TABLET KUNYAH
Tablet Kunyah adalah tablet
yang dimaksudkan untuk
dikunyah, memberi residu
dengan rasa enak dalam
rongga mulut, mudah ditelan
dan tidak meninggalkan rasa
pahit atau tidak enak.
Tujuan dari tablet kunyah adalah
untuk memberikan suatu bentuk
pengobatan yang dapat diberikan
dengan mudah kepada anak-anak
atau orang tua yang mungkin sukar
menelan obat utuh
Jens Martensson
• Jenis tablet ini digunakan dalam
formulasi tablet untuk anak,
terutama formulasi multivitamin,
antasida, dan antibiotika tertentu.
• Tablet kunyah dibuat dengan
cara dikempa, umumnya
menggunakan manitol, sorbitol
atau sukrosa sebagai bahan
pengikat dan bahan pengisi,
mengandung bahan pewarna
dan bahan pengaroma
• Dan berbagai Vitamin
• antasida (misalnya, kalsium
karbonat)
• antikonvulsan (misalnya,
carbamazepine)
• vasodilator (mis., isosorbid
dinitrat),
• analgesik (misalnya,
acetaminophen),
• Dan berbagai Vitamin

Jens Martensson
Karakteristik

Memiliki bentuk yang halus setelah hancur.

Mempunyai rasa enak dan tidak meninggalkan rasa pahit

atau tidak enak.

Mudah melarut dalam garam-garam logam yang digunakan

dalam tablet antasida.

Jens Martensson
Keunggulan tablet kunyah
Ketersediaan hayati lebih baik dan dapat meningkatkan
disolusinya.
Kenyamanan bagi penderita dengan meniadakan perlunya
air untuk menelan

Sebagai pengganti bentuk sediaan cair yang memerlukan

kerja obat yang cepat.

Meningkatkan kepatuhan penderita terutama anak-anak

dengan rasa yang enak.

Jens Martensson
Keterbatasan tablet kunyah

• Zat aktif yang rasanya tidak baik dan dosis yang tinggi sangat sulit dibuat
tablet kunyah.
• Rasa obat yang tidak enak/khas dan tajam sulit di tutupi

Jens Martensson
Flow chart of various aspects to be considered in connection with chewable tablets

TYPICAL PRODUCTS
Vitamins
Antacids
Analgesics
Cold Remedies

EVALUATION
FORMULATION FACTORS
DESIRED PRODUCT Taste panels
Amount of active
ATTRIBUTES Blood levels (for adsorbed
substances as a percent of
Good taste and mouthfeel drugs)
total tablet weight
Acceptable bioavailability In vitro vs. in vivo
Flow
and bioactivity ", correlation
Lubrication
Acceptable stability and for antacids
Disintegration
quality Stability (chemical,
Compressibility
Economical formula and physival,
Compactability-Stability
process organoleptic)
Organoleptic
Quality control and
considerations
assurance

FORMULATION Ion exchange complexes

Spray congealing and coating Formation of salts or derivatives
TECHNIQUES AND Granulation and Coating Excipients
APPROACHES Use of amino acid and protein Artificial sweeteners
Microencapsulation hydrolysates Flavoring
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Solid dispersions Inclusion complexes Molecular Coloring
 FORMULATION
FACTORS

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TASTE AND FLAVOR:
• Salt and sour tastes are derived form substances capable of ionizing in
solution.
• The term flavor generally refers to a specific combined sensation of taste
and smell.
EX: sugars has a sweet taste but no flavor whereas honey has a sweet
taste and a characteristic smell – the combination of the two being known
as honey flavor
AROMA:
• Pleasant smells are generally referred as aromas
EX well formulated orange- flavored chewable tablets
should have a characteristic sweet and sour taste and aroma
of fresh orange.

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MOUTH -FEEL
• The term mouth feel is related to the type of sensation or
touch that a tablet produces in the mouth upon chewing

AFTER –EFFECTS
➢ Iron salts leave a rusty after taste
➢ Saccharin in high amounts tends to leave a bitter after
taste
➢ Another common after effect is a numbing sensation of a
portion of the whole surface of the tongue and mouth

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PHYSICAL PROPORTIES
color, odor, taste, after taste, and mouth feel

Physical form: crystal , powders , amorphous solid, oily liquid etc

Melting temperature

Existing of polymers

Moisture content

Active drug stability on its own

Compressibility if applicable

CHEMICAL PROPERTIES

❖ Chemical structure and chemical class

❖ Major reactions of this chemical class

❖ Major incompatible compounds or class of compounds

❖ Drug dose and any limit on the final dosage size

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Assessment of the Formulation Problems

▪ The first step in the formulation of a chewable tablet is to obtain a complete

profile of the active drug. The drug profile should eliminate potentially
incompatible excipients, flavors, and the like at the outset, leading to the use of
excipients that would best compliment the drug chemically, physically and
organoleptically.

