HARD GELATIN CAPSULES

Hussan deep Singh

M-Pharm(Pharmaceutics)
Sri Sai College of Pharmacy, Badhani
2
Introduction

Capsules are solid dosage form in which one

or more medicaments are enclosed in a water-
soluble, biodegradable shell made up of
gelatin.

Hard gelatin capsule is also referred as dry

filled capsule (D.F.C. as their shell is hard
and consist of two sections used for filling dry
materials in body capsule.
3
Adantages of capsules
for oral administration
!. "asy to swallow due to their smooth and slippery nature.
#. "asy to handle and carry.
$. Can mas% the unpleasant taste, colour and odour of drug using
tasteless shell.
&. 'etter bioa(ailability than tablets and faster onset of action
than tablets.
). *he shells are physiologically inert and easily and +uic%ly
digested in the gastrointestinal tract.
,. *he shells can be opacified (with titanium dio-ide or
coloured, to gi(e protection from light.

4

Hand-operated capsule filling machines or Feton

capsule filling machine

Consist of a couple of plates are capable of

producing about #.. to #...capsules/hr.
!illing hard capsule shells
0 hand operated gelatin capsule filling machine consists of the following parts 1 -
!. 0 bed with #..-$.. holes.
#. 0 capsule loading tray
$. 0 powder filling tray
&. 0 pin plate ha(ing #.. or $.. pins corresponding to the number of holes in the bed and cap holding tray.
). 0 le(er handle
,. 0 Cam handle
2. 0 plate fitted with rubber top.
6
Filling hard capsule shells
The process of workin!

Rec"i#c$"ion

Sep$r$"in "he c$ps fro% e%p"& c$ps'(es

)i((in "he *o+ies

Scr$pin "he e,cess pow+er

Rep($cin "he c$ps

Se$(in "he c$ps'(es

C(e$nin "he o'"si+e of "he #((e+

c$ps'(es

-6./... c$ps'(es per 0ho'r shif"

1
3ectification

The e%p"& c$ps'(es $re orien"e+ so "h$"

$(( poin" "he s$%e +irec"ion i2e2 *o+& en+
+ownw$r+s

In ener$(/ c$ps'(e p$ss one $" $ "i%e

"hro'h $ ch$nne( 3's" wi+e eno'h "o
pro4i+e rip $" c$p en+

The c$ps'(es wi(( $(w$&s *e $(ine+ *o+&

en+ +ownw$r+s/ re$r+(ess of which en+
en"ere+ "he ch$nne( #rs" wi"h "he he(p of
speci$((& +esin$"e+ *($+es
0
4eparation of caps from body

The rec"i#e+ c$ps'(es $re +e(i4ere+ *o+&

en+ #rs" in"o "he 'pper por"ion of sp(i"
*'shins or sp(i" #((in rins

A 4$c''% $pp(ie+ fro% *e(ow p'((s "he

*o+& +own in"o "he (ower por"ion of "he
sp(i" *'shin

The +i$%e"er of "he *'sh is "oo ($re "o

$((ow "he% "o fo((ow *o+&

The sp(i" *'shins $re sep$r$"e+ "o e,pose

"he *o+ies for #((in
5
Filling

Auger fll principle! 6ec$'se "he

$'er %o'n"e+ in "he hopper ro"$"es
$" $ cons"$n" r$"e/ "he r$"e of
+e(i4er& of "he pow+er "o "he
c$ps'(es "en+ "o *e cons"$n"

)($" *($+e $'er

Screw $'er
E22 C$ps'e( "&pe 0 #((in %$chine
Se%i$'"o%$"ic c$ps'(e7#((in %$chine2 8$9::S$n+wich;; of c$p $n+ *o+& rins posi"ione+ 'n+er
rec"i#er "o recei4e e%p"& c$ps'(es2 <$c''% is p'((e+ fro% *ene$"h "he rins "o sep$r$"e c$ps
fro% *o+ies2 8*9 6o+& rin is posi"ione+ 'n+er foo" ofpow+er hopper for #((in2 8c9 Af"er #((in "he
*o+ies/ "he c$p $n+ *o+& rins $re re3oine+ $n+ posi"ione+ in fron" of pins2 These pins p'sh "he
*o+ies "o en$e "he c$ps2 8+9 The p($"e is sw'n $si+e $n+ "he pins $re 'se+ "o e3ec" "he c(ose+
c$ps'(es
--
Filling

Vibratory fll principle! In "he

pow+er/ $ perfor$"e+ resin p($"e is
posi"ione+ $n+ connec"e+ "o $
4i*r$"or

The pow+er *(en+ "en+s "o *e

>'i+i?e+ *& "he 4i*r$"ion of p($"e $n+
$ssis"s "he pow+er "o >ow in"o "he
*o+ies "hro'h "he ho(es in resin
p($"e
-2
"SA#A M"$%& '-()*
S%MI A+,"MA,IC CAPS+&%
!I&&I-. MACHI-%
-3
Filling

Piston tamp principle!

In "his pis"ons or "$%pin pins (ih"(&

co%press "he in+i4i+'$( +oses of "he
pow+ers in"o p('s8 $(so c$((e+ $s
s('s9 $n+ e3ec" "he p('s in"o e%p"&
c$ps'(e *o+ies

D@SAT@R PRINCIPLE

D@SING DISC PRINCIPLE

-4
Filling

Piston tamp principle!

