CHAPTER I

PRELIMINARY

A. Background

Drug dosage forms are pharmaceutical preparations in kind certain

according to needs, containing one or more active substances in a
carrier used as an internal medicine or external medicine. There is
various pharmaceutical dosage forms, which can be classified
according to the form of the substance and the route of administration
of the preparation. Based on the substance, drug dosage forms can be
divided into three, namely liquid form preparations (true solution,
suspension and emulsion), semisolid dosage form (cream, lotions,
ointments, gels, suppositories), and solid / solid dosage forms
(tablets,capsules, pills, granules and powder).

According to Pharmacopoeia Edition V (2014), tablets are

preparations solids containing medicinal ingredients with or without
fillers. Based on the manufacturing method, it can be classified as a
printed tablet and felt tablet. Most tablets are made by pressing and is
the most widely used dosage form. Felt tablet made by applying high
pressure to the powder or granule using steel mold. While printed
tablets are made in a way press the mass of low pressure moist powder
into the mold hole.

B. Formulation Of The Problem

1. Definition of Tuberculosis and Tablets ?
2. Prevalency of Tuberculosis ?
3. Main Active of Tuberculosis drugs ?
4. Additive Agents of Tuberculosis drugs ?
5. Explanation of choose subtance main active and additive
agents?

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 6. How the procedure for making tuberculosis drugs in tablets ?

C. PURPOSE
1. Students are able to understand the definition of Tuberculosis
and Tablets
2. Students are able to understand the of Prevalency of
Tuberculosis
3. Students are able to understand the Main Active of Tuberculosis
drugs
4. Students are able to understand the Additive Agents of
Tuberculosis drugs
5. Students are able to understand the Explanation of choose
subtance main active and additive agents
6. Students are able to understand the How the procedures for
making tuberculosis drugs in tablets

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 CHAPTER II
DISCUSSION

A. Definition

a. Definition of Tuberculosis

Definition of Tuberculosis: A highly contagious infection

caused by the bacterium called Mycobacterium tuberculosis.
Abbreviated TB. Tubercles (tiny lumps) are a characteristic finding in
TB. Diagnosis may be made by skin test, which if positive should will
be followed by a chest X-ray to determine the status (active or
dormant) of the infection. Tuberculosis is more common in people
with immune system problems, such as AIDS, than in the general
population. Treatment of active tuberculosis is mandatory by law in
the US, and should be available at no cost to the patient through the
public health system. It involves a course of antibiotics and vitamins
that lasts about six months. It is important to finish the entire
treatment, both to prevent reoccurrence and to prevent the
development of antibiotic-resistant tuberculosis. Most patients with
tuberculosis do not need to be quarantined, but it is sometimes
necessary.

Although there are millions of new cases of TB each year, not

everyone exposed to the bacterium becomes infected nor does
everybody infected with it develop clinical symptoms of TB. A
genetic region has been discovered to be associated with clinical TB.
People with at least one high-risk copy of this genetic region are ten
times more likely to develop TB than normal. The genetic region
contains a gene, NRAMP1, that is known to be involved in the
susceptibility to leprosy, which is caused by a bacterium related to
TB.

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b. Definition of Tablets

A tablet is a pharmaceutical oral dosage form (OSD). Tablets

may be defined as the solid unit dosage form of medicament or
medicaments with suitable excipients and prepared either by molding
or by compression. It comprises a mixture of active substances and
excipients, usually in powder form, pressed or compacted from a
powder into a solid dose. The excipients can include diluents, binders
or granulating agents, glidants (flow aids) and lubricants to ensure
efficient tabletting; disintegrants to promote tablet break-up in the
digestive tract; sweeteners or flavours to enhance taste; and pigments
to make the tablets visually attractive or aid in visual identification of
an unknown tablet. A polymer coating is often applied to make the
tablet smoother and easier to swallow, to control the release rate of the
active ingredient, to make it more resistant to the environment
(extending its shelf life), or to enhance the tablet's appearance.

Compressi tablet

In general, compressed tablet contain active ingredient and filler

(dilluent), binder, disintegrant, and lubricant, that could contain colour
substance and lacquer (the colored substance is absorbed on aluminum
hydroxide that doesn’t dissolve) that allows fragrance and sweet
substance.
Filler substance is added if the amount of active ingredient is low or
hard to compressed. The filler substance that usually is a lactose,
essence, phosphate calcium chem and microcrystalline cellulose.
Chewable tablets often contain sucrose, mannitol, and sorbitol as a
filler substance. If it only contain low active ingredient, the quality of
the tablet as a whole is determined by the filler substance that has a
high quantity. Because the problem of bioavailability hydropobic is if 
the dissoluble level on the water is low, then the filler substance will
be used for the chance to solluble is high.

B. The Prevalency of Tuberculosis

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 Tubercolosis situation in indonesia

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 The prevelency in indonesia is based on data from the ministry
of health Republic indonesia in 2018.estimates that the incidence of
tubercolosis in indonesia reached 842,000 million people cases with
tubercolosis 421,000 milion become cronic and liver cancer a
mortality of 107,000 milion people cases. With this data indonesia is
the third highest burden of TB in the world after india and china.so
that these conditon are alarming especially can have impact on social
and economic.

Tubercoulosis (TB) is an infectious disease and a problom for

indonesia.this disease can be transmitted easily so there must be an
implementation and strategy to prevent it said indonesia health
minister nina moeloek when met after attending an event in the
kuningan area,south jakarta, thusday
Most TB cases occur in the productive age which is between 15 to 54
years.this condition makes patients lose productive time due to
disability and premanture death which results in economic losses.
Thus to achieve the elimination of TB in 2018,an acceleration strtegy
is needed through six steps namely strengthening the role and
leadership of district or city-based program increasing access to
quality services controlling risk factors for TB transminission
enhancing partnerships,strengthening program managmen
andstrengtheng systems and managment TB though various efforts
including research and development.

