Tablet danTablet Salut

Dewi Setyaningsih
dewisetya03@yahoo.com
Tablet
 Definisi dan tipe
• Sediaan padat yang dibuat dengan kompresi
powder/granul secara tunggal atau ganda
dengan atau tanpa bahan pengisi (diluents)
Tablet juga dapat diperoleh dengan cara
pencetakan (moulding) atau ekstrusi.
• Bentuk tablet: silindris, permukaan flat atau biconvex,
terdapat simbol atau break-marks pada permukaan.
• Break-mark  functional  membagi tablet.
• Tablet dengan active inggredient narrow therapeutic
window  tidak boleh diberi break-mark
 Pertanyaan
• Seorang apoteker di Rnd akan mempercantik
produk tabletnya. Dia mendesain adanya
break mark pada permukaan tablet dengan
tujuan menambah penampilan tablet.
• Bagaimana pendapat anda? Setuju/tidak?
 Tablet salut

• Menyembunyikan rasa tidak enak

• Mempermudah penelanan (krn permukaan lebih
halus)
• Meningkatkan stabilitas terhadap lingkungan
• Memperlama waktu kedaluwarsa
• Salut enteric: tersalut dengan bahan yang mampu
melindungi tablet terdisintegrasi dalam suasana asam
 Tablet buccal dan sublingual

• Tablet yang penggunaannya dengan cara disisipkan di bawah

lidah (sublingual) dan di pipi bagian dalam (buccal).
• Zat aktif terlepas cepat (immediate release) untuk diabsorpsi
melalui mukosa
• Sangat baik untuk zat aktif yang tidak tahan asam dan
enzymatic degradation
• Contoh: vasodilator dan hormon-hormon steroid
 Tablet effervescent

• Adalah tablet dimana zat aktif harus terlepas dan terlarut

dalam air (dissolved tablet) seketika setelah bersentuhan
dengan air.
• Dalam tablet effervescent terdapat asam (asam sitrat dan
atau tartarat) dan anion carbonat atau bicarbonate
• Karakteristik: tablet terlarut secara cepat dan memberikan
rasa yang enak
 Tablet kunyah

• Adalah tablet yang harus dikunyah sebelum

ditelan
• Biasanya untuk pediatric dan berisi vitamin.
 Lozenges

• Tablet dengan aktifitas terapetik pada area sekitar

mulut dan tenggorokan, misalnya batuk.

• Tablet mengandung gula dan gum. Gum digunakan

untuk memberikan kekuatan dan kohesifitas yang
mampu memfasilitasi slow release dari zat aktif
Classification of Tablet Preparations
Tablet preparation processes
• Raw material
• Wighing
Direct compression • Mixing
• tableting

• Raw material
• Weighing
• mixing
Wet granulation • Granulation
• Mixing
• tabeltting

•Raw material
•Weighing
dry •mixing
•Granulation
granulation •Mixing
•tabeltting
 Manufakturing
• Direct compression : campur dan kempa
• Granulation :
– Dry granulation (granulasi kering)
– Wet granulation (granulasi basah)
• Granulation:
• Campur
• Granul
• kempa
 Pilihan metode tergantung pada
• Dose
– Low dose (< 25 mg)  direct compression
• Kompaktibilitas dan fluiditas
• Stabilitas bahan obat dan eksipien
 Direct compression
• Good flowability
• Good compactibility
 Measures of Powder Flowability

• Expressed in many different ways

• Hausner Ratio (HR) and Carr Index (CI)
The Hausner Ratio is calculated from equation
where BD is the powder bulk density, and TD is
the powder tapped density.
 Bulk and Tap Density
• Bulk density (grams per mL (g/mL)) =

• The bulk density of a powder is the ratio of the mass off an untapped
powder sample and its volume including the contribution of the
interparticulate void volume.

• The bulk density of a powder is determined (USP):

• by measuring the volume of a known weight of powder sample 
graduated cylinder (method I)
• by measuring the mass of a known volume of powder that has been
passed through a volumeter into a cup (Method II) or a measuring vessel
(Method III)

Procedure of the three methods : refer to USP.

