Formulation of Moringa Extract Chewable Gummy Tablet with
Na-Alginate and Pectin as Carriers
Karina C. Rani1, Titin U. Hasanah2, Baqrotul Ilmiah3, Nikmatul I. E. Jayani4*
1Departement of Pharmaceutics, Faculty of Pharmacy, University of Surabaya, Surabaya, Indonesia.
2,3Faculty of Pharmacy, University of Surabaya, Surabaya, Indonesia.
4Department of Pharmaceutical Biology, Faculty of Pharmacy, University of Surabaya, Surabaya, Indonesia.
*Corresponding Author E-mail: nikmatul.ikhrom@staff.ubaya.ac.id
ABSTRACT:
Introduction: Chewable gummy tablets are generally formulated with gelling agents such as pectin, gelatin, Na-alginate, and sugar. The selection of the appropriate carrier has a significant effect on the rheological properties of the product. Objective: To analyze the effect of different concentrations of Na-alginate and pectin on the physical characteristics of the preparation. Methods: In this research, 6 formulas were developed, namely Formula 1, 2, and 3 (with Na-alginate concentration of 6%, 7%, and 8%, respectively), Formula 4, 5, and 6 (with pectin concentration of 6%, 8, and 10%, respectively) and the active ingredient of ethanolic extract of moringa leaf (Moringa oleifera L.) extract. The evaluation of the preparation consisted of organoleptic test, pH, swelling ratio, dissolving time, weight variation, tablet dimension, and texture analysis (gumminess and chewiness). Results: The organoleptic test of the preparation showed that the preparation has square shape, green color, melon scent, sweet taste, and chewy texture. The pH value ranges from 5.06 ± 0.02 to 5.12 ± 0.04. The swelling ratio for Na-alginate carrier is between 20.00 ± 1.00% to 21.67 ± 0.58% while for pectin carrier ranges from 1.88 ± 0.24% to 2.08 ± 0.33%. The dissolving time ranges from 19.11 ± 0.19 minutes to 25.08 ± 0.02 minutes. The weight variation has an acceptance value between 3.96 ± 1.15 to 9.53 ± 1.16. Dimensions of Length, Width, and Thickness range from 1.50 cm x 1.50 cm x 1 cm. Texture analysis (Gumminess and Chewiness) on Na-alginate carrier is between 103.82 to 146.37 (Nxmm) and 46.24 to 146.37 (Nxmm), while on pectin carrier is between 90.4 to 1081.27 (Nxmm) and 36.16 to 3243.82 (N x mm). Conclusion: Swelling ratio, dissolving time, gumminess, and chewiness increase related to the concentration of Na-alginate and pectin. Na-alginate has a potential as a carrier for chewable gummy tablets at a concentration of 6%-7%. Meanwhile, pectin has a potential as a carrier with a concentration of 6%-10% in the development of chewable gummy tablets.
KEYWORDS: Chewable gummy, tablet, Na-alginate, pectin, Moringa.
INTRODUCTION:
Functional foods are sometimes referred to as nutritionals, both of which are considered to have nutritional and pharmaceutical functions3. According to the International Food Information Council (IFIC), functional foods are food or its components that can provide health benefits in addition to their basic nutrients. Nowadays, both nutritional and functional foods are in high demand because they are considered safe and have the potential to have nutritional and therapeutic effects such as preventing cancer, cardiovascular disease, obesity, and type 2 diabetes4.
Changes in the socio-economic condition of the society cause consumers to look for products that can provide health benefits in addition to their nutrition. Moringa oleifera is a plant that is widely used as a functional food. Almost all parts of the plant, which include root, bark, seed, flower, pod, oil seed, and leaf, have food, agricultural, and industrial potentials5. The most widely used and safe part of the plant for consumption and nutritional properties, that have been widely researched, is the leaves6,7. Moringa leaf is rich in nutrients such as; protein, carbohydrates, fiber, beta carotene, and Vitamin C as well as minerals such as calcium, potassium, iron, and phosphorus8,9. The high proximate content in Moringa leaf shows that it is a very good source of natural nutrition and energy for nutritional fulfillment or nutritional supplementation, combating malnutrition in infants, and supplements for pregnant and nursing mothers. The high vitamin content and polyphenol compounds make Moringa leaf rich in antioxidants and make it a natural source of antioxidants6,10. Moringa is also reported to be able to modulate the body's immune system which can boost the immune system11. This background encourages researchers to develop a functional food preparation with the active ingredient of Moringa leaf. Some functional food preparations made from Moringa leaves include: soup, moringa chocolate, biscuits, bread fortified with Moringa leaves, chin-chin (a Nigerian food), yogurt, and muffins8. The lozenges preparation containing M. oleifera leaf extract powder, has been reported by Panya (2016) where the results showed that all the criteria values were in an acceptable range and, microbial testing did not show the presence of microorganism contamination12.
Nutrition Business Journal, in 2018, reported that the sale of nutraceuticals with chewable gummy tablet dosage form was around 12% of the total sale in that year. Chewable gummy tablets are believed to provide a pleasant experience, are delicious, and are easy to consume13,14. Chewable gummy tablets have sweet characteristics (since they are generally obtained from sugar processing), chewable (gummy), and solubility in the mouth is relatively slow, with color, taste, and chewy texture15. Chewable gummy tablets can be interesting to children and adults with no swallowing disorders. Chewable gummy tablets are formulated with carriers derived from natural ingredients which are given some active ingredients. The carriers used are usually gelling agents such as pectin, gelatin, Na-alginate, and sugar. The selection of the appropriate carrier has a significant effect on the rheological properties of the product16.
