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HPMC

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HYDROXY PROPYL METHYL CELLULOSE Nonproprietary names: BP: Hypromellose JP: Hydroxypropylmethylcellulose PhEur: Hypromellosum USP: Hypromellose Synonyms:

yms: Benecel MHPC; Hydroxypropyl methylcellulose Chemical name and CAS registry number: Cellulose hydroxypropyl methyl ether [9004-65-3] Structural formula:

Functional category: Coating agent, film-former, rate-controlling polymer for sustained release, stabilizing agent, suspending agent, tablet binder, viscosity increasing agent. Description: HPMC is an odorless and tasteless, white or creamy-white fibrous or granular powder.

Typical properties: Acidity/alkalinity: pH = 5.58.0 for a 1% w/w aqueous solution. Density (bulk): 0.341 g/cm3 Density (tapped): 0.557 g/cm3 Density (true): 1.326 g/cm3 Melting point: Glass transition temperature is 170180C. Solubility: Soluble in cold water, forming a viscous colloidal solution; practically insoluble in chloroform, ethanol (95%) and ether, but soluble in mixtures of ethanol and dichloromethane, mixtures of methanol and dichloromethane, and mixtures of water and alcohol. Viscosity (dynamic): A wide range of viscosity types are commercially available. Aqueous solutions are most commonly prepared; Dichloromethane and ethanol mixtures may also be used to prepare viscous hypromellose solutions. Solutions prepared using organic solvents tend to be more viscous; increasing concentration also produces more viscous solutions. To prepare an aqueous solution, it is recommended that hypromellose is dispersed and thoroughly hydrated in about 2030% of the required amount of water. The water should be vigorously stirred and heated to 8090C and then the remaining hypromellose should be added. Then sufficient cold water should be added to produce the required volume. 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. Applications in pharmaceutical formulation or technology: Hypromellose is widely used in oral, ophthalmic 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 extended-release tablet formulations. Concentrations between 2% and 5% w/w may be used as a binder in either wet or dry granulation processes. High-viscosity grades may be used to retard the release of drugs from a matrix at levels of 1080% w/w in tablets and capsules. Depending upon the viscosity grade; concentrations of 220% w/w are used for film-forming

solutions to film-coat tablets. Lower-viscosity grades are used in aqueous film-coating solutions while higher-viscosity grades are used with organic solvents. Examples of film-coating materials that are commercially available include Any Coat C, Spectracel, and Pharmacoat. Hypromellose is also used as a suspending and thickening agent in topical formulations. It is also used as an emulsifier, suspending agent, and stabilizing agent in topical gels and ointments.

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