Formulation of enteric coated tablets containing pineapple (Ananas cqmosus Merr.) fruit juice - Widya Mandala Catholic University Surabaya Repository

(1)

I

zuANAS

odo

l/id

dMeeting

of

Nati

INTERNATIONAT

Scientification of

Jamu

Program

from

Plant

fenderal

Soedirman

University

Rector,

The

National

on

Indonesia

Organizing Committee

Chairperson,

n--A

Group

Plant

gAT'f,

that

in

on

Indonesia

Medicinal Plant

CE

ON MEDICINAL

PLANTS

rd

Jamu

Development):

A

Breakthrough

for

Health

Care

Purwokerto,

Indonesia

october

ll -

13,2012

as

resenter

Dra.

Warsinah,

M.Si.

I

h)

a

Secretary General,

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(2)

l;t, i.r I

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It

t.

Penerbit

:

UNIYERSITAS

IENDERAL

SOEDIRMAN

PURWOKERTO

",

I

t

Scientification

of

f

am u

(Evidence-based

jamu

Development):

A

Breakthrough

Program

from

Plant

to

Medicine

for

Health

Care

The

4f

Meeting of National

Working

Group

on

Indonesia

Medicinal

Plant

"Exploration, Conservation, Development,

and

Utilization of

lndonesian

Medicinal

Plant"

f

POKJANAS

|l

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teG

J

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PROCEEDINGS OF

INTERNATIONAL

CONFERENCE ON

MEDICINAL

PLANTS

scientification of

Jamu (Evidence-based Jamu

Deveropment):

A

Breakthrough program from

Plant

to

Medicine for Health care

ln occasion

of

The

43th

National Meeting

of

National Working Group on Indonesia

'

Medicinal Plant

11-13

October

2012

Purwokerto, lndonesia

Editors:

dr. Agung Saprasetya

Dwi

Laksana,

M'Sc',

PH'

HenY

Ekowati,

M.Sc',

APt'

Dr. Agus

Nuryanto,

M'Si'

Dr. Puii

Widodo, M'Sc'

Rehana,

M.si., APt'

Lay-out: Sarmoko Prima Andika Citra Revo Almandg Harris

Published

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Pe ra nca ng

Sampul

Penata Letak

P raceta k

dan

P rod u ksi

Perpustakaan

Nasional Rl: Katalog Dalam

Terbitan

PROCEEDINGS OF

INTERNATIONAL

CONFERENCE

ON MEDICINAT

PLANTS

Scientification of

Jamu (Evidence-based Jamu

Development):A Breakthrough

Program

from

Plant

to

Medicine

for Health

Care

O

U

niversitas

JenderalSoedirman

Cetakan

Pertama,2012

lla k

Cipta

dilindungi Undang-undang

All

Right

Reserved

Iditor

dr.

Agung Saprasetya

Dwi

Laksana, M.Sc.,

PH.

Heny

Ekowati,

M.Sc.,

Apt.

Dr. Agus

Nu

ryanto,

M.Si.

Dr. Puji

Widodo,

M.Sc.

Rehana, M.Si.,

Apt.

Pa n

itia

Sarmoko

Prima

Andika

Citra

Revo

Almando

Harris

Tim

UPT.

Percetakan

dan Penerbitan

Unsoed

UNIVERSITAS JENDERAL SOEDIRMAN

Jalan

Prof.

Dr.

H.R.

Boenyamin

708

Purwokerto

Kode

Pos

53122 Kotak

Pos

115

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Faksimile

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Committee

Sterring

committee:

Dr. Hj.

Retno Widiastuti,

MS

Indah

Yuning Prapti,

SKM., M.Kes.

Prof. lr. TotokAgung

DH,

M.P.,

Ph.D.

Prof.

Suwijiyo Pramono,

DEA.,

Apt.

Prof.

Dr.

lr. Suwarto,

MS.

lr. Agus

Margiwiyatno,

MS.,

Ph.D

Dr. Bambang

Heru Budianto,

MS.