D@SING DISC PRINCIPLE! $ so(i+ *r$ss

As"opB p($"e is s(i+in +own "he +osin
+isc "o c(ose oC "he ho(e2 )i4e se"s of
pis"ons co%press "he pow+er in"o
c$4i"ies "o for% p('s

D@SAT@R PRINCIPLE! i" consis"s of

c&(in+ric$( +osin "'*e #""e+ wi"h
%o4$*(e pis"on2 The posi"ion of "he
pis"on is prese" "o $ p$r"ic'($r heih"
"o +e#ne $ 4o('%e2 Pow+er en"ers "he
open en+ of +os$"or $n+ is s(ih"(&
co%presse+ $$ins" "he pis"on in"o $
p('2
HOFLIGER KARG AUO!AI"
"AP#ULE FILLI$G !A"HI$E
%A$A#I AUO!AI"
"AP#ULE FILLI$G !A"HI$E
-1
!illing of hard gelatin capsules

"+uipment used are1 -

Hofliger-#arg machine/

Formation of compacts in a die plate using tam

ping pins to form a compact.

0anasi or Martelli encapsulator/

Forms slugs in a dosator which is a hollow

tube with a plunger to e5ect capsule plug.
-0
!I&&I-. "! HA'$ .%&A,I-
CAPS+&%S
1arious !illing Machine Aaila2le3

"li-lily and Co

Farmatic

Hofliger and 6arg

7anasi

8ar%e-Da(is.

*hese machine differ in their design and output

-5
Cleaning and polishing capsules
4mall amount of powder may adhere to the
outside of capsules after filling.
! 4alt 8olishing- 9aCl
# Cloth Dusting.
$ 'rushing.
& 8an 8olishing- 0cela-cota pan is used to
dust and polish.
2.
CAPS+&%
P"&ISHI-.
MACHI-%
AUO !AI"
"AP#ULE
ARRA$GE!$
2-
4torage, pac%aging, and stability

)inishe+ c$ps'(es nor%$((& con"$in $n EDC of -37

-6E2

F -2E DC/ "he c$ps'(e she((s *eco%e *ri""(e

G-0E %$ke "he% "oo sof"

To %$in"$in $ re($"i4e h'%i+i"& of 4.76.E when

h$n+(in $n+ s"orin c$ps'(es2

HUALI7</ +e4e(ope+ *& Shionoi H'$(ic$ps/ is "he

#rs" HPDC c$ps'(e +e4e(ope+ for e4en"'$( 'se in
ph$r%$ce'"ic$( pro+'c"s2
Re($"i4e H'%i+i"& 8RH9/ Ge($"in Dois"'re Con"en"/ $n+ H$r+
Ge($"in C$ps'(e Proper"ies2
%1A&+A,I"- "! CAPS+&%S/

:eight (ariation

Content uniformity

Dissolution test

Disintegration test
23
24

Disintegration test for capsules

;ethod 1 -
*he capsules are placed in the bas%et-rac%
assembly, which is repeatedly immersed $. times
per minute into a thermostatically controlled fluid
at $2
.C and obser(ed o(er the time described in the indi(idual monograph.

E4$('$"ion of
c$ps'(es
2I

Dissolution test for capsules

*he apparatus, dissolution media and test
is the same as that for uncoated and plain
coated tablets.

26

:eight (ariation
:
capsule < :emptied shell = :content !. capsules
labeled amount or a(erage amount, >!.?

Content uniformity
*he amount of acti(e ingredient should be within the range of @)? to !!)? of the label amount for A
of !. capsules, with no unit outside the range of 2.? to !#)? of label amount.
21
Bnspecting, counting, pac%aging, and storing
capsules

Inspec"in
4is'$( or e(ec"ronic inspec"ion J 'nifor%
in $ppe$r$nce

Co'n"in
$9 co'n"in "r$&K
*9 co'n"in $n+ #((in %$chines

P$ck$in
'ni" +ose $n+ s"rip p$ck$in 8s$ni"$r&/
i+en"i#$*(e/ s$fe9

S"orin
in "ih"(& c$ppe+ con"$iner in $ coo(/ +r&
p($ce
3ecent Filling "+uipments

Ro"o7#((! 7 2 ($kh c$ps'(esL+$&

Acco7#((! 7 1I/... c$ps'(esLhr

Ro"o7weih

Ro"o7sor"! 7 -/I./... c$ps'(esLhr

25
References
!. *he theory and practice of industrial pharmacy. Ceon
Cachman, Herbert 0. Cieberman, Doseph C. 6anig. *hird
edition. Earghese publishing house. 8age no. ,@!-2.$.
#. 8harmaceutical dosage forms1 *ablets. Eolume $. second
edition. Ceon Cachman, Herbert 0. Cieberman, Doseph '.
4chwartF. 8age no. $.$-$,).
$. 8harmaceutical process scale <up edited by ;ichael
Ce(in.
&. ;odern pharmaceutics. "dited by Gilbert 4. 'an%er H
Christopher *. 3hodes. &
th edition.
).
www.google.com
3.