Kollicoat Ir White
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Technical Information
Kollicoat® IR White
January 2008 Supersedes issue dated April 2007 EMP 040901e-08/Page 1 of 12
®=R egistered trademark of BASF SE
Ready-to-use coating for instant-release dosage forms
Pharma Ingredients & Services
EMP 040901e-08 January 2008
Page 2 of 12
Kollicoat IR White
Contents Page
1.
Introduction
3
1.1
General
3
1.2
Structural formula
3
1.3
Physical form
3
2.
Specification and properties
4
2.1
Chemical nature
4
2.2
Physicochemical properties
4
2.3
Properties of aqueous solutions
4
2.4
Film properties
6
3.
Application and processing
6
3.1
Applications
6
3.2
Incompatibilities
7
3.3
Processing notes
7
4.
Typical formulations
8
4.1
Aspirin instant-release film-coated tablets
8
4.2
Propranolol instant-release film-coated tablets
9
4.3
Vitamin C instant-release film-coated tablets
10
5.
Storage conditions
11
6.
Stability
11
7.
Toxicology
11
8.
PBG, PRD Nos.
11
9.
Packaging
11
10. Note
11
EMP 040901e-08 January 2008
Page 3 of 12
Kollicoat IR White
1. Introduction 1.1 General
ollicoat IR White is a ready-to-use coating system based on Kollicoat IR K (polyvinyl alcohol‑polyethylene glycol graft copolymer) that is very readily redispersible in water. The extremely rapid redispersibility is due to the innovative manufacture of this combination of pigments and polymers. It is used primarily to manufacture film coatings that dissolve in the gastric juices (instant-release coatings).
1.2 Structural formula The recipe is based mainly on the highly flexible film former Kollicoat IR, which has the following structure:
1.3 Physical form
Composition Kollicoat IR Kollidon® VA 64 Titanium dioxide Kaolin Sodium lauryl sulfate
45%-74% 5%-10% 10%-20% 10%-20% 1%- 5%
Kollicoat IR is a white to off-white, free-flowing powder.
EMP 040901e-08 January 2008
Page 4 of 12
Kollicoat IR White
2. Specifications and properties 2.1 Chemical nature
Owing to the special manufacturing process for Kollicoat IR White, the fine pigments are embedded in a polymer matrix and therefore unable to separate or agglomerate. The spray-dried powder form and the particle size of approx. 200µm ensure good flowability and redispersibility in water.
2.2 Physicochemical properties
Kollicoat IR White can easily be dispersed in water. The viscosity of aqueous dispersions is relatively low (see 2.3 Properties of aequeous suspensions)
Film formation
An aqueous dispersion of Kollicoat IR White is cast on a smooth surface. When the water has evaporated, a clear colourless flexible film remains (see 2.4, Film properties).
Specification
Test parameter
Requirement
Identity (IR)
Must comply
Loss on drying (Ph.Eur 2.2.32 105 °C vacuo)
max. 5.0%
pH-value ( Ph.Eur 2.2.3; 20% w/w solution in water)
5.0 – 8.5
Viscosity (Brookfield, 20% w/w solution, sp 2 100 rpm, 23°C
50 – 250 mPas
Dispersibility in water (20% w/w residue on 100 µm filter)
max. 2%
Sulphated ash (Ph.Eur 2.4.1; 15 g)
24 – 38%
Acetate (GC)
max. 15 000
Vinyl acetate (GC)
max. 100 ppm
Residual solvents (Ph.Eur, USP) Methanol
max. 3000 ppm
Ethylene glycol 1,4 dioxane
max. 100 ppm
Methyl acetate
max. 1000 ppm
Ester value (Ph.Eur 2.5.2)
20 – 70 mg KOH/g
Microbial status (Ph.Eur 5.1.4, cat 3A)
Must comply
Analytical procedures (non compendial methods) are supplied upon request.
Pharmacopoeias
No monograph on Kollicoat IR has yet been registered in any of the main pharmacopoeias (USP, EP, JP). However, a number of products are currently being tested by the regulatory authorities in Europe, USA und Japan. The remaining components of the system conform to the corresponding monographs in EP, USP and JP.
