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.

Chemical Name: Hydroxypropyl Methylcellulose

Functions: Binder, Coating System, Taste Masker, Thickener, Viscosity Modifier

Dosage Form: Orally Disintegrating Films (ODFs), Pellets, Tablets

Labeling Claims: Allergen-free, Halal, Kosher, Non-GMO, Plant-Based

    Knowde Enhanced TDS

    Identification & Functionality

    CAS No.
    9004-65-3
    EC No.
    618-389-6

    Features & Benefits

    Applications & Uses

    Manufacturing Technology

    Properties

    Physical Form
    Typical Properties
    ValueUnitsTest Method / Conditions
    Bulk Density (Fluid Bed 1% Tylopur 606)0.41g/cm3
    Bulk Density (Fluid Bed 4% Tylopur 606)0.3g/cm3
    Heavy Metalsmax. 20ppmEP
    Hydroxypropoxy Content7.0 - 12.0%EP
    Loss on Dryingmax. 5.0%
    Loss on Drying (Fluid Bed 1% Tylopur 606)0.5%
    Loss on Drying (Fluid Bed 4% Tylopur 606)1.1%
    Methoxy Content28.0 - 30.0%
    pH5.0 - 8.0EP
    Sulphated Ash /Residue On Ignitionmax. 1.5%EP
    Visocity4.8 - 7.2mPas
    Coating Properties
    ValueUnitsTest Method / Conditions
    Inlet Air Flow (Coating Parameters)Constantm3/h
    Inlet Air Flow (Coating Parameters)400.0m3/h
    Inlet Air Temperature (Coating Parameters)80.0⁰C
    Nozzle Pressure Bar (Coating Parameters)0.65bar
    Nozzle Pressure Bar (Coating Parameters)2.9bar
    Pan Speed (Coating Parameters)22.0rpm
    Pan Speed (Coating Parameters)11.0rpm
    Spray Rate (Coating Parameters)4.3 - 6.1g/minEP
    Spray Rate (Coating Parameters)9 - 23g/minEP
    Tablet Bed Temperature during Coating38 - 40⁰C
    Tablet Bed Temperature during Coating35 - 40⁰C
    Tablet Bed Temperature during Coating40.0⁰C
    Processing Parameters
    ValueUnitsTest Method / Conditions
    Air Flow (Granulation Parameters for 4% Tylopur 606)40.0m3/h
    Air Flow(Granulation Parameters for 1% Tylopur 606)40.0m3/h
    Angle of Response (Fluid Bed 1% Tylopur 606)46.4
    Angle of Response (Fluid Bed 4% Tylopur 606)44.4
    Bowl (Granulation Parameters for 4% Tylopur 606)3.0L
    Bowl (Granulation Parameters for1% Tylopur 606)3.0L
    Disintegration Time728.0S
    Dissolution(>80%) min10.0EP
    Filter Cleaning / pause (Granulation Parameters for 1% Tylopur 606)5 / 0.5SEP
    Filter Cleaning / pause (Granulation Parameters for 4% Tylopur 606)5 / 0.5SEP
    Filter Pressure (Granulation Parameters for 1% Tylopur 606)1.5 - 2.0barEP
    Filter Pressure (Granulation Parameters for 4% Tylopur 606)1.5 - 2.0barEP
    Inlet Air Temperature (Granulation Parameters for 1% Tylopur 606)65.0⁰C
    Inlet Air Temperature (Granulation Parameters for 4% Tylopur 606)65.0⁰C
    Nozzle Position / Pressure (Granulation Parameters for 1% Tylopur 606)1.2mm / 1.5 bar
    Nozzle Position / Pressure (Granulation Parameters for 1% Tylopur 606)1.2/ 1.5mm / bar
    Nozzle Position / Pressure (Granulation Parameters for 4% Tylopur 606)1.2mm / 1.5 bar
    Nozzle Position / Pressure (Granulation Parameters for 4% Tylopur 606)1.2/ 1.5mm / bar
    Process time - Drying (Granulation Parameters for 1% Tylopur 606)8.0minutes
    Process time - Drying (Granulation Parameters for 4% Tylopur 606)4.0minutes
    Process time - Granulation (Granulation Parameters for 1% Tylopur 606)20.0minutes
    Process time - Granulation (Granulation Parameters for 4% Tylopur 606)85.0minutes
    Product Temperature - Drying (Granulation Parameters for 1% Tylopur 606)31.0⁰C
    Product Temperature - Drying (Granulation Parameters for 4% Tylopur 606)29.0⁰C
    Product Temperature - Granulation (Granulation Parameters for 1% Tylopur 606)25.5⁰CEP
    Product Temperature - Granulation (Granulation Parameters for 4% Tylopur 606)28.3⁰CEP
    Product Temperature - warm up (Granulation Parameters for 1% Tylopur 606)31.0⁰CEP
    Product Temperature - warm up (Granulation Parameters for 4% Tylopur 606)31.0⁰C
    Spraying Speed (Granulation Parameters for 1% Tylopur 606)5.4 - 11g/min
    Spraying Speed (Granulation Parameters for 4% Tylopur 606)upto 12g/min
    Particle Size Distribution
    ValueUnitsTest Method / Conditions
    Particle Size (x50) (Fluid Bed 1% Tylopur 606)104.0µm
    Particle Size (x50) (Fluid Bed 4% Tylopur 606)188.0µm

    Regulatory & Compliance

    Packaging & Availability

    Packaging Type