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Effervescent Tablet Formulation and Physical Evaluation of Gong-Gong Shell Waste (Strombus turturella)
Article · January 2021
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Effervescent Tablet Formulation and Physical Evaluation of Gong-Gong Shell Waste (Strombus turturella)
SUCI FITRIANI SAMMULIA 1*, HASYRUL HAMZAH2, CHAERUL FADLY MOCHTAR3, AMELINDA OKTAVIANI 1
1 Program Study of Pharmacy, Health Institute of Mitra Bunda, Batam, 29444, Riau Island, Indonesia
2 Faculty of Pharmacy, Universitas Muhammadiyah Kalimantan Timur, Samarinda, 75124, Kalimantan Timur, Indonesia.
3 Faculty of Medicine, Public Health, and Nursing, Universitas Gadjah Mada, 55281, Yogyakarta, Indonesia,
*Corresponding Author
Email: [email protected]
Received: 11.08.20, Revised: 08.09.20, Accepted: 25.10.20
ABTRACT
The gong-gong snail (Strombus turturella) is a type of sea snail commonly found around Bintan Island, Riau Archipelago. It is a culinary tour of the typical food of the Riau Islands. This food produces shell waste that is not used correctly. The main composition of gong-gong shells is calcium carbonate (CaCO3), which is very good for preventing osteoporosis. With the presence of calcium, the waste of gong-gong shell can be used as a raw material for the manufacture of pharmaceutical preparations that are effective, efficient, and have high aesthetic value. This study aims to obtain a formulation of effervescent tablets from the waste of gong-gong shells with a variety of active substances and good physical properties. Effervescent tablets were made by wet granulation method in 3 formulas with various concentrations of FI (15%), FII (30%), and FIII (45%) at the concentration of gong-gong shells. The resulting granules and tablets were evaluated. The results of the granule evaluation show that the granules produced from the three formulas meet the requirements. The tablet evaluation results showed that the organoleptic test, weight uniformity, size uniformity, hardness, and pH of the three formulas had met the requirements of a good effervescent tablet. While the three formulas did not meet the brittleness test requirements, the dissolving time test of F III did not meet the requirements. The results of this study indicate that the shells of the gong-gong can be formulated into effervescent tablets and have good physical properties.
Keywords: Effervescent Tablets, Gong-Gong Snail, Strombus turturella, Shell Waste INTRODUCTION
The gong-gong snail (Strombus turturella) is a type of sea snail that is found around the waters of the Riau Islands. The gong-gong snail is a culinary object of Tanjung Pinang and Batam specialties, the gong-gong snail also reflects the maritime area of the Riau Islands Province which is Geographically 95% of the Sea Area [1]. The gong-gong snail (Strombus turturella) is a marine biota belonging to the mollusc phylum of the gastropod class which has an important role for the aquatic environment in the food chain and as an indicator of water quality [2].
The local community uses a lot of bark meat as a source of protein and the waste from the shells of gongs is only a result of creativity. However, the shells of these gongs have the potential to contain quite high calcium [3]. The presence of this
content in the waste of gong-gong shells can be used as raw material for the manufacture of pharmaceutical preparations such as effervescent calcium tablets. In previous research, it was stated that the shell of the gong-gong conch contains CaCO3 compounds [4]. So that it can be processed as a source of calcium.
Effervescent tablets are tablets that produce carbon dioxide (CO2) gas as a result of the chemical reaction of tablet-making materials with a solvent (water). Effervescent tablets are used to make soft drinks practically. Effervescent tablets are self-dissolving in the presence of CO2 gas which helps the dissolving process. This dosage form can increase consumer preference for the product. The impression as a medicine will also decrease because the taste can mask the bitter taste so that it can attract consumers who do not
Suci Fitriani Sammulia et al/ Effervescent Tablet Formulation and Physical Evaluation of Gong-Gong Shell Waste (Strombus turturella)
like to consume drugs [5–7]. Previous researchers have previously made effervescent tablets from mollusk shell waste, namely effervescent nano calcium formulations from crab shells (Portunus sp.) [8,9].
Research related to the use of gong-gong snail shell waste as pharmaceutical preparation has never been carried out. So that researchers are interested in researching the formulation of effervescent tablets from the shell waste of the gong-gong snail (Strombus turturella) which is an icon of the Riau Islands.