2.3 Properties of aqueous suspensions Viscosity
The viscosity of aqueous dispersions of Kollicoat IR White increases with the polymer concentration, but remains very low.
EMP 040901e-08 January 2008
Page 5 of 12
Kollicoat IR White
Viscosity of aqueous Kollicoat IR White suspensions as a function of polymer concentration (at 23°C)
Viscosity of Kollicoat IR White suspensions as a function of solids concentration
Viscosity of various spray suspensions (20% w/w, 23°C)
Surface tension
The surface tension of a 20 % Kollicoat IR White suspension is very low (39.5 mN/m). Good wetting and spreadability are therefore achieved even on lipophilic surfaces.
EMP 040901e-08 January 2008
Page 6 of 12
Kollicoat IR White
2.4 Film properties
Kollicoat IR White forms smooth, white, highly flexible films that disperse very rapidly in water. Kollicoat IR White films are not tacky and can be readily printed.
Elongation at break of various ready-to-use instant-release films (23°C, 58% r. h.)
Adhesiveness
Kollicoat IR White films adhere extremely well to tablet surfaces of varying lipophilic character.
Coating engravings
The very low viscosity and excellent wetting and spreading properties ensure that even fine engravings are uniformly coated and no bridging occurs.
3. Application and processing 3.1 Applications
Kollicoat IR White can be used in all applications where a readily redispersible, flexible coating is required. • Instant-release coating - P rotects against unpleasant taste and odor, improves appearance, makes tablet easier to swallow, gives distinctive coloring, protects active ingredients (prevents interaction). The special advantages of Kollicoat IR White are high flexibility, low viscosity and rapid manufacture of coating suspensions. Kollicoat IR White suspensions for spraying on to tablets can be applied with a high solids content, which greatly reduces the coating time and minimizes costs. The high flexibility of the films ensures that they do not crack on the tablets. Kollicoat IR White can be combined with water-soluble dyes, lakes or iron oxides to obtain a particular shade. Water-soluble dyes and dispersible color concentrates are especially easy to use. Kollicoat IR White can also be used together with ready-mix colors (e.g. SepispersTM Dry) to make colored tablets.
EMP 040901e-08 January 2008
3.2 Incompatibilities
Page 7 of 12
Kollicoat IR White
Ibuprofen can lead to discoloration of Kollicoat IR White coatings when film-coated tablets are stored under light. This yellowing effect is caused by an incompatibility of ibuprofen with kaolin contained in Kollicoat IR White. For ibuprofen tablets we recommend to use Kollicoat IR and titanium dioxide as pigment.
3.3 Processing notes Because of the high flexibility of Kollicoat IR White films, it is not necessary to add a plasticizer. A spray suspension is conveniently prepared as follows: Stir Kollicoat IR White into water and redisperse. The mixer speed should be adjusted so that little or no foam is produced. After stirring for 15 min, Kollicoat IR White is ready for further processing.
The figures clearly illustrate the simple redispersion of Kollicoat IR White.
On account of its much lower viscosity, Kollicoat IR White can be processed in spray suspensions of much higher concentration than other ready-to-use instant-release formulations. This greatly shortens the spraying and processing time in the manufacture of film-coated tablets. Suspensions with a solids concentration of 15 – 30% can be processed without problem.
The high elasticity of Kollicoat IR White ensures that it does not crack on the tablets when they are exposed to varying humidity during storage. The coating system can be applied on all the usual coaters, e.g. horizontal drum coaters, fluidized bed coaters, immersion sword coaters, and coating pans, under the usual conditions for aqueous solutions. The following conditions have produced good results in numerous trials: Inlet air temperature: 50-80°C Outlet air temperature: 30-50°C Atomizing pressure: 2-4 bar Temperature of spray suspension: 20-70°C
Cleaning
The product can very easily be cleaned off equipment with warm or cold water.