Dr.

lr. Akhmad Sodiq,

M.Sc., Agr.

Sugiyono,

Ph.D

Tuti

Sri

Suehesti,

M.Sc.

Dr. Lesley Braun

Assoc.

Prof. Wandee Gritsanapan

Chariperson

:

Dra.

Warsinah,

M.Si.,

Apt.

(6)

Potential Combination of Temulawak (Curcuma xanthorrhiza), Turmeric (Curcuma

aorroti*)

_ana Red Ginger (Zingiber officinale cv. Rubrum) As Preventive of Nephrotoxicity Due to the Use

of

Doxorubicin

soraya

Diliwiyani,

_{Ulya Rahmawati, Ayu Mayangsari, Retna pancawati, Dina Arumi, sarmoko}

97

Combination Extract Curcuma domestica, Zingiber

oficinale

cv. Rubrum and

Criiu'*o xa"thorrhtn

101

As Anticardiotoxicity of Doxorubicin

Yohan Budi Alim, IVulan P. Rahayu, Agustin Damayanti, Ning Uswiyatun, Rika Triyanaputri, Heny Ekowati

Protective Effect of Curcuma xanthoruiza, Curcuma donrestica, and, Zingiber

ffi"iiot"

Conbinatio"

Against Doxorubicin: A Hematological Study

106 Revo Almando Harris. Ekowati

PotentialEthanolExtractsofRedFruitGuava(Psidiu,'g,o

that Induced Glucose Kristianto,

Safety Evaluation of Slimming Herbal

X

In Liver Function otpernale wistar Rat Giva Oliviana Yudhista, Hanif Nasiatul Baroroh, Vitis Vini Fera

Acute and Subchronic Toxicity Study of Extract Secang (Cresnlpinia

sappartl

Agus Triyono, Sari Haryati

EffectofAntidiabeticoleumAzadirachtaeSemenUsingG

.c,rrcct or AnnqlaDetlc uleum _{Azaolrachtae Semen Uslng Ulucose 'folerance Test in}_Albino_Male

Rats

₁₃₁ Ugnica ll/idyawati Setyawan, Irwan Setyctbudi, Yohanes Hermawan

llidjaya

BioactivityStudyoftheLarvaeofMyrrneIeontidaeSpecies(M

Hypoglycemic Agent

P.A

Novita, Nadia , Harwoko

Naphtoquinone Derivativesas Potential Inhibitors of o-Glucosidase

Actiuity

127

142

Mutia

Mutia Hardhiyun a, Ri lianawati, Firdayani, Sttsi

Effect Of Hydroxy Group Addition on 1,4 NaphNaphtoquinon to Inhibit Alpha Glycoside Enzyme

Siska Andrina K.

147 Siska Andrina Kusuntastuti, Rilianawati, Mutia Hardb,uno, S.tsi Kusumanin

Diuresis Effect comparison Between Ethanolic Leaf Extract of

cort"olopay"

L.

*ith

Hydroclorotiazid to Male White Rat

Ratih Febrina Puspitasari, Rendy Printananda Zilnti, Santigun

153

EvaluationofFormulationofAntidiabeticHerbalrabl"tof'n,a,,'@

Endang Darmawan, Sri Mulyaningsih 157

FormulationandEvaluationMetforminHydrochloriden"uaffi

Alginate Crosslinkage 162

LVahyu Kurniawan, Vitis Vini Fera, Prisci permanasuri

FormulationandEvaluationofPreparationsLotionAntioxidantEtffi

(Annona muricata L.)

Shinta A Iskandar Tuti Sri Suhesti

Formufation of Enteric coated rablets containing pineapple

(Ar;""t

co*or^

_Merr.)

F^'rt

Teguh Ll/idodo, Alisyahbana, Ferry lrawan t77

InfluenceofVariousConcentrationsofPVPK-30Asuein

(Phyllantus acidus\ Leaves Extract Tablet 184 Kuncoro Foe, LI/idodo, Julein

Standardization and Formulation of Antip L.)