Jens Martensson
FORMULATION TECHNIQUES

Jens Martensson
Formulation Techniques
• Coating by Wet Granulation
• Microencapsulation
• Solid Dispersions
• Adsorbate Formation Technique
• Solvent method
• Melting method
• Ion Exchange
• Spray congealing and spray coating
• Formation of different salts or derivatives
• Use of Amino acids and protein hydrolysates

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 COATING BY WET GRANULATION

➢ In this technique drug particles to be coated are fluidized by means of suspension

in a controlled high –velocity warm air or stream directed through a perforated plate
into a coating chamber,

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(a) Top spray fluidized bed system. (b) Bottom spray fluidized system.

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 MICRO ENCAPSULATION
1. Formation of three immiscible phases

i.e. liquid manufacturing vehicle phase, a core material drug

phase, and a coating material phase.

2. Depositing the liquid polymer coating by sorption around

the core material under controlled physical mixing of the
three phases.

3. Rigidizing the coating usually by thermal cross linking or

dissolution techniques to form a rigid microcapsule

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• The typical coating material include

Carboxy methyl cellulose .

Cellulose acetate phthalate

Ethyl cellulose.

Gelatin

Poly vinyl alcohol, gelatin –acacia, shellac .

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 SOLID DISPERSION
• Bad tasting drugs can be prevented from stimulating the taste buds by
adsorption on to substrates capable of keeping the drugs adsorbed while
in the mouth but releasing them eventually in the stomach or GIT

• Good example is the adsorption of dextrometharphan hydro bromide on

to magnesium trisilicate substrate

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ADSORBATE FORMATION TECHNQUES

SOLVENT METHOD

➢The formation of an adsorbate involves dissolving

the drug in a solvent, mixing the solution with the
substrate and evaporating the solvent–leaving the
drug molecules adsorbed upon the substrate

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MELTING METHOD

➢ Here the drug or drugs and a carrier are melted together by

heating, the melted mixture is then cooled and rapidly
solidified in an ice bath with vigorous stirring . The product is
then pulverized and sized.

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ION EXCHANGE

➢When used as a drug carrier ion exchange materials

provides a mean for binding drugs on to an insoluble
polymeric matrix and can effectively mask the problems of
taste and odor

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USE OF AMINO ACIDS AND PROTEIN HYDROLYSATES

• By combining amino acids their salts or a mixture of two it is

possible to substantially reduce the bitter taste of penicillin.

• Some of the preferred amino acids are sacrosin, alanine ,

taurine, glutamine acid and especially glycine.

Jens Martensson
 EXCIPIENTS
NAME PARTICLE SIZE LOD

BROWN SUGAR 92%ON 50 MESH 0.7%

MOLASSES 100%ON 12 MESH 1%

GRANULES
COMPRESSIBLE 50% ON 60 MESH 4%
MOLASSES
COMPRASSIBLE 50% ON 60 MESH 4%
HONEY

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COMPRESSIBLE 75% ON 100 MESH 0.5%
SUGAR

DEXTRON/FRUCTO 3% ON 20 MESH 7%
SE/MALTOSE

DEXTRONE 3% ON 20 MESH 9%

LACTOSE 20 % ON 60 MESH 1 %

MANNITAL 75% ON 80 MESH 0.3%

SORBITAL 33%ON 60 MESH 1%

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SWEETENERS
MATERIALS RELATIVE SWEETNESS
ASPARTAME 200
CYCLAMATES 30 – 50
GLYCYRRHIZIN 50
SACCHARIN 450
DEXTRON(GLUCOSE) 0.7
FRUCTOSE(LEVULOSE) 1.7
LACTOSE 0.2
MALTOSE 0.3
MANNITOL 0.5-0.7
SORBOTAL O.5-0.6
SUCROSE 1
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FLAVORS
SWEET VANILLA, STONE FRUITS, GRAPE,BERRIES,MAPLE

SOUR CITRUS,CHEERY,RASHBERRY,STRAW BEERY

SALTY NUTTY,BUTTERY,SPICE,MELON

BITTER LICORICE,ANISE,CHERRY,NUT,GRAPE FRUIT

ALKALINE MINT , CHOCOLATE, CREAM

METALIC GRAPE, LEMONE-,LIME

Jens Martensson
 COLORANTS

Colorants are used in the manufacturing of the chewable tablets

for the following reason

1. To increase aesthetic appeal to the consumer

2. To aid in product identification and differentiation

3. To mask unappealing or non uniform color of raw materials

4. To complement and match the flavor used in the formulation

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MANUFACTURING
PROCESS

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 Four important aspects of the chewable tablet

manufacture are the

1. Proper incorporation of the coloring agent

2. Assurance of necessary particle size distribution

3. Maintenance of correct moisture content

4. Achievement of the proper tablet hardness

Jens Martensson
• If the granulation process involves wet granulation the extent
of wetting and the rate and extent of drying should be
considered.

• Over wetting can expected to produce hard granules that

may have poor compression characteristics resulting in more
softer and friable tablets. So care must be taken

• The method and appropriate order for the addition of the

flavor and color must be determined if wet granulation is
being used.

