REPORT OF PLENARY DISCUSSION

Blok 11 Scenario 3

Muhammad Fathur Muntazky (20170350027)

Anisa Kusnindyasita (20170350098)
Andika Ardi Pradana (20170350024)
Rawi Ingra Savitri (20170350015)
Siti Sarah (20170350005)
Hasna Audita Zahra (20170350107)
Nor Halipah (20170350059)
Seputri Merilla (201700350063)
Fernando Martonggo (20170350099)
Herlyn Destrilia Pingkansary (20170350106)
Hasna Raidatus Syida (20170350030)
Risfina Fithratul Hasanah (20170350072)

FACULTY OF MEDICINE AND HEALTH SCIENCES

UNIVERSITAS MUHAMMADIYAH YOGYAKARTA
1st TUTORIAL

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 PREFACE
Assalamualaikum Wr.Wb.

In the name of Allah, the most Beneficent, the Merciful.

Praise be to Allah, the king of kings, the Lord of the world, and the master of the day after,
which has given us the blessing and guidance. Because grace and mercy good writer can write
with a plenary discussion entitled "REPORT PLENARY DISCUSSION BLOCK 12 SCENARIO
3". As the final report of the block 12 scenario 3 have been given. Sholawat and sallam may God
send them to our Prophet Muhammad, (peace be upon him), his family, his friends, and his
followers. Best envoy for people worldwide. this world to be peaceful because of his efforts in
providing advice humans.
writter aware that this report is far from prefection. So, writter'm sorry if there are some
mistakes. And also writter who hope readers who can give us some critical and suggestions.
On this occasion, the author hereby would like to express deep gratitude, more than he could
reveal, for:
Allah, who has given us the blessing and grace
writters parents', who always pray, encourage, give love and affection, give.
Ingenida Hadning M.Sc., Apt as teacher Group 1
All the people who helped us to write this report
May Allah reward to help anyone who has supported writters, and hope this paper can be
useful for us and the development of science. May God always protect us. Aamiin
Wassalamu'alaikum Wr.Wb.

Yogyakarta, June 28, 2019

writters

TABLE OF CONTENT

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PREFACE i

TABLE OF CONTENTii

CHAPTER I : INTRODUCTION

Background of Study1

The objective of the study1

CHAPTER II : THE RESEARCH FINDING

2.1. Scenario2

2.2. Analysis of Scenario2

a. Halal sertification2

b. The laws related to halal products 2

c. Steps and requirements to get halal certification 2

d. Analysis methods can be used to authenticate halal products 4

e. Causes a restaurant that has been certified halal can contain pork in food9

f. The critical points of halal halalness9

g. HAS 2300011

h. Halal assurance system criteria 14

CHAPTER III : CONCLUSION AND REFERENCES

3.1. Conclusion17

3.2. References 17

CHAPTER I

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 INTRODUCTION

1.1 Background of Study

Leearning skill block is the first block of Problem-Based Learning Pharmacy Education
Faculty of Medicine and Health Science, Muhammadiyah University of Yogyakarta. Inthe
sixth bolock of plenary discussion scenario explain that students of pharmacy can tell about
formulation of effervescent tablets from Vitamin B complex and vitamin C.
1.2 The Object of The Study
1. This report written as a report of scenario 3 of twelfth block’ discussion so that student can
understand teoriticaly.
2. The writter be able to finish case that given in scenario with analysis methode and learning
with group discussion
3. Reach the achievement of the purpose of the tutorial learning methods.

CHAPTER II
THE RESEARCH FINDING

2.1. Scenario
BM is the QA staff. BM is the handling of customer complaints about product effervescent
multivitamin that contains vitamins B1, B2, B6, B12 and C. The complaint is not completely soluble tablets.