EMP 040901e-08 January 2008
Page 8 of 12
Kollicoat IR White
4. Typical formulations 4.1 Aspirin instant-release film-coated tablets
Formulation No. P053/01
Composition of tablets
100 mg acetylsalicylic acid, 148.5 mg Ludipress® LCE, 50 mg Avicel® PH 102, 1.5 mg magnesium stearate
Composition of spray suspension
The formulation is designed for 6 kg of tablets (tablet weight 300 mg, diameter 9 mm) Weight [g] Spray suspension Kollicoat IR White Water
209 836 1 045
Proportion [%]
20 80 100
Preparation of spray suspension
Spray suspension: Stir the Kollicoat IR White into the specified quantity of water. After 15 min the spray suspension is ready for further processing.
Machine parameters
Coating machine
Accela-Cota drum coater (24 inch) 6 kg 60°C 36°C 35°C 410 m3/h 2 bar 1 bar 1 30 g/min 35 min 60°C / 4 min 5 mg/cm2 solids
Batch size Inlet air temperature Outlet air temperature Product temperature Outlet air flow Atomizing pressure Forming air pressure Number of spray nozzles Spraying rate Spraying time Final drying Quantity applied Tablet properties Appearance Hardness Friability Disintegration time
Core white 67 N 0% 3:17 [min:s]
Film-coated tablet white 75 N 0% 3:29 [min:s]
EMP 040901e-08 January 2008
4.2 Propranolol instant-release film tablets Composition of tablets
Composition of spray suspension
Page 9 of 12
Kollicoat IR White
Formulation No. P053/02
40 mg propranolol-HCl, 97.5 mg Ludipress, 12.5 mg Kollidon VA 64, 2.5 mg magnesium stearate, 97.5 mg Avicel PH 102 The formulation is designed for 250 kg of tablets (tablet weight 250 mg, diameter 9 mm) Weight [g] Polymer suspension Kollicoat IR White Water Pigment suspension Indigotin lake, E 132 Water
Preparation of spray suspension
Proportion [%]
7 755 25 000
18.80 60.61
495 8 000 41 250
1.20 19.39 100.00
Polymer suspension: Stir the Kollicoat IR White into the specified quantity of water. Pigment suspension: Add the indigotin lake to the specified quantity of water and homogenize with a high-shear mixer, e.g. Ultra-Turrax. Spray suspension: Stir the pigment suspension into the polymer suspension.
Machine parameters
Coating machine
Driacoater drum coater,Type 900 250 kg 70°C 45°C 47°C 4 600 m3/h 4 bar 6 700 g/min 60 min. 60°C / 5 min 3.0%
Batch size Inlet air temperature Outlet air temperature Product temperature Air flow Atomizing pressure Number of spray nozzles Spraying rate Spraying time Final drying Quantity applied Tablet properties Appearance Hardness Friability Disintegration time Drug release
Core white 94 N 0% 5:51 [min:s] 10 min: 51% 20 min: 99%
Film-coated tablet blue 112 N 0% 6:02 [min:s] 10 min: 53% 20 min: 99%
EMP 040901e-08 January 2008
Page 10 of 12
Kollicoat IR White
4.3 Vitamin C instant-release film tablets
Formulation No. P053/03
Composition of tablets
103.1 mg Vitamin C 97, 180.0 mg Ludipress, 14.4 mg Kollidon VA 64, 5.0 mg Kollidon CL, 2.5 mg magnesium stearate
Composition of spray suspension
The formulation is designed for 1 kg of tablets (tablet weight 300 mg, diameter 8.5 mm) Weight [g] Polymer suspension Kollicoat IR White Water
Proportion [%]
25.872 105.000
18.48 75.00
Kollicoat IR White
1.764
1.26
Sicovit Red 30
1.764
1.26
5.600 140.000
4.00 100.00
Pigment suspension
Water
Preparation of spray suspension
Polymer suspension: Stir the Kollicoat IR White into the specified quantity of water. Pigment suspension: Stir the Kollicoat IR White into the specified quantity of water. Then stir in the color pigment and homogenize with a high-shear mixer, e.g. Ultra-Turrax. Spray suspension: Stir the pigment suspension into the polymer suspension.