Pectin is sensitive to pH, contains sugar, and is a cation. High methoxy pectin is a polysaccharide derived from orange peel and apple pomace17. Pectin gel is thermo irreversible, clear, transparent, can be dispersed in cold water, dissolved in cold or hot water, does not dissolved if the cave content is more than 25%, has pH of 2.5-4, stable temperature between 40°C -850°C, syneresis, low viscosity, and is commonly used in the range of 0.15%-6.3%18. Na-alginate is a polysaccharide extracted from brown algae, which has a thermo-reversible texture due to the presence of calcium ion19. Alginate that does not contain calcium is clear, transparent, can be dispersed in cold water, when added with acid (pH < 4), alginic acid precipitation occurs which can be prevented by the addition of sodium citrate, can be dissolved in cold or hot water, dissolving in cold water takes several hours to hydrate, has pH of 2.8-10, requires calcium to form a gel, undergoes syneresis, low viscosity and is generally used in 0.5%-1% range20.
In this research, the development of Moringa leaf extract chewable gummy tablets with Na-alginate and pectin as carriers is carried out to analyze the potential of the two gelling agents as the matrix constituents of chewable gummy tablets. This research also aims to analyze the effect of the different concentrations of Na-alginate (6%, 7%, and 8%) and pectin (6%, 8%, and 10%) on the physical characteristics of the chewable gummy tablets of Moringa leaf extract. Several evaluations were carried out on Moringa leaf extract chewable gummy tablet, including evaluation of organoleptic, pH, swelling ratio, dissolving time, weight variation, tablet dimension, and texture analysis (gumminess and chewiness).
MATERIAL AND METHODS:
Materials:
Moringa leaf powder (Royal Moringa, Kelorina®), Na-alginate (Asian Bahan Farmasi Semarang), pectin (CV. Harapan Kimia Indonesia), mannitol (CV. Harapan Kimia Indonesia), sucrose, sorbitol (CV. Harapan Kimia Indonesia), tartaric acid (CV. Harapan Kimia Indonesia), sodium metabisulfite (CV. Harapan Kimia Indonesia), sodium benzoate (CV. Harapan Kimia Indonesia), essence (CV. Harapan Kimia Indonesia), corn syrup (CV. Harapan Kimia Indonesia), corn oil (CV. Harapan Kimia Indonesia), ABTS solution (Sigma Aldrich).
Instrumentation:
Analytical scale (Ohauss®), gram scale (Ohauss®), square-shaped candy mold, spatula, pan, Microplate Reader (FLUOstar® Omega), rotary evaporator (Buchi), texture analyzer (Agrosta Texturometer Version 2), micropipette (Socorex), micropipette tips (blue and yellow), dark bottles, and laboratory glassware.
Moringa Leaf Extract Preparation:
The extraction method was done by maceration using ethanol solvent 96% (3x24 hours). The liquid extract was concentrated using a rotary evaporator and then concentrated in a water bath with the temperature of 40°C21.
Table 1. The Formula of Moringa Chewable Gummy Tablets 1
|
Components of the formula |
Na-alginate |
Pectin |
||||
|
F1 (6%) |
F2 (7%) |
F3 (8%) |
F4 (6%) |
F5 (8%) |
F6 (10%) |
|
|
(%) |
(%) |
(%) |
(%) |
(%) |
(%) |
|
|
Moringa leaf extract |
2 |
2 |
2 |
2 |
2 |
2 |
|
Mannitol |
10 |
10 |
10 |
10 |
10 |
10 |
|
Sucrose |
28 |
27 |
26 |
28 |
26 |
24 |
|
Na-alginate |
6 |
7 |
8 |
- |
- |
- |
|
Pectin |
- |
- |
- |
6 |
8 |
10 |
|
Tartaric acid |
1 |
1 |
1 |
1 |
1 |
1 |
|
Sodium benzoate |
0.5 |
0.5 |
0.5 |
0.5 |
0.5 |
0.5 |
|
Sorbitol |
25 |
25 |
25 |
25 |
25 |
25 |
|
Sodium metabisulfite |
0.5 |
0.5 |
0.5 |
0.5 |
0.5 |
0.5 |
|
Melon Essence |
5 |
5 |
5 |
5 |
5 |
5 |
|
Corn syrup |
8 |
8 |
8 |
8 |
8 |
8 |
|
Corn oil |
5 |
5 |
5 |
5 |
5 |
5 |
|
Aquadest |
10 |
10 |
10 |
10 |
10 |
10 |
Testing of Moringa Leaf Extract Antioxidant Activity:
The method of testing the antioxidant activity refers to Setiawan (2018) by employing ABTS method (2,2’-Azinobis [3-ethylbenzothiazoline-6-sulfonic acid]-diammonium salt). The absorbance measurement was carried out with a Microplate Reader (FLUOstar® Omega). From the calculation result of each concentration of the test solution, the % inhibition was obtained. The concentration curve (ppm) of the % inhibition was made, then the regression equation, y = a + bx, was obtained. The IC50 (inhibitory concentration) value was calculated to determine what concentration of the sample was needed to have 50% of the inhibition 22.
