10

com

mercially availab

le tablets

Equ

ipm

ent &

Mach

ines U

sed

Tablet D

efects

A tablet is a pharmaceutical dosage form. It comprises a mixture of active substances

and excipients, usually in powder form, pressed or compacted from a powder into a solid

dose. The excipients can include diluents, binders or granulating agents, glidants and lub-

ricants to ensure efficient tableting; disintegrants to promote tablet break-up in the di-

gestive tract; sweeteners or flavours to enhance taste; and pigments to make the tablets

visually attractive. A polymer coating is often applied to make the tablet smoother and

easier to swallow, to control the release rate of the active ingredient, to make it more

resistant to the environment or to enhance the tablet's appearance.

The compressed tablet is the most popular dosage form in use today. About two-thirds of

all prescriptions are dispensed as solid dosage forms, and half of these are compressed

tablets. A tablet can be formulated to deliver an accurate dosage to a specific site; it is

usually taken orally, but can be administered sublingually, buc-

cally, rectally or intravaginally. The tablet is just one of the many forms that an oral drug

can take such as syrups, elixirs, suspensions, and emulsions. Medicinal tablets were orig-

inally made in the shape of a disk of whatever color their components determined, but

are now made in many shapes and colors to help distinguish different medicines. Tablets

are often stamped with symbols, letters, and numbers, which enable them to be identi-

fied. Sizes of tablets to be swallowed range from a few millimeters to about a centimeter.

Some tablets are in the shape of capsules, and are called "caplets". Other products are

manufactured in the form of tablets which are designed to dissolve or disintegrate.

Part I: 10 commercially

available tablets

BUCCAL TABLET

SU

BLING

UAL TABLET

1

2

EXCIPIENTS & use

Mannitol - Sweeting agent

Sodium starch glycolate - Disintergrant

Potassium bicarbonate - Buffering agent

Magnesium stearate - Diluent

Magnesium stearate- Diluent

Sodium citrate - Alkalizing agent, buff-

ering agent, emulsifier, or sequester-

ing agent

Povidone - Synthetic polymer

Citric acid, anhydrous - pH regulator

Starch, pregelatinised (maize)

- Disintegrant and Binder

Lactose monohydrate - Diluent

Sunset yellow (E110)

Crospovidone

Mannitol - Sweeting agent

EXCIPIENTS & use

INS

TANT-RELEAS

E TABLET

IMM

EDIATE

RELEASE TABLET

3

4

EXCIPIENTS & use

Citric acid - pH regulator

Gelatin - Binder

Mannitol - Sweeting agent

Mint flavour - Flavoring agent

Calcium phosphate - Diluent

Colloidal silicon dioxide - Anti-Caking

agent, Adsorbent, Disintegrant

Iron oxides - Coloring agent

Magnesium stearate - Diluent

Microcrystalline cellulose - Suspending agent

Polyethylene glycol - Plasticizer

Povidone - Synthetic polymer

Sodium starch glycolate - Disintegrant

Maize starch - Binder

Sucrose - Sweeting agent

Talc - Lubricant

EXCIPIENTS & use

MU

LTIPLY CO

MPRES

SED TABLET

CHEW

ABLE TABLET

5

6

EXCIPIENTS & use

Cellulose-Microcrystalline - Suspending agent

Magnesium Stearate - Diluent

Silica-Colloidal Anhydrous - Anticaking agent

Starch-Pregelatinised Maize - Binder

Mannitols- sweetener

polyvinyl alcohol- binders.

EFFERVESCEN

T TABLET

FILM CO

ATED TABLET

7

8

NON-AQUEOUS

* film former- cellulose acetate, phthalate

* alloying substance- polyethylene glycol

*plasticizer castor oil

* surfactant- polyoxyethylene sorbitan derivatives

* opaquants and colorants opaquant, titanium dioxide,

colorant, FD & C o D& C dyes

* sweeteners, flavors and aromas sweeteners, saccha-

rin, flavors and aromas, vanillin

* glossants beeswax

* volatile solvents- alcohol mixed with acetone

AQUEOUS

*film forming polymer- cellulose ether polymers

such as hydroxypropylmethylcellulose, hydroxy-

propylcellulose and methylcellulose

* plasticizers glyrcerin, PEG, propylene glycol,

diethyl phthalate and dibutyl subacetate

* colorant and opacifier- FD & C or D& C lakes, iron

oxide pigments

EXCIPIENTS & use

polyvinyl alcohol- binders.