MATERIALS AND METHODS Materials
Materials used are bark snail shell flour from gong-gong snail (Strombus turturella), citric acid, tartric acid, sodium bicarbonate, mannitol, magnesium stearate, PVP (Polyvinylpyrrolidone), Talk, Lemon Essence, Tartrazine, Ethanol 70%.
Equipment
Analytical scales (Kenko), sieve, stopwatch, friabilator tester (Teq-Ind), calipers (Vernir caliper), Singel punch tablet press (Flight), pH meter (Milwaukee), oven, dropper pipette, mortar and pestle, measuring cup (Iwaki), parchment paper, spatula.
Make powdered gong-gong shells
Samples were obtained from seafood restaurant waste in Batam City. and is determined in advance at the Faculty of Andalas University in the pharmaceutical biology department. The taken shells are washed using running water, then boiled for 1 hour, then dried in the sun as dry as possible to reduce the moisture and
moisture content of the shells. The dried shell of the gong-gong is then heated using hot coals for
± 1 hour by placing the shell of the gong-gong on the ground and adding charcoal. Then after being burned, put the gong-gong shells in the water and dry again in the sun until dry, after that grind the shells of the gongs and sieve using a 100 mesh sieve and weigh the shells of the gong- gong snails that have become flour.
Water Content Test
Porcelain dishes are dried in an oven at a temperature of 102-105 0 C for 15 minutes. Put the cup in a desiccator (30 minutes) and let it cool after it is weighed. Snail shell sample weighing 5 grams. Then the porcelain plate that has been filled with the sample is put in an oven with a temperature of 102-1050 C for 6 hours. The porcelain plate was put into a desiccator and cooled then weighed [10].
Ash content
Clean the porcelain dishes and dry them in an oven at 105 0 C for 30 minutes. The porcelain plate was put into a desiccator (30 minutes) then weighed. A sample of 5 g of gong-gong snail shell flour was put into a porcelain dish.
Furthermore, it is burned on an electric stove until it is not smoky and put in an ashing furnace with a temperature of 600 0 C for 6 hours. The cup is put inside desiccator, allowed to cool and then weighed [10].
Effervescent Tablet Manufacturing
Barking waste effervescent tablets were made in 3 variations of the active substance concentration (Table I).
Table I. Formulation of the active substance concentration
Ingredient Formulation
Function FI (%) FII (%) FIII (%)
Bark Snail Shell Flour 15 30 45 Active substance
PVP 5 5 5 Binder
Citric Acid 4 4 4 Source of acid
Tartaric Acid 3 3 3 Source of acid
Sodium Bicarbonate 6 6 6 Source of CO2
Magnesium Stearate 1 1 1 Lubricant
Talk 2 2 2 Glidant
Tartrazine 0,2 0,2 0,2 Coloring
Essence lemon qs Qs qs Flavor
Manitol ad 700 mg ad 700 mg ad 700 mg Filler
Making Effervescent Tablets Wet Granulation Method
Preparation of effervescent tablets from waste shells using wet granulation method. Effervescent granules are made separately between acid granules and wet granules. Acid granule is made by mixing gong-gong shell flour, citric acid, tartric acid, part of PVP, tartrazine and lemon essence.
Meanwhile, the wet granule is made by mixing sodium bicarbonate, mannitol with the remaining PVP and then wetted with 70% ethanol dropwise.
The mass to be granulated is then sieved with a sieve and then oven at 500 C for 15 minutes. After sifting from the oven again and then adding talc, magnesium stearate is then tested for its physical properties. do the same for formulas 2 and 3 [11].
Test The Physical Properties Of The Effervescent Granules Of The Bark-Shells
Moisture content
Weigh 5 grams of granule (w0), then put it in aluminum foil and flatten it, put it in the oven at 1050 C for 2 hours. Then weigh the granules after drying (w1). Then calculate the percent water content. The water content requirement of effervescent tablets is ≤ 5% [12].
Silent corner
A total of 25 g of powder was put into the flow time test funnel. The funnel cover is opened so that the powder comes out and is collected on a flat surface. The powder that falls from the flow properties and the height of the cone formed and the length of the powder is measured then the angle of rest is measured [7].
Flow Time
As much as 25 grams of powder mass is slowly poured into the measuring funnel over the edge of the funnel. The lid of the funnel is opened slowly, the powder is allowed to flow out. Time is recorded with a stopwatch until all powder has flowed out. The flow rate is calculated in units of gram / second [13].
