Documentne

SEMINAR ONSUPERDISINTEGRANT

Introduced By: Kunal M. Jerajani

Guided by : Mrs. Anjali Wanegaonkar

INTRODUCTION• Disintegrant:

Disintegrating agents are substances routinely included in the tablet formulations to aid in the break up of the compacted mass when it is put into a fluid environment.

Eg: starch, starch derivatives, clays, cellulose, cellulose derivatives.

SUPERDISINTEGRANTS These newer substances are more effective at

lower concentrations with greater disintegrating efficiency and mechanical strength

It provides improved compressibility, compatibility to the formulation containing high dose drugs.

It include a particulate agglomerate of co processed starch or cellulose and a sufficient amount of an augmenting agent to increase the compatibility of the Superdisintegrants

TYPES OF SUPERDISINTEGRANTS

MODIFIED STARCHES

MODIFIED CELLULOSES

CARBOXYMETHYLCELLULOSE AND ITS DERIVATIVE (CROSCARMELLOSE SODIUM)

L-HPC(LOW SUBSTITUTED HYDROXY PROPYL CELLULOSE)

CROSS-LINKED POLYVINYLPYRROLIDONE

• SOY POLYSACCHARIDE

• CROSS-LINKED ALGINIC ACID

• GELLAN GUM

• XANTHAN GUM

• CALCIUM SILICATE

• ION EXCHANGE RESINS

METHODS OF INCORPORATING

DISINTEGRATING AGENTS

I. Internal Addition (Intragranular)

II. External Addition (Extra granular)

III. Partly Internal and External

DISINTEGRATION MECHANISM

1

DISINTEGRATION MECHANISM

2

4

1.WATER WICKING

• Eg. sodium starch glycolate & crospovidone

• Washburn equation:

L2= [yCOSθ/2n] rt

2.SWELLING• A superstructure (matrix) is

required against which the disintegrant swells that leads to development of swelling force

• Dependence on PH of media

3.DEFORMATION RECOVERY

Eg. Crospovidone, starch

4.REPULSION THEORY

5.HEAT OF WETTING:

Particles exhibit slight exothermic properties during wetting, which cause localized stress resulting from the expansion of air retained in the tablet matrix.

DESCRIPTION OF SUPERDISINTEGRANT

1) SODIUM STARCH GLYCOLATE

• Non proprietary name BP: Sodium Starch Glycolate. USP: Sodium Starch Glycolate.

• Functional category: Tablet and capsule disintegrant.

• Description: it is a white to off-white, odorless, tasteless, free-flowing powder. It consists of oval or spherical granules.

• Method of Manufacture

2) CARBOXYMETHYLCELLULOSE

SODIUM

• Nonproprietary names BP: Carmellose sodium. USP: Carboxymethylcellulose

sodium.

Structural formula

• Functional category Tablet and capsule disintegrant;

tablet binder; stabilizing agent; suspending agent; viscosity-increasing agent; water absorbing agent.

• Description: it occurs as a white to almost white colored, odorless, granular powder.

• Method of Manufacture

3) CROSPOVIDONE • Nonproprietary Names BP: Crospovidone. USP: Crospovidone.• Structural formula (C6H9NO)x• Functional category Tablet disintegrant.• Description: it is a white to creamy-

white, finely divided, free flowing, practically tasteless, odorless hygroscopic powder.

• Method of Manufacture

4) ALGINIC ACID

• Nonproprietary names BP: Alginic acid USPNF: Alginic acid

• Structural formula: (C6H8O6)n

• Functional category– Stabilizing agent; suspending agent;

tablet binder; tablet disintegrant.

• Description: it is a tasteless, practically odorless, white to yellowish-white, fibrous powder.

• Method of Manufacture

FACTOR AFFECTING DISINTEGRANT ACTIVITY

• PARTICLE SIZE

• MOLECULAR STRUCTURE

• EFFECT OF COMPRESSION FORCE

• MATRIX SOLUBILITY

• INCORPORATION IN GRANULATION

• INCORPORATION IN HARD GELATIN CAPSULES

• EFFECT OF REWORKING

COMPANIES MANUFACTURING SUPERDISINTEGRANTS

PRODUCTS

• JRS SUPERDISINTEGRANTS EXPLOTAB® VIVASTAR® VIVASOL® EMCOSOY® SATIALGINE H8®

ROQUETTE SUPERDISINTEGRANTS GLYCOLYS

CONCLUSIONThe development of fast disintegrating tablets provides an opportunity to take an account of tablet disintegrant. Therefore, there is a huge potential for the evaluation of new disintegrant or modification of an existing disintegrant into superdisintegrants, so as to formulate fast dissolving dosage form