Please check it
 Bulk and Tap Density

• Tapped density is obtained by mechanically

tapping container.
Observing initial powder weight and volume, and
after tapping until the volume is not changing .
• The prosedures is in USP. Please check it.
• Tap density : M/Vf. Vf : final volume.
Static angle of repose

• static angle of repose

• The static angle of repose is the angle formed between the
side of a stationary pile of powder and the horizontal
• the greater the angle of repose, the more cohesive the
powde
• The method is best-known measures of flowability, but
suffers from poor reproducibility  angle formed by
cohesive powders is not stable
Quality of angle of repose
 Direct compression

• Untuk memperbaiki sifat alir dan

kompaktibilitas menggunakan spesial filler-
binder dan glidant
• Untuk mengurangi gesekan dengan mesin 
lubricant
• Untuk mempercepat waktu hancur 
superdisintegrant
 Contoh formulation untuk metode DC

Bahan Komposisi
API (active pharmaceutical inggredient) 1 bagian
Filler-binder 2-3 bagian
Disintegrant
starch 10-20%
superdisintegrant 2-5%
Glidant
Colloidal silica 0.5-1%
Lubricant
Mg Stearat 0.5-1%
 Keuntungan metode DC
• Lebih ekonomis (waktu, ruangan, bahan, alat,
personil)
• Menghindari panas dan lembab pada
granulasi basah
• Tablet lebih cepat terdisintegrasi menjadi
partikel kecil

GRAN

DC
 Kelemahan metode DC
• Masalah untuk low dose: content uniformity
(keseragaman kandungan)
• Sulid dilakukan untuk obat dosis besar dengan
sifat alir, kompaktibilitas yang buruk
• Membutuhkan kontrol ketat pada pemilihan
filler binder
– Karena filler binder untuk DC adalah filler binder
yang sudah dimodifikasi
 Contoh filler-binder untuk DC
• Microcrystalline celluloce (MCC)
• Isolasi dari selulose fiber dengan hidrolisis
asam
– Produk: Avicel
• Kompaktibilitas bagus
• Membutuhkan sedikit lubricant
• Mampu terdisintegrasi cepat
 Contoh filler-binder untuk DC
• Spray processed lactose
– Fast flow lactose
• Granulasi kristal laktose, perekat lactose amorf
• Dikalsium fosfat dihidrat
– Emcompress, Ditab
• Granulasi kristal dikalsium fosfat dihidrat
• Spray processed sucrose
– Granulasi kristal sucrose dengan perekatnya adalah
dextrin
– Chewable tablet
 Kasus
• Zat aktif X dengan kadar besar (>250
mg/tablet). Sifat alir dan kompaktibilitas
buruk. Serbuk tidak mengalir dan sulit untuk
dikempa. Bagaimana cara mengatasi?
 Granulasi
• Granulasi : gabungan
partikel membentuk
granul  bulat, ukuran
lebih besar (size
enlargement processes)
• Bulat  sifat alir lebih
baik
• Gabungan partikel 
adanya pengikat (binder)
 kompaktibilitas lebih
baik
Drying
 Reasons for granulation
• To prevent segregation of the constituents of the
powder mix
– Segregration  Size, density, and proportion. In granul all
particles are consolidate in one granul.
• To improve the compaction characteristics of the
mixture
– Some powders (with adhesive) are difficult to compact,
but granules more easily compacted and produce
stronger tablets due to be more distributed of binders.
Migration results in binder rich surface  binding between
binders assist consolidation of weakly bonding materials
 Reasons for granulation
• To improve the flow properties of the mix
– Small size, irregular shape or surface characteristics,
are cohesive and do not flow well  large weight
variation
– Granules  larger size and more isodiametric  to
improved flow properties
• Reduce the hazard of toxic dust powders
– reduce the hazard associated with the generation of
toxic dust that may arise when handling powders
– Thus granules should be non-friable and have a
suitable mechanical strength
 Reasons for granulation
• Reduce the hazard of hygroscopic powder
adhesion
– Materials which are slightly hygroscopic may adhere
and form a cake if stored as a powder.
– The granules will be able to absorb some moisture
while retain their flowability because of their size
• More convenient for storage
– Granules are denser than the powder mix, they
occupy less volume per unit weight. They are
therefore more convenient for storage or shipment
 Granulation vs non-granulation