2.2. Problem Identification

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 In accordance with the title scenario, in relation to the implementation of education programs at
university, functions and contribution to the implementation of the program Pharmacy. In connection
with that scenario, then the problem can be identified as follows:

a. What is the meaning of effervescent tablets?

b. What are method for making effervescent tablet ?
c. What is the special condition for active substance and exipient for effervescent tablet ?
d. The advantages and the diadvantages from effervescent tablets form ?
e. What is the critical point of effervescent tablets?
f. How is the effervescent formulation of the active substance in the scenario?
g. What are the evaluation of effervescent tablets form ?
h. What is the cause of the problem in the scenario?
i. How to pack and store properly and corectly on effervescent tablets form ?
2.3. Analysis of Problem's scenario
a. Effervescent tablets
Effervescent is defined as the emergence of gas bubbles from liquids as a result of
chemical reactions. Effervescent tablets are non-coated tablets, generally containing
acid and carbonate or bicarbonate compounds that react quickly with the presence of
water by releasing carbon dioxide.
According to (Lieberman, et al., 1992) effervescent can be defined as a dosage form
that produces gas bubbles as a result of solution chemical reactions. The gas produced
when effervescent dissolution is carbon dioxide so that it can give a sparkling effect
(taste like soda water).
Effervescent tablets are tablets made by molding effervescent salt granules or
other materials that have the ability to remove gas when in contact with water. The
effervescent mixture has been known and used as medicine since 100 years ago.
Effervescent tablets are a convenient method for administering a number of active
substances or chemicals that have been previously measured by dissolution.
b. Technic for making effervescent tablets.
1. Wet granulation method
The wet granulation method is a process of converting powder particles into spheres in a
regular form called granules. The granules obtained have good adhesion and flow properties.
2. Dry granulation method
Dry granulation is a granulation process without using liquid and heat. The dry granulation
process is done by compressing dry ingredients into tablets.
3. Direct press method
The requirements of the direct press method are to have good flow and compatibility. In
general this method is used for small doses. The method of making it uses water to avoid a long
granulation process.
The method chosen in this scenario is the dry granulation method because it avoids the use
of water and high humidity so that the acid and base do not react first. Because the material in
the scenario is not heat resistant and has high humidity

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c. Special condition of active substance and exipient for effervescent tablets form
- Active substances requirements :
1. active substance that is easily damaged by gastric flui
2. active substances that are sensitive to ph
3. active substances that are sensitive to light, temperature and humidity
4. active substances dissolve in water
- Additional material requirements:
1. soluble in water so that it can form a clear solution
2. provide comfort when consumed (example: sweetener, coloring)
d. Advantage and disadvantages of effervescent tablet's form.
Effervescent tablet's form also have several advantages and disadvantages, such as :
-Advantages Of Effervescent Tablets
1. Fast onset of action
Effervescent tablets have major advantage that the drug product is already in
solution at the time it is consumed. Thus, the absorption is faster and more complete
than with conventional tablet. This is particularly helpful in treating acute symptoms of
pain. Faster absorption means faster onset of action, critical in treating acute symptoms
such as pain. Buffered preparations with adjustable stomach pH optimize formula
performance characteristics.
Effervescent drugs are delivered to the stomach at a pH that is just right for
absorption. Many medications travel slowly through the gastrointestinal tract or have
absorption that is hampered by food or other drugs. To achieve desired absorption
levels, such drugs have to be often administered as injections or with increased dosages.
2. No need to swallow tablets
Effervescent medications are administered in liquid form so they are easy to take
as compared to tablets or capsules. The number of people who cannot swallow tablets
or who dislike swallowing tablets and capsules is growing. Many diseased conditions
require the patient or customer to swallow several tablets at a time. The elderly, in
particular, have difficulty in swallowing tablets. With an effervescent dosage form, one
dose can usually be delivered in just 3 or 4 ounces of water. The amount used when
someone swallows a conventional tablet or capsule.
3. Good stomach and intestinal tolerance
Effervescent tablets dissolve fully in a buffered solution. Reduced localized contact
in the upper gastrointestinal tract leads to less irritation and greater tolerability.
Buffering also prevents gastric acids from interacting with the drugs themselves, which
can be a major cause of stomach and esophageal upsets.
4. More portability
Effervescent tablets are more easily transported than liquid medication because no
water is added until it's ready to use. .
5. Improved palatability