Machine parameters
Coating machine
Hi-Coater (Freund Industrial Co.) 1 kg 54 – 57°C 34 – 35°C 1.5 bar 1 5.2 – 5.4 g/min 28 min 8 min (outlet air temp. 34 – 40°C) 3.15%
Batch size Inlet air temperature Outlet air temperature Atomizing pressure Number of spray nozzles Spraying rate Spraying time Final drying Quantity applied Tablet properties Appearance Hardness Friability Disintegration time
Core white 150 N 0% 5:18 [min:s]
Film-coated tablet red 180 N 0% 5:06 [min:s]
EMP 040901e-08 January 2008
Page 11 of 12
Kollicoat IR White
5. Storage conditions
Store at room temperature.
6. Shelf life
At least 3 years in the original sealed containers at room temperature.
7. Toxicology
A complete toxicological characterization of Kollicoat IR White for application as a pharmaceutical adjuvant has been carried out. A summary of the available data is available on request under Secrecy Agreement.
8. PBG, PRD Nos.
PBG: 10 581 609, PRD: 30235578
9. Packaging
120 l plastic drum with PE liner, 30 kg capacity.
10. Note This document, or any answers or information provided herein by BASF, does
not constitute a legally binding obligation of BASF. While the descriptions, designs, data and information contained herein are presented in good faith and believed to be accurate, it is provided for your guidance only. Because many factors may affect processing or application/use, we recommend that you make tests to determine the suitability of a product for your particular purpose prior to use. It does not relieve our customers from the obligation to perform a full inspection of the products upon delivery or any other obligation. NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, ARE MADE REGARDING PRODUCTS DESCRIBED OR DESIGNS, DATA OR INFORMATION SET FORTH, OR THAT THE PRODUCTS, DESIGNS, DATA OR INFORMATION MAY BE USED WITHOUT INFRINGING THE INTELLECTUAL PROPERTY RIGHTS OF OTHERS. IN NO CASE SHALL THE DESCRIPTIONS, INFORMATION, DATA OR DESIGNS PROVIDED BE CONSIDERED A PART OF OUR TERMS AND CONDITIONS OF SALE. January 2008
EMP 040901e-08 January 2008
Page 12 of 12
Kollicoat IR White
BASF SE - Care Chemicals Division - Pharma Ingredients & Services - 67117 Limburgerhof - www.pharma-ingredients.basf.com
Kollicoat® IR White
January 2008 Supersedes issue dated April 2007 EMP 040901e-08/Page 1 of 12
®=R egistered trademark of BASF SE
Ready-to-use coating for instant-release dosage forms
Pharma Ingredients & Services
EMP 040901e-08 January 2008
Page 2 of 12
Kollicoat IR White
Contents Page
1.
Introduction
3
1.1
General
3
1.2
Structural formula
3
1.3
Physical form
3
2.
Specification and properties
4
2.1
Chemical nature
4
2.2
Physicochemical properties
4
2.3
Properties of aqueous solutions
4
2.4
Film properties
6
3.
Application and processing
6
3.1
Applications
6
3.2
Incompatibilities
7
3.3
Processing notes
7
4.
Typical formulations
8
4.1
Aspirin instant-release film-coated tablets
8
4.2
Propranolol instant-release film-coated tablets
9
4.3
Vitamin C instant-release film-coated tablets
10
5.
Storage conditions
11
6.
Stability
11
7.
Toxicology
11
8.
PBG, PRD Nos.
11
9.
Packaging
11
10. Note
11
EMP 040901e-08 January 2008
Page 3 of 12
Kollicoat IR White
1. Introduction 1.1 General
ollicoat IR White is a ready-to-use coating system based on Kollicoat IR K (polyvinyl alcohol‑polyethylene glycol graft copolymer) that is very readily redispersible in water. The extremely rapid redispersibility is due to the innovative manufacture of this combination of pigments and polymers. It is used primarily to manufacture film coatings that dissolve in the gastric juices (instant-release coatings).
1.2 Structural formula The recipe is based mainly on the highly flexible film former Kollicoat IR, which has the following structure:
1.3 Physical form
Composition Kollicoat IR Kollidon® VA 64 Titanium dioxide Kaolin Sodium lauryl sulfate
45%-74% 5%-10% 10%-20% 10%-20% 1%- 5%
Kollicoat IR is a white to off-white, free-flowing powder.