The Formula of Moringa Chewable Gummy Tablet Preparation:
In this research, 2 types of carriers were used to make Moringa Chewable Gummy Tablets, namely Na-alginate and Pectin. The preparation with Na-alginate carrier was made in 3 formulas (Formula 1, 2, and 3) with a concentration of 6%, 7%, and 8% of Na-alginate, respectively. The preparation with pectin carrier was made in 3 formulas (Formula 4, 5, and 6) with a concentration of 6%, 8%, and 10% of pectin. The formula of Moringa Chewable Gummy Tablets with Na-alginate and pectin carriers can be seen in Table 1.
The Making of Moringa Chewable Gummy Tablets with Na-Alginate Carrier:
Na-alginate, Corn oil, and Corn syrup were heated and stirred until they dissolved (mixture a). Sucrose and sodium benzoate were mixed with mannitol, tartaric acid, sodium metabisulfite, essence, and moringa extract, respectively, then mixed homogeneously, heated at 60°C (mixture b). Mixture a and mixture b were homogenized while heated at 60°C. The mixture was then put into the mold and left to cool down, then the quality of the preparation was evaluated23.
The Making of Moringa Chewable Gummy Tablets with Pectin Carrier:
The pectin was diluted with hot water first. Sorbitol, mannitol, sucrose, sodium benzoate, sodium metabisulfite, tartaric acid, and essence were heated at 60°C. After it was homogeneously dissolved, the moringa extract was added into it and heated again at 60°C for 5 minutes. The mixture was then homogenized with pectin solution. Corn oil and corn syrup were added, stirred until homogeneous by heating at 60°C. The mixture was then poured into the mold and left to cool down, then the quality of the preparation was evaluated24.
Organoleptic Evaluation:
The chewable gummy tablets were observed visually regarding the taste, shape, aroma, and texture of the preparation25.
pH Evaluation:
The pH evaluation is carried out on the mold mass before the molding process and on the finished product. The pH evaluation of the chewable gummy product was carried out by dispersing the preparation in 50ml of purified water then tested using a pH meter26.
Swelling Ratio Evaluation:
The swelling process is the same as the osmosis process, which is the process of water entering cells quickly. The degree of swelling is related to the absorption of water by the polymer system as the water volume increases. The determination of the swelling ratio was done by weighing the initial weight of the chewable gummy tablets to obtain the dry weight. The tablets were then immersed in 100ml of purified water for 10 seconds and were weighed so that the wet weight was obtained. Wet weight (W wet) dry weight (W dry). Then, they were included into the equation to measure the swelling ratio27,28.
Swelling ratio = (W wet – W dry)/W dry x 100%
Dissolving Time Evaluation:
The dissolving time evaluation describes the process of drug transfer from the solid phase to the surrounding medium, such as water, polymer, and tissue. This evaluation was carried out at 37°C in a beaker glass containing 100mL of water, while being stirred constantly16. The dissolving time evaluation was carried out to determine the time span the chewable gummy could be dissolved before entering digestion system. The dissolving time requirement of chewable gummy tablets based on previous research is 10-30minutes23.
Weight Variation Evaluation:
The evaluation of weight variation was carried out on chewable gummy tablets because the preparations contained active ingredients ≥ 25mg and ≥ 25%29. The evaluation of weight variation was carried out on each formula by weighing 10 chewable gummy tablets one by one. Based on the result of the weight of the tablets, then an estimate amount of active substance (Moringa leaf extract) was determined in percent. The next step was to calculate the acceptance value of the preparation using formula; │M - X│+ k.s. The result of the acceptance value calculation is declared to meet the requirements for the variation of weights if the acceptance value is less than 15%29.
Tablet Dimension Evaluation:
This test aims to measure the length, width, and thickness of the chewable gummy tablets. This test was conducted to determine the uniformity of the size of the chewable gummy tablets. The dimension of the tablets was measured using a caliper and 10 tablets were needed in this test. The requirement for tablet dimension test is that the standard deviation of chewable gummy tablets is not more than 5%30.
Texture analysis:
Texture analysis was performed using a texture analyzer at a room temperature (22±2°C). In the compression test, the p100 analytic probe is lowered to be in each sample of chewable gummy tablet to be tested at a predetermined rate, which was forced down to every 1 mm/s using a 5kg load accompanied by 5.0g trigger force. After the trigger force had reached 5.0g, the probe was continued by compressing the sample to 20% of its original height, held for 60 seconds, then pulled from the sample and returned to the starting position. The results would be determined in the form of a graph between force vs time or force vs distance and would show the firmness characteristics of the chewable gummy tablet16. The parametes that were analyzed included gumminess and chewiness.