Farida Lanawati Darsono, Yuliani. Sri

Harti

EffectivenessofAntifungiGalangaEssentialoil1,a/pi,,,g@

Tri

Aw

Apriyani, Banu

Aji

wijayanto, Ardhea Fredyantara, Testy Dwi septiandini, sarmoko

t9'7

Potential and Anafysis Larvacide Fraction of Interest on Rumput

L^"t (E,y"gi"*

f""tid"^

202 Mosquito Lama Aedes aeg/pti

Budi Untari, Herlina

ApplicationofHighPerformanceLiquid.Chromatog.ap

Samples 210

Dadan Hermawan, Nur Aticlah binti Abu Bakar, LI/an

Aini

l(an lbrahim, Mohd Marsin

Separation and Enrichment,of Triterpenoid and Flaronoid

friidentetlo

osiatica LeafExtracts

Harwoko, Esy Nansy, Suwijiyo Prantono 219

(7)

Proceedings International Conference on Medicinal Rlants

I

f ZZ

2072 I

Formufation

of

Enteric Coated Tablets Containing Pineapple lAnanos

cgmosus

Merr.)

Fruit

Juice

Teguh

Widodo*,

Alisyahbana,

Ferry

lrSwan

Faculty of Pharnacy,

llidya

Mandala Catholic Unitersity,

Jl

Dinoyo 12-JJ Surabaya *Corresponding author ; teguhu'idodoI3@ynai l.conr

Abstruct

Pineapple fruit has been enrpirically used as an anthelmintic. one obstacle of the usage of pirreapple as an anthelmintic is that its chenrical conteni can increase.the _{incidence of gastric mucous}_membrane_initatioi._{To overcome}_tr,il_prour.rn.

an

enteric-coated tablet dosage fbrm rvas sel.ected, which can prevent the dissolution oftablet in the gastric fluid but ir can dissolve in an

alkaline rnedium. Thtrs it can eradicate the worms that live in the intestine. A study on the lbmrulation of enteric coated tablet containing pineapple fruit juice has been carried out. Pineapple juice was obtained by using a.juicer.

iuui.i,

*.r.

prepared

by wet granulation method.The physical quality of resulting-granules was evaluated incluairig moisture conterrt. repose angle,

llorv rate- and conrpressibility. Granules were then compressed to yield rablets of 300 mg, in ra.hich each tablet contains 71.5

mg

of

pineapple

liuit

extract. The quality

of

_{resuiting tableis rvas evaluated inchrding}

friabilitl.

_hardness._*eight

unifbrnrities' and disintegration tinte. one formula of tablet was prepared and tlren coated using a coating solution of Euclragit

L-100 r'vith the additional weights of 3vo' 4%. and 5o/o. The.quality of resulting enteric coated iablets

uis

evaluated including additional _{ueight trnifomrities'Jrardness, disintegration time. and}_{physical-appearance}

of

tablet. The stabilitl testing

of

contents rvas perlbrmed using TLC. Physical appearance data rvere inalyzed'irsing chi square.

lt

can be concluded thar

pineapple tiLrit.itrice could be tbrmulated as an enieric coated tablet with the addirional rreight of 4Zo.

Kcyn ords: coated tablet: Eudragit L-1 00: pineapple fiuit.

Background

worrn

_{inl'ection is one o1'the emerging diseases due to the}_pool_{condition ol'sanitation and}

h1.giene.

worm

is a

parasite that liVes in the body. leading to the retardation ol'phl,sical and intellectual der,elop'rerrt

of

childr.en.

'fhe

_sr.rnptoms

of

_{patient are as}_tbllorvs:

weak physical condition. big tumml

.

skinnl.although pollphagia. no

appetite' Based on diagnostic laboratory results. rryorm int'ection is characterized by the preser.lce of egg q.orms in the f'eces. sputum. u'ine or finger of patients (Sukarban

&

_Santosa.,|995).