Granulation
Powder Granules

sieving

Segregated Powder Monosized Granules

 Particle bonding mechanism in granul
• adhesion and cohesion forces in the immobile
liquid films between individual primary powder
particles
• interfacial forces in mobile liquid films within
the granules
• the formation of solid bridges after solvent
evaporation
• attractive forces between solid particles
• mechanical interlocking
 adhesion and cohesion forces –wet
granulation
• Liquid: a very thin, immobile layer, there will be an
effective decrease in interparticulate distance and
an increase in contact area between the particles.
– Thin liquid film can be formed by addition of viscous
solution of adhesive (muscilago).
• The van der Waals forces of attraction are
proportional to the particle diameter and
inversely proportional to the square of the distance
of separation.
 adhesion and cohesion forces – dry
granulation
• the pressures used will increase the contact
area between the adsorbed layers and
decrease the interparticulate distance and
this will contribute to the final granule
strength (by van der Waals attraction)
Interfacial forces in mobile liquid films within the granules
 States in granules formation
• Pendular state
– At low moisture levels
– Liquid bridge  adhesion due to surface tension forces of the
liquid–air interface and the hydrostatic suction pressure
• Capillary state
– all the air has been displaced from between
the particles
– capillary suction liquid–air interface
• Funicular state
– Intermediate stage between the pendular and capillary states
• Suspension: appears droplet (granule ) formation in spray
drying.
 Solid bridges
• These can be formed
– partial melting
– hardening binders
– crystallization of dissolved substances
 Partial melting
• the pressures used in dry
granulation methods may cause melting
• When the pressure is relieved, crystallization
will take place binding the particles together
 Hardening binders
• Occurs in wet granulations when an adhesive is
included in the granulating solvent
• The adhesive will harden or crystallize on drying
to form solid bridges to bind the particles
• Exp: polyvinylpyrrolidone, the cellulose
derivatives (such as carboxymethylcellulose) and
pregelatinized starch
 Crystallization of dissolved substances

• The solvent used to mass the powder during

wet granulation may partially dissolve one of
the powdered ingredients
• During drying: crystallization of this material
will take place and the dissolved substance
then acts as a hardening binder
• Exp: Lactose
 Attractive force between solid particles

• Two types of attractive force which can operate

between particles in pharmaceutical systems
– Electrostatic forces
– Powder cohesion and the initial formation
of agglomerates, e.g. during mixing

• Van der Waals forces

– The magnitude of these forces will increase as the
distance between adjacent surfaces decreases and in
dry granulation this is achieved using pressure to force
the particles together
 Mechanism of granules formation
• Mechanism of granules formation: nucleation, transition and ball
growth
• Nucleation
• particle–particle contact and adhesion due to liquid bridges
• Transition
• the presence of a
large number of small granules with a fairly wide size
distribution
• Nuclei formation:
• single particles can be added to the nuclei by pendular bridges
• two or more nuclei may combine
 Mechanism of granules formation
• Ball growth
– Further granule growth produces large, spherical
granules
– Occurs during agitation in mixer (planetary mixer)
– Four possible mechanisms of ball growth :
Coalescence, breakage, abration transfer, layering
Mechanism of granules formation
 Filler – granulasi basah
• Lactose
• Dicalcium phosphate
• Sucrose
• MCC
Excipients
 Contoh formula tablet – Granulasi basah

API 300 mg
Filler 182.5 (lactose)
Binder 15 mg (3% escarmellose)
lubricant 2,5 mg (0.5% Mg stearat
 Contoh dan sifat lubricant

