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TYLOPUR® 606
TYLOPUR® 606 is a versatile hypromellose, compliant with USP, JP, EP. It is a film coating material that provides an excellent finish.It is a effective binder, it does not interact with drugs.It also enhances the solubility of poorly solule APIs.
Properties
- Physical Form
- Powder
- Solid
- Pharma and Nutraceuticals Functions
- Binder
- Coating System
- Taste Masker
- Thickener
- Viscosity Modifier
Product families
Applications
Healthcare & Pharma — Drug Delivery & Care Solutions
- Oral
Healthcare & Pharma — Pharmaceutical Manufacturing
- Excipients & Coatings
Product Families
Pharmaceuticals & Nutraceuticals — Excipients
- Binders & Disintegrants
- Flavors & Taste Maskers
- Formulation & Processing Aids
- Pharmaceutical Coatings
Other characteristics
- Brand
- TYLOPUR
- Functions
Binder, Coating System, Taste Masker, Thickener, Viscosity Modifier
- Dosage Form
Orally Disintegrating Films (ODFs), Pellets, Tablets; Orally Disintegrating Films (ODFs); Pellets; Tablets
- Labeling Claims
Allergen-free, Halal, Kosher, Non-GMO, Plant-Based; Allergen-free; Halal; Kosher; Non-GMO; Plant-Based
- Grade
- Pharma Grade
- Markets
- Healthcare & Pharma
- Technology
- Pharmaceuticals & Nutraceuticals
- Packaging Type
- Bags
- Boxes
- Chemical Inventories
- AICS (Australia)
- DSL (Canada)
- ENCS (Japan)
- KECI (Korea)
- NZIoC (New Zealand)
- PICCS (Phillipines)
- TCSI (Taiwan)
- TSCA (USA)
- Manufacturing Technology
- Tablet Coating
- Certifications and Compliance
- EU Compliant
- EXCiPACT
- European Pharmacopeia (Ph. Eur.)
- FCC Compliant
- FDA Compliant
- FSSC 22000
- GMP
- Generally Recognized As Safe (GRAS)
Technical data
Table 1 of 4
11 rows| Characteristic | Value | Unit | Method |
|---|---|---|---|
| Bulk Density (Fluid Bed 1% Tylopur 606) | 0.41 | g/cm3 | — |
| Bulk Density (Fluid Bed 4% Tylopur 606) | 0.3 | g/cm3 | — |
| Heavy Metals | max. 20 | ppm | EP |
| Hydroxypropoxy Content | 7.0 - 12.0 | % | EP |
| Loss on Drying | max. 5.0 | % | — |
| Loss on Drying (Fluid Bed 1% Tylopur 606) | 0.5 | % | — |
| Loss on Drying (Fluid Bed 4% Tylopur 606) | 1.1 | % | — |
| Methoxy Content | 28.0 - 30.0 | % | — |
| pH | 5.0 - 8.0 | — | EP |
| Sulphated Ash /Residue On Ignition | max. 1.5 | % | EP |
| Visocity | 4.8 - 7.2 | mPas | — |
Table 2 of 4
12 rows| Characteristic | Value | Unit | Method |
|---|---|---|---|
| Inlet Air Flow (Coating Parameters) | Constant | m3/h | — |
| Inlet Air Flow (Coating Parameters) | 400.0 | m3/h | — |
| Inlet Air Temperature (Coating Parameters) | 80.0 | ⁰C | — |
| Nozzle Pressure Bar (Coating Parameters) | 0.65 | bar | — |
| Nozzle Pressure Bar (Coating Parameters) | 2.9 | bar | — |
| Pan Speed (Coating Parameters) | 22.0 | rpm | — |
| Pan Speed (Coating Parameters) | 11.0 | rpm | — |
| Spray Rate (Coating Parameters) | 4.3 - 6.1 | g/min | EP |
| Spray Rate (Coating Parameters) | 9 - 23 | g/min | EP |
| Tablet Bed Temperature during Coating | 38 - 40 | ⁰C | — |
| Tablet Bed Temperature during Coating | 35 - 40 | ⁰C | — |
| Tablet Bed Temperature during Coating | 40.0 | ⁰C | — |
Table 3 of 4
30 rows| Characteristic | Value | Unit | Method |
|---|---|---|---|
| Air Flow (Granulation Parameters for 4% Tylopur 606) | 40.0 | m3/h | — |
| Air Flow(Granulation Parameters for 1% Tylopur 606) | 40.0 | m3/h | — |
| Angle of Response (Fluid Bed 1% Tylopur 606) | 46.4 | ⁰ | — |
| Angle of Response (Fluid Bed 4% Tylopur 606) | 44.4 | ⁰ | — |
| Bowl (Granulation Parameters for 4% Tylopur 606) | 3.0 | L | — |
| Bowl (Granulation Parameters for1% Tylopur 606) | 3.0 | L | — |
| Disintegration Time | 728.0 | S | — |
| Dissolution(>80%) min | 10.0 | — | EP |
| Filter Cleaning / pause (Granulation Parameters for 1% Tylopur 606) | 5 / 0.5 | S | EP |
| Filter Cleaning / pause (Granulation Parameters for 4% Tylopur 606) | 5 / 0.5 | S | EP |
| Filter Pressure (Granulation Parameters for 1% Tylopur 606) | 1.5 - 2.0 | bar | EP |
| Filter Pressure (Granulation Parameters for 4% Tylopur 606) | 1.5 - 2.0 | bar | EP |
Table 4 of 4
2 rows| Characteristic | Value | Unit |
|---|---|---|
| Particle Size (x50) (Fluid Bed 1% Tylopur 606) | 104.0 | µm |
| Particle Size (x50) (Fluid Bed 4% Tylopur 606) | 188.0 | µm |