The lbllorving _{synthetic medicines can be administered}

to

_{treat rvorm intbction including: levanrizol.}

diethlI

carbamazine. _{thiamizole and pyrantel}_{pamoate (Sukarban}

&

_Santosa.

1995).

In

general. sl,nthetic drugs at.e

relativell

expensive and tiequently elicit unwanted side efl'ects such as nausea. r..omitin_q. _{dizziness and allergic}

reactions' As a subsitute to the synthetic drugs. traditional medicines u

ith

relativell.

lo1

side- ellects could be

empfoyed' I'he tbllou'ing _{plants are ellicacious}

lbr

_{worm inl'ection: pineapple}_(.lnana.s

cont,tlusys Merr..). papa) a

(Carica popa)'a

L.l.

bangle rhizome (Zingiber

purpttrea

Roxb)- remu

giring

(('ttt.cutna heyneona yal.)- _tenttr

hilant (Cttrc'trnn aenrginosa Roxb.) andpjnang _{(Areca catechu L.) ( Anony,mous. l9g9).}

considering the

availability.

relatively

low

cost. pleasant taste enabling

its

use

tbr

childrcn. pineapple

tiuit

(Ananas co"'tllttstts Merr) was selected in _{this study. The chemical constituents}_in_pineapple._anron-s_others._are:

b|omelin

_{enz)me- saponins. flavonoids. polyphenols. r,itamirr}

C.

_or-eanic_{acids. dertrose}

and

saccharose

(AnollvmoLrs' 1989)' Bromelin errzyme is allegedll'etl-ective as an anthelnrintic as this prorcolltic enzlme

c,uld

cleave the pt'oteins in the tissue. This

will

in

turn soften and u'eaken the bod_r

ol'r'orrn.

l)ineapple e.\tr.act at a

concentt'alion t>l'l2o/o

\y'v

_{demonstrates anthelmintic eff'ect.}_{similar to}_3.5%

ri/r

_{pipcrazinc citrate (wulandar.i.}

2004).

one obsttrclc ol'the usage o1'pineapple as an _{anthelmintic is that its chemical content can}_incr-ease_{the incidence}

of'gastric

Inttcol-ls membt'ane

irritation' To

_overcome_this_{problem. an cnteric-cgateci}

tablct dosarge

fbrrr

*.as

selected"[ his dosa-ue lbrm was selected because

it

has nranl _{advantages such as: r-clatircl_r snrall r,6lume}

*ith

(8)

178

|

T.

widodo

et o/.

The widely used enteric coated films include: celulose acetate phthalate (CAP), Eudlagit L, Eudragit S, HPMCP

arrd polyvinyl acetate phthalate. Eudragit L was selected in this study because this

fllm

is resistant to gastric acid rrrd soluble in intestinal

lluid

at pFI 6.

It

is also stable during storage and water rnedium can be used as a solvent

to plepare a coating solution. The spraying time of this coating solution is shorter, the coating solution has a low

viscosity and is relatively lovv cost. The usual concentration

of

Eudragit L-100 is 3-6% (Agoes, 1984; Rowe el ot .2009).

Material

and Mehods ,\4atetials and Equipme nls

Pineapple (Ananas comtllusus Merr) rvas collected tiorn the plarrtation in Kediri, East.lava. Priol to the study, the

cletelmination

of

plant

material rvas conducted

by

the

Indonesian

lnstitute

of

Sciences

(LlPl)

Purwodadi Botanical Garden. Pasuruan-East Java. Othel materials ofpharmaceutical grade included aerosil, dibasic calcium

lrhosphate, Ac-Di-Sol. magnesium stearate. talcurn. PVP K-30. ethanol. acetone, PEC 400. and Eudragit L-'l 00.

l:quipments used

in

this

stud1, \eere oven. moisture analyzer (Sartorius

MA

30

type. Gernrany), analytical lralance

(Toledo Metler

AL

204

tS,pe. Celrnany).

single

punch tabletting nrachine.

tablet

hardness tester

iSchleuniger

6D-30

ty"pe. Gernrany),

tablet

tiiability

testef

(Erweka

TA-3

type,

Gerrnany). disintegration

irpparatus (Elrveka ZT

3-l

t-vpe. Germany). glass apparatus and othel suppolting equiprnents. Preparation o.f Cntde 14atet'ial

l)ineapple ti-uit ernplol,ed in this

stud;

r.vas a fiesh. ripe and

lello*.

r.ro fotten and

liee fiom

pests and diseases.

