PHARMADEEP REMEDIES

111' Mgf of Pharmaceutical formulation s

TABLET SECTION
• Introduction
• Types of Tablets
• Excipients
• Tablets Production
• Tablets Compression
• Tablets Coating
• Quality Control
 INTRODUCTION
medicaments or medicaments, usuaJJy
Tabl ets are the solid dosa ge form containing
circu lar in shap e and may be fla t or bicon vex.
od and are hence called the "Com pressed
Tablets are usual ly prepa red by compression meth

Table ts"
Advantag es of tablets
I. Table ts are easy to admin ister.
2. Easy to D ispen se and Economical dosage form.
3. Thes e are th e most stable dosage forms .
4. They main tain the accuracy of dosag e.
easily in tab let fo rm after givin g a
5. Bitte r and nauseous substances can be given
suitab le coating to the tablets.
e forms.
6. They lightest and the most comp act of all the dosag
and cheapest regarding pack ing and
7. Of al l the dosage form Lab lels arc easiest
transport.
as compared with any other unit oral
8. They are bette r suited to a large scale production
dosage form .
mo is ture content.
9. They have a longer expiry period due to lower
Jo. They are more temper proof in comparison lo capsules.
Disadvantages of tablets
 their amorphous natu re or low
1. Some dnrgs res ist compress ion into tab let form due to
density character.
or drugs that arc sens iti ve to
2. Bitter tasti ng drugs, drn gs with objec ti onab le odor
ati on or a special type of
oxygen or atmos pheri c moisture may req uire encap sul
coaling which may increa se the cost of fini shed tabl ets.
3. Dnrgs with poor wetti ng and slow dissolution prope
rties are diffic ult to convert into

tablets which provi de full drug bioav ailability.

se of the slow rate of drug
4. The tablets cannot be used in emergency cases becau
release.
5. Bioav ailabili ty of some drugs may be low due to
poor absorption from the gastri c

tract.
.
6. It is probl emati c in elderly and children during swallowing

TYPE S OF TABLETS
(a) Tabl ets inges ted oraJJy:
I. Com press ed tablets
2. Multiple compressed tablets
3. Enteric coated tablets
4. Sugar coated tablets
5. Film coated tablets
6. Chewable ta bl ets
(b) Tablets used in the oral cavities:
I. Bucc al Tablets
2. Sublingual tablets
3. Lozenges
4. Dental cones
(c) Tabl ets admi niste red by other roulc s:
I. Impl antation tablets
2. Vaginal tablets
(d) Tabl ets used to prepa re solu tions:
1. Effervescent tab lets
2. Dispensing ta bl ets
3. Hypodermic tablet s
 4. Tablet tri turatcs

(a) TABL ETS ING ES TE D ORA LLY

l. CO MP RES SED TA BLE TS
pression and , in their
Com pres sed tablets arc fo rm ed by com
ing. They are made
sim p lest fo nn, con tain no special coat
materials, alone or
fi-om pow dered, crys ta lline, or granular
ntegrants, controlled-
m com bi-n ation with binders, disi
, and , in many cases,
rele ase pol yme rs, lubricants, diluents
ets commercialized
colo rant s. The vast majority of tabl
er in an uncoated or
today are com pres sed tablets, eith
coa ted state.

LETS
2. MU LTI PLE COMPRESSED TAB
tablets made by
Mu l ti-c omp ress ed tablets are compressed
This process is best
mor e than one com pres sion cycle.
edients is needed for
use d whe n separation of active ingr
ess is inadequate to
stab ility pur pos es or if the mixing proc
two or more active
gua rantee uniform distribution of

ingr edie nts.

3. EN T ERIC COATED TABLETS

st solu tion in
tablets coated with sub stan ces that resi
Ent eric -coa ted tablets are compressed
fo r tabl ets
intestine. Ente ric coatings can be used
gas tri c fl uid but disinteg rate in the
drug substances
containing
inactiva ted or destroyed in the
stom ach , for thos e that irritate the
muc osa , or as a means of delayed
release of the med icat ion. Core Enterlc coating

