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CELOPRE® ME30M

CELOPRE® ME30M
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USP/EP Pharmacopoeia Grade HPMC + Ultra-High Viscosity (25,000–35,000 mPa·s) + High Hydroxypropyl Substitution (7.5–12%).

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 25,000‐35,000 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 % 28.0 – 30.0 USP
Hydroxypropoxyl Content % 7.5 – 12.0 USP
Total Microbial Count cfu/g Max 1000
Total Mould and Yeast cfu/g Max 100
E.Coli Negative

 

CELOPRE® ME30M Applications

CELOPRE® ME30M is high-viscosity, pharmaceutical-grade HPMC for controlled-release Systems which can form a stable, robust, and sustained gel barrier, enabling prolonged and smooth drug release.

  • Sustained-release and Controlled-release Tablets

    Sustained-release and Controlled-release Tablets

    CELOPRE® ME30M is primarily utilized in sustained-release and controlled-release tablets—typically for 12-hour sustained-release, 24-hour controlled-release, and once-daily dosage forms.

    It is particularly well-suited for APIs with moderate to low solubility, as well as for formulations requiring a smooth release profile to prevent fluctuations in blood drug concentration, thereby ensuring sustained and stable therapeutic efficacy.

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  • High-viscosity Matrix Tablets

    High-viscosity Matrix Tablets

    CELOPRE® ME30M is utilized in high-viscosity matrix tablets; by constructing a hydrophilic gel matrix, it controls the diffusion pathway of the API, effectively prevents initial burst release, and achieves smooth, controlled drug release.

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  • Multilayer Tablets and Complex Release Systems

    Multilayer Tablets and Complex Release Systems

    CELOPRE® ME30M is suitable for bilayer tablets (immediate-release + sustained-release), stepped-release (multiphasic release) formulations, and fixed-dose combination products.

    Its key advantage is construction of a stable hydrophilic gel matrix, which enables the precise regulation of different drugs or release phases, thereby meeting the requirements for customized drug release profiles.

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