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C. Main Active of Tuberculosis drugs

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D. Additive Agents of Tuberculosis drugs

a. Stuffing
These materials are intended to achieve the desired weight of
tablets and volume, especially for small amounts of active
materials. Current economic spending requires extracting it so
that it can be molded to produce the right dose of the tablet, thus
marking off the final volume to achieve the desired weight of
the tablet.
When active materials in stufficient quantities, added filings
are intended to reduce exposure during mixing and emptation
and or to acquire the right flow and compressions properties.
Stuffing can also be used to improve the character of active
ingredients, which has not met the right granul character for an
AD, such as improving cohesive or immobility, improving the
flow and flexibility of the water levels in the granul.
The stuffing agent used is: lactose 10%

b. binder
The binder material added to the tablet's formulation gives
the powder cohesive power to form granulators, so the bibs at
home will produce a compact tablet. Cordants can also prevent
scattering of dust when it is rounded up. Application of
libinaries is tuned to other materials from tweaked data of
experience.
The binding agent used is : amylum manihot 10%
(Penuntun praktikum teknologi sediaan solid Institut sains dan
teknologi nasional)

c. Lubrikan

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 The function of the lubricant is to reduce the friction and
surface of the tablets with die walls during the making or
discharge of the tablet.
The lubricants used are:
 Lubrication: Talkum 3%
Lubrication used to reduce friction between the granulat and die
walls during compression and the production of the tablets from
the die.
 Anti Adheren: Mg. Stearat 0.5%
Anti Adheren commonly used for neither sticky granules nor
sticky tablets in the die or punch.

E. Explanation of choose subtance main active and

additive agents
1. Main Active
The reason I chose the main substance is pyrazinamide
and isoniazid because both of these drugs are one of the drugs
used to treat tuberculosis pyrazinamide and isoniazid used by
using and increasing the development of tb bacteria.
dangerous.
The reason I think choosing the dose is because it is in
accordance with the dose of the drug which is related to the
information on Indonesian medicine specialty

2. Aditive Agents
The reason I chose the stuffing material lactose because,
lactose to produce a good compressibility, odorless and inert.
And can be used as a sweetener and reduce bitter taste.
( Lachman, 1994)

Reason I chose the binder Amylum Manihot because,

able to inflate when contact with water and amilosa, can
produce a force reject between particles between the

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 constituents of the tablet when the contact with water and the
hydrophilic part of the Amyum.( Anselitic,1989).

I use a tablet wheel to reduce increased friction at the interface

of the tablet and the metal mold wall during compression and
rejection / removal of the tablet from the mold.
 
F. Procedure for FDC formulas from Isoniazide and Pyrazinamide

The method used is Wet Granulation.

Wet Granulation is the process of mixing particles of active and

excipient substances into larger particles by adding the right amount
of binding fluid so that a moist mass can be granulated. This method is
usually used if:

The active ingredients are resistant to moisture and heat.

Aktif Active ingredients that are difficult to print directly, due to their
poor flow and compressibility.
The principle of the wet granulation method is to wet the mass of the
tablet with a certain binding solution until it gets a certain degree of
wetness, then the wet mass is granulated.
Main Actives Isoniazid, pyrazinamide
Disintegrants Amylum Manihot 10%
Binders Amylum Manihot 10%
Fillers Laktosa 10%
Coloring -
Sweeteners -
Fragrance -
Absorbent -

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Anti frictional agents Lubrikan : Talkum 3% : Anti-Adheren : Mg,
Stearat 0,5%

Ways of working

1. Isoniazid (18,7% or 75mg), Pyrazinamide(400mg) and Rifampisin

(160mg )as an active substance, Lactose as much as 10% as a filler
and Amylum Manihot as much as 10% as a disintegrants
homogeneously mixed into a container that will produce granules.

2. Then moisten with a solution of binding agents, namely Amylum

Manihot 10%. Binders can also be added in the dry form.

3. No need to add colorings, sweeteners, fragrance and absorbents.

4. Then sifted to become granules.

5.and dry the drying cupboards at a temperature of 40-50oC.

6. After drying, it is sifted again to get granules with the required size.

7. Added anti frictional agents , Lubricant: Talkum 3%: Anti-

Adherent: Mg, Stearic 0.5%.

8. And printed into tablets using a tablet machine and the desired size.

9. Test the uniformity of weights

10. Test the violence

11. Test uniformity of size

12. Time test is disintegrants

(http://poltektegal.ac.id/v2012/wp-content/uploads/2017/03/4.-PRAKTEK-1-
GRANULASI-BASAH.pptx)

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 Reference

(http://poltektegal.ac.id/v2012/wp-content/uploads/2017/03/4.-PRAKTEK-1-
GRANULASI-BASAH.pptx)

(Penuntun praktikum teknologi sediaan solid Institut sains dan teknologi nasional)

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Jendral Pengawasan Obat Dan Makanan; 1995.

Ikatan Apoteker Indonesia, Informasi Spesialite Obat Indonesia Volume 50. Jakarta:
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https://m.detik.com/health/berita-detikhealth/d-4312669/tbc-di-indonesia-tertinggi-
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Maryani, Siswanti, Yanthy, dkk. Ilmuresep kelas 11. 2013. Penerbit : Pilar Utama Mandiri

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https://www.medicinenet.com/script/main/art.asp?articlekey=6304

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