be used.
Equipment:
- Stainless steel vessel with a capacity that is 25% higher than the total dispersion volume.
- The height of the vessel should be nearly 25% more than its diameter.
- The speed of the propeller stirrer should be variable and its blade diameter should be nearly 1/3rd of the vessel diameter. (As shown in Figure, h > d and ds = (1/3)d)
Reconstitution procedure:
- Take recommended quantity of ECOPOL™ S 100 in to 500 gms of IPA + Purified Water (9:1) mixture at continuous stirring. Continue the stirring up to 45 mins till the clear solution is formed.
- Take recommended quantity of Titanium Dioxide, colorant, talc & plasticizer (DBS or DEP or TEC) & Polysorbate 80/60 in to balance part of IPA + Purified Water (9:1) or (8:2) mixture. Pass the dispersion through Colloidal mill/homogenizer and homogenize for 10 mins & filter the homogenized/colloidal dispersion through # 80 mesh.
- Add the colloidal dispersion into ECOPOL™ S 100 solution & continue the stirring during the entire coating process.
Precautions:
- The use of high speedstirrer or homogenizer is not recommended.
- The prepared dispersion should not be passed through colloid mill.
- The dispersion may need gentle stirring during the operation to prevent settling.
Coating parameters for ECOPOL™ S 100:
Parameters |
Auto coater |
Conventional Pan |
Pan diameter |
24” |
48” |
60” |
12” |
36” |
Solvent |
Hydro-alcoholic |
Hydro-alcoholic |
Hydro-alcoholic |
Hydro-alcoholic |
Hydro-alcoholic |
Solids content (% w/w) |
8.0 |
8.0 |
8.0 |
8.0 |
8.0 |
Pan speed* (rpm) |
10-14 |
3-5 |
1.5-3 |
18-20 |
8-12 |
Baffles |
4-6 |
6-8 |
6-10 |
3 |
4 |
Tablet charge**(kg) |
10-15 |
100-130 |
250-300 |
0.5-1 |
40-50 |
Tablet bed temperature (ºC) |
30 – 35 |
30 -35 |
30 -35 |
30 – 35 |
30 - 35 |
Spray nozzle (mm) |
1 |
1.2-1.5 |
1.2-1.5 |
1 |
1.2 |
Number of spray guns |
1 |
2-3 |
4-6 |
1 |
1 |
Atomizing air pressure (bars) |
1.5-2.5 |
2.0-2.8 |
2.0-3.0 |
1.2-1.8 |
1.5-2.2 |
Spray procedure |
Continuous |
Continuous |
Continuous |
Continuous |
Continuous |
Spray rate (g/min) |
20-25 |
120-140 |
200-250 |
4-8 |
50-60 |
Inlet air temperature (ºC) |
60-65 |
60-65 |
60-65 |
60-65 |
60-65 |
Weight gain (%) |
8 |
8 |
8 |
8 |
8 |
* Pan speed would depend upon the tablet shape, size, friability and the number of baffles, so as to effect proper mixing during the coating process.
** Tablet charge would vary depending upon the tablet shape and size. |