RESULTS AND DISCUSSION:
Antioxidant Activity of Moringa Leaf Extract:
In this research, the determination of the Moringa leaf extract antioxidant activity was carried out using ABTS test. ABTS is a radical that has a nitrogen center with a characteristic of blue-green color, when reduced by antioxidants, ABTS changes to a non-radical form (from greenish blue to colorless). This method is very sensitive to light, therefore, the ABTS formation process requires an incubation time of about 12-16 hours in the dark. The principle of the antioxidant activity test with ABTS method is to remove or to reduce the color of the ABTS cation to measure the ability of antioxidant to directly react with ABTS cation radical. The antioxidant compound found in Moringa leaf extract neutralized the free radical (ABTS) so that the color of the ABTS solution changed from greenish blue to colorless. The color change occurred proportionally with the increase in the concentration of Moringa leaf extract, indicating an increase in antioxidant activity22. The decrease in ABTS absorbance due to color changing after the extract was added indicated the ability of Moringa leaf extract to ward off free radicals. Based on the absorbance data, the % inhibition was calculated for each concentration of Moringa leaf extract. The linear regression equation between the concentration of Moringa leaf extract (ppm) against the % inhibition can be seen in Figure 1. The regression equation obtained was y = 0.1325 x + 32.571 (R2 = 0.9207). From this equation, the IC 50 value was 131.49 ppm. Based on the IC 50 value, it can be concluded that Moringa leaf extract has antioxidant activity, although it is included in the weak category31,32.
Figure 1. Linear Regression Curve of Moringa Extract Concentration Vs % Inhibition
Organoleptic Evaluation of Chewable Gummy Tablets:
The results of the organoleptic observation of the preparation can be seen in Figure 2. The figure showed that the preparation was square, green, smelled of melon, had a sweet taste, and had a chewy texture. Based on physical observations, chewable gummy tablets with Na-alginate carrier showed a firmer and less elastic consistency compared to pectin carrier.
|
(1) |
(2) |
(3) |
|
|
|
|
|
(4) |
(5) |
(6) |
Figure 2. Organoleptic of Moringa Chewable Gummy Tablets Preparation, Formula 1 Na-alginat 6% (1); Formula 2 Na-alginat 7% (2); Formula 3 Na-alginat 8% (3); Formula 4 Pektin 6% (4); Formula 5 Pektin 8% (5) and Formula 6 Pektin 10% (6)
Table 2. Evaluation of Moringa Chewable Gummy Tablets Preparation
|
Parameters |
Na-alginate |
Pectin |
Preparation Specifications |
|||||
|
F1 (6%) |
F2 (7%) |
F3 (8%) |
F4 (6%) |
F5 (8%) |
F6 (10%) |
|||
|
Organoleptic |
Scent |
Melon |
Melon |
Melon |
Melon |
Melon |
Melon |
Melon |
|
Color |
Green |
Green |
Green |
Green |
Green |
Green |
Green |
|
|
Flavor |
Sweet |
Sweet |
Sweet |
Sweet |
Sweet |
Sweet |
Sweet |
|
|
Shape |
Square |
Square |
Square |
Square |
Square |
Square |
Square |
|
|
pH |
|
5.05±0.02 |
5.05±0.02 |
5.12±0.04 |
5.11±0.01 |
5.11±0.01 |
5.11±0.01 |
5.00-6.00 |
|
Swelling ratio (%) |
20.00±1.00 |
20.67±1.15 |
21.67±0.58 |
1.96±0.19 |
2.08±0.33 |
1.88±0.24 |
15-25 |
|
|
Dissolving Time (minute) |
25.08±0.02 |
25.04±0.04 |
25.01±0.01 |
19.11±0.07 |
19.54±0.08 |
19.63±0.11 |
10-30 |
|
|
Weight Variation (Acceptance value) |
9.53±1.16 |
5.14±9.82 |
3.96±1.15 |
4.62±0.84 |
4.39±0.15 |
5.18±0.23 |
< 15.0 |
|
|
Tablet dimension |
Length (cm) |
1.49±0.03 |
1.49±0.04 |
1.49±0.04 |
1.50±0.00 |
1.50±0.00 |
1.50±0.00 |
SD < 5.0% |
|
Width (cm) |
1.49±0.03 |
1.49±0.04 |
1.49±0.04 |
1.50±0.00 |
1.50±0.00 |
1.50±0.00 |
||
|
Thickness (cm) |
1.00±0.00 |
1.00±0.00 |
1.00±0.00 |
1.00±0.00 |
1.00±0.00 |
1.00±0.00 |
||
|
Texture Analysis |
Gumminess (N x mm) |
115.6 |
146.37 |
103.82 |
90.4 |
819.65 |
1081.27 |
- |
|
Chewiness (N x mm) |
46.24 |
146.37 |
57.68 |
36.16 |
2458.96 |
3243.82 |
- |
|
Evaluation of Chewable Gummy Tablets Preparation:
The evaluation of Chewable Gummy Tablets preparation can be seen in Table 2. The evaluation includes organoleptic, pH, swelling ratio, dissolving time, weight variation, dimension, and texture of the preparation.
pH Evaluation:
The pH evaluation of Moringa leaf extract chewable gummy tablet was carried out to predict the suitability of the pH of the preparation with an acceptable pH range in the oral mucosal cavity (pH 5-9)23. The pH of the chewable gummy tablet preparation is also an important parameter that determines the taste and stability of the gel structure33. The result of the pH evaluation of Moringa leaf extract chewable gummy tablet with Na-alginate and pectin carriers ranged from 5.06 ± 0.02 to 5.12±0.04. pH is an important factor in the formation of gel on pectin. The lower the pH of the preparation, the firmer the pectin gel will be. However, if the pH is too low or too high, it can cause syneresis and rupture of the gel structure34. The pH value also affects the gelation process and the interface tension of Na-alginate. pH also affects the release of the drug from the Na-alginate matrix. The results of previous studies showed the optimal characteristic of development, interface tension, and drug release from Na-alginate gel are at pH 4.0-7.035. The pH result of the preparations obtained in this research is in accordance with the optimum pH of Na-alginate and pectin as forming gel structure. The pH of the chewable gummy tablet preparation in this research is also in the stable pH range of the antioxidant component of Moringa leaf extract, which is in the pH range 4.0-9.036. This condition can maintain the chemical stability of the preparation.
