Formulation and Evaluation of Moringa Tablets for Diabetes Management

Moringa oleifera is a medicinal plant that has gained a lot of interest for its diverse biological properties. Reviewed evidence indicates the biological capabilities of this plant expand to protecting against complications linked with heart disease, cancer, fatty liver, and diabetes mellitus¹. For example, a previously published review supported the beneficial effects of the leaves of the Moringa oleifera in improving blood glucose control in experimental models of diabetes. Notably, this review indicated draw backs such as the limited number of studies that have reported on the potential beneficial effects of this plant, including the fact that summarized literature was mainly conducted in animals, through in vitro and in vivo preclinical models². Nevertheless, while such information already affirms the hypoglycaemic potential of this medicinal plant, data regarding the prominent biochemical mechanisms implicated in the antidiabetic effects of Moringa oleifera have not been critically reviewed. Recently, Louisa and others supported the potential benefits of Moringa oleifera in cardiovascular or metabolic disorders, mainly by ameliorating the undesired pro-inflammatory response and inhibiting oxidative stress by mediating molecular mechanisms such as hindering nuclear factor kappa B (NF-κB) translocation or enhancing the antioxidant response of nuclear factor-erythroid factor 2-related factor 2 (Nrf2) in different preclinical models³. Thus, there is a need to better understand such intracellular responses of Moringa oleifera within a setting of diabetes or in related metabolic complications. The current study provides a brief overview on Moringa oleifera as medicinal plant, followed by its therapeutic mechanisms in controlling diverse diabetic complications⁴.

Drug Profile:

• Biological Source: Moringa oleifera
• Family: Moringaceae
• Common Names: Drumstick tree, horseradish tree
• Origin:  Is native to India, Arabia, and the East Indies. It is now widely cultivated in tropical and subtropical regions of the world⁵. 

Figure 1: Moringa leaves and powder

Parts Used:

• Primary: Leaves, Drumstick
• Others: flower, seeds, roots and bark.

The nutrient composition of dried moringa leaf powder:

Table 1: composition of dried moringa leaf powder⁶

Medicinal Uses of Moringa Leaves:

1. Anti-diabetic activity

• Moringa has been shown to cure both Type 1 and Type 2 diabetes. Type 1 diabetes is one where the patients suffer from non-production of insulin, which is a hormone that maintainsthe blood glucose level at the required normal value. Type 2 diabetes is one associated with insulin resistance. Type 2 diabetes might also be due to Beta cell dysfunction, which fails to sense glucose levels, hence reduces the signaling to insulin, resulting in high blood glucose levels⁹.

2. Anticancer activity

• Cancer is a common disease and one in seven deaths is attributed due to improper medication. Around 2.4 million cases are prevalent in India, while there are no specific reasons for cancer to develop. Several factors like smoking, lack of exercise and radiation exposure can lead to the disease. Cancer treatments like surgery, chemotherapy and radiation are expensive and have side effects. M. oleifera can be used as an anticancer agent as it is natural, reliable and safe, at established concentrations. Studies have shown that moringa can be used as an anti-neoproliferative agent, thereby inhibiting the growth of cancer cells¹⁰.

3. Antiasthmatic Activity

• Without showing any adverse effects with M. oleifera seed kernel, improvement was observed in the treatment of bronchial asthma patients and also their concurrent respiratory functions¹¹. 

4. Cardiac and circulatory stimulant

• The bioactive compound alkaloids from Moringa trees act as a cardiac stimulant¹². Which are evident to stabilize blood pressure and reduce fat and cholesterol to prevent hyperlipidemia and reduce serum triglyceride and serum cholesterols¹³. 

5.  Antispasmodic and Antiulcer Effects

• Because of the spasmolytic activity of Moringa trees, it is used traditionally to treat gastrointestinal motility disorder¹⁴. It is also reported that the methanolic extracts from this plant protects gastric lesions¹⁵. 

Characterization of Moringa Oleifera Powder:

1. Moisture content:

The moisture content of Moringa oleifera powder was determined using water analysis. Sugar weighing 3 g was poured into the mixed water and divided into strips. The machine was set at 130 ± 1°C. Measurements were made when the machine was stopped. The test was repeated twice and the moisture content was taken as the average of three measurements content¹⁶.

