| Supplier |
CD Formulation |
| Product # |
PE-0206 |
| Pricing |
, Inquire for price
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| product1 |
Coating Systems Excipients
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| Applications |
Hypromellose is widely used in oral, ophthalmic, nasal, and topical pharmaceutical formulations. In oral products, hypromellose is primarily used as a tablet binder, in film-coating, and as a matrix for use in extendedrelease tablet formulations.
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| Safety |
Hypromellose is widely used as an excipient in oral, opthalmic, nasal, and topical pharmaceutical formulations. It is also used extensively in cosmetics and food products. Hypromellose is generally regarded as a nontoxic and nonirritating material, although excessive oral consumption may have a laxative effect. The WHO has not specified an acceptable daily intake for hypromellose since the levels consumed were not considered to represent a hazard to health. In fact, high dosages of hypromellose are being investigated for treating various metabolic syndromes. LD50 (mouse, IP): 5 g/kg LD50 (rat, IP): 5.2 g/kg
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| Incompatibilities |
Hypromellose is incompatible with some oxidizing agents. Since it is nonionic, hypromellose will not complex with metallic salts or ionic organics to form insoluble precipitates.
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| Synonyms |
Benecel MHPC; E464; hydroxypropyl methylcellulose; HPMC; hypromellosum; Methocel; methylcellulose propylene glycol ether; methyl hydroxypropylcellulose; Metolose; MHPC; Pharmacoat; Tylopur; Tylose MO
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| CAS Number |
9004-65-3
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| Category |
Bioadhesive Material; Coating Agents; Controlled-release Agents; dispersing Agents; Emulsifying Agents; Emulsion Stabilizer; extended-release Agents; Film-forming Agents; foaming Agents; Granulation Aid; modified-release Agents; mucoadhesive;
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| UNII |
B1QE5P712K
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| Chemical Name |
Cellulose hydroxypropyl methyl ether
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| Grade |
Pharmceutical Excipients
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| Administration route |
Ophthalmic and nasal; oral
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| Dosage Form |
Ophthalmic and nasal preparations; oral capsules, suspensions, syrups, and tablets
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| Stability and Storage Conditions |
Hypromellose powder is a stable material, although it is hygroscopic after drying. Solutions are stable at pH 3-11. Hypromellose undergoes a reversible sol-gel transformation upon heating and cooling, respectively. The gelation temperature is 50-90℃, depending upon the grade and concentration of material. For temperatures below the gelation temperature, viscosity of the solution decreases as temperature is increased. Beyond the gelation temperature, viscosity increases as temperature is increased. Aqueous solutions are comparatively enzyme-resistant, providing good viscosity stability during long-term storage. However, aqueous solutions are liable to microbial spoilage and should be preserved with an antimicrobial preservative: when hypromellose is used as a viscosity-increasing agent in ophthalmic solutions, benzalkonium chloride is commonly used as the preservative. Aqueous solutions may also be sterilized by autoclaving; the coagulated polymer must be redispersed on cooling by shaking. Hypromellose powder should be stored in a well-closed container, in a cool, dry place.
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| Commonly used amount and the maximum amount |
A purified form of cellulose, obtained from cotton linters or wood pulp, is reacted with sodium hydroxide solution to produce a swollen alkali cellulose that is chemically more reactive than untreated cellulose. The alkali cellulose is then treated with chloromethane and propylene oxide to produce methyl hydroxypropyl ethers of cellulose. The fibrous reaction product is then purified and ground to a fine, uniform powder or granules. Hypromellose can then be exposed to anhydrous hydrogen chloride to induce depolymerization, thus producing low viscosity grades.
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