Lebih effective menggunakan campuran lubricant: mg

stearat dan colloidal silica
 Lubricant
• Fungsi mencegah friksi pada permukaan
tablet, tablet dan punch (mesin tablet)
• Glidant: memperbaiki sifat alir dengan cara
mengurangi kontak antara partikel
 Lubricant
• Lubricant  hidrofobik sehingga
penggunannanya perlu diperhatikan. Terlalu
banyak lubricant  disintegration <<< dan
dissolution <<<
• Lubricant  mempengaruhi interaksi antara
partikel dalam tablet. Terlalu banyak atau
terlalu lama mencampur dengan lubricant 
tablet lunak
 Lubricant
• Lubricant dicampurkan sesaat sebelum masuk
ke pengempaan
• Pencampuran 2-5 menit
• Hidrophobic lubricant lebih effective
dibanding water soluble one
• Water soluble lubricant hanya digunakan pada
– Tablet soluble (effervescent)
– Contoh: sod benzoat, PEG 8000, dan DL Leucin
 Glidants
• Untuk memperbaiki sifat alir
• Penggunaan biasanya 1% atau 0.25-0.5% untuk
colloidal silica
 Disintegrant

• Disintegrant  higroskopis
• Menarik air  tekanan hidrostatik
• Setelah menarik air
• Swelling secara cepat (Sod Starch Glycolate)
• Tidak terlalu swelling (Crosscarmellose)
• Tidak swelling (Starch, Crosspovidone)
Disintegrant
 Penggunaan disintegrant
• Starch 5-15%
• Crosscarmellosa sodium : 1-3% (DC) dan 2-4%
(gran basah)
• Crosspovidone (2-4%)
• Sod Starch Glycolate (4-6%) 
superdisintegrant
 Kapan disintegrant ditambahkan
• Sebelum granulation (ikut di granul) internal
• Setelah granulasi  eksternal
 Tableting
• Kegiatan tableting adalah kompaksi
(compaction) yang melibatkan 2 proses:
kompresi dan konsolidasi
• tabletting\single punch tablet press machine
capsule pressing equipment Small pharma
medicine making machine - YouTube
[360p].mp4
 Kompaktibilitas
• Kemudahan suatu tablet dibuat dengan
kekuatan mekanis (mechanical strength) yang
sesuai
• Kekuatan mekanis
– Kekerasan (tablet hardness)
– Kerapuhan (friability)
 Classification of tabletting meschine
• Tablet presses:
a. single-punch presses
b. multi-station rotary presses
Compression stages
 Stages in compression
• Kompresi:
– Memaksa partikel kontak lebih dekat, mengurangi
volume
• Konsolidasi
– Interaksi antara partikel  kekuatan mekanis
(mechanical strength)
• tabletting\How a Tablet Press Works - YouTube
[360p].mp4
Fase-fase kompresi
Kompresi dan konsolidasi

Kompresi

Konsolidasi
 Step step kompresi
• Gaya kompresi membawa partikel lebih dekat
satu sama lain (consolidation) pori serbuk
berkurang terbentuk interaksi (lemah) 
hanya mungkin bila partikel sangat dekat  perlu
ditekan. Interparticulate bond:
– Van der Waals tablet hardness
– H-bonding

• Tablet hardness (kekerasan) adalah fungsi gaya

atraktif dan area dimana gaya itu ada
• During compression, materials experience
complex stresses :
– particle rearrangement,
– plastic deformation, and
– fragmentation.
Problema setelah keluar dari mesin tablet

Partikel terlalu lastis, ikatan antara partikel lemah

 Capping

• Upper or lower segment of the tablet separates

horizontally during ejection from the tablet press, or
during subsequent handling

