HPMC for pharmaceutical grade suspensions
1. It has excellent water solubility in cold water. It can be dissolved into a transparent solution with a little stirring in cold water. On the contrary, it is basically insoluble in hot water above 60 °C, and can only swell. It is a non-ionic cellulose ether. Its solution has no ionic charge, does not interact with metal salts or ionic organic compounds, and does not react with other raw and auxiliary materials in the preparation process;
2. It has strong anti-sensitivity, and with the increase of the degree of substitution in the molecular structure, its anti-sensitivity is stronger and more stable;
3. It has a metabolic character. As a pharmaceutical excipient, it is not metabolized or absorbed, so it does not provide calories in medicines and food. It is unique to the low-calorie, salt-free, non-mutagenic medicines and foods needed by diabetic patients. applicability;
4. It is relatively stable to acid and alkali, but if the pH value exceeds 2 to 11, and it is affected by higher temperature or stored for a long time, its viscosity will decrease;
5. It has an effective emulsifying effect and can be used as an effective stabilizer and protective colloid;
6. Its aqueous solution has excellent film-forming properties and is a good coating material for tablets and pills. The film formed by it has the advantages of colorless and tough, and the addition of glycerin can also improve its plasticity
Hydroxypropyl methylcellulose (HPMC), HPMC is white or milky white, odorless and tasteless, fibrous powder or granules, the loss on drying does not exceed 10%, can be dissolved in cold water but not in hot water, slowly in hot water Swells, peptizes, forms a viscous colloidal solution, cools to a solution, and accordingly becomes a gel when heated. It is usually used in pharmaceutical excipients and can be used as thickener, dispersant, emulsifier and film-forming agent.
Formula
(n~2)/2
OR=-OH、-OCH3、-[OCH2CH(CH3)]nOH or-[OCH2CH(CH3)]OCH3
Specific application and viscosity range
Viscosity | 60YT HPMC | 65YT HPMC | 75YT HPMC |
50 | 50 | 100 | |
5~50 | 5~50 | ||
35~50 | 35~50 | 35~50 | |
Slow~release | 35~100 | 35~100 | 35~100 |
film | 50~100 | 50~100 | 50~100 |
Capsule sustained~ | 50~100 | 50~100 | |
15~50 | 15~50 |
Specification
Type Item | 60YT HPMC | 65YT HPMC | 75YT HPMC | |
Methoxy % | 28.0~30.0 | 27.0~30.0 | 19.0~24.0 | |
Hydroxypropyl % | 7.0~12.0 | 4.0~7.5 | 4.0~12.0 | |
Gel temperature ℃ | 58.0~64.0 | 62.0~68.0 | 70.0~90.0 | |
Viscosity mPa.s | 3,5,6,15,30,50,4000 | 50, 4000 | 100, 4000,15000, 100000 | |
pH | 5.5~7.5 | |||
Insoluble matter in water | % | <0.4 | ||
Loss on drying | % | ≤4.5 | ||
Burning residue | % | <1.4 | ||
Heavy metal | ppm | <10 | ||
Arsenic salt | ppm | <2 | ||
Microbial Limit | Total number of aerobic bacteria |
cfu/g |
≤600 | |
Total Mold and Yeast | cfu/g | ≤60 | ||
Escherichia coli | cfu/g | Not checked out |
Applied to medical features
This product is a multi~functional pharmaceutical excipient, which can be used as thickener, dispersant, emulsifier, film ~ forming agent, etc. As film coating and adhesive in oral solid preparations, it can significantly improve the stability and dissolution of drugs, and enhance the waterproof of tablets. It can also be used as a suspension aid in suspension, as a matrix material in ophthalmic preparations, as a skeleton material in hydrophilic gel skeleton sustained ~ release tablets and intragastric floating tablets. The indicators comply with USP, EP and Chinese Pharmacopoeia.
HPMC packaging and storage
Barrel or paper plastic bag lined with polyethylene film inner bag. Net weight of each bag: 25kg.
Protect from sun and rain during storage and transportation.
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