EMP 040901e-08 January 2008
Page 4 of 12
Kollicoat IR White
2. Specifications and properties 2.1 Chemical nature
Owing to the special manufacturing process for Kollicoat IR White, the fine pigments are embedded in a polymer matrix and therefore unable to separate or agglomerate. The spray-dried powder form and the particle size of approx. 200µm ensure good flowability and redispersibility in water.
2.2 Physicochemical properties
Kollicoat IR White can easily be dispersed in water. The viscosity of aqueous dispersions is relatively low (see 2.3 Properties of aequeous suspensions)
Film formation
An aqueous dispersion of Kollicoat IR White is cast on a smooth surface. When the water has evaporated, a clear colourless flexible film remains (see 2.4, Film properties).
Specification
Test parameter
Requirement
Identity (IR)
Must comply
Loss on drying (Ph.Eur 2.2.32 105 °C vacuo)
max. 5.0%
pH-value ( Ph.Eur 2.2.3; 20% w/w solution in water)
5.0 – 8.5
Viscosity (Brookfield, 20% w/w solution, sp 2 100 rpm, 23°C
50 – 250 mPas
Dispersibility in water (20% w/w residue on 100 µm filter)
max. 2%
Sulphated ash (Ph.Eur 2.4.1; 15 g)
24 – 38%
Acetate (GC)
max. 15 000
Vinyl acetate (GC)
max. 100 ppm
Residual solvents (Ph.Eur, USP) Methanol
max. 3000 ppm
Ethylene glycol 1,4 dioxane
max. 100 ppm
Methyl acetate
max. 1000 ppm
Ester value (Ph.Eur 2.5.2)
20 – 70 mg KOH/g
Microbial status (Ph.Eur 5.1.4, cat 3A)
Must comply
Analytical procedures (non compendial methods) are supplied upon request.
Pharmacopoeias
No monograph on Kollicoat IR has yet been registered in any of the main pharmacopoeias (USP, EP, JP). However, a number of products are currently being tested by the regulatory authorities in Europe, USA und Japan. The remaining components of the system conform to the corresponding monographs in EP, USP and JP.
2.3 Properties of aqueous suspensions Viscosity
The viscosity of aqueous dispersions of Kollicoat IR White increases with the polymer concentration, but remains very low.
EMP 040901e-08 January 2008
Page 5 of 12
Kollicoat IR White
Viscosity of aqueous Kollicoat IR White suspensions as a function of polymer concentration (at 23°C)
Viscosity of Kollicoat IR White suspensions as a function of solids concentration
Viscosity of various spray suspensions (20% w/w, 23°C)
Surface tension
The surface tension of a 20 % Kollicoat IR White suspension is very low (39.5 mN/m). Good wetting and spreadability are therefore achieved even on lipophilic surfaces.
EMP 040901e-08 January 2008
Page 6 of 12
Kollicoat IR White
2.4 Film properties
Kollicoat IR White forms smooth, white, highly flexible films that disperse very rapidly in water. Kollicoat IR White films are not tacky and can be readily printed.
Elongation at break of various ready-to-use instant-release films (23°C, 58% r. h.)
Adhesiveness
Kollicoat IR White films adhere extremely well to tablet surfaces of varying lipophilic character.
Coating engravings
The very low viscosity and excellent wetting and spreading properties ensure that even fine engravings are uniformly coated and no bridging occurs.
3. Application and processing 3.1 Applications
Kollicoat IR White can be used in all applications where a readily redispersible, flexible coating is required. • Instant-release coating - P rotects against unpleasant taste and odor, improves appearance, makes tablet easier to swallow, gives distinctive coloring, protects active ingredients (prevents interaction). The special advantages of Kollicoat IR White are high flexibility, low viscosity and rapid manufacture of coating suspensions. Kollicoat IR White suspensions for spraying on to tablets can be applied with a high solids content, which greatly reduces the coating time and minimizes costs. The high flexibility of the films ensures that they do not crack on the tablets. Kollicoat IR White can be combined with water-soluble dyes, lakes or iron oxides to obtain a particular shade. Water-soluble dyes and dispersible color concentrates are especially easy to use. Kollicoat IR White can also be used together with ready-mix colors (e.g. SepispersTM Dry) to make colored tablets.