►'lg, 2; ~:1,1eri1• co111i11g or lahlel

4. SUGAR
COATE D
 '

,.~~
TABLETS
. Such coatings
Sugar-c oated tablets are compressed tablets surrounded by a sugar coating
ing objectio nable
may be colored and [Link] benefic ial in coverin g up drug substances possess
s were once
tastes or odors and in protecting materi als sensitive to oxidation. TIJese coating
validation.
quite commo n, but lost commercial appeal due to the high cost of process
l advan ces.
Recently, they have made a comeback, due to patient popularity and technica
5. FILM COATED TABLETS
of a water-s olubl e
Film-co ated tabl ets [Link] compressed tablets covered with a thin layer or film
be used. Film
material. A number of polymeric substances with film -formin g properties may
advanta ge of
coating imparts the same general characte ristics as sugar coating with the added
the greatly reduced time required for the coating operation .

Fdm coating composition

Sproy/ Atom~tion
O wetting even film
f) Spreading
•••••• o ~ Film adhesion

Toblet core rilm-toated [Link]

6. CHEWABLE TABLETS
These are the tablets which arc required to be broken
and chewed in between the teeth before ingestion. These
tablets are given to the children who have difficulty in
 .
sw all ow ing a nd to the adu lts wh o dis like sw all ow111g . These tab lets should have very
acc cpt ahl c tas te d fl lets (o 1·g1·ene) .
· an avo ur. Ex- An tacid tab
b
CAVI TY :
( ) TABLETS USE D fN ORAL
1. BUCC AL TABL ETS
.
These ta ble ts are t 0 be placed m tJ1e sid e of the
ere they dis sol ve or
che ck (bu cca l pou c h) wh
ero de slo wl ·v and are a bsor bed dir ect ly in
cav ity wi tho ut .
pas s ing into the
bu cca l
ali me nta ry can al.
are formulated and
Therefore. the y
t pre ssu re to giv e a
com pre ssed wi th suf fic ien
on e tablets .
ha rd tab let. e.g. Pro ges ter

E TS
2. SU BL IN GU AL TABL
pla ced und er the tongue
Th ese tab let s are to be
int egr ate qui ckl y and are
wh ere th ey dis sol ve or dis
pas sin g into GTT. e.g.
abs orb ed di rec tly wi tho ut

tab let s of
hyd roc hlo rid e or
nit rog lyc eri n, iso pro ter eno l

ery thr ito l tet ran itra te.

3. LO ZE NG ES
e
to exe rt a local effect in th
Th ese tab let s are des ign ed
lets are com mo nly used to
mo uth or thr oat . Th ese tab
d.
l cou gh ing in com mo n col
tre at sor e thr oat to con tro
Th ey ma y con tai n loc
al ane sth etics, antisepti
cs,
ltlll~~· - -- -1-,ls
---
f
- ·cofs
:)~;=--~
rin gen ts. -~T ·-::- )I
.
o

ant iba cterial age nts and ast -._,. _- ~

pre ssion at a hjgh pressure

• Th ese are pre par ed by com
a
s and gen era lly con tain
by the mo ldi ng pro ces

g age nt a11d
sw eet eni ng age nt, fl avo rin
a substa nce wh ich pro duc
es a coo lin g
I~ l',\H \~I lf1H 'l't111 ~
" r Grnta

Str eps ils.

eff ect . e.g . Vic ks loz eng es,
p ·. , •
·• i,,\f 1HB l,11,,

4. DENTAL CONE S
 after tooth extraction.
Tiicsc arc compressed tablets meant fo r place ment in lhc empty sockets
such extract ion by using
They preven t the multiplicatio n of bacteri a in the socket fo llowing
slow-releasi ng astri ngent.
nate and sodium chloride.
These tablets contain an excipient like lactose , sodi um bicarbo
TI1csc cones genera lly get dissolv ed in 20 to 40 minutes.

(c) TAB LETS ADMINISTERED BY OTHER ROUTES:

1. lMPLANT ATION TABLETS
ly by means of minor
• These tablets are placed under th e skin or inserted subcutaneous
by heavy compressi on but
surgic al operation and are slowly absorbed. These may be made
be packed indi viduall y
are norma lly made by fu sion . The implan ts must be sterile and should
honn ones such as
in steri le condi tion . Implants are mainly used for the admini stration of
y exploited for birth
testosterone steroid s for contraception . These tablets are very usefull
control purpos e in human beings.
ng rate of release with
• The d isadvantages of implant tablets are their admini stration , changi
change of surface area and possibility of tissue reactions.