-lhe _fiLrit

\.vas peeled and the cofe

of

pineapple tir"rit u'as lerrro',cd. to obtain the

liuit

tlesh

only

and then rvas

rr ashed thoroughli .

P re parati on of ex lrac I povde

r

()ne kilogram of pineapple tlesh sas cut ilrto small pieces. clushed in a blender to obtain a slufry mass. then was

squeezed using

a

tlannel

cloth

to

obtain

a

pirreapple

fiuit

juice.

The _.luiceu,as heated

in

a

rvater bath

at

a

controlled temperature not nlore than 50 "C to

yield

a viscous extract. Aerosol u,as added at a ratio o1'l:0.75

corrsidering the resultin-s dr,\ extract

of

l0%.

r.r'as poured into a tray and dried

in

an oven at a temperature

of

-50 "C--. _{to obtain}_a_{drr,€xtract.}_{The resulting extract was rveighed.}_lirrely_{glounded and sieved thlough a-40}_mesh

sievel to obtain a dr1' extract ready to be used tbr tablet manufbcturirrg process.

Do.se Calculations

Based

on

Wulandari

(2004).

l2

_-e

of

dry

extract

is

equivalent

to

3.5

g

of

pipelazine citrate.

The

dose

of

pipelazine citrate in the rnarket ra,as 500 mg. Dose of anthelmintics in the dr-v extract:

(12 g I 3.5 g) x 500 nig

:

1.714 g dr1, extract

/

dal

In this stud1 . each tablet contained

dq,ertract

o1'pirreapple

liuit.iuice

71.5 mg and eight tablets rvere

administered three times daily. Toblet Forntula

"l-lrc core tablets

of

pineapple

fiuit.iuice

r'r,as prepaled bv

uet

granulation rnethod

in

one

lbrrlula

replicate.

lt

contained 71.5 rng of dr',r,extract as shou,n irr Table

l.

Core tablets o1'good quality were coated with Eudragit

L-I ()0 coating solution at a concentration of 47o as shou,n in Table 2.

(9)

Proceedings International Cbnference on Medicinal Rlants

I

f ZS

2Ot2

|

Table 1. The tbrmula of tablets

Name of materials

Function

Weight of one tablet

(mg)

One batch (g) Pineapple dry extract

Aerosil

Dibasic calcium phosphate

Ac-Di-Sol(4%)

Magnesium stearate ( I %) Talcum (3%)

PVP K-30 (3%)

Active ingredient Desiccant Filler Disintegran Lubricant Glidant Binder Total weight

71 .5 71.5 124 t2 J o 9 300 92.95 92.95 161.20

t 5.6 3.9

1l .7

1t .7

390 Table 2. The fblrnula of coatins

Materials Weight (g) Eudragit L-100

PEG 4OO

Ethanol: xcetone

:

60: 40

4

0.4

to 100 mL

'l

oblet l,lanufacluring Process

'l'heclryextractofpineappletiuit.iuiceof

l85.9grrasmixedrvith

l6l.20gofdibasiccalcittnrphosphate.

