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| NOVOMIX - (Regular / MR / ENT & SP) Organic Film Coating System |
Application Guideline For NOVOMIX.
NOVOMIX - homogeneous ready mix for tablets film coating material which consisting of ingredients such as film forming Polymers, Plasticizers, Pigments, Opacifier and other Additives.
NOVOMIX - can be reconstituted in suitable solvent system to form homogeneous film coating suspension. |
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| ORGANIC SOLVENT SYSTEM |
| Weight Gain Retained - 3% for Regular, MR & SP & 8% w/w for ENT |
| Reconstitution level of NOVOMIX - 5% w/w |
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Coating Solution Formula :
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Reconstitution |
Qty. for Regular, MR & SP |
Qty. for ENT |
| NOVOMIX |
5% |
3.0 kg |
8.0 Kg* |
| Solvent |
95% |
57.0 kg |
152.0 Kg |
| Total |
100 % |
60.0kg |
160.0 Kg |
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Recommended wt. gain of 3 % for Regular, MR & SP & 8% for ENT for 100 Kg tablet load.
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Solvent Composition |
Qty for Regular, MR & SP |
Qty. for ENT |
| Methylene Chloride |
65% |
37.05 kg |
98.8 Kg* |
| IPA |
35% |
19.95 kg |
53.2 Kg |
| Total |
100 % |
57.0kg |
152.0 Kg |
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| Organic Solvent System |
| Weight Gain Retained - 3% for Regular, MR & SP & 8% w/w for ENT |
| Reconstitution level of NOVOMIX - 5% w/w |
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| Method of Reconstitution of NOVOMIX. |
| Weight Gain Retained - 3% for Regular, MR & SP & 8% w/w for ENT |
| Reconstitution level of NOVOMIX - 5% w/w |
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- Take total quantity of Isopropyl Alcohol in a container and form a liquid vortex by stirring with a propeller type of stirrer.
- Add NOVOMIX - in a fine stream, as fast as possible to avoid floating of the powder. Increase the stirrer speed to maintain
a vortex.
- After complete addition of NOVOMIX -stir continuously till uniform wet slurry is formed. Then add total quantity of Methylene
Chloride
and stir for 5 minutes.
- Reduce stirrer speed to eliminate vortex. Continue stirring for 45 minutes. Homogeniser need not be used.
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Application Guidelines for - NOVOMIX - (Regular / MR / ENT & SP) organic Film Coating System.
Organic Solvent System
| Parameters |
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| Atomizing Pressure |
40 – 50 Psig |
| Drying Air Temperature |
50 – 60°C |
| Tablet Bed Temperature |
35 – 40°C |
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Distance between spray nozzles to tablet bed 6 - 8 inches
Weight gain retained on tablets 3% for Regular,
MR & SP & for ENT till enteric property achieve (UP TO 8%)
| Important Note |
A) Pass the final suspension through fine mesh (100#)
B) Some heavily pigmented suspensions may show settling of pigment particles during coating process.
Therefore, it is advisable
to provide intermittent and gentle stirring to the coating suspension while spraying.
C) The above guidelines for NOVOMIX - are general and varies from type, size of coating equipment and nature of the product.
D) The above reconstitution level for MR/ENT can be increased up to 10% w/w & for Regular it can be up to 20% depending on the
type of the coating equipments. The coating parameters e.g., Atomizing pressure and Drying Air Temperature should be
adjusted accordingly to achieve the best results.
E) Storage Condition :
Store in well closed air tight containers to avoid evaporation loss.
Reconstituted solution of NOVOMIX - can be used within 48 hours of reconstitution.
However, the solution of NOVOMIX - should be stirred for 15 minutes befor use.
Evaporation loss if any can be adjusted with the respective solvent.
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NOVOMIX-GEN PVA Based Aqueous Solvent Coating System
| Aqueous Solvent System |
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| Weight Gain Retained |
3% |
| Reconstitution level of NOVOMIX - |
20-25% w/w |
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Coating Solution Formula :
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Reconstitution |
Qty. |
| NOVOMIX |
20% |
3 kg |
| P. Water |
80% |
12 kg |
| Total |
100 % |
15 kg |
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Recommended wt. gain of 3% for 100 Kg tablet load.
| Solvent Composition |
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Qty. of water |
| NOVOMIX |
100% |
12.0 kg |
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| Organic Solvent System |
| Weight Gain Retained - 3% for Regular, MR & SP & 8% w/w for ENT |
| Reconstitution level of NOVOMIX - 5% w/w |
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| Method of Reconstitution of NOVOMIX |
- Take total quantity of purified water in a container and form a liquid vortex by stirring with a propeller type of stirrer.