Jens Martensson
CHEWABLE MULTI VITAMIN TABLETS

Vitamin A acetate 12.50 mg

Vitamin D1 4.50mg

VitaminD2 0.58mg

Vitamin E. 50 % SD 33.00mg
Ascorbic acid 90% 67.00mg
Folic acid 0.40mg
Vitamin B2 5.20mg
Vitamin B 6 6.00mg

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Vitamin B 12 6.00
NIACINAMIDE 60.00
FERROUS FUMARATE 18.00
PHARMASWEET POWDER 8.70
NATURAL ORANGE 10.90
FLAVOR
EMDEX 938.52
COLOR ORANGE NO q,s
S31282
MAGNESIUM STEARATE 8.70

Jens Martensson
EVALUATION OF CHEWABLE TABLETS

 Organoleptic evaluation takes place at various

stages in the development of a chewable tablets

 For example evaluation of dextrometharphan,

ephidrine for their bitterness followed by the taste
comparison of these drugs after absorption onto a
polycarboxylic acid resin

Jens Martensson
CHEMICAL EVALUATION

ASSAY FOR DRUG CONTENT

➢A suitable analytical method (chromatographic ,

titrimetric, spectrophotometric, etc) is used to
determine the active content on a respective
sample (usually an aliquot of 20 randomly selected
tablets after pulverization)
➢The recovered amount of the active drug is then
expressed as percent of labeled drug content

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DOSAGE UNIFORMITY

As is usually the case with chewable tablets where

provision is made for a large use of sweet
excipients ,coating agents and for taste masking
and mouth feel .then individual assay of the given
number of randomly selected dosage unit is done
to obtain drug content in the various samples

Jens Martensson
 PHYSICAL EVALUATION
• Tablet physical appearance : as one of the quality control
procedure tablets should be inspected for smoothness,
absence of cracks, chips and undesirable characteristics

• If the tablets are colored this would include examination for

mottling and other evidence of non uniform color
distribution except where they are used intentionally

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HARDNESS

➢The hardness test is performed to provide a

measure of tablet strength. Tablets should be hard
enough to with stand packing and shipping but not
so hard to create undue difficulty upon chewing
FRIABILITY

➢for chewable tablets friability value of up to 4% are

accepted

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DISINTIGRATION
➢This test indicate the ability of the tablet to
disintegrate and still provide the benefit of the drug if
it accidentally swallowed

DISSOLUTION

➢Chewable tablets should be tested in two forms :

intact and partially crushed

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STABLITY TESTING

• Stability testing of dosage forms or drug products is carried

out to evaluate time –dependent changes.

• Accelerated stability testing is used to predict quickly

potential changes that may occur in a product.

• There are three areas of major concern in the stability testing

of chewable tablets : organoleptic, chemical, physical the
data obtained from chemical evaluation of the tablets at
elevated tem and humidity ,stress condition are most useful

Jens Martensson
OTHER TESTS IN THE STABILITY PROGRAM
WOULD INCLUDE

• Active drug content determination.

• Changes in physical characterization of the tablet

• Change in the tablet hardness, friability ,dissolution rate and

extent of dissolution

• Moisture content of the tablets

• Stability of the coating systems

• Stability of the colorants

Jens Martensson
Contoh formulasi tablet kunyah vitamin C :
Zat mg/tablet
• Asam askorbat (berlebih 10%) 275
• Ethocel 7 cp, 10% dalam isopropanol q.s.
• NuTab 275
• Sta-Rx-1500 50
• Na-sakarin 1
• Lake (FD&C) q.s.
• Penyedap q.s.
• Mg-stearat 5

Jens Martensson
Contoh formula : Tablet kunyah Asetaminofen (Mikroenkapsulasi)
Zat mg/tablet
Mikrokapsul (100 mesh)
• Asetaminofen
• Penyalut (selulosa-malam)
• Eksipien : Manitol, Mikrokristalin selulosa (Avicel), Talk, Sakarin, Gom
Guar, Flavor, Mg-stearat

Jens Martensson
APPLICATION

1. Local therapy: Chewable tablet can release an active substance at a controlled rate over an extended
period of time providing a prolonged local effect.
2. Pain: Successful treatment of minor pains, headaches, pains of cold, muscular aches, etc. requires
rapid absorption of therapeutic doses of the active substance. Chewable tablet as a drug delivery
system could be beneficial in minor pain treatment, when buccal absorption results in fast onset of
action and reduces the risk of gastrointestinal side effects.
3. Systemic Therapy: Chewable tablet provides benefits to systemic drug delivery, especially if the active
substance is absorbed through the buccal mucosa.
4. Smoking Cessation: Chewing gum formulations containing nicotine, lobeline and silver acetate have
been clinically tested as aids to smoking cessation.
5. Obesity: Several chewing gum formulations containing caffeine, guarana or chromium are available.
Caffeine and guarana are central stimulating anorectic agents that have proved to increase the
metabolic rate.

Jens Martensson
INSYA ALLAH BERMANFAAT

Jens Martensson