CLARINEX'
Red11abs'
{~rt5 m}i® -~•w. :~•
,.

2. VAGINAL TABLETS
• These tablets are mean t t.o dissolve
slowly in the vagina l cavity. The tablets GYNO-TIOCOSIDs
TIOCONAZOI.E
O
100 mg
are typical ly ovoid or pear shaped for th e 3 Comprlmts vaglnakls /

ease of insertion . these tablets are used 1

• 1
aktarin «:Omg I Myco
,Gyno-O
®
to release steroids or antimicrobial , .. ten
agents . the tablets are often buffered to
1
p ·~·-,~
[Link]
..... ,._,.,...
1'°'1\v

promo te a pH favorable to the action of a

like lactose or sodium
specified antimicrobia l agent. The contains easily solub le components

bicarbonate.

(d) TAB LETS USER TO PREPARE SOLU TION S:

 I . EFFERVESCENT TAB LETS
simultaneous release
Fffel"\csccnt tablets arc designed to produce a sol ution rapidly with the
the active ingredien ts
of carhon dto\ idc. TI1e tablets arc typical ly prepared by compressi ng
sodi um bicarbonate.
with nm. tures of orgam c acids- such as ci tric acid or tartaric acid- and
n is initiated between
When such a ta blet 1s dropped into a glass of water, a chemi cal reactio
acid, and to produce
the acid and the sodium bicarbonate to fo rm the sodium salt of the
compl eted within one
carbon dioxide and water. The reaction is quite rapid and is usually
solutions, such tablets
mmute or less. In addfrio n to having the capabili ty of produc ing clear
in masking the taste of
also produce a pleasa ntly fl avored carbonated drink, which assists
Th e most widely produced efferve scent tabl et today
certain drugs .

"' ... ·

2. DISPENSING TABLE TS
• These tablets provide a convenient quantity of potent
drug that can be readily convert into powders and
incorporate into liquids , thus circumventing the necessity
to weigh small quantities. these tablets are supplied
·ence for extemporaneous
primarily as a conven l
compounding and should never be dispensed as dosage

form .
• e.g. The drugs commonly incorpo rated are mild silver
. bi·chJoride of mercury merbrom in an
potenttate,
quaternary ammonium compounds.

3. HYPO DERMIC TABLETS

were used for the
• Hypodermic tablets are soft, readily soluble ta blets and originally
. f t· to be inicctcd. These lablcls arc disso lved in steri le water or water for
preparat10n o so 1u 10ns :.i
-days
. . . d dm . · t ed by parenteral route. These tab lets are nol preferred now-a
mJect10n an a rn1s er
because the resulting solution is nol always sterile.
•
ta
r.
f.l
i.
II
II
II

,• 4. TA BL E T TRJTUR
ATES

lde d into tablets. They

are flat,

• • Th es e ar e po wd ers mo
usu aIJ y co nta ini ng a potent
subs tance

• cir cu lar dis cs ,

ose, or
d wi th lac tos e, lac tos e and sucrose, dextr
mi xe

• ot he r su ita bl e di lu en t

•
ly in
e the y ar e int en de d to disintegrate very quick
• Si nc
cts are
, wa ter ins oluble adjun
t co nt ac t wi th rno isr ure
propriate
' tablet triturate ' is ap
av oid ed . Th e na me
• be ca us e th ey us uall y
co nta in trituration s (tr
ituratio n =

• dil uti on wi th an ine rt su

bs tan ce) .

•
I
• E X C IP IE N T S/A DDIT
1n ad dit ion to ac tiv e
IVES
ing red ien ts, tab let s co nta in a numb er of inert ma
terials known as

• ad dit ive s or ex cip ien ts.

D ifferen t ex cipients are
ma ke
:
the req uir ed bulk of the tablet when
the drug

• fill ers us ed to
1) Diluen ts: D ilu en ts are hesion, to permit use
to pr od uc e the bu lk. Al so used to improve co
ate
do sa ge its elf is ina de qu

,' of dir ec t co mp res sion .

Example : La cto se , starch
, ma nn ito l , ca lci um ca rbo na te and dicalc ium phosph

for a direc tl y compresse

d tab let.
ate .