• Reason:
– Capping is usually due to the air–entrapment in a
compact during compression, and subsequent expansion
of tablet on ejection of a tablet from a die.
 Capping : causes and solutions in formulation
Causes
• Large amount of fines
• very low moisture content
 poor binding force
• High moisture content in
granules
• Improper / insufficient
binder or lubricant
• Granular mass too cold
solutions
• Remove some or all fines
through 100 to 200 mesh
• Moisten the granules
suitably. Use hygroscopic
materials: sorbitol, methyl-
cellulose or PEG- 4000
• Dry the granules properly
• increasing the amount of
binder
• Adding dry binder : PVP,
hydrophilic silica or
powdered sugar.
• Lubricant >>> or change
 Lamination

• Separation of a tablet into two or more layers

• Reason:
– Air–entrapment during compression and
subsequent release on ejection and xaggerated by
higher speed in tabletting
Lamination: causes and solutions in formulation

causes solutions
• Oily or waxy materials • Modify mixing process
in granules • Add adsorbent or
• Too much of absorbent
hydrophobic lubricant • Use a less amount of
• Magnesium-stearate lubricant or change the
type of lubricant
 Chipping

• breaking of tablet edges

• Reason:
– Incorrect machine settings, specially mis-set
ejection
 Chipping: causes and solutions in
formulation
causes
• Sticking on punch surface
• Too dry granules
• Too much binding
solutions
• Dry the granules properly or
increase lubrication
• Moisten the granules to
plasticize with hygroscopic
materials
• Optimize binding, or use dry
binders
 Cracking

• fine cracks observed on the upper and lower

central surface of tablets

• Reason:
– rapid expansion of tablets, especially when deep
concave punches are used
 Chipping: causes and solutions in formulation

Causess Solutions
• Large size of granules • Reduce granule size. Add
• Too dry granules fines.
• Moisten the granules 
• Tablets expand better binding efect
• Granulation too cold • Improve granulation
• Compress at room
temperature
 Sticking

• Tablet material adhering to the die surface

• Reason:
– Improperly dried or improperly lubricated
granules
 Sticking: causes and solutions in formulation
Causes
• Granules not dried properly
• Too little or improper
lubrication
• Too much binder
• Hygroscopic granular
material
• Oily or way materials
• Too soft or weak granules
Solutions
• Dry the granules properly
• Increase or change lubricant
• Reduce the amount of binder
• Modify granulation and
compress under controlled
humidity
• Modify mixing process. Add an
absorbent.
• Optimize the amount of binder
and granulation
 Picking

• small amount of material from a tablet is sticking to

and being removed off from the
tablet-surface by a punch face

• Reason:
– small amount of material from a tablet is sticking to and
being removed off from the tablet-surface by a punch face
 Picking: causes and solutions in formulation

Causes Solutions
• Excessive moisture in • Dry properly
granules • Increase lubrication
• Too little or improper
lubrication • Add high melting-point
materials
• Low melting point
substances • Compress at room
• Too warm granules when temperature.
compressing • Cool sufficiently before
• Too much amount of binder compression
 Binding

• Tablets adhere, seize or tear in the die

• Reason:
– Binding is usually due to excessive amount of
moisture in granules and lack of lubrication
 binding: causes and solutions in formulation
Causes
• Too moist granules
• Insufficient or improper lubricant
• Too coarse granules
• oo hard granules for the lubricant
to be effective
• Granular material very abrasive
• Granular material too warm
• sticks to the die
Solutions
• Dry the granules properly
• Increase the amount of
lubricant
• Reduce granular size, add
more fines
• Modify granulation
• Reduce temperature
 Mottling

• Unequal distribution of colour on a tablet.

• Reason:
– One cause of mottling may be a coloured drug
 Mottling: causes and solutions in formulation
Causes
• A dye migrates to the
surface of granulation while
drying
• Improperly mixed  direct
compression
• Improper mixing of a
coloured binder solution
Solutions
• Change the solvent system,
Change the binder,
Reduce drying temperature
and Use a smaller particle size
• Mix properly and reduce size if
it is of a larger size
to prevent segregation
• Incorporate dry colour additive
 Pengujian tablet
In processes control
Pemeriksaan selama proses pembuatan tablet

