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CELOPRE® MF4M

CELOPRE® MF4M
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USP/EP Pharmacopoeia Grade HPMC + High Viscosity (3000–5000 mPa·s) + Low Hydroxypropyl Substitution (4.0–7.5%).

Test Item Unit Specification Standard
Appearance White to Yellowish white Visual
Characters Conforms EP
Identification A Conforms EP/USP
Identification B Conforms EP/USP
Identification C Conforms EP/USP
Identification D Conforms EP
Identification E Conforms EP
Identification F Conforms EP
pH 5.5-8.0 EP/USP
Apparent Viscosity mPa.s 3,000-5,000 EP/USP
Appearance of Solution Conforms EP
Chlorides % Max 0.5 EP
Loss on Drying % 5.0 Max EP/USP
Residue on Ignition % 1.0/1.5 Max EP/USP
Heavy Metals % Not more than 0.001 EP/USP
Arsenic ppm 3.0 Max USP
Methoxyl Content % 27.0 – 30.0 USP
Hydroxypropoxyl Content % 4.0 – 7.5 USP
Total Microbial Count cfu/g Max 1000
Total Mould and Yeast cfu/g Max 100
E.Coli Negative

 

Controlled Release Grade CELOPRE® MF4M HPMC Applications

High-viscosity, low-substituted pharmaceutical-grade HPMC forms a controlled-release system characterized by slower release, greater stability, and resistance to disintegration.

  • Sustained-Release / Controlled-Release Tablets (SR / CR)

    Sustained-Release / Controlled-Release Tablets (SR / CR)

    CELOPRE® MF4M can be used to including sustained-release tablets and controlled-release matrix tablets.

    Its mechanism of action involves absorbing water and swelling to form a gel layer, thereby controlling the diffusion rate and release profile of the Active Pharmaceutical Ingredient (API) to achieve a steady release of the drug.

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  • High-dose Sustained-release Drug Delivery Systems

    High-dose Sustained-release Drug Delivery Systems

    CELOPRE® MF4M can be used to tablets with high drug loads, highly soluble APIs (prone to burst release), and applications requiring prolonged release over 12 or 24 hours.

    Its key advantage lies in its ability to effectively control the release rate by forming a stable gel layer, thereby preventing drug dumping and achieving a smooth, sustained-release profile.

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  • Skeletal Tablet Systems

    Skeletal Tablet Systems

    CELOPRE® MF4M can be used to including hydrophilic gel-matrix tablets, bilayer tablets, and complex controlled-release structures.

    Its key advantage lies in its ability to absorb water and form a stable gel-matrix layer, thereby enabling precise control over the drug release rate; it is particularly well-suited for multilayer and irregularly shaped controlled-release designs.

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