EMP 040901e-08 January 2008
3.2 Incompatibilities
Page 7 of 12
Kollicoat IR White
Ibuprofen can lead to discoloration of Kollicoat IR White coatings when film-coated tablets are stored under light. This yellowing effect is caused by an incompatibility of ibuprofen with kaolin contained in Kollicoat IR White. For ibuprofen tablets we recommend to use Kollicoat IR and titanium dioxide as pigment.
3.3 Processing notes Because of the high flexibility of Kollicoat IR White films, it is not necessary to add a plasticizer. A spray suspension is conveniently prepared as follows: Stir Kollicoat IR White into water and redisperse. The mixer speed should be adjusted so that little or no foam is produced. After stirring for 15 min, Kollicoat IR White is ready for further processing.
The figures clearly illustrate the simple redispersion of Kollicoat IR White.
On account of its much lower viscosity, Kollicoat IR White can be processed in spray suspensions of much higher concentration than other ready-to-use instant-release formulations. This greatly shortens the spraying and processing time in the manufacture of film-coated tablets. Suspensions with a solids concentration of 15 – 30% can be processed without problem.
The high elasticity of Kollicoat IR White ensures that it does not crack on the tablets when they are exposed to varying humidity during storage. The coating system can be applied on all the usual coaters, e.g. horizontal drum coaters, fluidized bed coaters, immersion sword coaters, and coating pans, under the usual conditions for aqueous solutions. The following conditions have produced good results in numerous trials: Inlet air temperature: 50-80°C Outlet air temperature: 30-50°C Atomizing pressure: 2-4 bar Temperature of spray suspension: 20-70°C
Cleaning
The product can very easily be cleaned off equipment with warm or cold water.
EMP 040901e-08 January 2008
Page 8 of 12
Kollicoat IR White
4. Typical formulations 4.1 Aspirin instant-release film-coated tablets
Formulation No. P053/01
Composition of tablets
100 mg acetylsalicylic acid, 148.5 mg Ludipress® LCE, 50 mg Avicel® PH 102, 1.5 mg magnesium stearate
Composition of spray suspension
The formulation is designed for 6 kg of tablets (tablet weight 300 mg, diameter 9 mm) Weight [g] Spray suspension Kollicoat IR White Water
209 836 1 045
Proportion [%]
20 80 100
Preparation of spray suspension
Spray suspension: Stir the Kollicoat IR White into the specified quantity of water. After 15 min the spray suspension is ready for further processing.
Machine parameters
Coating machine
Accela-Cota drum coater (24 inch) 6 kg 60°C 36°C 35°C 410 m3/h 2 bar 1 bar 1 30 g/min 35 min 60°C / 4 min 5 mg/cm2 solids
Batch size Inlet air temperature Outlet air temperature Product temperature Outlet air flow Atomizing pressure Forming air pressure Number of spray nozzles Spraying rate Spraying time Final drying Quantity applied Tablet properties Appearance Hardness Friability Disintegration time
Core white 67 N 0% 3:17 [min:s]
Film-coated tablet white 75 N 0% 3:29 [min:s]
EMP 040901e-08 January 2008
4.2 Propranolol instant-release film tablets Composition of tablets
Composition of spray suspension
Page 9 of 12
Kollicoat IR White
Formulation No. P053/02
40 mg propranolol-HCl, 97.5 mg Ludipress, 12.5 mg Kollidon VA 64, 2.5 mg magnesium stearate, 97.5 mg Avicel PH 102 The formulation is designed for 250 kg of tablets (tablet weight 250 mg, diameter 9 mm) Weight [g] Polymer suspension Kollicoat IR White Water Pigment suspension Indigotin lake, E 132 Water
Preparation of spray suspension
Proportion [%]
7 755 25 000
18.80 60.61
495 8 000 41 250
1.20 19.39 100.00
Polymer suspension: Stir the Kollicoat IR White into the specified quantity of water. Pigment suspension: Add the indigotin lake to the specified quantity of water and homogenize with a high-shear mixer, e.g. Ultra-Turrax. Spray suspension: Stir the pigment suspension into the polymer suspension.
