CELOPRE® MK30M

CELOPRE® MK30M

USP/EP/NF Pharmacopoeia Grade HPMC — Low-Methoxyl Type (K-type) + Ultra-High Viscosity (25,000–35,000 mPa·s)

Test Item Unit Specification Standard
Characters Conforms EP/USP NF
Identification A Conforms EP/USP NF
Identification B Conforms EP/USP NF
Identification C Conforms EP/USP NF
Identification D Conforms EP/USP NF
Identification E Conforms EP/USP NF
Identification F Conforms EP/USP NF
pH 5.5-8.0 EP/USP NF
Apparent Viscosity mPa.s 25,000 – 35,000 EP/USP NF
Appearance of Solution Conforms EP/USP NF
Chlorides % Max 0.5 EP/USP NF
Loss on drying % 5.0 Max EP/USP NF
Residue on ignition % 1.0 Max EP/USP NF
Heavy metals % Not more than 0.001 EP/USP NF
Methoxyl Content % 19.0 – 24.0
Hydroxypropoxyl content % 4.0 – 12.0
Total Microbial Count cfu/g Max 1000
Total Mould and Yeast cfu/g Max 100
E.Coli Negative

 

CELOPRE® MK30M Applications

High-Viscosity K-Type Pharmaceutical HPMC for Controlled Release: A controlled-release matrix material characterized by slower hydration, superior erosion resistance, and enhanced stability.

  • Controlled-release and Long-acting Sustained-release Systems

    Controlled-release and Long-acting Sustained-release Systems

    CELOPRE® MK30M is primarily utilized in 12-hour and 24-hour sustained-release tablets, as well as controlled-release matrix tablets.

    It is particularly well-suited for formulations containing highly soluble APIs and preparations requiring strictly defined release profiles to prevent dose dumping.

    Its key advantage is construction of a highly stable hydrophilic gel matrix, which enables the precise modulation of drug diffusion rates, effectively prevents burst release, and ensures a smooth, sustained release profile.

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  • High Drug-Loading Systems

    High Drug-Loading Systems

    CELOPRE® MK30M is specifically designed for  a high API content where standard HPMC struggles to maintain structural integrity.

    Advantages

    • Maintains tablet structural integrity even at high drug-loading levels
    • Prevents excessively rapid or uncontrolled drug release
    • Suitable for formulations with a high API-to-excipient ratio—a challenge typically beyond the capabilities of standard HPMC
    • Balances structural strength with consistent, controlled-release performance
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  • Complex Controlled-release Systems

    Complex Controlled-release Systems

    This product is suitable for multi-layer tablets (bi-layer tablets), gradient release formulations, and combination controlled-release systems.

    Advantages

    • Supports multi-layer tablet structures, enabling the design-based separation of different drugs or release phases.
    • Facilitates the construction of gradient release profiles to meet individualized drug delivery requirements.
    • Applicable to combination controlled-release systems, offering compatibility with a variety of release mechanisms.
    • Maintains matrix stability, ensuring controlled release even within complex structural configurations.
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