_15.6g

ot'Ac-Di-Sol

and I1.7 g

of

PVP K-30 until homogeneous. Water sas tlren added to tornr a granulate tnass and

sr-rbsequentll sieved thlough a-16 mesh siever. Clanules were dricci in an oven at a tempcratrrrc

ol'50

"Cl

tbf

8

hours and u.ere le-sieved through a-20 mesh siever. -l'he resultin-u grarrules

*ere

treiqhcrl. Cranules rt'ele mixed

uith

3% of'talcurn and l7o

of

magnesiunr steafate. and their ph),sical clLralil.l rias cvirluated including: nroistut'e content. corlpressibility. flowability and repose angle. Crarrules ol'good clualitl'rrele compresscd rrsin-e a sin,ele

pLrnchtablettingnrachinewitha-l0rnrrrdiameterol'moldandatablet\.\'eightol'300m9.'fhequalitl

of resulting tablets uas evaluated including: rveight unitbrmity. haldness.

fiiabilitl,and

disinteglation time. Clofe tablets ol' good

qualitl

\,vere coated with Eudlagit L-100 coating solution at a concentration of 47o to rveight coating la1'er

3yo

(FA).

4%

(FB)

and 5o/o (FC). The quality

of

resulting coated tablets r.r'as evaluated including: u'eight

of

coating la1-er Lrnilbrrnities. hardness. disintegration tinre and visuirl inspection on the sult'ace ol'coated tablets.

C hctrac't e ris t ic q ua I i ty of granu les

.\loistrrre contenl (% MC)

Granrrles as much

as

l-2 g

were evaluated using

a

moisture anal)'zer

at

100'C until

a constant \\,eight. The quality standard moisture content of 2

-5%

(Bandelin

&

Shanglarv. 1989;

Voigt.

1995).

Flotv time and repose angle

Determination

of

flow

properties

of

granules

u'ith

Cartenserr

nrethod

using 100

glanrs

of

porvder glanules. Determination of tlovv properties of granules nrade using the parameters ol'time and lepose angle. The

qualitystandardtlowtimeof

lessthan

l0seconds(Voigt.

1995)andleposeanglc

25-40'lMalshall.

1996). Compressibility

Complessibility is the percentage ratio between the dill'erence

in

tapped

densitl

and bLrlk densitl

.

The quality standald compresibility of 5-18% (Fierse

&

Hagen. 1996).

Charccteristic physical qualiry of

bblet

Weighr uniformity

(10)

180

I

T. Widodo et o/.

Hat'dness

The test was done using

l0

tablets. The quality standald hardness

of4-8

kgf(Parrot,

l97l).

Ft'iability

lhe

test rvas done at 25 rpnr fbr 4 rnin using 20 tablets. The quality starrdard

tiiability of

less than 1%r (Banker

&

Anderson.1996).

Disintegralion time

Disinteg|ation

time

test using

6

tablets.

l'ablet

core: use \\,ater as

a

medium

of

disintegration at tetrrpe|ature 37+2"C. the quality standard disinteglation time of no nrore than

l5

minutes (Anonymous. 1979). Enteric coated

tablet: used

artiflcial

gastric

f)uid

as a disinteglation media at temperature 37+ 2 -C and equipments fun

tbr

2

hours. tablets should

not

be broken. cracked

or

become soft.

After

that

replace

artificial

intestinal

lluid

LP ternperature 37+2"C as

a

disintegration media

fbr

a

period

of

I

houl with

the

time

limit

specitied

in

each

rnonograph all which is tablets should be crushed all (Anonymous, ,I995).

l'iunl

inspection on coated tablel

Visual inspection on the sult'ace of coated tablets made

bl,taking

100 tablets at randonr in each lbrmula and thcn observed

by

l0

panelists using the tbllon,irrg criteria: + (rough

surlace).

+

+ (father rough sulf'ace) and + + +

( _{smooth sulthce).}

Data analysis

Phy'sical qualitl, tablet include rveight. hardness and disintegration time using one rvay

ANOVA

(p <0.05) and a

visual test using the chi-squale (p

<0.0i).

Results and Discussion

Pineapple

liuit

used

tbr

research

in

the fbrrn

of

tiesh

fiuit.

ripe and

yellow.

no rotten and

tiee ol'pests

and diseases. and determined by the lndonesian Institute

of

Sciences

(LIPI)

Punvodadi Botanical Garderr.