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 Drugs delivered with the effervescent base, taste better than most liquids, mixtures
and suspensions. Superior taste masking is achieved by limiting objectionable
characteristics and complementing formulations with flavors and fragrances.
Effervescent pharmaceuticals retain their flavor after lengthy storage. The effervescent
tablets essentially include flavorings so they taste much better than a mixture of a non-
effervescent powder in water. Moreover, they produce fizzy tablets, which may have
better consumer appeal than the traditional dosage forms.
6. Superior stability
Excellent stability is inherent with effervescent formulations, particularly
surpassing liquid forms.
7. More consistent response
Drugs delivered using effervescent technology have predictable and reproducible
pharmacokinetic profiles that are much more consistent than tablets or capsules.
8. Incorporation of large amounts of active ingredients
In many cases, one effervescent tablet will equal to three conventional tablets in
active dose amounts.
9. Accurate dosing
Researchers have shown that effervescent tablets enhance the absorption of a
number of active ingredients (e.g. disulfiram and caffeine), compared to conventional
formulations. This is because the carbon dioxide created by the effervescent reaction
can induce enhanced active-ingredient permeability due to an alteration of the
paracellular pathway. The paracellular pathway is the primary route of absorption for
hydrophilic active ingredients in which the solutes diffuse into the intercellular space
between epithelial cells. It is postulated that the carbon dioxide widens the intercellular
space between cells, which leads to greater absorption of active ingredients (both
hydrophobic and hydrophilic). The increased absorption of hydrophobic active
ingredients could be due to the non-polar carbon dioxide gas molecules partition into
the cell membrane, thus creating an increased hydrophobic environment, which would
allow the hydrophobic active ingredients to be absorbed.
10. Improved therapeutic effect
The effervescent components aid in improving the therapeutic profiles of the active
ingredients. They also help in solubilization of poorly soluble drugs.
-Disadvantages Of Effervescent Tablet
1. May require a large volume to be fully dispersed.
2. Must be fully dispersed before administration to avoid gas production in the enteral
feeding tube.
3. Sodium content can be high.
4. Excipients may not dissolve and may sediment out.5. Cannot be dispersed in syringe
owing to the production of gas.
e. Critical point of effervescent tablet's form.
2.2.1 Critical point

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 - The characteristics of vitamin B6 are insoluble in water and vitamin B12 is difficult
to dissolve in water so effervescent tablets that are not water soluble.
- Moisture around the tablet causes rapid deterioration in the product so that there
is an active substance that does not dissolve completely. This is due to the hygroscopic
nature of the active substance which easily to absorbs water.
- Packaging must be closed tightly and stored in a dry place.
- The high pressure force during pressing cause tablet density to be small so the
penetration of the liquid becomes difficult and affects solubility.
- The high content of added sugar causes the longer of tablet to dissolve in water.
The solubility level of sugar in water is about 67.7% at a temperature 20 Celsius so more
sugar will affects the solubility of tablet.

f. The formulation of effervescent tablet's form from combination of Vitamin B Complex

and Vitamin C.
1. Formulation
One effervescent tablet is made with a weight of 1.5 grams.
Formula for 1 effervescent tablet:
Vitamin C 500 mg
Pyridoxine 20 mg
PVP 3% 45 mg
Sukrose 15% 225 mg
Citric acid monohydrate 208 mg
Tatrate acid 222,9 mg
Natrium bikarbonat 249,5 mg
PEG 8000 30 mg
2. Calculation of 1500 mg effervescent tablet weight
Phase in weight 98% = 98/100 1500 mg = 1470 mg
Outer phase (consisting of lubricant) weight 2% = 2/100 "1500 mg = 30 mg
The inner phase consists of active substances, acids, bases, binders, and fillers.
and base weight = inner phase - (active substance + binder + filler) = 1470 mg - (520 + 45 + 225)
mg = 680 mg
a. Citric acid monohydrate
- BM = 210.13
- Equivalent number = 3
- Equivalent weight = 210.13 / 3 = 70.04
b. Tartrat Acid:
- BM = 150.09
- Equivalent number = 2
- Equivalent weight = 150.09 / 2 = 75.05
c. Sodium bicarbonate:
- BM = 84.01
- Equivalent number = 1
- Equivalent weight = 84.01 / 1 = 84.01

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 70.04 moles equivalent + 75.05 mol equivalent + 84.01 mol equivalent = 680 mg
229.1 moles equivalent = 680 mg

equivalent
mole = 2.97
- Citric
acid monohydrate =
70.04 ´ 2.97 = 208 mg
- Tartrat acid = 75.05 "2.97 = 222.9 m
- g sodium bicarbonate = 84.01 "2.97 = 249.5 mg
3.

