Filling of Hard Gelatin Capsules

8/12/2019 Filling of Hard Gelatin Capsules

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HARD GELATIN CAPSULES

Hussan deep Singh

M-Pharm(Pharmaceutics)

Sri Sai College of Pharmacy, Badhani


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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 drymaterials in body capsule.


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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 usingtasteless shell.

&. 'etter bioaailability than tablets and faster onset of actionthan tablets.

). *he shells are physiologically inert and easily and +uic%ly

digested in the gastrointestinal tract.. *he shells can be opacified (with titanium dioide or

coloured, to gie protection from light.


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Hand-operated capsule filling machines or Feton

capsule filling machine

Consist of a couple of plates are capable ofproducing about # to #capsules/hr.

!illing hard capsule shells


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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 haing # or $ pins corresponding to the number of holes in the bed and cap holding tray.

). 0 leer handle

. 0 Cam handle

2. 0 plate fitted with rubber top.


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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"


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3ectification

The e%p"& c$ps'(es $re orien"e+ so "h$"$(( poin" "he s$%e +irec"ion ie *o+& en++ownw$r+s

In ener$(/ c$ps'(e p$ss one $" $ "i%e"hro'h $ ch$nne( 's" wi+e eno'h "oproi+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 ofspeci$((& +esin$"e+ *($+es


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4eparation of caps from body

The rec"i#e+ c$ps'(es $re +e(iere+ *o+&en+ #rs" in"o "he 'pper por"ion of sp(i"*'shins or sp(i" #((in rins

A $c''% $pp(ie+ fro% *e(ow p'((s "he*o+& +own in"o "he (ower por"ion of "hesp(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


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Filling

Auger fll principle! ec$'se "he$'er %o'n"e+ in "he hopper ro"$"es$" $ cons"$n" r$"e/ "he r$"e of

+e(ier& of "he pow+er "o "hec$ps'(es "en+ "o *e cons"$n" )($" *($+e $'er

Screw $'er E C$ps'e( "&pe 0 #((in %$chine


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Se%i$'"o%$"ic c$ps'(e7#((in %$chine 8$9::S$n+wich;; of c$p $n+ *o+& rins posi"ione+ 'n+errec"i#er "o receie e%p"& c$ps'(es


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--

Filling

Vibratory fll principle! In "hepow+er/ $ perfor$"e+ resin p($"e isposi"ione+ $n+ connec"e+ "o $

i*r$"or The pow+er *(en+ "en+s "o *e

>'i+i?e+ *& "he i*r$"ion of p($"e $n+

$ssis"s "he pow+er "o >ow in"o "he*o+ies "hro'h "he ho(es in resinp($"e


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"SA#A M"$%& '-*

S%MI A+"MAIC CAPS+&%

!I&&I. MACHI%


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Filling

Piston tamp principle!

In "his pis"ons or "$%pin pins (ih"(&co%press "he in+ii+'$( +oses of "hepow+ers in"o p('s8 $(so c$((e+ $ss('s9 $n+ eec" "he p('s in"o e%p"&c$ps'(e *o+ies D@SAT@R PRINCIPLE D@SING DISC PRINCIPLE


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Filling

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

s"opB p($"e is s(i+in +own "he +osin

+isc "o c(ose o "he ho(e )ie se"s ofpis"ons co%press "he pow+er in"oc$i"ies "o for% p('s


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D@SAT@R PRINCIPLE! i" consis"s ofc&(in+ric$( +osin "'*e #""e+ wi"h

%o$*(e pis"on The posi"ion of "hepis"on is prese" "o $ p$r"ic'($r heih""o +e#ne $ o('%e Pow+er en"ers "heopen en+ of +os$"or $n+ is s(ih"(&

co%presse+ $$ins" "he pis"on in"o $p('


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HOFLIGER KARG AUO!AI""AP#ULE FILLI$G !A"HI$E

%A$A#I AUO!AI""AP#ULE FILLI$G !A"HI$E


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!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 hollowtube with a plunger to e5ect capsule plug.


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!I&&I. "! HA'$ .%&AI

CAPS+&%S

1arious !illing Machine Aaila2le3 "li-lily and Co

Farmatic Hofliger and 6arg 7anasi 8ar%e-Dais.

*hese machine differ in their design and output


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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.


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2.

CAPS+&%

P"&ISHI.

MACHI%

AUO !AI""AP#ULE

ARRA$GE!$


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2-

4torage, pac%aging, and stability

)inishe+ c$ps'(es nor%$((& con"$in $n EC of -37-6

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

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

To %$in"$in $ re($"ie h'%i+i"& of 4.76. whenh$n+(in $n+ s"orin c$ps'(es

UALI7


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Re($"ie H'%i+i"& 8RH9/ Ge($"in ois"'re Con"en"/ $n+ H$r+Ge($"in C$ps'(e Proper"ies


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%1A&+AI" "! CAPS+&%S/

:eight ariation

Content uniformity

Dissolution test

Disintegration test

23


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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 $2C and obsered oer the time described in the indiidual monograph.

E$('$"ion of

c$ps'(es


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Dissolution test for capsules

*he apparatus, dissolution media and test

is the same as that for uncoated and plain

coated tablets.


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:eight ariation

:capsule < :emptied shell = :content ! capsules

labeled amount or aerage amount, >!?

Content uniformity

*he amount of actie 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.


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Bnspecting, counting, pac%aging, and storing

capsules

Inspec"in

is'$( 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


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3ecent Filling "+uipments

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

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

Ro"o7weih Ro"o7sor"! 7 -/./... c$ps'(eshr


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References

!. *he theory and practice of industrial pharmacy. eon

achman, Herbert 0. ieberman, oseph . 6anig. *hird

edition. Earghese publishing house. 8age no. @!-2$.

#. 8harmaceutical dosage forms1 *ablets. Eolume $. secondedition. eon achman, Herbert 0. ieberman, oseph '.

4chwart. 8age no. $$-$).

$. 8harmaceutical process scale


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Filling of Hard Gelatin Capsules

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