Hypromellose K100M

Category

Thickener; Stabilizer; Emulsifier; Gelling Agents; Suspension Agents

Molecular Formula

C8H15O8-(C10H18O6)n-C8H15O8

Molecular Weight

10 000~1 500 000

Grade

Pharmceutical Excipients

UNII

3NXW29V3WO

Chemical Name

/

CAS Number

9004-65-3

Synonyms

Cellulosehydroxypropyl methyl ether; HPMC; methyl hydroxypropylcellulose; hydroxypropyl ; methylcellulose propylene glycol ether

Administration route

Ophthalmic, oral; Topical and vaginal

Dosage Form

Ophthalmic preparations, oral capsules, suspensions, syrups and tablets; Topical and vaginal preparations

Stability and Storage Conditions

Hydroxypropyl methylene cellulose after drying moisture absorption, but the property is stable. The solution is stable at pH 3 ~ 11. The viscosity of solution decreases as temperature increases. Heating - cooling can make the reversible transformation of hydroxypropyl methylene cellulose from solution to gel state. Depending on different grades and concentrations, the gelation temperature is 50 ~ 90℃. The aqueous solution of hydroxypropyl methylcellulose has anti-enzyme effect and maintains good viscosity stability during long-term storage. However, its aqueous solution is susceptible to microbial attack, so preservative and bacteriostatic agents should be added during storage. When hydroxypropyl methylcellulose is used as a thickening agent in eye drops, benzalkonium chloride is usually added as a preservative. Aqueous solution can be autoclaved. The clumps shake and redisperse as they cool. Hydroxypropyl methylcellulose powder must be stored in an airtight container and kept in a cool and dry place.

Source and Preparation

The purified cellulose obtained from lint or wood pulp is reacted with sodium hydroxide solution to produce a swollen alkali cellulose, which is more chemically active than untreated cellulose. This alkali cellulose is treated with chloromethane and propylene oxide to obtain methyl hydroxypropyl ether of cellulose. The resulting fibrous product is purified and ground into uniform fine powder or particles.

Applications

1.Thickener; Stabilizer; Emulsifier; Gelling agent; Suspension agent; 2.Used as synthetic resin dispersant, coating molding agent, can also be used as a thickening agent; 3. This product is used as thickener, dispersant, binder, emulsifier and stabilizer in textile industry. Also widely used in synthetic resin, petrochemical, ceramics, paper, leather, medicine, food, cosmetics and other industries; 4.Used in synthetic resin, petrochemical, ceramics, paper, leather, textile printing and dyeing, medicine, food, cosmetics and other daily chemicals, as dispersant, thickening agent, binder, excipient, capsule, oil resistant coatings and fillers; 5-hydroxypropyl methylcellulose is widely used in oral and topical preparations. In oral preparations, hydroxypropyl methylcellulose is mainly used as tablet binder, film coating material and skeleton of sustained release tablets. As the adhesive of wet granule tablet, the use concentration is 2%, and the use concentration of dry granule tablet binder is 5%. Hydroxypropyl methylcellulose with high viscosity can be used as a blocker of tablet and capsule skeleton when the use concentration is 10-80% w/w, and has the effect of delaying drug release. According to different viscosity levels, the concentration of 2~20% can be used as the tablet film coating solution. The low viscosity grade can be used as water-based film coating solution, while the high viscosity grade can be used as organic solvent system coating solution. Hydroxypropyl methylcellulose can be used as suspension aid and thickener in local preparations, especially in ophthalmic preparations. Compared with methyl cellulose, the solution formed by hydroxypropyl methylcellulose is more clear, only a very small amount of non-dispersed fibers exist, so it is often used in ophthalmic preparations. Usually 0.45~ 1.0% w/w hydroxypropyl methylcellulose can be used as eye drops and artificial tear thickening agent. Hydroxypropyl methylcellulose can also be used as emulsifier, suspension and stabilizer for topical gels and plasters. Hydroxypropyl methylcellulose forms protective colloids that prevent milk droplets or particles from aggregating or gathering, thus inhibiting the formation of fallout. In addition, hydroxypropyl methylcellulose can be used as a binder for plastic bandages in the production of capsules. Can also be used as contact lens wetting agent. It is also widely used in cosmetics and food products.

Safety

Hydroxypropyl methylcellulose is widely used as excipients in oral and topical preparations. It is also widely used in cosmetics and food products. It is generally believed that hydroxypropyl methylcellulose is non-toxic, non-irritating material, but excessive oral can cause diarrhea. Ordinary intake is not harmful to human health, WHO has no clear rules on the daily intake of hydroxypropyl methylcellulose. LD50(mice, intraperitoneal injection): 5 g/kg LD50(rats, intraperitoneal injection): 5.2 g/kg

Incompatibilities

Hydroxypropyl methylcellulose and some oxidants have incompatibility. Since hydroxypropyl methylcellulose is a nonionic compound, it can form insoluble precipitates with metal salts or ionized organic matter.