Sodium bicarbonate-base

dextrose, sorbitol, xyitol, and lactose binders

acesulfame potassium, sodium saccharin, aspartame

sweeteners

EXCIPIENTS & use

ENTERIC CO

ATED TABLET

SU

GAR CO

ATED TABLET

9

10

EXCIPIENTS & use

Cellulose acetate phthalate, Shellac (35% in alcohol, phar-

maceutical glaze) enteric coating

EXCIPIENTS & use

Sugar Coating - Liquid glucose and Sucrose

Xylitol- sweetener

Part II: Equipment &

machines used

Impact Mill Particles are reduced in size by high-speed me-

chanical impact or impact with other particles; Im-

pact mill are primarily are distinguished from one

another by the configuration of the grinding

heads, chamber grinding liners

Cutting mill

Although cutting mills may differ from one

another in whether the knives are movable

or fixed and in the classifier configuration

Tumbling mill

Particles are reduced in size by attrition utiliz-

ing grinding media. Tumbling mill primarily

are distinguished from one another by the

grinding media used and by whether the mill

is vibrated.

PA

RT

ICL

E S

IZE

RE

DU

CT

ION

/S

EP

AR

AT

ION

Fluid Energy Mill

Particles are reduced in size as a result of

high-speed particle-toparticle impact and/

or attrition; also known as micronizing

GR

AN

UL

AT

OR

S

Fluidized bed spray granulator

The unit is same as fluidized bed dryer. When the

unit is used as granulator the dry ingredients are placed in the

chamber and fluidized while the granulating liquid is sprayed

into the bed causing the particles agglomerate into granules.

Nauta Mixer Processor

A screw assembly is mounted in a conical chamber within the

screw lifting the powder from bottom to top. The screw assem-

bly orbits around the conical chamber wall to ensure more uni-

form mixing. The operation is power mixing with incorporation

of the liquid granulating agents, wet massing and drying as hot,

dry air is passed through the wet materials.

Double cone mixer dryer processor

This is modified double cone blender used to

perform operation mixing, wet massing, agglomeration and

drying. Liquid feed system is through the trunion of the ma-

chine and sprayed. Vacuum system is through same or oppo-

site trunion providing a nilon filter. Agitators rotate within the

powder

mix

er

s

Sigma blade mixer

Sigma type blades are rotates in same di-

rection along horizontal axis. Suitable for

powder, semisolid material

Ribbon mixer

Two spiral ribbons are fixed on a horizontal

shaft, which rotates the ribbon. The bend-

ing of the ribbon is such that two ribbons

move materials in two opposite direction

and promote uniform mixing.

High-speed chopper blade mixer

The mixer consists of a bowl mounted in

vertical position. A high-speed mixer blade

revolves around the bottom of the bowl.

The mixer also contains a high-speed chop-

per blade which functions as lump or ag-

glomerate breaker.

Ta

bl

et

dr

ye

rs

Fluidized bed dryer

In FBD, the fluidizing air stream is introduced by a fan or blower mounted in at

the top of the apparatus. The air is heated to the required

temperature in an air heater and flows upward through the wet materials,

which contained in a drying chamber fitted with a wire mesh supported at the

bottom

Tray dryer

Also called shelf, cabinet or compartment dryer.

Area of each tray: 4 to 8 sq.ft.

Load thickness: 0.5 4 inches.

Capacity: 500-2000lb/batch

Ta

bl

et

co

mp

re

ss

ion

ma

ch

ine

Intelligent Press Tablet Machine A compact, intelligent rotary tablet press, suitable for the small-

size production of tablets in the medicine R&D center and labora-

tories in the pharmaceutical industry. It has double-pressing func-

tion (pre-pressing and main-pressing). Utilize the variable frequen-

cy stepless speed control device, easy to operate safe and reliable.