Pasut'uan-East Java.The.iuice u,as heated in a rvater

bath

to yield a viscous extlact and aerosil u'as added therr dtied in oven at 50 oC. Standaldized o1'dr1'extract include: organoleptic, loss on

drying

and chemical iderrtiflcation as in

l'able 3.

Table 3. Standaldization o1'dr','" extract of pirreapple tiuit.iuice (Anonymous. I 989).

No. Analysis Reference

Results

Remarks

L

Olganoleptic:

-

Color

-

Odor

-

Taste Loss on dr'y ing Identiflcation

-

+ 5 drops of concentrated l-l2SO,r

-

+ 5 drops o1'HrSOq

l0

N

-

+ 5 dlops NaOI-l P 5')/o s'/v in ethanol

-

+ 5 drops

ot'Nl

llOFl (25%) P

-

+ 5 drops of FeClr P 5Vo wlv

2.

J.

Yellow

Aromatic Sweet

Not more than 870

Brou n B ror'r'n

Yellou'

Pale brou,n

Yellowish brown

.

Yellow Aromatic Sweet 6.7'A Brown Brown Yellorv Pale brown

Yellowish blown

Confbrnred Contbrrned Confbrrned

Con fbrrrecl Confbrrred Conlbrrrred Confbrrned Contbrmed Cclntbrrned

Tablet prepared b1' u,et granulation method.

'*'ith

concentlation

of

PVP K-30

as binders 3oh.To deternrine u'hethel the resulting granules can be conrpressed into tablets, granules should be dry errough so

it u,ill

not stick in the mold and has such a good

flou

and cornplessibilitl'. The lesults of testing the quality of the

-elanLrles as in

(11)

Proceedings International Conference on Medicinal Plants 20L2 Table 4. Evaluation of the quality of granules

t

I

rar

No. Examination Requirements Results Remarks

l.

2.

J.

1.

The water content Flow time Repose angle Kompersibilitas (%)

2-5Yo

< | 0 seconds

20-40'

5-r8%

4.13

*

0.18 8.36 r"0.02 35.24 r. 0.04

8.82 + 0.03

Confbrmed Conlbrmed Confbrmed Confbrmed

J'he lesults shor'ved that granules lrave met the qualitl' standard of'good _eranules. namely the rrroisture content ot'

2-5% (Bandelin

&

Shanglaw, 1989; Voigt. 1995). the tlorv time ol'less than

l0

seconds

(Voigt.

1995). the repose

angle of

20-40'(Malshall.

1996). compressibilitl

of

5-18% (['ierse

&

Hagen. 1996).

Good quality of tablets should meet the qLrality requirernents as desired. including weight and dose unifbrmities, lack of incompatibilities, attractive app€arance. as well as possible and

eltcient

large scale production (Bandelin

&

Shanglaw. 1989). The result of the quality of pineapple extlact core tablet as in table 5.

"

Table 5. EvalLration of the oualitv of tablet

No. Examination Requirements Results Remarks

l.

2.

4.

Weight unilbrmity

Flardness

Friability

Disintegration time

x+

5vo

a-8

kgi

11.%

<

l5

minutes

299.35

+

l.i5

11.29 + 0.29 0.34

*

0.08 7.79 + 0.02

Confbrmed Contbrmed Conlblmed

Cont-ormed

Based on data

fionr

table 5. core tablet containing pineapplc

fiuit.iuice

demonstrated good vveight unifbrmitl'

since none of the tablets shou,ed weight deviatior.rs o f' urore than 5ol ( Anonvmous, I 979). tablet hardness greatel' than the standard 4-8 kgl'(Parrot

,

1971) required that the tablet is resistant to collisions that occur during the coating process and not easily. eroded or broken.

liiability

ol'lcss than

l%

(Banker

&

Anderson. 1996) and the tablet disinteglation time of no more than

l5

minutes (Anonl'nrous. 1979).

