Tableting technology

TABLETING TECHNOLOGY

Presented By:Amit Kumar kundu : 113-29-320

Lubricants

Lubricants- prevent adhesion of the tablet material to

the surface of the dies and punches, reduce interparticle

friction, facilitate an easy ejection of tablets from the die

cavity and improves rate of flow of tablet granulation.

Eg. Talc, magnesium stearate, calcium stearate, stearic

acid, hydrogenated vegetable oil and PEG.

The quantity of lubricant significantly varies from 0.1 to

5%.

List of Lubricants

Lubricants Conc. Comments

Stearates(Magnesium Stearate, Calcium Stearate, Sodium stearate)

0.25 -1 Reduce tablet strength; prolong disintegration; widely used.

Talc 1 -2 Insoluble but not hydrophobic; moderately effective.

Glyceryl behapate (Compritol®888)

1 - 5 Both lubricant and binder;

Glidants

Glidant-

Improves the flow characteristics of a powder mixture.

Always added in the dry state just prior to compression.

Eg. colloidal silicon dioxide and asbestos free talc etc.

They are used in concentration less than 1%.

Talc is also used and may serve the dual purpose of

lubricant/glidant.

Glidants Range

Colloidal silica i.e. syloid, pyrogenic silica 0.25%

Hydrated sodium silioaluminate 0.75%

List of Glidants

Rotary Tablet Machines

Main Part of Rotary Tablet Machines

•Feeder•Weight Cam•Precompression Roll•Compression Roll•Ejection Cam

Rotary Tablet Machines

Tablet making process:

Active pharmaceutical ingredient(API) + Intragranular disintegrating agent.

mixing

Then addition of binder to the power mixture to form wet mass.

Binder containing3-5% starch in H2O

After that the wet mass is passed through the particular mesh by sieving process to break up the larger particle in to smaller.

Fig: sieve & mesh

The granules are then dried in fluid bed dryer, keeping granules little moisture for better compression.

Tablet making process:

Then the granules along with disintegrating agent (extragranular), Lubricant & Glidants are put in to the hopper.

At last granules placed in to the die. And following the process....

Tablet making process:

Finally we get tablets.

Tablet making process:

Tablet Compression Tooling Standards

There are two main standards:

a) B-tooling B-tools subcategories with – EU19 (Europe) TSM 19 (USA/Japan)

b) D-Tooling D-tools subcategories with – EU1 (Europe) TSM 1 (USA/Japan)

Fig. Standard sizes of B- and D-tooling

Comparison between B-tooling and D-tooling

1) B-tools subcategories with EU19, TSM 19And D-tools subcategories with EU1, TSM 1

2) D-tooling is thicker than B-tooling

3) European toolings (both B- and D-types) are longer compared to TSM (USA/Japan) types.

Process Related Problems

The defects related to Tableting Process are as follows:i) CAPPINGii) LAMINATIONiii) CRACKING

i) CAPPING‘Capping’ is the term used, when the upper or lower segment of the tablet separates horizontally, either partially or completely from the main body of a tablet and comes off as a cap, during ejection from the tablet press, or during subsequent handling.

Reason: Capping is usually due to the air–entrapment in a compact during compression, and subsequent expansion of tablet on ejection of a tablet from a die.

ii) LAMINATIONSeparation of a tablet into two or more distinct horizontal layers.

Reason:Air–entrapment during compression and

subsequent release on ejection.The condition is exaggerated by higher speed

of turret.

iii) CRACKINGSmall, fine cracks observed on the upper and lower central surface of tablets, or very rarely on the sidewall are referred to as ‘Cracks’

Reason: It is observed as a result of rapid expansion of tablets, especially when deep concave punches are used.

Thanks To All