Swelling Ratio Evaluation:
Swelling ratio evaluation was conducted to determine the swelling ability of the carriers used in each formula. The process of developing the preparation occurs due to the formation of hydrogen bonds between carrier molecules or hydrogen bonds with water molecules. The monomer that makes up each carrier due to the presence of these hydrogen bond becomes more open and bonded to water molecules27. Increasing the concentration of Na-alginate in the chewable gummy tablet formulation resulted in an increase in the swelling ratio of the preparation. In general, increasing the hydrophilic component in a preparation will increase the water absorption capacity. Na-alginate is a hydrophilic polymer with a linear chain. Increasing the concentration of Na-alginate in the hydrogel structure has an impact on increasing the hydrophilicity of polymer tissue37. This is in line with the phenomenon observed in formula 1 to formula 3 of chewable gummy tablets with Na-alginate as the carrier.
The increase in pectin concentration from 6% to 8% in the chewable gummy tablet formula also caused an increase in the swelling ratio of the preparation, but at a concentration of 10%, it decreased. The higher the pectin concentration causes the ability of the preparation to absorb water also increases. Water trapped in the preparation causes the pectin polymer tissue to expand, observed as the swelling ratio. The increase in pectin concentration which is getting higher does not always have a linear impact on increasing the swelling ratio as in formula 6 which uses 10% pectin. This is because the increase in gel viscosity occurs when the pectin concentration increases significantly. The increase in the viscosity of the gel made it difficult for the aqueous media to concentrate into the polymer chain tissue, the impact of the swelling ratio in formula 6 is lower than formula 5 which used 8% pectin27. The evaluation results also showed that pectin as the carrier produces a lower swelling ratio of chewable gummy tablets compared to Na-alginate. This is because the polymer tissue structure formed by pectin is denser and stronger than Na-alginate, so that it is more difficult for water molecules to enter the chewable gummy tablet structure38. These differences in characteristics will also have an impact on the ability of the carrier to hold water molecules during storage and the tendency to release water molecules trapped in polymer tissue (syneresis)26.
Dissolving Time Evaluation:
Dissolving Time evaluation was carried out on Moringa leaf extract chewable gummy tablets to obtain an overview of the disintegration and release of active ingredients from each carrier26. Dissolving time evaluation can also be used to predict the early onset of drug. The faster the chewable gummy tablet dissolves, the faster the dissolved active ingredients can be absorbed. The result showed that an increase in the concentration of carriers, both pectin and gelatin, has an impact on increasing the dissolving time of the preparation. This is because there are stronger and more cross-links between the polymers, resulting in a solid gel39. The stronger the gel structure, the longer it takes for the chewable gummy tablet to dissolve. The six chewable gummy tablet formulas have a solubility time ranging from 19.11-25.8 minutes, which is in accordance with the requirements, namely 10-30 minutes. Moringa leaf extract chewable gummy tablets with pectin carrier showed a faster dissolving time than Na-alginate. Pectin is a polymer that has a high swelling rate and the gel structure that is formed can experience erosion40. The faster dissolving time with pectin carrier is due to the fact that the tablet not only expands then slowly dissolves, but there is also an erosion mechanism on the tablet surface26.
Weight Variation Evaluation:
Weight variation evaluation of the chewable gummy tablet was conducted to predict the content uniformity of Moringa oleifera leaf extract in the dosage form. The results showed that all formulas exhibited uniform weight. It can be concluded from the accepted value which lay below 15%. According to these results, sodium alginate and pectin were promising as a chewable gummy tablet carrier to produce homogeneity in the prepared formulas.
Tablet Dimension Evaluation:
The evaluation of tablet dimension was carried out to determine the uniformity of the size of the Moringa leaf extract chewable gummy tablets. The dimension of the tablets is influenced by the process of pouring the mixture into the mold. This evaluation is carried out by measuring the length, width, and thickness of the chewable gummy tablets using a caliper. The dimension of the tablets is closely related to the weight of the chewable gummy tablets, so they also have an impact on the uniformity of the active substance content in each preparation. The dimension of the chewable gummy tablets will also affect the size of the packaging. Tablet preparation is stated to have homogeneous dimension if the standard deviation of each dimensional parameter (length, width, and thickness) is not more than 5%30. Based on the evaluation result, it is known that all formulas of Moringa leaf extract chewable gummy tablets in this research showed uniform dimensions.