- Add NOVOMIX - in a fine stream, as fast as possible to avoid floating of the powder. Increase the stirrer speed to maintain a vortex.
- Reduce stirrer speed to eliminate vortex. Continue stirring for 45 minutes. Homogeniser need not be used.
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Application Guidelines for - NOVOMIX - GEN aqueous Film Coating System
| Aqueous System |
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| Parameters |
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| Atomizing Pressure |
70 - 80 Psig |
| Drying Air Temperature |
70 - 75°C |
| Tablet Bed Temperature |
50 - 55°C |
| Distance between spray nozzles to tablet bed |
8 -10 inches |
| Weight gain retained on tablets |
3% |
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| Important Note |
- Strain the final suspension through fine mesh (100#)
- Some heavily pigmented suspensions may show settling of pigment particles during coating process. Therefore, it is advisable to provide intermittent and gentle stirring to the coating suspension while spraying.
- The above guidelines for NOVOMIX - are general and varies from type, size of coating equipment and nature of the product.
- The above reconstitution level can be increased up to 25 % w/w depending on the type of the coating equipments. The coating parameters e.g., Atomizing pressure and Drying Air Temperature should be adjusted accordingly to achieve the best results.
- Storage Condition
Store in well closed air tight containers to avoid evaporation loss.
Reconstituted solution of NOVOMIX - can be used within 48 hours of reconstitution. However, the solution of NOVOMIX - should be stirred for 15 minutes before use. Evaporation loss if any can be adjusted with the respective solvent.
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| NOVOMIX- (Regular / MR & SP) Aqueous Film Coating System |
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For NOVOMIX - Regular / MR & SP weight Gain Retained 3% & for NOVOMIX-ENT weight Gain Retained up to 8% Reconstitution level of NOVOMIX - 10% w/w.
Coating Solution Formula NOVOMIX- Regular / MR & SP :
| Reconstitution |
Qty. |
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| NOVOMIX |
10% |
3.0 kg |
| Solvent |
90% |
27.0 kg |
| Total |
100 % |
30.0kg |
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Recommended wt. gain of 8% for 100 Kg tablet load.
| Solvent Composition |
Qty. |
Qty. of water |
| Purified Water |
100% |
27.0 kg |
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Coating Solution Formula for NOVOMIX-ENT :
| Reconstitution |
Qty. |
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| NOVOMIX |
10% |
8.0 kg |
| Solvent |
90% |
72.0 kg |
| Total |
100 % |
80.0kg |
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Recommended wt. gain of 8% for 100 Kg tablet load.
| Solvent Composition |
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Qty. of water |
| Purified water |
100% |
72.0 kg |
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| Method of Reconstitution of NOVOMIX |
- Take total quantity of purified water in a container and form a liquid vortex by stirring with a propeller type of stirrer.
- Add NOVOMIX - in a fine stream, as fast as possible to avoid floating of the powder. Increase the stirrer speed to maintain a vortex.
- Reduce stirrer speed to eliminate vortex. Continue stirring for 45 minutes. Homogeniser need not be used.
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Aqueous System For NOVOMIX - REGULAR / MR & SP :
| Solvent Composition |
| Parameters |
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| Atomizing Pressure |
70 – 80 Psig |
| Drying Air Temperature |
70 – 75°C |
| Tablet Bed Temperature |
50 – 55°C |
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| Parameters |
| Atomizing Pressure |
70 – 80 Psig |
| Drying Air Temperature |
70 – 75°C |
| Tablet Bed Temperature |
50 – 55°C |
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Aqueous System For NOVOMIX - ENT :
| Parameters |
| Atomizing Pressure |
70 - 80 Psig |
| Drying Air Temperature |
60 - 65°C |
| Tablet Bed Temperature |
45 - 48°C |
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| Important Note |
A) Strain the final suspension through fine mesh (100#)
B) Some heavily pigmented suspensions may show settling of pigment particles during coatin process.
Therefore, it is advisable to provide intermittent and gentle stirring to the coating suspension while spraying
C) The above guidelines for NOVOMIX - are general and varies from type, size of coating equipment and nature of the product.
D) The above reconstitution level can be increased up to 12 % w/w depending on the type of the coating equipments. The coating parameters e.g., Atomizing pressure and Drying Air Temperature should be adjusted accordingly to achieve the best results.
E) Storage Condition :
Store in well closed air tight containers to avoid evaporation loss.
Reconstituted solution of NOVOMIX - can be used within 48 hours of reconstitution.
However, the solution of NOVOMIX - should be stirred for 15 minutes before use.
Evaporation loss if any can be adjusted with the respective solvent. |
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