Compressibility
Weighed 25 grams of the mass of the tablet powder put in a 100 ml measuring cup, then the volume was measured (V1). Bulk density = The mass in the measuring cup is tapped 100 times from a height of 2.5 cm to a fixed volume (V2) [13].
Physical properties test, gong-gong shell effervescent tablets
The test of the physical properties of the tablets included organoleptic test, uniformity of weight and size, tablet hardness test, tablet friability test, dissolving time test, and pH test according to Indonesian Pharmacopoeia [14] and Badan Pengawas Obat dan Makanan [12].
Data Analysis
Data obtained from the physical test results of Effervescent tablets were statistically analyzed using One-Way ANOVA, with a confidence level of 95%. The data from tablet evaluation results are first tested for normality with the Kolmogorov- Smirnov test to determine whether the data has been normally distributed or not by looking at the significance (> 0.05), then the variant homogeneity test is carried out to determine whether the variant is homogeneous or not by looking at its significance (> 0 05). If the data is normally distributed and homogeneous, then it is followed by a parametric statistical analysis of variance (ANOVA) test. The one way ANOVA method was used to determine the effect of variations in the concentration of gong-gong snail shells on each test. The results of the ANOVA test were significantly different from their significance (<0.05), then it will be continued with the Least Significant Difference (LSD) analysis to find out which groups are significantly different from their significance (<0.05) [15].
RESULTS AND DISCUSSION Make flour gong-gong shells
The process of processing the sample of gong- gong snail shell waste is carried out using running water to remove dirt that is still attached to the shell, then boiling for 1 hour aims to remove unpleasant odors and clean the remains of the shell contents. the gong-gong snail still attached to the shell. Still attached to make it easy to remove, the boiled gong-gong snail shell is then dried in the sun to reduce moisture and moisture content in the gong-gong snail shells [16].
The process of making gong-gong snail shell flour, processing should use the calcination method. The calcination process that converts carbonate into calcium oxide through the following reaction: (CaCO3 → CaO + CO2) at 900°C for 4 hours using a furnace [17]. Due to limited tools, the researchers used the traditional method. After burning the gong-gong snail shells soaked in lazy water so as to accelerate the brittleness of the gong-gong snail shells, then grind and sift, after obtaining flour then weighing it to get the renamed from gong snail shell flour. - gong. The renamed yield was 68.5%. Based on research conducted by Ariyanti et al [18] the
Suci Fitriani Sammulia et al/ Effervescent Tablet Formulation and Physical Evaluation of Gong-Gong Shell Waste (Strombus turturella)
renamed on the scallop shell was 88.32% and the shellfish shell was 78.46%.
The materials used in the process of making effervescent tablet preparations from waste of gong-gong snail shells include flour from bark snail shells as an active substance, PVP (provinyl pyrrolidone) as a binder which is most often used in the manufacture of effervescent tablets and has flow properties well. The main components in the effervescent tablet formula are the acidic and alkaline parts, where these parts will produce and give a bubble effect like soda foam when mixed with water. The source of the acid used is a combination of tartric acid and citric acid because it is very soluble in water. Using only a single tartric acid will produce granules that agglomerate easily and only citric acid will produce a sticky mixture. The source of the base used is sodium bicarbonate because it can accelerate solubility and form reactions [19].
Mannitol as a filler as well as a sweetener aims to achieve the desired tablet weight and has good solubility. Magnesium stearate and talc as a lubricant are intended to reduce friction during the tablet pressing process and are useful for preventing the printing period from sticking to the mold. Tartrazine for added aesthetics as a color enhancer in tablets. Lemon essence is used as a fragrance to disguise the odor of the active substance of the bark snail shells.
Effervescent tablets made from waste of gong- gong snail shells were made as many as 50 tablets per formula with an average weight of one 700 mg tablet with different concentrations of active substances. Formula I contains active substances (15%), formula II (30%), formula III (45%) and in each ingredient 10% exaggeration to prevent underweight in the working process and when repeating the granule evaluation.
