Hydroxy Propyl Methylcellulose Project Report

2.2. POLYMER PROFILE

2.2.1 HYDROXY PROPYL METHYLCELLULOSE30

1) Non proprietary Name

BP: Hypromellose, JP: Hydroxy propyl methylcellulose, PhEur: Hypromellosum,

USP: Hypromellose

2 ) Synonyms

Benecel MHPC; E464; hydroxyl propyl methylcellulose; HPMC; Methocel; methyl cellulose propylene glycol ether; methyl hydroxyl propyl cellulose; Metolose.

3) Molecular Weight

Molecular weight is approximately about 10 000–1 500 000.

4) Structural Formula

5) Functional Category

Coating agent, rate-controlling polymer,film-former, for sustained release,stabilizing agent, suspending agent, tablet binder and viscosity increasing agent.

6) Description

Hypromellose is white or creamy-white fibrous or granular powder ,it is odourless and tasteless

7) Typical

Solubility: Ethyl cellulose is practically insoluble in Glycerin, Propylene glycol, and Water. Ethyl cellulose that contains less than 46.5% of ethoxyl groups is freely soluble in Chloroform, Methyl acetate, and Tetrahydrofuran and in mixtures of aromatic hydrocarbons with ethanol (95%).

8) Stability and Storage Conditions

a) Ethyl cellulose is a stable, slightly hygroscopic material. It is chemically resistant to alkalis of both dilute and concentrated, and to salt solutions, even though it is more sensitive to acidic materials than are cellulose esters.

b) Ethyl cellulose is subject to oxidative degradation in the presence of sunlight or UV light at elevated temperatures. This could be prevented by the use of antioxidant and chemical additives that absorb light in the 230 – 340 nm

It should not be stored next to oxidizing agents or other peroxides.

9) Incompatibilities

Incompatible with paraffin wax and microcrystalline wax.

10) Safety

a) Ethyl cellulose is not metabolized following oral consumption and is therefore a non calorific substance. Because ethyl cellulose is not metabolized it is not recommended for parenteral products, parenteral use may damage the kidneys.

b) Ethyl cellulose is generally regarded as a non-toxic, non-allergenic, and nonirritating material. 11) Applications in Pharmaceutical Formulation or Technology

Ethyl cellulose is widely used in oral and topical pharmaceutical Formulations. The major use of ethyl cellulose in oral formulations is as a hydrophobic coating agent for tablets and granules. Modified release tablet formulations may also be produced using ethyl cellulose as a matrix former (1Highviscosity grades of ethyl cellulose are used in drug microencapsulation. In tablet formulations, ethyl cellulose may additionally be employed as a binder, the ethyl cellulose being blended dry or wet-granulated with a solvent such as