1. Keseragaman ukuran
– Diameter tablet tidak lebih dari 3 kali dan tidak
kurang dari 1 1/3 kali tebalnya tablet
 Pengujian tablet
2 Keseragaman Bobot dan Keseragaman sediaan
Keseragaman Bobot
• Keseragaman bobot ditetapkan sebagai berikut:
– Ditimbang 20 tablet dan dihitung bobot rata-ratanya
– Jika ditimbang satu persatu, tidak boleh lebih dari 2 tablet
yang menyimpang dari bobot rata-rata lebih besar dari
harga yang ditetapkan pada kolom “A” dan tidak boleh ada
satu tablet pun yang bobotnya menyimpang dari bobot
rata-rata lebih dari harga dalam kolom “B”.
– Jika perlu dapat diulang dengan 10 tablet dan tidak boleh
ada satu tablet pun yang bobotnya menyimpang lebih
besar dari bobot rata-rata yang ditetapkan dalam kolom
“A” maupun kolom “B”.
Tabel ketentuan keseragaman bobot
 Pertanyaan
• Mengapa pada bobot tablet kecil toleransi
penyimpangan bobot sesuai dalam kolom A
dan B lebih besar dibandingkan dengan tablet
dengan bobot yang lebih besar
 Keseragaman kandungan
• Persyaratan keseragaman bobot dilakukan terhadap tablet yang
mengandung zat aktif 50 mg atau lebih yang merupakan 50% atau
lebih dari bobot satuan sediaan.

• Keseragaman bobot bukan merupakan indikasi yang cukup dari

keseragaman kandungan jika zat aktif merupakan bagian kecil dari
tablet atau jika tablet bersalut gula.

• Oleh karena itu, umumnya farmakope mensyaratkan tablet bersalut

dan tablet yang mengandung zat aktif 50 mg atau kurang dan
bobot zat aktif lebih kecil dari 50% bobot sediaan, harus memenuhi
syarat uji keseragaman kandungan yang pengujiannya dilakukan
pada tiap tablet.

• Penilaian keseragaman kandungan: CV kurang dari 5%

 Waktu hancur
• Disintegration tester Tablet Disintegration Tester DISI-
2M - YouTube [240p].flv
• Memasukkan 5 tablet ke dalam keranjang, turun-
naikkan keranjang secara teratur 30 kali tiap menit.
• Tablet dinyatakan hancur: tidak ada bagian tablet yang
tertinggal diatas kasa, kecuali fragmen berasal dari zat
penyalut.
• Kecuali dinyatakan lain, waktu yang diperlukan untuk
menghancurkan kelima tablet tidak lebih dari 15 menit
untuk tablet tidak bersalut dan tidak lebih dari 60
menit untuk tablet bersalut gula dan bersalut selaput.
 Waktu hancur tablet bersalut enterik
• Alat disintegration tester, sesuai dengan cara diatas,
namun air diganti dengan lebih kurang 250 ml asam
klorida (HCl) 0.06 N
• Pengerjaan dilakukan selama 3 jam, tablet tidak larut
kecuali zat penyalut. Angkat keranjang, cuci segera
tablet dengan air. Ganti larutan asam dengan larutan
dapar pH 6,8 atur suhu antara 36° dan 38°, celupkan
keranjang ke dalam larutan tersebut.
• Lanjutkan pengujian selama 60 menit. Pada akhir
pengujian tidak terdapat bagian tablet di atas kasa
kecuali fragmen zat penyalut.
Kekerasan tablet
 Friability - Friabilator

% kehilangan bobot oleh karena erosi

atau gesekan selama testing
Tablet salut (Coated tablet)
The last critical step in the tablet
production cycle.
 TABLET PROPERTIES
• Tablet to be coated must posses the proper physical
characteristics like spherical shape and uniform surface.
• To tolerate attrition of tablets during coating process they
must be resistant to abrasion and chipping.

