Hydroxypropyl Methyl Cellulose Phthalic Ester(HPMCP)

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I. Chemical Name：Hydroxypropylmethyl cellulose phthalate（ HPMCP ） II. Technical Requirements： (the product is in accordance with USP24/NF19 standards) Specification Item: HP55 （ 200731 ） HP55S （ 200731 ） Viscosity:（ 10 ％， 20±0.1℃ ） 32-48 136-204 Loss on drying: ≤5.0 ％ Residue on ignition ≤0.2 ％ Chloride ≤0.07 ％ Arsenic ≤2ppm Heavy metal ≤0.001 ％ Free phthalic acid≤1.0 ％ Phthaloyl: 27.0-35.0% Methoxy:18.0-22.0% Hydroxypropyl: 5.0-9.0% III. Important Properties of HPMCP： 1. Itself has the plasticity, good film forming ability; when afterbirth does not use or seldom uses the plasticizer, then not only can improve the tablet's appearance but also can enhance the tablet intensity, also can use together with a small amount of shellac(80:20) in order to strengthen the resistance to the gastric juice. 2. Compare to the acrylic resin, it has lowerdissolving PH value, faster material dissolving speed and higher bioavailability. 3. HPMCP has the good storing stability, under storage conditions, it will not deteriorate within 3-4 years; its influence to the medicine release and absorption is smaller than the acrylic resin. 4. HPMCP is safe, nontoxic has no teratogenic action. 5. Its coating has strong plasticity, the coating film's thickness won't affect medicine's dissolution. 6. HPMCP, to be as the enteric solubility film material, its effect is better than the cellulose actetate-phthalate, and because it does not contain acetoxy in its chemical structure, so during the storage period, it won't dissociate the acetic acid like the CAP does and cause the medicine's degeneration. 7. The HPMCP ammonium salt polymer is one of principal constituents for enteric capsule, which matches together with the gelatin or HPMC can form the tenacious and transparent film, it can dissolve or disintegrate in the intestinal tract. IV. Physicochemical property： 1. Appearance：tasteless and odorless white powder or granule. 2. Specific gravity： 1.28 。 3. Bulk unit weight： 0.2-0.4fg/cm3 4. Organic solvent's solubility： HP55 & HP55S can dissolve in organic solvents, such as the acetone, acetone / water（ 95 ： 5 ），acetone / ethanol（ 1 ： 1 ），dichloromethane / ethanol（ 1 ： 1 ），ethanol / water（ 8 ： 2 ）and so on; but is does not dissolve in water and acidic buffer. 5. HP55S has higher molecular weight than HP55, has stronger film strength and stronger resistance to the simulated gastric fluid. 6. HP55 can dissolve in the media of PH5.5, the HP50 can dissolve in the media of PH 5.0. V.The preparation of coating liquid： 1. The concentration of coating liquid： HP55 HP55S tablet: 6-10% 5-8% pelletized granule: 5-7% 4-6% 2. The organic solvents that used for the HP： dichloromethane / ethanol （ 1 ： 1 ） acetone / ethanol （ 1 ： 1 ） ethanol / water （ 8 ： 2 ） 3. Dissolving method： Adds a given weight of solvent into the vessel, under stirring condition, slowly adds HPMCP and to stir evenly. 4. HPMCP dosage：is 6-10% of the core of the bobbin. VI. Packing & Storage： Cardboard drum encapsulating, inner lining double-layer polyethylene plastic bag, 20kg/ drum or 1kg/ drum. Store under the condition of cool, dry and ventilative, and must be waterproofing and moisture-proofing, avoids the high temperature and solarization. VII. Use： HPMCP is a kind of enteric solubility film coating material with good properties. It mainly is used as the enteric solubility coating material and slow release framework material of tablet, pelletized granule, etc. It is used for making the bond as well as the microcyst matrix, embedding agent, the gradient releases the medicine system, the microballoons, the oral cavity capsule, the solid disperser and so on; moreover it is also widely applied in the aspects of livestock breeding, industry, biological technology, etc.

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Shandong Head Co.,Ltd

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