Texture Analysis:
The texture analysis of Moringa leaf extract chewable gummy tablets was carried out using a texture analyzer. Texture has an important role in the development of chewable gummy tablets because it affects the sensory response and the ease of swallowing the preparation. The difference in texture of chewable gummy tablets is very important to be developed to meet the varied consumers' sensory expectations41. The important parameters determined in the analysis include gumminess and chewiness. Gumminess is the energy needed to crush or break down semi-solid food into a form that is ready to be swallowed, meanwhile chewiness is the rate at which an object returns to its original shape after a change in shape or deformation occurs42. Gumminess is also defined as a sticky nature which describes the deformation of the dosage form, whereas chewiness indicates the amount of energy required to chew a food product before being swallowed. The shape deformation is influenced by the cohesion and adhesion forces43.
The results of the analysis of gumminess and chewiness parameters of moringa leaf extract chewable gummy tablets formula showed that an increase in the concentration of both Na-alginate and pectin carriers led to an increase in the value of gumminess and chewiness. The opposite condition is observed in Formula 3 with a concentration of 8% Na-alginate. This formula shows a decrease in gumminess and chewiness values compared to Formula 2 which uses 6% Na-alginate concentration. In general, increasing the concentration of hydrocolloid carriers will result in a stronger and more elastic gel system. This is because there are stronger and more cross-links between the polymers. The results of previous studies also showed a similar profile. The increase in carrier concentration caused the chewable gummy to become stickier, as observed from the increase in the gumminess value43. The higher the pectin concentration in the formula, the denser the fine powder structure formed in the polymer tissue44. This condition results in an increase in the force required to chew the preparation until it is ready to be swallowed. The increase in force was observed as an increase in chewiness value along with an increase in pectin concentration.
A slightly different phenomenon was observed in formula 3 with a concentration of 8% Na-alginate. The use of Na-alginate with a concentration of 8% caused a decrease in the value of gumminess and chewiness. This condition is related to the ability of the carrier to hold water in the gel structure which decreases at this concentration compared to the 6% concentration. The decrease in water retention ability will have an impact on the gel structure which tends to be softer and there are a lot of free water molecules41. Previous studies regarding the effect of Na-alginate concentration on gel structure also showed similar results. Increasing the concentration of Na-alginate increases the cohesiveness, but when the concentration used is too high, the gel cohesiveness decreases. This is because the alginate gel cannot show linear viscoelasticity when the concentration of use is above 5%. The use of Na-alginate with a concentration of 8%-32% caused damage to the three-dimensional cross-linking structure, resulting in a change in its characteristics from non-linear solid viscoelastic to liquid viscoelasticity45.
CONCLUSION:
Based on the results of the research, it is known that Na-alginate and pectin are potential carriers for the development of moringa leaf extract chewable gummy tablets. Increasing the carrier concentration generally causes an increase in swelling ratio, dissolving time, gumminess, and chewiness. Na-alginate can be used as a carrier for chewable gummy tablets at a concentration of 6%-7%. Meanwhile, pectin can be used as a carrier with a concentration of 6% -10% in the development of chewable gummy tablets.
ACKNOWLEDGEMENT:
Thank you very much to KWT Sri Rejeki, Bogo Village Officials, and Bojonegoro Regency Officials for their support in the development of Moringa leaf-based products which are the superior commodity of Bojonegoro Regency.
CONFLICT OF INTEREST:
There was no conflict of interest
REFERENCES:
1. Jalili T, Medeiros DM and Wildman REC. Dietary fiber and coronary heart disease. in Handbook of Nutraceuticals and Functional Foods, Edited by Wildman REC. CRC Press Taylor & Francis Group, Boca Raton. 2016; 2nd ed: 131-142.
2. Pathak Y. Nutraceuticals: Definitions, Formulations, and Challenges. in Handbook of Nutraceuticals, Edited by Pathak Y. CRC Press Taylor & Francis Group, Boca Raton. 2010; 1st ed: 15-25
3. Webb GP. Dietary Supplements and Functional Foods: Second Edition. Blackwell Publishing Ltd, London. 2013.
4. Takaoka S, Ogasawara K and Moriyama H. Production of Nattokinase as a Fibrinolytic Enzyme by an Ingenious Fermentation Technology: Safety and Efficacy Studies in Biotechnology. in Functional Foods and Nutraceuticals, Edited by Bagchi D, Lau FC and Ghosh DK. CRC Press Taylor & Francis Group, Boca Raton. 2010; 1st ed: 331-348.
5. Shamim Q, Jitendra P, Reddy A, Safiullah S and Mohapatra P. Phytochemicals and Pharmacological Activities of Moringa oleifera Lam. Research Journal of Pharmacology and Pharmacodynamics. 2010; 2(2):183-186.
6. El-Sohaimy SA, Hamad GM, Mohamed SE, Amar MH and Al-hindi RR. Biochemical and functional properties of Moringa oleifera leaves and their potential as a functional food. Global Advanced Research Journal of Agricultural Science. 2015; 4(4):188–99.
7. Pachava VR, Krishnamurthy PT, Dahapal SP and Chinthamaneni PK. An updated review on “Miracle tree”: Moringa oleifera. Research Journal of Pharmacognosy and Phytochemistry. 2018;10(1):101-108. doi: 10.5958/0975-4385.2018.00016.X.
8. Sahay S, Yadav U and Srinivasamurthy S. Potential of Moringa oleifera as a functional food ingredient: A review. International Journal of Food Science and Nutrition. 2017; 2(5): 31-37.