In this study, researchers have tried using the direct pressing method but the tablets cannot be printed. So the researchers chose to use the wet granulation method in this study. The purpose of using the wet granulation method is to improve the flow properties and compressibility which is done by mixing the active substance and excipient into larger particles with the addition of the right amount of binder so that a moist print mass can be obtained that can be granulated and produces tablets that are not fragile [20,21]. Before the ingredients are mixed, they must be weighed one by one according to the formula. Effervescent
granules are made separately between acid and alkaline granules to avoid premature effervescent reactions [11]. Acid granule is made by mixing gong-gong shell flour, citric acid, tartric acid, part of PVP, tartrazine and lemon essence. Meanwhile, the wet granule is made by mixing sodium bicarbonate, mannitol with the remaining PVP and then wetted with 70% ethanol dropwise until it can be crushed. The use of PVP and 70%
ethanol produces granules with good compression power, besides that it also produces effervescent tablets that are strong, and dissolve quickly [22]. Then it is sieved with a sieve so that it becomes granular and then oven at 500C for 15 minutes. After from the oven, sift again and mix with the acid granule and add talc and magnesium stearate to mix until homogeneous.
The next step is to evaluate the granules which include moisture content test, flow time, angle of rest and compressibility. Granule evaluation is carried out to determine the quality of the granule before it is compressed using a molding tool.
Good granules are granules of uniform size and granule shape and uniform granule color [13,23].
Granule Physical Properties
The physical properties of the granules affect the tablet-making process, so it is necessary to test the physical properties of the granules, including:
moisture content test, flow time, angle of rest and compressibility (Table II).
Moisture content
The results obtained from the three formulas showed that the moisture content test met the requirements, namely ≤ 5% (Table II). The results of the moisture content test showed that the greater the active substance, the higher the moisture content. Low water content is good for storing preparations for a longer period of time, while high water content is a medium for the growth of microorganisms such as fungi [13].
Flow Time
The results of the flow time test showed that all formulas had a good flow time, namely ≤ 5%.
Based on statistical analysis using ANOVA One Way, it shows a significance value of 0.009 (<0.05). So that it can be continued the LSD test shows that the difference in the concentration of the active substance of each formula is significantly different with the flow time.
Table II. The results of the physical properties test of the effervescent granules
Granule Physical Properties Formula I Formula II Formula III Terms / Literature
Moisture (%) 1,6 2,8 4,5 ≤ 5% [12]
Flow Time (seconds) 2,13 ± 0,10 2,22 ± 0,06 2,45 ± 0,05 2.5 seconds for 25 grams of powder [13]
Angle of Rest (degrees) 19,28 ± 1,02 25,46 ± 1,88 26,99 ± 2,09 <200 (very good) 250- 300 (good)
[24]
Compressibility (%) 10,92 ± 0,63 12,81 ± 0,37 14,30 ± 0,42 5% -12% (very good), 12-16% (good) [24]
This means that the variation in the number of gong-gong shells affects the flow time. Citric acid can release crystalline water during melting, which can bind other particles to form larger granules. Meanwhile, tartric acid does not release crystalline water. Larger granules flow faster under the influence of gravity. So that theoretically, the greater the percentage of gong- gong shell powder used, the better the flow properties of the granules because the size of the granules formed is larger.
Silent Angle
The results of this test are formula I (19,280), formula II (25,460) and formula III (26,990). It was concluded that formula I was very good while for formulas II and III good. The one-way ANOVA test showed a significant difference, namely 0.04 (<0.05). Then the LSD test was continued to see the differences in each formula, so the results were not significant differences in formulas II and III, which means that there was no significant difference between formulas II and III. From the
table, it can be seen that the greater the concentration of gong-gong shell powder, the larger the angle of rest of the granules. This may be due to the mixture of active substances and additionally reducing the cohesiveness of the particles thus increasing the angle of rest.
Compressibility
The results obtained from the compressibility test, formula I (10.95%) is very good, while formula II (14.49%) and III 15.32%). has a good compressibility value. One-way ANOVA test there is a significant difference, namely 0.000 (<0.05).
The LSD test showed that there was a significant difference between the theoretical formulas with the greater percentage of gong-gong shell powder and the greater compressibility as shown in Table II. This is probably because the formula with a larger percentage of gong-gong shell powder tends to produce a small particle size (fines). These small particles will fill the gaps between the granules during tapping, resulting in a decrease in granule volume.
Table III. The results of the physical properties test of the effervescent tablet Granule Physical
Properties Formula I Formula II Formula III Term/Literature
Organoleptic Yellow color, round and flat shape, lemon scent
Yellow color, round and flat shape, lemon scent
Yellow color, round and flat shape, lemon scent
-
CV Uniformity of
weight (%) 2,59 2,68 2,35 ≤ 5 % [25].
