CHAPTER-3POLYMER PROFILE

3.2 POLYMER PROFILE

 HYDROXY PROPYL METHYL CELLULOSE K15 M

 Structural formula:

Where R is H, CH3, or CH3CH [OH] CH2

 Nonproprietary names

 BP : Hypromellose

 JP : Hydroxypropylmethylcellulose

 PhEu : Hypromellosum

 USP : Hypromellose

 Synonyms: Benecel MHPC; E464; hydroxy propyl methylcellulose; HPMC;

methylcellulose propylene glycol ether; methyl hydroxypropylcellulose; Metolose:

Tylopor.

 Chemical name: Cellulose hydroxy propyl methyl ether.

 Functional category: Coating agent; film-former; rate-controlling polymer for

sustained release; stabilizing agent; suspending agent; tablet binder; viscosity- increasing

agent.

 Description: Hypromellose is an odorless and tasteless, white or creamy-white

fibrous or granular powder.

RKDF SCHOOL OF PHARMACEUTICAL SCIENCEPage 34

CHAPTER-3POLYMER PROFILE

 Typical properties

Acidity/alkalinity : pH = 5.5–8.0 for a 1% w/w aqueous solution.

3 3
Density [bulk] : 0.341 g/cm . Density [tapped] : 0.557 g/cm . Density
3
[true] : 1.326 g/cm .

Melting point : Browns at 190–200°C; chars at 225–230°C. Glass transition

temperature is 170–180°C.

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.
 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. Concentration 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 10–80% w/w

in tablets and capsules. Depending upon the viscosity grade; concentration of 2–20% 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.

 Viscosity [dynamic]

A wide range of viscosity types are commercially available [table 6 ]. Aqueous

solutions are most commonly prepared; Dichloromethane and ethanol

RKDF SCHOOL OF PHARMACEUTICAL SCIENCEPage 35

CHAPTER-3POLYMER PROFILE

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.

Table. 6 Typical viscosity values for 2% [w/v] aqueous solutions of methocel,

viscosities measured at 20°C.

Nominal viscosity
Methocel product USP 28 designation
[mPa s]
Methocel K100 premium LVEP 2208 100

Methocel K4M premium 2208 4000

Methocel K15M premium 2208 15 000

Methocel K100M premium

2208 100 000
Methocel E4M premium
2910 4000
Methocel F50 premium 2906 50

Methocel E10M premium CR 2906 10 000

Methocel E3 premium LV 2906 3

Methocel E5 premium LV 2906 5

To prepare an aqueous solution, it is recommended that hypromellose is dispersed and

thoroughly hydrated in about 20–30% of the required amount of water. The water should be
vigorously stirred and heated to 80–90°C 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.

RKDF SCHOOL OF PHARMACEUTICAL SCIENCEPage 36

CHAPTER-3POLYMER PROFILE

 Polyvinyl Alcohol
 Nonproprietary Names: PhEur: Poly [vinylis acetas], USP: Polyvinyl alcohol
 Synonyms: Alcotex; Gelvatol; Lemol; Mowiol; Polyvinol; PVA; Vinyl alcohol polymer,
PVOH, INS No. 1203
 Chemical Names: Ethenol homopolymer
 C.A.S. Number: 9002-89-5
 Definition: Polyvinyl alcohol is a synthetic resin prepared by the polymerization of vinyl
acetate, followed by partial hydrolysis of the ester in the presence of an alkaline catalyst.
The physical characteristics of the product depend on the degree of polymerization and
the degree of hydrolysis.
 Chemical Formula: [C2H3OR]n where R=H or COCH3 [randomly distributed]
 Chemical Structure:

 Empirical Formula: Weight range of approximately 20000-200000. [C2H4O]n. The

value of n for commercially available materials lies between 500 and 5000, equivalent to
a molecular weight.
 Molecular Weight: 20000-200000.
 Melting Point: 228°C for fully hydrolyzed grades; 180-190°C for partially hydrolysed
grades
 Solubility: Soluble in water; slightly soluble in ethanol [95%]; insoluble in organic
solvents. Dissolution requires dispersion [wetting] of solid in water at room temperature
followed by heating the mixture to about 900°C for approximately 5 min mixing should
be continued while the heated solution is cooled to room temperature.
 Description Polyvinyl alcohol is a water-soluble synthetic polymer. Polyvinyl alcohol
for food use is an odourless and tasteless, translucent, white or cream colored granular
powder. Typically a 5% solution of polyvinyl alcohol exhibits a pH in the range of 5.0 to

RKDF SCHOOL OF PHARMACEUTICAL SCIENCEPage 37

CHAPTER-3POLYMER PROFILE

6.5. It has degree of hydrolysis of 86.5 to 89%. Polyvinyl alcohol has excellent film
forming, emulsifying, and adhesive properties. PVA is an atactic material but exhibits
crystallinity as the hydroxyl groups are small enough to fit into the lattice without
disrupting it.
 Functional Category: Coating agent; binder; sealing agent; lubricant; stabilizing agent;
viscosity-increasing agent and surface-finishing agent.
 Applications: Polyvinyl alcohol is used as an emulsion polymerization aid, as protective
colloid, to make polyvinyl acetate dispersions. It is used primarily in topical
pharmaceutical and ophthalmic formulations. It is used as stabilizing agent for emulsions
[0.25-3.0% w/v]. Polyvinyl alcohol is also used as a viscosity-increasing agent for
viscous formulations such as ophthalmic products. It is used in artificial tears and contact
lens solutions for lubrication purposes, in sustained release formulations for oral
administration and in transdermal patches. Polyvinyl alcohol may be made into
microspheres when mixed with a glutaraldehyde solution. It is also used as emulsifying
agent. Polyvinyl alcohol is the raw material to make other polymers like Polyvinyl
nitrate, Polyvinyl acetals, Polyvinyl butyral, and Polyvinyl formal.

RKDF SCHOOL OF PHARMACEUTICAL SCIENCEPage 38