9. Dhimmar N, Patel NM, Gajera V and Lambole V. Pharmacological activities of Moringa oleifera: An overview. Research Journal of Pharmacy and Technology. 2015; 8(4): 476–80. doi: 10.5958/0974-360X.2015.00079.7
10. Masum NH, Hamid K, Zulfiker AH, Hossain K and Urmi KF. In vitro Antioxidant Activities of Different parts of the Plant Moringa oleifera Lam. Research Journal of Pharmacy and Technology. 2012; 5(12): 1532-1537.
11. Mehwish HM, Riaz Rajoka MS, Xiong Y, Zheng K, Xiao H, Anjin T, Liu Z, Zhu Q and He Z. Moringa oleifera–A Functional Food and Its Potential Immunomodulatory Effects. Food Reviews International. 2020;36(7): 1-20. doi:10.1080/87559129.2020.1825479
12. Panya T, Chansri N and Daodee S. Development and evaluation of lozenge from Moringa oleifera leaf extract. Research Journal of Pharmacy and Technology. 2016; 9(7): 805–9. doi: 10.5958/0974-360X.2016.00154.2
13. Akhtar S and Dev P. Formulation And Evaluation Of Chewable Multivitamin Tablet. International Journal of Current Pharmaceutical Research. 2017; 9(4): 61-64. doi: 10.22159/ijcpr.2017v9i4.20958
14. Arifa-Begum SK, Padma SV, Anusha V, Keerthi VZ, Vinitha SP, Prameela K, Nazeema MD and Padmaltha K. Formulation and evaluation of pediatric oral soft jellies of salbutamol sulphate. Research Journal of Pharmacy and Technology. 2018;11(11): 4939–4945. doi: 10.5958/0974-360X.2018.00899.5
15. Vergara-Jimenez M, Almatrafi MM and Fernandez ML. Bioactive components in Moringa oleifera leaves protect against chronic disease. Antioxidants. 2017; 6(4). 1-13. doi: 10.3390/antiox6040091
16. Čižauskaite U, Jakubaityte G, Žitkevičius V and Kasparavičiene G. Natural ingredients-based gummy bear composition designed according to texture analysis and sensory evaluation in vivo. Molecules 2019; 24(7). 1-16. doi: 10.3390/molecules24071442.
17. Yadav P, Pandey P, Parashar S and Neeta. Pectin as Natural Polymer: An overview. Research Journal of Pharmacy and Technology. 2017; 10(4):1225-1229. doi: 10.5958/0974-360X.2017.00219.0.
18. Lersch M. Texture – A hydrocolloid recipe collection. Creative Commons, California. 2014.
19. Desai J, Patil J, Kulkarni R, Marapur S and Dalavi V. Alginate-Based Microparticulate Oral Drug Delivery System for Rifampicin. Research Journal of Pharmacy and Technology. 2009; 2(2): 301–303.
20. Szekalska M, Puciłowska A, Szymańska E, Ciosek P, and Winnicka K. Alginate: Current Use and Future Perspectives in Pharmaceutical and Biomedical Applications. International Journal of Polymer Science. 2016; 2016(2): 1-17. doi: 10.1155/2016/7697031.
21. Engsuwan J, Waranuch N, Limpeanchob N and Ingkaninan K. HPLC methods for quality control of Moringa oleifera extract using isothiocyanates and astragalin as bioactive markers. Science Asia. 2017; 43(3):169–174. doi: 10.2306/scienceasia1513-1874.2017.43.169
22. Setiawan F, Yunita O and Kurniawan A. Uji Aktivitas Antioksidan Ekstrak Etanol Kayu Secang (Caesalpinia sappan) Menggunakan Metode DPPH, ABTS dan FRAP. Media Pharmaceutica Indonesiana. 2018; 2(2): 82-89.
23. Kadhim ZM and Ali WK. Preparation and evaluation of granisetron chewable pediatric oral jelly. International Journal of Drug Delivery Technology. 2019; 9(3):145–149. doi: 10.25258/ijddt.v9i3.4.
24. Carneiro SB, Duarte FÍC, Heimfarth L, Quintans JDSS, Quintans-Júnior LJ, Júnior VFDV and Neves-de-Lima AA. Cyclodextrin-drug inclusion complexes: In vivo and in vitro approaches. International Journal of Molecular Sciences. 2019; 20(3): 1–23. doi: 10.3390/ijms20030642.
25. Juliantoni Y, Wirasisya DG and Hasina R. Formulasi Nutraseutikal Sediaan Gummy Candies Sari Buah Duwet (Syzygium cumini). 2018; 7(2): 9–11.
26. Prakash K, Satyanarayana VM, Nagiat HT, Fathi AH, Shanta AK and Prameela AR. Formulation development and evaluation of novel oral jellies of carbamazepine using pectin, guar gum, and gellan gum. Asian Journal of Pharmaceutics. 2014; 8(4): 241–249. doi:10.22377/ajp.v8i4.450.
27. Kowalski G, Kijowska K, Witczak M, Kuterasiński L and Lukasiewicz M. Synthesis and effect of structure on swelling properties of hydrogels based on high methylated pectin and acrylic polymers. Polymers (Basel). 2019;11(1):1–16. doi: 10.3390/polym11010114.
28. Hingmire LP, Deshmukh VN and Sakarkar DM. Development and Evaluation of Sustained Release Matrix Tablets Using Natural Polymer as Release Modifier. Research Journal of Pharmacy and Technology. 2008; 1(3):193–196.