2. Angle of repose:

       Tan θ = ?/r

Where, h= height of the heap and r= radius of the circular heap. The experiment was repeated twice and the average of the three readings was taken as the angle of repose.

3. Bulk density:

The bulk density of each powder / granule sample was determined by pouring 10 g (M) of the powder into a 50 ml glass measuring cylinder and the bulk volume (Vo) determined.  The bulk density (Db) was then calculated from the relationship:

         Db = M/Vo

Triplicate determinations were made and the mean values reported.

4. Tapped density:

The tapped density of each powder was determined using Stampf Volumeter (model STAV 2003, JEF Germany). The ten grams (M) of each powder/granules sample after the bulk density determination was subjected to 250 taps mechanically and the volume V250 of the powder column determined and applied to evaluate tapped density (Dt) using the relationship:

           Dt = M / V250

Triplicate determinations were made and the mean values reported¹⁷.

5. Relative density:

Relative density and porosity of powder /granules bed after 250 taps were determined respectively:

       RD = TD250/ ps

       € = 1- RD

Where RD = relative density, ρs = particle density, ε = porosity¹⁸.

6. Determination of Carr’s Index:

Carr’s index CI, was calculated from the results obtained from bulk and tapped densities above using the relation;

         CI = (Td – Bd) x 100/Td

7. Determination of Hausner’s Ratio: Hausner’s ratio HR, was determined using the results obtained from both bulk and tapped densities. It was calculated using the formula

          HR = Td / Bd

8. Ash value:

A 2 g sample of powder was cast into solid nickel, preheated to 105°C to constant weight, and then cooled. The solid and its contents are slowly heated until they become moisture-free and saturated. The temperature is gradually increased until most of the carbon is burned to °C. The sample was then superheated to 600°C until residue no longer contained any carbon (i.e., was almost white). Its essence and ingredients are cold and wet approved. The heating and cooling steps were then repeated until residue (ash) was formed always. The weight of the ash was then determined and the percentage ash value calculated:

        % Ash value = Wax 100/ Wsp

Where Wa and Wsp are weight of ash formed and initial weight of Moringa powder respectively¹⁹.

Characterization Result of Moringa Oleifera Powder:

Table 2: Characterization of Moringa Oleifera Powder

MATERIAL AND METHODS

• Table of Ingredients:

Table 3: Table of Ingredients

Trail 1:

• Formulation Table:

Table 4: Table of Ingredients

METHODOLOGY:

1. Preparation of Moringa Powder:

• Harvesting: Moringa leaves are collected and cleaned thoroughly to remove any dirt or contaminants.
• Drying: The leaves are then dried, preferably in a shaded, well-ventilated area or using a drying oven at a low temperature (not exceeding 40°C) to preserve the nutritional content.
• Grinding: Once the leaves are fully dried, they are ground into a fine powder using a grinder.

2. Mixing the Ingredients:

• Binder Addition: Add a Starch to the Moringa powder.
• Disintegrants: Add a Sodium starch to help the tablet dissolve efficiently in the stomach. Sodium starch is commonly used for this purpose.
• Lubricants: Add a magnesium stearate to prevent the tablets from sticking to the compression machine.
• Fillers: Cellulose added to increase the tablet bulk.

3. Granulation Process:

• Wet Granulation:
  • In this process, a small amount of Starch solution added to the dry powder mixture to form a wet mass.
  • The wet mass is then passed through a sieve to form granules, which are dried in an oven or air-dried.
  • The dried granules are then sieved to ensure uniform particle size.

4. Compression:

• The final granules are fed into a tablet compression machine. The machine applies pressure to form tablets.
• Adjust the tablet compression machine to the required pressure to form tablets of the desired size, shape, and hardness.

Observation: The First Trail is failed due to Cracking of tablets, so decided addition of HPMC E₅.

Figure 2: Cracking of tablets.

Trail 2:

• Formulation Table:

Table 5: Table of Ingredients

METHODOLOGY:

1. Preparation of Moringa Powder:

• Harvesting: Moringa leaves are collected and cleaned thoroughly to remove any dirt or contaminants.
• Drying: The leaves are then dried, preferably in a shaded, well-ventilated area or using a drying oven at a low temperature (not exceeding 40°C) to preserve the nutritional content.
• Grinding: Once the leaves are fully dried, they are ground into a fine powder using a grinder.