,, siv e co mp ac ts
~ 2) Bind ers: to for m co he
acia, gentian .
Example : Tr ag ac an th , ac he sion of lhe table! mater
ial s to the
de d Lo pr ev en t ad
nts arc inten
3) Lu bricants: Lu br ica lhe rute of flow of

, su rfa ce of die s an d pu nc
the tab let gr an ula tio n.
he s, reduce inter particle
ction and may improve
fri

Talc
arate, ca lci wn stearate,
~ Ex am pl e: M ag nesium ste
ote flo w of granules or powd
er material by
are int en de d to pr om
4) Glidants: Gl ida nts
,
~
red uc ing the friction be
twee n the particles.

,
•
t Emm· ple ·
· Magncsmm· stearatc , calc ium slcaratc.

•• S) Anti- adh erents : Anti -adherents are

added to the tablet formulations to prev

mat erial from sticking to the wall s of the tab

let press.
en t the

t• Exa mple Ta lc, metallic stearate .

6
) Disin tegrates ; Added to a tablet
when it contacts water in the GIT.
fonnu lati on to faci li tate its brea king or disi
nteg ration

• Exa mple: Maize starch, potato starc h, cros

pov idon e

• 7) Col orin g Age nts: The use of co lors

and dyes in a tablet has three purposes:

•t (A) Mask.i ng of off color drugs

(B) Product Iden tifi cation
(C) Producti on of a more eleg ant product.
t

,•
Col ora nts Common Nam e

Brilliant blue

, FDC Blu e # I
FDC Blu e #2 Indigo tine

, FDC Red #3 Erythromycin

, FDC Yell ow #5 Tartrazine

, FDC Yell ow #6
8) Flav orin g Agents: Flavoring oils are
Sunset yellow
needed for chewable tablets. The oil is gene
lets.
raIJy

added in a dry form such as spray-dried bead

-
t
Exa mpl e: Peppermint oil, mango flavor,
fruit flavor, chocolate flavor and vanilla flav
ts in a tablet formulation is necessary if the
or.
product
9) Abs orbents: The inclu sion of absorben
render
t to water. Hygroscopic materials, if pres ent,
contains a substance with a high affinity

•
~
the blend wet and difficult to handl e during
Examp le: Kaolin; Magnesi um Alumi num
manufacture.
Silicate; Tricalcium Phosphate
olved in
10) Swe eten ing Agents: The y are adde
d to tablets, which are required to be diss
• buccal cavi ty and to mask the unpl easant or
bitter taste of the drug .

• Exa mple: Lactose , sucrose, sacchari n, and

cyclamates .

• TABLETS PRODUCTION
• Compressed tablets are man ufac ture d by the
fo llowing two methods:

• I . Dry method
• (a) Dire ct com pres sion

'• (b) Slugging or double compression

2. Wet method

'
•~
I
•~ DRY METHOD
• Direct compression : Most manufacturers agree that direct compression is superior with few
• steps since it docs not require much equipment and handling ex penses as requi red fo r wet
method of tablet manufac ture. The medicaments with large doses having good bulk density,
• flowability and compressibility can be directly compressed.
•-
There are few crystall ine substances such as inorgani c salts (e.g. NaCl , KC!, and [Link]), which
may be compressed directl y with very few additives such as lubricants and glidants. However,
sometimes these compressed tabl ets may not disintegrate in the given time limit, and hence,
-
,•
substances such as disintegrating agents are added.
Slugging or double compression: Thi s method is used for those drugs, which are sensitive to
, heat, moisture, or both. This method is also called as granulation by compression or double
, compression method . The various process steps involved are as follows :
, 1. Size reduction: In this step, the size of the drug is reduced and passed through sifter to get
, the desired particle size of the drug.
2. Mixing: In this step, drug along with additives that are compressible like dicalciurn
phosphate granules, which are prepared previously are mixed along with glidant and lubricant
,• and punched or compressed into compact masses called slugs by using flat punches using
, high compression force using multi-station tablet compression machine.
3. Milling: In this step, slugs are size reduced by using multi mill and passed through sifter to
• get the desired granules.
4. Blending: The obtained granules are then blended with additives such as disintegrating
• agents, lubricants and glidants for sufficient period of time using double cone blender.
•
•
• cf
•
•t
•
I
~
~ 5. Compression: TIile lubricated granules are finally compressed into tablets of desired
weight, hardness, and thickness using multi station lablet compression machine.
WET METHOD
The various process steps involved in wet method are as follows :
 sieve number such
I. Sifting/millin g: Wei ghed ingredients are passed through th e desi red
that the drug and the addi tives are of un ifo rm size an d shape.
dis integrating
2. Dry mixing: fn th is process, the drug along w ith add itives such as dil uents,
and color lakes if
agents (half the weighed quanti ty as intragranul ar disi ntegrating agent),
me.
present in the formu lae are mixed in a suitable mi xer for a predetermined ti
I
/fl .,~ I
-~
• ' ------
•
•
IJ
..
3. Granulat ion : In thi s stage, the powder mi xture is converted into granules
by adding binder
• in form of solution and mixed for suitabl e time period to get a coherent mass
or dough mass.
• The concentra tion of binder and amount of solution added should be optimized
; otherwi se,
• the granul es obtained may contain large amou11ts of fines and may be
concentra tion of binder or with excess binder the granules obtained may