Procedure
In this formulation use Dry Granulation Method for making Effervescent tablets. The active
substances and excipients are each smoothed in a separate place. Mixed together then mixed
until homogeneous. The powder mass is dislugging, then crushed to a certain degree of fineness.
Sieved with sieve number 16 mesh.The granule flow test was obtained.The flow obtained must
be 10 g / sec. If no flow of that size is obtained, slugging must be done again until the desired
flow is obtained. After the granule has a flow of 10 gr / sec, lubricant is added to the granule.
Granules ready to be pressed into tablets with a weight of 1.5 gr.

g. Evaluation for effervescent tablet's form

-Evaluation of effervescent granules ( In Process Control) :
1. Moisture Test (Lachman, 1989)

The wet granules are weighed and then dried in a drying cabinet until a fixed
weight is obtained. Water content is calculated by the formula :

a.) LOD (Loss on Drying) which is a statement of moisture content based on wet
weight calculated as follows :

b.) MC (Moisture Content) which is a statement of moist content based on dry

weight calculated as follows :

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 According
to Fausett (2000)
the
requirements for water content in effervescent powder ranged from 0.4% -0.7%.

2. Angle Test (Lachman, 1989)

The dried granule is weighed as much as 25 grams, then put in a funnel that is
closed at the bottom. Then the bottom of the funnel is opened so that the granule can flow
on the table which has been coated with graph paper.

Furthermore, the height and diameter of the formed granule were measured. The resting
angle is calculated by the formula :

α = Resting angle

h = granule heap height

d = Granule heap diameter

3. Flow Velocity Test (Lachman, 1989)

The dried granule is weighed as much as 25 grams, then put in a funnel that is
closed under. Then the bottom of the
funnel is opened so that the granules
can flow on the paper-coated table.
The granule flow time is determined when the granule starts flowing until the granule
stops flowing using a "stopwatch". Flow speed is calculated by formula :

The greater value of flow velocity shows that the powder produced has better quality
(Fudholi, 2001).

4. Soluble Time

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 Soluble time indicates the amount of time needed by powder in a serving size to
dissolve completely in a certain volume of water. According to Mohrle (1989) the time to
dissolve effervescent powder which is good ranges from 1-2 minutes.

5. True density (Lachman, 1989)

Testing of true density is done by weighing an empty 50 ml picnometer (a). the

piknometer is filled with liquid paraffin and weighed again (b).

1 gram of granule is loaded into an empty 50 ml piknometer, then weighed (c). Then
the liquid paraffin is added to the picnometer until it is full and weighed again (d). True
type weight is calculated by formula :

- Evaluation of
Efferenten Tablets :

1. Size Uniformity Test (Dirjen POM, 1979)

Twenty
tablets were taken
randomly and
measured in
diameter and thickness of each tablet with calipers. Unless stated otherwise, the diameter
of the tablet is not more than 3 times and not less than 11/3 times the thickness of the
tablet.

2. Weight Uniformity Test (Dirjen POM, 1979)

Twenty tablets were taken randomly and cleaned from dust then weighed one by one
and calculated the average weight. If weighed one by one, no more than 2 tablets of each
weight deviating from the average weight is greater than the price set in column A and
not one tablet whose weight deviates from the average weight greater than the price
specified in column B.

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 Average weight Average weight deviation (%)

A B

25 mg or less 26 mg 15 % 30 %

26 mg to 150 mg 10 % 20 %

151 mg to 350 mg 7,5 % 15 %

More than 300 mg 5% 10 %

3. Tablet Hardness Test (Gennaro, 1998)

Tests were carried out on 6 tablets using a tablet hardness test (Stoches). The tablet
is placed between the anvil with a flat plate that is stationary and clamped by turning the
pressure device. The number indicated by the pointer on the scale is expressed as a zero
point. The press is rotated until the tablet is cracked or broken and the numbers on the
scale are recorded. Tablet hardness requirements of 6-12 kg.4.