Machine parameters
Coating machine
Driacoater drum coater,Type 900 250 kg 70°C 45°C 47°C 4 600 m3/h 4 bar 6 700 g/min 60 min. 60°C / 5 min 3.0%
Batch size Inlet air temperature Outlet air temperature Product temperature Air flow Atomizing pressure Number of spray nozzles Spraying rate Spraying time Final drying Quantity applied Tablet properties Appearance Hardness Friability Disintegration time Drug release
Core white 94 N 0% 5:51 [min:s] 10 min: 51% 20 min: 99%
Film-coated tablet blue 112 N 0% 6:02 [min:s] 10 min: 53% 20 min: 99%
EMP 040901e-08 January 2008
Page 10 of 12
Kollicoat IR White
4.3 Vitamin C instant-release film tablets
Formulation No. P053/03
Composition of tablets
103.1 mg Vitamin C 97, 180.0 mg Ludipress, 14.4 mg Kollidon VA 64, 5.0 mg Kollidon CL, 2.5 mg magnesium stearate
Composition of spray suspension
The formulation is designed for 1 kg of tablets (tablet weight 300 mg, diameter 8.5 mm) Weight [g] Polymer suspension Kollicoat IR White Water
Proportion [%]
25.872 105.000
18.48 75.00
Kollicoat IR White
1.764
1.26
Sicovit Red 30
1.764
1.26
5.600 140.000
4.00 100.00
Pigment suspension
Water
Preparation of spray suspension
Polymer suspension: Stir the Kollicoat IR White into the specified quantity of water. Pigment suspension: Stir the Kollicoat IR White into the specified quantity of water. Then stir in the color pigment and homogenize with a high-shear mixer, e.g. Ultra-Turrax. Spray suspension: Stir the pigment suspension into the polymer suspension.
Machine parameters
Coating machine
Hi-Coater (Freund Industrial Co.) 1 kg 54 – 57°C 34 – 35°C 1.5 bar 1 5.2 – 5.4 g/min 28 min 8 min (outlet air temp. 34 – 40°C) 3.15%
Batch size Inlet air temperature Outlet air temperature Atomizing pressure Number of spray nozzles Spraying rate Spraying time Final drying Quantity applied Tablet properties Appearance Hardness Friability Disintegration time
Core white 150 N 0% 5:18 [min:s]
Film-coated tablet red 180 N 0% 5:06 [min:s]
EMP 040901e-08 January 2008
Page 11 of 12
Kollicoat IR White
5. Storage conditions
Store at room temperature.
6. Shelf life
At least 3 years in the original sealed containers at room temperature.
7. Toxicology
A complete toxicological characterization of Kollicoat IR White for application as a pharmaceutical adjuvant has been carried out. A summary of the available data is available on request under Secrecy Agreement.
8. PBG, PRD Nos.
PBG: 10 581 609, PRD: 30235578
9. Packaging
120 l plastic drum with PE liner, 30 kg capacity.
10. Note This document, or any answers or information provided herein by BASF, does
not constitute a legally binding obligation of BASF. While the descriptions, designs, data and information contained herein are presented in good faith and believed to be accurate, it is provided for your guidance only. Because many factors may affect processing or application/use, we recommend that you make tests to determine the suitability of a product for your particular purpose prior to use. It does not relieve our customers from the obligation to perform a full inspection of the products upon delivery or any other obligation. NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, ARE MADE REGARDING PRODUCTS DESCRIBED OR DESIGNS, DATA OR INFORMATION SET FORTH, OR THAT THE PRODUCTS, DESIGNS, DATA OR INFORMATION MAY BE USED WITHOUT INFRINGING THE INTELLECTUAL PROPERTY RIGHTS OF OTHERS. IN NO CASE SHALL THE DESCRIPTIONS, INFORMATION, DATA OR DESIGNS PROVIDED BE CONSIDERED A PART OF OUR TERMS AND CONDITIONS OF SALE. January 2008
EMP 040901e-08 January 2008
Page 12 of 12
Kollicoat IR White
BASF SE - Care Chemicals Division - Pharma Ingredients & Services - 67117 Limburgerhof - www.pharma-ingredients.basf.com
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