Suci Fitriani Sammulia et al/ Effervescent Tablet Formulation and Physical Evaluation of Gong-Gong Shell Waste (Strombus turturella)
CV Uniformity of
size (cm) 19,28 ± 1,02 25,46 ± 1,88 26,99 ± 2,09
Frability Test (%) 5,45 3,11 2,35 0,5-1% [26]
Dissolve Time Test
(minute/second) 2,31 ± 0,07 3,21 ± 0,22 9,24 ± 0,06 ≤ 5 menit [12]
pH test 6,476 ± 0,670 6,493 ± 0,596 6,583 ± 0,573 pH 6-7 [27]
Physical Properties of Effervescent Tablets Granules that have undergone a process of pressing into tablets. The tablet physical test is carried out to ensure that the tablets that have been made meet the requirements of Indonesian Indonesian Pharmacopoeia [14] and Badan Pengawas Obat dan Makanan [12]. The physical evaluation of the tablets included organoleptic, weight uniformity, size uniformity, hardness, friability, pH and dissolving time of effervescent tablets.
Organoleptic
The organoleptic test was observed by looking at the shape, color and smell produced.
Organoleptic test of tablets was performed visually (Table III). The resulting tablet color is not uniform between one formula and another. The difference in color is caused by differences in the content of the active substance. The higher the concentration of active substances, the faded the color of the tablets produced [11].
Uniformity of Weight
Evaluation of weight uniformity aims to determine the uniformity of active substances in tablets which affect the uniformity of the therapeutic effect of these tablets, the uniform weight of tablets will contain the same amount of nutritious substances [19]. The evaluation results of weight uniformity fulfill the requirements of good tablet weight uniformity. not more than 5% [25].
Uniformity of Size
Evaluation of size uniformity aims to determine whether each tablet has the same size uniformity.
The tool used in the size uniformity test is a caliper. The requirement for the uniformity of tablet size is that the tablet diameter is not more than three times and not less than 1 1/3 the thickness of the tablet [7]. The results of the uniformity of size obtained from the three formulas have met the requirements of a good tablet (table III).
Fragility
The evaluation of the fragility test aims to provide clues as to whether the tablet is able to withstand
minor scratches or damage in handling, packaging and shipping. The requirement for tablet fragility is less than or equal to 1% [13]. All of the results obtained from the three formulas did not meet the requirements. Factors that influence the fragility value of tablets are room temperature and humidity, because effervescent tablets are easily decomposed in room temperature and high humidity. Room for manufacture effervescent tablets require special conditions, namely a maximum humidity level of 25% with room temperature <25°C [28].
Time Over
Solubility evaluation aims to determine how long the tablets can dissolve in solvents such as mineral water. The requirement for the dissolving time of effervescent tablets is less than 5 minutes [12]. From the test results, the dissolving time of the tablets for formula I and II met the requirements while for the formula III does not meet the requirements. The very long difference in dissolving time is due to humidity conditions greater than 25%, this is due to the difficulty of controlling humidity in the room where the study was conducted [13]. The results of the one-way ANOVA test showed a significant difference, namely 0.000 (<0.05). The LSD test showed a significant difference from each formula with different concentrations of the disintegration time (Table III).
pH of the solution test
PH of solution prepared putting tablets into water was affected by storage condition due to liberation of CO2 [29]. The last tablet evaluation is the pH test. The purpose of doing the pH test is because if the effervescent solution is too acidic it can irritate the stomach while if it is too alkaline it can cause a bitter and unpleasant taste. The pH of the effervescent solution is said to be good if the pH is close to neutral, namely pH 6-7 [27].
The pH test results of the three formulas meet the specified pH requirements, this can be seen from the results of anova analysis of 0.974 (> 0.05).
CONCLUSION
The flour from the waste of barking snail shells can be formulated into effervescent tablet dosage forms. The results of the physical evaluation of the effervescent tablets showed that formulas I and II were the best formulas almost as a whole because they met the requirements of good physical properties of granules and effervescent tablets.
Acknowledgment
The author gives thanks to Allah SWT for his grace so that this research can run smoothly.
KEMENRISTEK-DIKTI has funded this research with Number B/87/E3/RA.00/2020. Mitra Bunda Health Institute which has provided facilities and infrastructure so that this research can run smoothly. Authors declare that they have no conflict of interest.
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FORMULASI TABLET EKSTRAK
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