fragile with less

be very hard and
compression and
sometim es sticky in nature, whi ch may impose problems during
t disintegration .
4. Wet sifting: The dough mass or coherent mass obtained is then passed through
a specified
~ sieve to get the desired size wet granules. The sieve number is usuall y selected
based on the
mg of the tablet
weight of the tablet to be com pressed. For examp le, for wei ghts above 500
•~ weight, the sieve no. selected can be 12, fo r weights between 200-400
selected can be 16.

mg, the sieve no.

ined period of
r 5. Dryi ng: Wet granules obtained were dried in a suitable dryer for a predeterm
time and temperatu re to get the dried granules wi th the required moi sture content.
to get the
6. Regra nulation: Dried granules are then passed through desired sieve number
granules as per requirement.
 ,I
a
I
r-
~ 7. Blending: In this stage, granul es arc trans ferred into a
~ suitable blender such as double cone blender, V-cone
~
blender. and other additives such as lubricants, glidants,
anti-adherents and remaining quantity of disintegrating
ra agents (intergranular disi ntegrati ng agent) were added and ~
~ mixed for a suitable time period.
~
~
8. Compression: Tbe blended granules should be carefu ll y
handled and tbe granules are compressed into tab lets with
predetermined wei ght, hardness and thickness using suitable
ia
,I
punches and dies in a multi-station tab let compression
~ machine.
~
~
~ TABLETS COMPRESSION
~
~ Basic Component of Compression Machine
,
Head- Contain upper puncbs, dies, lower punchs.
~ )
Body- Contain operating machinaries.
Hopper- Holding feeding granules. I
~ Dies- Define size, shape of tablet. I
• Punches - For compression with in di es.
,:I;,.
,~ Cam [Link] - Guidi ng the movement of punches.
Feed fram e- Guiding the granul es from hopper to di es.
~ -
~
U pper turret- Holds th e upper punches.
Low er turret- Hold the lower punches.
~
, 1 Die table- Contain the di es.
Working Princi ple of Compression Machine:
ti
,
1. Filling and Dosing of the Oles
~
,,
:4'
,,
,,
•
-a
•
•t Yr ;~"
-·. --I
~,o-~
~
~: ··,
l
bf ◄\'
• ~ -J' ,. ' ~, ~ ~ ' ...
►
•
~
The material to be pressed reaches the rotary or gravity feeder from the material supply. The
fill cam below the feeder pull s the lower punches down by a fixed amount and the dies are
fi ll ed with ma terial. The quantity of the materia l fill ed in is larger than the actual amount
• I
required i.e. excess dosin g is done. Thereafter, the dosing unit lifts the lower punches un ti l
► only
~
:,I 2. Compression of the Tablets
• After that, the upper cam course lowers the upper punch until the upper punches are inserted
into the dies. The lower punches are guided to the pre-compress ion cam. When the punches
pass the pre-compression cam, they are inserted a little more into the dies and the material is
pre-compressed and the slugs are formed . Thereafter, in the main compression roll er, the
tablets reach their final heiight and hardness.
3. Ejection and Exit of tbe Tablets
After the compression, thie upper cam course pulls the upper punches into their top position
and simultaneously the ejection device lifts the lower punches until the tablets are ejected
from the dies. The tablet stripping device strips the tablets off the lower punches and passes
them on to the discharge chute.
► TABLETS COATING
► Tablets are coaled for the foll owin g purposes ;
• I .To mask the unp lca.'ianl t1as te and odour.
• [Link] improve the appearance of tab lets.
• [Link] control the si te of ac tion o f drng&.
Types of Coating
- I .Sugar coali ng
' [Link] m coaling
'
'
[Link] coating
METHOD- PAN COATING
'
'
 /
In this technique the coating is done in a pan made up of copper on stainless steel. The pan is
rotated with the help of an electric motor. The tablets to be coated are placed in the pan. Hot
air is blown in. The speed of the pan is adjusted in such a way that the tablets remain
separated from each other in the pan . After coating, polishing is done in polishing pan.
QUALITY CONTROL TESTS FOR TABLETS
Tablets when formulated may undergo physical and chemical changes thereby altering the
bioavai labil ity of the dosage form. The manufactured tablet batches are to be evaluated before
dispensing to ascertain stability and bioavailability throughout its shelf Life.
Evaluation of tablets can be carried out by the following tests.
Unofficial Tests
Tablet appearance: The tablet appearance is considered as one of the most important factors
in evaluation based on th e consumer acceptance. It. also ensures whether the batch of tablets
produced has maintained un iformity in its elegance, which includes color, taste, presence of
flavor, identifying marks, surface texture.
Orgaooleptic parameters: The organoleptic parameters, which are considered in tablets,
mainly incl ude ils color, taste and odor.
1. Color of the tablet: The color distribution within the tablets should be uniform, and it
should not vary from one lot to another. Non-uniform distribution of color within a tablet is
known as mottling. Mottling should be avoided as it not only provides a poor appearance to
the tablet but also does not give a satisfactory look to the consumer.
•
2 Odor of the tablet: This helps to know whether the tablet has deteriorated thereby stabi lity
of the tablet is affected. For ex ample, Aspi ri n tab let- instab ili ty indi cated by a characteristic
aceti c acid odor.
T hickn ess of th e tablet: The thickn ess of the tabl et is influenced by the amoun t o f fill
material in the di e cavity , die di ameter and th e compaction fo rce appl ied. Thi ckness
spec1ficat10n is characteri sti c to each tablet product, but in general the tablet thickn ess is
requi red to be withi n ±5% of the prescri bed values.
Factors affecting tablet thickness
l . The tru e and bulk density and also the crystalline nature of the raw materi al influence tbe
--:
I

