 Tablet Salut Gula

 Tablet Salut Selaput

 Tablet Salut Kempa
 Tablet Salut Enterik
1. Melindungi zat aktif yang bersifat higroskopis
atau tidak tahan terhadap pengaruh udara,
kelembaban atau cahaya

2. Menutupi rasa dan bau yang tidak enak

3. Membuat penampilan lebih baik dan menarik

4. Mengatur tempat pelepasan obat dalam

saluran cerna (misalnya, salut enterik yang
pecah di usus)
1. Memperpanjang massa kedaluarsa dari tablet
karena komponen tablet terlindungi dari
lingkungan (cahaya, kelambaban, dan oksidasi)

2. Tablet salut lebih mudah dikonsumsi dibanding

dengan tablet inti (terutama untuk tablet yang
berukuran besar)

3. Warna coating dapat menutupi perbedaan

penampilan fisik tablet dari batch yang berbeda

4. Mempermudah proses identifikasi produk dalam

proses produksi
5. Mengurangi terjadinya kontaminasi silang selama
proses produksi

6. Tablet yang disalut akan lebih mudah dalam

proses pengemasannya

7. Proses coating akan mengurangi debu dari tablet

inti

8. Tablet yang disalut akan meningkatkan nilai jual

dari produk karena mudah mengidentifikasinya
 Merupakan metode tradisional dalam penyalutan
tablet

 Melibatkan aplikasi yang beruntun mulai dari

melapisi tablet inti dengan larutan gula
menggunakan peralatan yang sesuai

 Peralatan konvensional dengan aplikasi yang

manual masih banyak digunakan walaupun
peralatan yang lebih khusus dan otomatis sudah
ada
 Sealing tablet inti
 Subcoating
 Smoothing
 Colouring
 Polishing
 Printing
 Standard Coating Pan
 Proses pengeringan
tablet dapat
ditingkatkan dengan
cara mengalirkan
udara kering melalui
perforated metal
sword.
 The Driacoater introduces drying
air through hollow perforated ribs
located on the inside periphery
In the Accela-Cota and Hi-Coater of the drum. As the coating pan
systems, drying air is directed into rotates , the ribs dip into the
the drum, passed through the tablet bed, and drying air passes
tablet bed, then exhausted through through and fluidizes the tablet
perforations in the drum. bed. Exhaust is from the back of
the pan.
 Keberhasilan dalam proses penyalutan
tergantung kepada keahlian dari operatornya
 Operator yang menentukan jumlah larutan
penyalut yang ditambahkan, kapan harus
disemprotkan udara kering, berapa lama dan
berapa cepat tablet harus diputar di dalam
pan
 Larutan penyalut dapat disemprotkan ke
dalam pan
 Proses penyemprotan secara signifikan dapat
mengurangi waktu pengeringan selama proses
penyalutan
 Salut film dapat didefinisikan sebagai
proses pembentukan lapisan coating
berbasis polimer (rentang 20-200 µm)
diaplikasikan pada inti yang dapat berupa
tablet, granul, kapsul, serbuk powder atau
kristal
 Dapat menggunakan alat yang
konvensional, tetapi saat ini sudah banyak
alat khusus yang dapat memberikan
banyak keuntungan seperti dapat
mempercepat proses penyalutan
 Larutan penyalut (larutan atau suspensi)
mengandung polimer dalam medium
pelarut yang cocok dengan
penambahan pigmen dan plasticizer.
Larutan ini disemprotkan ke dalam
coating pan. Pengeringan akan
menghilangkan pelarut dan
meninggalkan lapisan tipis dari larutan
penyalut di area tablet inti
1. Polimer
2. Plasticizer
3. Surfaktan
4. Anti tack agent
5. Pewarna
 Beberapa contoh polimer yang digunakan adalah :
 Cellulose derivatives (Hydroxypropyl Methylcellulose
(HPMC),Hydroxypropylcellulose (HPC),
Hydroxyethylcellulose (HEC), Methylcellulose (MC),
Ethylcellulose (EC), Sodium carboxymethylcellulose
(Na CMC)
 Vinyls (Polyvinyl pyrrolidone, PVP)
 Glycols (Polyethylene glycols, PEG)
 Acrylic polymers (Dimethylaminoethyl methacrylate
– methylacrylic acid ester copolymer, Ethylacrylate
– methylmethacrylate copolymer).
 Most of these polymers are water – soluble,
however water insoluble polymers (EC and some
acrylate derivatives) can be used at low polymer
loading levels as non-functional coatings.
 Enteric polymers can be either
 Natural polymers (Shellac)
 Cellulosic (Cellulose Acetate Phthalate CAP,
Cellulose Acetate Trimellitate CAT, Hydroxypropyl
Methylcellulose Phthalate HPMP, Hydroxypropyl
Methylcellulose Acetate Succinate HPMAS)
 Acrylic (Poly (Methacrylate – Ethylacrylate) 1:1, Poly
(Methacrylic acid – methyl methacrylate) 1:1)
 Polymers used in extended release film coating
include
 Natural polymers (Zein),
 Cellulosic polymers (Ethylcellulose)
 Silicone elastomers
 Acrylic esters.
 Biasanya merupakan pelarut organik dengan
titik didih yang tinggi yang digunakan untuk
memberikan fleksibilitas bahan polimer
 Contoh Plasticizer:
 Water soluble: Glycerin, propylene glycol,
low molecular weight polyethylene glycols
(PEG 200 and 400). Triethyl citrate (Citroflex®)
and surfactants such as Tweens.
 Water insoluble: Acetyl triethyl citrate
(ATEC), Acetyl tributyl citrate (ATBC), Dibutyl
phthalate (DBP), Dibutyl sebacate (DBS),
Diethyl phthalate (DEP), Tributyl citrate (TBC).
 Surfaktan mencegah terjadinya
aglomerasi dan penyatuan partikel
polimer selama shelf life nya
 Surfaktan membasahi dan
menghomogenkan larutan penyalut
seperti halnya plasticizer
 Contoh : Tween, Cetyl alkohol, SLS.
 Insoluble additives including talc,
kaolin, Mg stearate and colloidal silica
have been used as anti-tack agents
or anti-adherents to help reduce
agglomeration or sticking of coated
substrates during and after coating.
 Usually water-insoluble colours (pigments).
 Examples of colourants:
 Iron oxide pigments.
 Titanium dioxide.
 Aluminium Lakes.
A B C
 A: Granulator Top-Spray Process, preferred when taste
masking coating is being applied, also for application
of hot melt coatings.
 B: Wurster, Bottom-Spray Process, preferred for the
application of modified-release coatings to a variety
of multiparticulates, also suitable for drug layering
when drug dose is in the low-to-medium range.
 C: Rotor, Tangential-Spray Process, suitable for the
application of modified-release coatings to a variety
of multiparticulates. Ideal for drug layering when the
dose is medium-to-high. Also useful as a spheronizing
process for producing spheres from powders.
latex particles dispersed
in aqueous phase