5. Time Test of Efferent Tablets (Director General of POM, 1979)

The device consists of a glass containing 180 ml of water at a temperature of 20oC

and a timer (stopwatch). Two tablets are inserted into the glass, then the stopwatch is
turned on when the tablet is inserted into the glass until the tablet dissolves completely.
The requirement for dissolving efferent tablets is 2 tablets dissolved completely in 180 ml
of water at a temperature of 17.5 ° C ± 2.5 ° C within 5 minutes.
h. Cause of problem in scenario.
- The cause of problem in scenario
a.) Magnesium stearate is a hydrophobic ingredient and insoluble in water, if the
effervescent being put into water there will be residue from magnesium stearate so the
effervescent will not dissolve perfectly.
b.) High amount of water content of effervescent tablet cause the tablet become
not sensitive to water because it already form a hydrate that decrease the solubility
(Lieberman et al., 1992). Water also cause the effervescent’ s system unstable. Small
presence of water will activate the effervescent system and react before the time
(Mohrle, 1989).
- The solution for the problem in scenario

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 a.) Avoid using hydrophobic ingredient. Use Active Pharmaceutical Ingredient (API)
and excipient that soluble in water.
b.) Storage the effervescent in well-closed tube with aluminium wrap.
c.) To reduce the high amount of water content, dry the raw materials in oven after
the drying spray.

i. Packaging and storage method for effervescent tablet's form.

- Packaging
Packaging Effervescent tablet packaging and material must have a lid or tightly
closed. Multipurpose containers such as tubes must have a lid that can be resealed if
one tablet has to be taken. The container is equipped with a sachet containing silica gel
to absorb moisture. Aluminum foil can protect effervescent tablets from the influence
of moist air and sunlight. This material is not toxic and is resistant to microbes and has
excellent heat conductivity. The thickness of aluminum foil commonly used is between
0.00035 inch and 0.002 inch. The thinnest aluminum foil can be used but will cause a
reduction in material protection against moisture. The thinner the aluminum foil the
more small holes in the material will be. All packaging processes are carried out in room
conditions that have low humidity (≤ 25%) at 250C.
- Storage
Effervescent tablets are stored in a dry room that is not moist, and is maintained at
room temperature. not exposed to direct sunlight
CHAPTER III
CONCLUDING AND REFERENCE

3.1. Concluding
Effervescent is defined as a dosage form that produces gas bubbles as a result of a
chemical reaction solution. The gas produced during Effervescent dissolution is carbon
dioxide so that it can give a sparkling effect. Effervescent tablets are made by pressing
materials active ingredients with a mixture of ingredients organic materials such as citric
acid, tartaric acid and sodium bicarbonate as well as other tablet supporting materials
such as lubricants, disintegrants, and others. If the tablet is dissolved in water it will
produce carbon dioxide gas which will break the tablet so that the tablet can dissolve
quickly. The method of making effervescent tablets is divided into two, namely dry
method and wet method. The dry method consists of direct press and dry granulation,
while the wet method is wet granulation. The advantage of effervescent tablets is the
preparation of the solution in an instant that contains the right dose of medicine. In
addition, effervescent tablets can produce carbon dioxide gas which gives a good taste
because there are carbonates that help improve the taste of certain drugs. Besides having
several advantages, effervescent tablets also have several disadvantages, both in

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production and in packaging. In terms of production, effervescent tablets must be made
in special rooms that have a relative humidity of 20-25% so it is difficult to produce
chemically stable products.

3.2. References
Ansel, H., 1989. Introduction to the Forms of Pharmaceutical Preparations. Edition to 4 UI
Press. Jakarta Harler. 1997. Yogyakarta Tea Manufacturing
Direktorat Jenderal Pengawasan Obat dan Makanan. 1979. Farmakope Indonesia. Edisi
III. Departemen Kesehatan Republik Indonesia. Jakarta. 6,7.
Jhon Wiley and Sons Inc. New York Voight, R. 1995. Pharmacy Technology Textbook
Second edition. Soendari Translator. Gajah Mada University Press.
Lieberman, H.A. L.Lachman dan J.B. Schwartz. 1989. Teori dan Praktek Farmasi Industri
Volume 1. Marcel Dekker Inc. New York.
Mohrle, R. 1989. Effervescent tablet. Dalam : H.A. Lieberman, L. Lachman dan J.B.
Schwartz (Editors). Pharmaceutical Dosage Tablet. Volume 1, 2nd Edition. Marcel Dekker
Inc. New York
Oxford University Press. London Hui, Y.H., 1992. Encyclopedia of Food Science and
Technology.

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