Tablet surfaces that are brittle and soften in presence of

heat or effected by coating composition and tend to
become rough in the early stages of coating process are
unacceptable for film coating.
 Tablet coating process
• The coating of tablets classified into three types

I. Sugar coating

II. Film coating

III. Enteric coating

96
 Tablet coating processes
• tabletting\Tablet Coating - YouTube
[360p].mp4

Tablet coating is accomplished by the movement

of tablets in perpendicular or vertical direction
to the application of the coating composition
COATING COMPOSITION

IS APPLIED TO

MOVING BED OF TABLETS

HEATED AIR IS
INTRODUCED

EVAPORATION OF THE SOLVENT

98
 Equipments

Perforated coating pan

Standard coating pan

99
Fluidizised coating
 Sugar coating involves following steps

 Sealing

 Sub-coating

 Syruping(smoothing)

 Finishing

 Polishing 100
 SEALING
• It prevents moisture penetration in to the tablet core.
• Seal coating agents -
shellac,zein,Oleicacid,PG,PEG4000,alcohol,methylene
chloride.

• Zein is alcohol-soluble protein derivative.

 Shellac is more effective(because of polymerization of

shellac),
 But it lengthens tablet disintegration
and dissolution times. 101
 SUB COATING
Sub coating is applied :

To form uniform edges,

To build up the tablet size.

Sub coating increases the tablet weight from 50 to 100

percent.

Examples- Gelatin, sugarcane powder, corn syrup,

syrup , distilled water, Gum acacia. 102
 SYRUPING
 It is done to cover the imperfections in the Tablet surface caused
during sub coating step.
 It involves-
 Application of syrup coating with grossing syrups followed by the
addition of dilute colorants to provide tinted base.

 In subsequent steps, the syrup solution containing dye are

applied until
final size and Color are achieved.

 The final step a clear syrup coat without dye are applied.
103
 POLISHING
• The desired luster to the tablet is obtained by polishing .

Tablets are polished

in a

Standard coating pans

by application of

carnauba wax(yellow), bees wax(white),paraffin wax

(Or) warm solutions of waxes in suitable volatile solvent.

104
 FILM FORMING AGENTS

The film forming agents tablet coating are

classified into:

1.Non - enteric film formers

2.Enteric film formers

105
 NON-ENTERIC FILM FORMERS
• They are incorporated to give uniform film with desired
mechanical strength which are as follows:
1. HPMC(Hydroxy propyl methyl cellulose)
2. MHEC(Methyl hydroxyl ethyl cellulose)
3. EC(Ethyl cellulose)
4. HPC(Hydroxy propyl cellulose)
5. POVIDONE
6. ACRYLATE POLYMERS

106
Kapsul
 Definisi
• Sediaan padat dimana zat aktif berupa serbuk atau
cairan berada dalam cangkang kapsul yang larut air
(water soluble shell)
• How to make turmeric supplement capsules at home. -
YouTube [240p].flv
• Medicine Capsule Manufacturing - YouTube [240p].flv
• semi automatic capsule filling equipment
Pharmaceutical filling machine for
capsules&amp;tablets - YouTube [240p].flv
 Teridiri atas
• Soft gelatine (kapsul lunak): kapsul tunggal yang
berisi cairan
• Hard gelatine (kapsul keras): cangkang dan penutup.
– Digunakan untuk mengisikan serbuk, tablet kecil atau
granul
 Keuntungan kapsul
• Menutup rasa dan bau yang tidak enak
• Mudah untuk ditelan
• Ekonomis (dibandingkan tablet)
• Mudah dibawa
• Dapat melepaskan obat di tempat tertentu di
GIT
• Terbuat dari gelatin (inert)
 Kerugian kapsul
• Bahan yang higroskopis tidak
direkomendasikan dimasukkan ke dalam
kapsul karena dapat menyerap air dari kapsul
yang dapat menyebabkan kapsul menjadi
retak
 Kapsul dan eksipien
• Eksipien dalam kapsul:
• Diluents
• Absorben
• Glidan
• Antidusting
 Pengujian Kapsul
• Keseragaman bobot
• Waktu hancur
• Keseragaman kandungan