The four sides of tablet pressing chamber are made of trans-

parent organic glass, and openable completely, easy

to clean the inside and maintain.

Single Punch Tablet Press

Single punch machine all of the compres-

sion is applied by the upper punch, making

the single punch machine a stamping press

Rotary die tablet machine

Multi station presses are termed rotary because

the head of the tablet machine that holds the up-

per punches, dies, and lower punches in place ro-

tates. As their head rotates, the punches are guid-

ed up and down by fixed cam tracks, which control

the sequence of filling, compression and ejection.

Ta

bl

et

co

at

ing

Tablet coater

High efficiency coater is mainly used for tablet and candy to carry out organic

thin film coating, water soluble thin film coating, sugar-coating and chocolate

in pharmaceutical and foodstuff industry. It is electromechanical integration

coating equipment and conforms to the requirement of cGMP Information:

Peristaltic pump with constant pressure variable, eliminate reflux pipe.

Tablet coating pan

The tablets are tumbled in a bowl or pan which rotates about an axis

inclined about 30C to the horizontal. With the correct pan load a three

dimensional circulation is established and sufficient coating solution is added to wet

the tablet surfaces. Hand manipulation of the wetted tablets ensures

Part III: Tablet defects

Ahesion of the tablet granulation onto the die wall

Always occurs in low melting point substances, and moisture

supports this defects, lower the speed up of upper and lower

punch leads to weight variation of tablets.

Solution: selection of lubricant in desired proportion will mini-

Is the separation of the tablet into two or more distinct layers.

Occur upon storage period, or soon after compression. Air en-

trapment between layers of tablet.

Solution: Change the method of granulation. By direct compres-

sion technique it is prevented to some extent.

An expression that describes the partial or complete separation

of the top or bottom of the tablet from the main body.

Solution: Capping minimized by keeping the feed material with

cohesive nature.

Refers to the removal of the material from the surface of the

tablet, and its adherence to the face of the punch

Solution: Use higraded dies and punches. Avoid wet granules.

Is An unequal distribution of color on the surface of the tablet,

with light or dark areas standing out in an otherwise uniform

surface. The incorporation/addition of different excipients with

dividing colors is main factor .At high temperature dyes are easi-

ly migrate to surface and spread to upper surface.

Is due to unsatisfactactory granulation granulation.

Improper blending of granules. Lack of sufficient of lubricant .

lImproper drying making tablet with different weight.

The removal of the edges of the tablet. This defects accompa-

nied with damaged surfaces at its corners of tablet ,easily frag-

mented by even smooth handling also.

Solution: Use optimum level of binding agent.

Has the same causes as Tablet weight varation tablet. Hardness

depends on the weight/density of the material & spaces be-

tween te upper and lower punches at the time of compression.

If the volume of the material varies, or the distance between

the punches varies, tablet hardness is inconsistent

Wherein the monogram or design of the impressed on the low-

er punch can be seen imprinted again during the rotation of the

punch ; upon ejection of the tablets

Roughness of the tablet surface due to failure of spray droplets

to coalesce.

This can be the result of soft or friable tablets (and the pan turn-

ing too fast), an over-wetted tablet surface, inadequate drying,

or lack of tablet surface strength.

Filling in of the score line or indented logo on the tablet by the film

Appearance of larger amounts of film fragments flaking from

the tablets surface

Disintegration time is extended in tablet. Use of high compres-

sion on punches. Incorporation of lubricant in excess quantity.

Overcome by using proper suitable surfactant concentration.

Addition of more concentration of binding agent. Too low com-

pression also favors extend disintegration time.

The Heirs Pharmaceutical Laboratory

Centro Escolar University

Mendiola, Manila

Doculan, Gladys10 commercially available

Espiritu, Criscelle10 commercially available

Florencondia, JeanEquipment & Machines

Grepo, Franchesca Layout & cover, Tablet defects

Jamabalos, KatrinaEquipment & Machines

BSP3D

Submitted To:

Mr. Denlo Asuncion

Pharmaceutics 2 Lecture