29. Ministry of Health of the Republic of Indonesia. Farmakope Indonesia Edisi VI. Kementrian Kesehatan Republik Indonesia, Jakarta. 2020.
30. Augsburger LL and Hoag SW. Pharmaceutical Dosage Forms - Tablets. In: Pharmaceutical Dosage Forms: Tablets, Edited by Augsburger LL and Hoag SW. Informa Healthcare, New York. 2008; 2nd ed: 570.
31. Phongpaichit, Nikom S, Rungjindamai J, Sakayaroj N, Hutadilok-Towatana J, Rukachaisirikul N, Kirtikara V and Kanyawim. Biological activities of extracts from endophytic fungi isolated from Garcinia plants. FEMS Immunology and Medical Microbiology. 2007; 51(3): 517–525. doi: 10.1111/j.1574-695X.2007.00331.x.
32. Charde RM, Charde MS, Fulzele SV, Satturwar PM, Kasture AV and Joshi SB. Evaluation of ethanolic extract of Moringa oleifera for wound healing, anti-inflammatory and antioxidant activities on rats. Research Journal of Pharmacy and Technology. 2011; 4(2): 254–258.
33. Saha S, Tomaro-Duchesneau C, Daoud JT, Tabrizian M and Prakash S. Novel probiotic dissolvable carboxymethyl cellulose films as oral health biotherapeutics: In vitro preparation and characterization. Expert Opinion on Drug Delivery. 2013; 10(11): 1471–1482. doi: 10.1517/17425247.2013.799135.
34. Evageliou V, Richardson RK and Morris ER. Effect of pH, sugar type and thermal annealing on high-methoxy pectin gels. Carbohydrate Polymers. 2000; 42(3): 245–259. doi: 10.1016/S0144-8617(99)00191-5.
35. Chuang JJ, Huang YY, Lo SH, Hsu TF, Huang WY, Huang SL and Lin YS. Effects of pH on the Shape of Alginate Particles and Its Release Behavior. International Journal of Polymer Science. 2017; 2017 (1). 1-10. doi: 10.1155/2017/3902704.
36. Arabshahi-DS, Vishalakshi DD and Urooj A. Evaluation of antioxidant activity of some plant extracts and their heat, pH and storage stability. Food Chemistry. 2007; 100(3): 1100–1105. doi:10.1016/j.foodchem.2005.11.014.
37. Manjula B, Varaprasad K, Sadiku R and Raju KM. Preparation and characterization of sodium alginate-based hydrogels and their in vitro release studies. Advance in Polymer Technology. 2013; 32(2):1–12. doi: 10.1002/adv.21340.
38. Ramdhan T, Ching SH, Prakash S and Bhandari B. Physical and mechanical properties of alginate based composite gels. Trends in Food Science and Technology. 2020; 106(October):150–159. doi:10.1016/j.tifs.2020.10.002.
39. Kaya AOW, Suryani A, Santoso J and Rusli MS. Karakteristik Dan Struktur Mikro Gel Campuran. J Kimia dan Kemasan. 2015; 37(1): 19–28.
40. Muhammad NWF, Nurrulhidayah AF, Hamzah MS, Rashidi O and Rohman A. Physicochemical properties of dragon fruit peel pectin and citrus peel pectin: A comparison. Food Research. 2020; 4: 266–273. doi: 10.26656/fr.2017.4(S1).S14.
41. Utomo BSB, Darmawan M, Hakim AR and Ardi DT. Physicochemical Properties And Sensory Evaluation Of Jelly Candy Made From Different Ratio Of K-Carrageenan And Konjac. Squalen Bulletin of Marine and Fisheries Postharvest and Biotechnology. 2014; 9(1): 25-34. doi: 10.15578/squalen.v9i1.93.
42. Mahat MM, Sabere ASM, Shafiee SA, Nawawi MA, Hamzah HH, Jamil MAFM, Che-Roslan N, Abdul-Halim MI and Safian MF. The Sensory Evaluation and Mechanical Properties of Functional Gummy in the Malaysian Market. Preprints. 2020; (October): 1-11. doi: 10.20944/preprints202010.0213.v1.
43. Kusumaningrum A, Parnanto NHR and Atmaka W. Kajian Pengaruh Variasi Konsentrasi Karaginan-Konjak Sebagai Gelling Agent Terhadap Karakteristik Fisik, Kimia Dan Sensoris Permen Jelly Buah Labu Kuning (Cucurbita maxima). Jurnal Teknosains Pangan. 2016; 5(1):1–11.
44. Amelia O, Astuti S and Zulferiyenni. Pengaruh penambahan pektin dan sukrosa terhadap sifat kimia dan sensori selai jambu biji merah (Psidium guajava L.). Prosisding Seminar Nasional Pengembangan Teknologi Pertanian. 2016; (September):149–59.
45. Roopa BS and Bhattacharya S. Alginate gels: I. Characterization of textural attributes. Journal Food Engineering. 2008; 85(1):123–131. doi:10.1016/j.jfoodeng.2007.07.012
Received on 09.04.2021 Modified on 10.08.2021
Accepted on 04.10.2021 © RJPT All right reserved
Research J. Pharm. and Tech. 2022; 15(6):2513-2520.
DOI: 10.52711/0974-360X.2022.00420