tablet thickness.
2. The particle size and size distribution of the granules affect the tabl et thickness.
•I
~.
3. Th e length of both upper and lower punches should be uniform , if not it affects th e tablet
thi ckness.
•I

Thickness of the tablet is evaluated by micrometer di gital readout sliding caliper scale
method.
• Hardness of the tablet: Tt is also termed as its crushing strength . It may be defined as the
compressional fo rce required to break or fracture the tablet when such force is appli ed
diametrically. It is influenced by three variables- bonding strength, internal strain and
brittleness. It is determined using the instrument Monsanto Hardness Tester or Pfizer
Hardness Tester, and expressed with the units kg/cm2.
~ ~
__...,,... f'-.:
Monsan to Hardness Tester Pfizer Hardness Tester
Official Tests
Friability test: Friab ility in additi on to hard ness gives the measure of tab let strength. Tt is
defi ned as its resistance to shock and abrasion encountered du ring the process of manufacture,
packing, transport and ultimately its usage.
Factors contributing to tablet friability are deep concave punches used during the compression
leading to formation of whiskered tablets, [Link] moisture content of the granules, over drying
of the granules, etc . It is determined using the instrument Roche friabilator, and the value is
calculated using the following equation:

. b.111ty
Fna . o/1 0 = -------==--------=--
Initial weight- Final weight I 00
x
Initial weight

The batch tablets pass the test for friability, if the value is less than 1.
Weight variation test: The average weight is determined by randomly selecting 20 tabl e ts
and w eighing them inclividually. Not more than two of the individual weights deviate from
the average weight by more than the percentage given in the pharmacopeia and none devi ates
by more th an twice that percentage. 1P limits for tablet weight variation are given as follow s:

IP/BP Limit
80 mg or less 10%
More than 80 mg and less than 250 mg 7 .5 %
250 mg or more 5%