formation of thin film with

water evaporation through film

continuous film
 picking/chipping

 roughness

 sticking

 film cracking/peeling
 Average
Reconstitution
Description weight Application examples
level
gain
HPMC based Amoxycilli n, Azi thro myci n, Atenolol,
Aqueous 11% to 15% 2.5 % Amlodipine, Amitriptyline, Ampicilin
system Ciprofloxacin, Cephadroxil ,
Cimitidine, C alci um Tablets, Citrizi ne
HPMC based , Chloroquine Phosphate,
Organic Clarithromyci n, Erythromyci n,
5% 2.5%
solvent Ferrous Fumarate, Famotidine,
system Ferrous Sulphate, Ibu profen,
Ind apamine, Losartan Potassium,
HPMC based Levamisole, Methyl-Dopa,
Aqueous/ Aqueous 11%
Metronidazole+Tinidazole,
Organic Organic Solvent Metronidazole, Methyl Coblamine,
Solvent/ 5% 2.5% Mefenamic Acid, Metoprolol Tartrate,
Hydro Hydro Alcoholic Norfloxacin, Nifidipine,
Alcoholic Norfloxacin+Tinidazole, Ofloxac in,
9%
system Paracetamol, Quinine Sulphate,
Roxythromyci n, Secni dazole,
PVA based Sildenafil Citrate, Trimetazidine,
Aqueous 20% to 25% 2.5% Tinidazole, Tinidazole-Doxycycli ne,
system Tinidazole + Tetracycli ne, Verapamil
 Average
Reconstitution
Description weight Application ** examples
level
gain
Organic Enteric
Coating sys tem, Aspirin, Bisacodyl
5% 8%
Cellulose Acetate
Phtha late based
Diclofenac Sodium
Aqueous c oating
system & Organic
enteric coating Doxyl amine Succinate
Organic: 5%
system. Hydroxy 8%
Aqueous: 10%
Propyl M ethyl
Cellulose Phthalate Garlic Tablets, Omeprazol,
based system. Pentaprazole,

Aqueous 20%
Methacrylic acid Pentoxyfyli ne, Rabeprazol ,
Hydro Alcoholic
copolymer type "C"
10% 9%
USP/NF based
system Organic Sys tem Serrosipeptadise
10%