Core tablet coated u'ith Eudragit

Ll00

solution concentration ol'4o/o to rveight coating layer 3Yo (FA). 4% (FB)

and 5o/o (FC) can be seen ln Figure

l.

Test results _-eeneratedcoated tablets can be seen in table 6.

Figurel.

Coated tablets of pineapple fi'uir e\tracr: IrA (3%). FB (4%) and FC (5%) Table 6. [:r,aluation ot'coatcd tablet

No. Examination FA (3,%) FB (4o/") FC (5o1,)

l.

2.

J.

4.

Weight

of

coatin_e layer Tablet hardness

Disintegration time Visual inspection:

-+

-

++

-

+++

3.31 + 0.29 t4.41

*

0.03

14.98

r

0.26

o

t4

84

4.34

r

0.33

t5.29+

0.t3

17.61

*

0.45

J

il

83

5.43 + 0.34 t6.06 + 0.2 |

22.52

*

0.81

J 7

90 Notes:

*

: Rough tablet surlhce +

+

: Rather rough sud'ace

+++

: Smooth tabletsurtace

(12)

182

|

T.

widodo

et o/.

Statistical analysis by one-way

ANOVA

fbllowed Tukey test (p<0.05) on the unifot'mity of coating layer weight

fbr

FA. FB

and FC shou,ed a significant diffb|ence. The g|eater rveight

of

coating layer causes hardness and

disintegration time increased probabll, due to

the

coating layer thickness so that the tablet strength increased and rvater is more dit'ficult to get into the tablet'

Visual inspection

by

l0

panelists

to

100 coated tablets produces smooth tablet

surt'ace

as much as 83

I

83and 90 tablets. fbr FA. FB and FC lespectively. Statistical analysis using Chi-Square (p< 0.05) showed there r'r'as no

significant differ.ence

tbr

sur.t'ace smoothness

FA.

FB and FC coated tablet. Probably this caused

by

coating eftect

of

3

%

weight coating layer in 300 mg

tablet

already produced smooth coating layer,so incleasing the

prosentage

ofcoating layer

to 4 and 5 7o does not all-ect significantly the level ofsrnoothness |esulting coating

liry er.

I he chromatogram prof iles

of

tablet during nranuf'acturing pl'ocess: crude material. viscous extracts- -et'anules

and coated tablets using a-GF25a silica plate as a stationary phase and mixture

of

n-butanol: acetic acid: waler

(4:l:5.v/v)asamobilephase.wasobselvedin

UV254and366nmcorrespondingtothecontentofflavonoids

can be seen in tigure 2. The results showed du|ing the rnanutacturing process fiorrr the coated tablets- thet'c is rrtr

tlif,let.ence of tlre spot and Rf value betrveen the crr-rde extfact. viscot-ts extract. granules and tablets

Figure 2. Chfomatogr.arr of constitutents in pineapple

fiuit.iuice. tiom

clude r]1aterials.viscous extract granules and coated tablets obselved under' tJV 254

&

366. Notes:

l.

Crude materials: 2. Viscous extract: 3.

Gt'anules: 4. Tablet. Conclusions

pineapple

liuit

_{extract can be}tblmulated into entelic coated tablet dosage

lbrin

using Eudragit L-100 as coating agent

with

u,eight

of

coating layer was

4%. During the

rr.ranut'acturing ptocess

of

enteric coated tablet

of

pineapple

liuit

juice using lvet glanulation method. no charrges in chenrical cotllpounds were observed-References

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LV..

Popovich NG and Ansel

FlC.20ll.

Pharmacer.rtical Dosage Fot'm and Dlug Delivery Slsterrrs- 9'h

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&

Wilkins- Philadelphia. USA. Agoes. G. 1984. Penl'n1u1un Tablet. Edisi 10, l-12-73-84,

Multi

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Anonl,mogs. 1979. Falnrakope Indonesia, ed.

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Anonymous. 1995, Farmakope Indonesia,

Edisi

4,

1086-1043. Departemen Kesehatan Republik Indonesia-.lakarta

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ln:

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l.

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The

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&

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