Drug content: Thirty tab lels are selected randoml y. Ten of these tablets are assayed
individually. The tablet passes the test if 9 of the 10 tablets contain not less than 85% and not
more th an 115% of the labe led drug con ten t (± 15%) and the 10th tablet may not conta in less
than 75% and more than J25% of the labeled content (±25%). If these conditions are not met
,
then the remain ing 20 tabl ets arc assayed individually. The botch samp le complies w ith the
test if the drug content of not more than 3 in dividual tablets out of tb e total 30 sampled tablets
is outside the limits by ± 15% and none may fall outside of the limi ts of±25%.
Disintegration test: This method is used lo evaluate tJ1e rate of disintegration of SDF of
tablets. D isintegration is defined as the breakdown of SDF into smaJI particles after it is
ingested . The ti me of disintegration is a measure o r the quali ty. Ir the disintegration ti me is
too !ugh. it suggests that the tab let ts highl y comp ressed. Al so, if the disi ntegration time is not
umfom1 m a set of samples bei ng analyzed, it indicates batch inconsistency and lack o f batch
unifom11ty. The test is performed by random ly selecting six tablets using the instrument
Di sintegration Test Apparatus.

Some of the types of dosage fo rms and their disintegration tests are as follows :
1. Uncoated tablets: Tested usin g distilled water as medium at 37 ± 2 °C at 29- 32 cycles per
minute. The test is completed if all the tablets dis integrate within 15 minutes. It is acceptable
when there is no palpabl e core at th e end of the cycle and if the mass does not sti ck to the
immersion disc.
2 . Coated tablets: The test procedure given for uncoated tablets is adopted. For film coated
tablets, th e disintegration time limit is 30 minutes and for sugar coated tablets it is 60 minutes.
3. Enteric coated/Gastri c resistant tablets: The test is carried out first in 0. l M HCl (up to 2
hours during whi ch all the tablets should be completely intact foll owed by replacement with
phosphate buffer pH 6.8 for l hour during which the tablets should disintegrate .
Dissolution test: Dissoluti on is pharmaceutically defined as the rate of mass transfer from a
solid surface into the dissolution medium or solvent under standardized conditions of liquid or
solid interface, temperature and solvent composition . It is a dyn amic property that changes
with time and explains the process by which a homogenous mixture of a solid or a liquid can

be obtained in a
solvent.
Dissol ution test can be performed in two ways-in vitro, in vivo.
In vivo test is performed i.n selected ani mal and human subj ects (ex pensive and ti me

consumi ng).
In vitro test is performed using dissolution test apparatus (inexpensiv e and less time
consum ing).
Factors to be considered for design ing in vitro dissolution test are as follow s:
1. Factors rel ated to the dissolution apparatus
2. Factors related to disso lution fluid or medium
~ 1 nl ton. rclntNl to the test med ium
Dissolution test apparatus- ! (basket type): The sample which fl oats in th e lest medi a is
plnl'ed m a small "ire me~h basket attached lo the bottom of the sha fl con nected 10 a vari able
speed motor The basket i:-. immersed in a dissolution medium (as specified in monograph)
contamed m a 1000 ml fl ask. The fl ask is cylindrical with a hemispherical bottom. The fl ask
1s maintamed at 37±0.5 °C by a constant temperature bath. The motor is adj usted lo turn al the
specified speed and samples of the fluid are withdrawn at predeterm ined time interva ls to
detem1ine the amount of drug in solutions.
BASKET TYPE

Dissolution test apparatus-2 (paddle type): It is same as apparatus- I, except the basket is
replaced by a paddle. The dosage form is allowed to sink to the bottom of the fl ask before
stirring. For dissolution test USP specifies the dissolution test medium and volume, type of
apparatus to be used, rpm of the shaft, time limit of the test, and assay procedure for the same.
The test tolerance is expressed as a
percentage of the labeled amount of drug dissolved in the time limit.

CONCLUSION

I have visited the PHARMADEEP REMEDIES undergone training where it helped me to

enhance and develop my skill abilities knowledge learning about tablet manufacturing ,tablet
coating capsule filling and manufacturing of capsule and syrup it was an amazing experience
to work under such a great premises and I have learn a lot in field of pharmaceutical science.

REFERENCE