2. Mixing the Ingredients:

• Binder Addition: Add a Starch to the Moringa powder.
• Disintegrants: Add a Sodium starch to help the tablet dissolve efficiently in the stomach. Sodium starch is commonly used for this purpose.
• Lubricants: Add a magnesium stearate to prevent the tablets from sticking to the compression machine.
• Fillers: Cellulose added to increase the tablet bulk.

3. Granulation Process:

• Wet Granulation:
  • In this process, a small amount of Starch solution added to the dry powder mixture to form a wet mass.
  • The wet mass is then passed through a sieve to form granules, which are dried in an oven or air-dried.
  • The dried granules are then sieved to ensure uniform particle size.

4. Compression:

• The final granules are fed into a tablet compression machine. The machine applies pressure to form tablets.
• Adjust the tablet compression machine to the required pressure to form tablets of the desired size, shape, and hardness.

Observation:

The Second Trail also failed due to Cracking of tablets, because of less amount of added.

Figure 3: Cracking of tablets

Trail 3:

• Formulation Table:

Table 6: Table of Ingredients

METHODOLOGY:

1. Preparation of Moringa Powder:

• Harvesting: Moringa leaves are collected and cleaned thoroughly to remove any dirt or contaminants.
• Drying: The leaves are then dried, preferably in a shaded, well-ventilated area or using a drying oven at a low temperature (not exceeding 40°C) to preserve the nutritional content.
• Grinding: Once the leaves are fully dried, they are ground into a fine powder using a grinder.

2. Mixing the Ingredients:

• Binder Addition: Add a Starch to the Moringa powder.
• Disintegrants: Add a Sodium starch to help the tablet dissolve efficiently in the stomach. Sodium starch is commonly used for this purpose.
• Lubricants: Add a magnesium stearate to prevent the tablets from sticking to the compression machine.
• Fillers: Cellulose added to increase the tablet bulk.

3. Granulation Process:

• Wet Granulation:
  • In this process, a small amount of Starch solution added to the dry powder mixture to form a wet mass.
  • The wet mass is then passed through a sieve to form granules, which are dried in an oven or air-dried.
  • The dried granules are then sieved to ensure uniform particle size.

4. Compression:

• The final granules are fed into a tablet compression machine. The machine applies pressure to form tablets.
• Adjust the tablet compression machine to the required pressure to form tablets of the desired size, shape, and hardness.

Figure 4: Moringa Tablets

Due to better result we decided to finalize this formula for next batches.

Evaluation Parameter for Formulated Tablets:

1. Hardness test:

The tablet to be tested is held between a fixed and a moving jaw, and reading of the indicator is adjusted to zero. The force applied to the tablet edge is gradually increased by moving the screw knob forward until the tablet breaks. Reading is noted from the scale which indicates the pressure required in kg to break the tablet. Hardness of 4kg is considered suitable for handling the tablets, Hardness of 6kg or more will produce tablets of highly compact nature¹⁵.

Figure 5: Hardness tester

Result: The hardness of the tablets occurred 4.5 kg/sq.cm which is between the normal range.

2. Friability Test:

20 tablets are selected and carefully measured. They were then placed in a Friabilator drum and rotated at a speed of 25 rpm for four minutes. Unremoved pellets are removed from the barrel, dusted and weighed. The weight percentage is calculated and recorded as a simple value.

Figure 6: Friability testing

Calculation:

1. Weight of tablet before friability test =  5.16(5160mg)
2. Weight of tablet after friability test    = 5.09(5098mg)

                                                                         0.07(62mg)

Result: The loss of tablet after friability test occurred 62mg, which range is acceptable. According to British   pharmacopoeia.

3. Disintegration Time test:

Six tablets were randomly selected and placed on their handles in six channels on the shelf of the folding machine. The metal is raised and lowered at a constant rate in deionized water in a glass beaker suspended in a water bath whose temperature is maintained at 37 ± 1 °C. The time required for the final mass or part of it to pass through a 2 mm mesh in water (depleted water) is recorded as the settling time.

Figure 7: Disintegration test

Result:  The Moringa tablets disintegrate in 25 minutes, in water this result occurs in normal range.

4. Weight variation test:

Twenty tablets were randomly selected and weighed individually. The mean weight of the tablets was then calculated and the standard deviation determined.

Table 7: Weight variation