Formulation And Evaluation of Polyherbal Antidiabetic Tablet

Medicinal plants constitute an important source of therapeutic agents, with many modern drugs derived directly or indirectly from plant constituents.The plant kingdom is rich in bioactive organic compounds that have been extensively utilised for medicinal purposes.

Diabetes mellitus is characterised by chronic hyperglycemia, often accompanied by hypertriglyceridemia and hypercholesterolemia. Although synthetic hypoglycemic agents are effective, they are frequently associated with adverse effects, including hepatic, renal, and haematological complications. In contrast, plant-based medicines are generally considered to have fewer side effects, prompting increasing interest in herbal antidiabetic therapies.

According to the World Health Organization, nearly 80% of the global population relies on botanical medicines for primary healthcare. Type 2 diabetes is primarily associated with unhealthy diet, physical inactivity, impaired insulin secretion, and reduced insulin sensitivity. The global burden of metabolic disorders is projected to rise substantially in the coming years.--

Despite the availability of insulin and oral antidiabetic drugs, long-term management remains challenging due to adverse effects and incomplete prevention of complications.[6] Traditional medicinal plants have therefore gained attention as safer therapeutic alternatives. Polyherbal formulations may enhance pharmacological efficacy through synergistic interactions while minimizing adverse effects.

Accordingly, a polyherbal antidiabetic formulation was developed incorporating extracts of Momordica charantia, Azadirachta indica, Eugenia jambolana, Phyllanthus amarus, Glycyrrhiza glabra, and Piper nigrum to explore their combined hypoglycemic potential.

MATERIALS AND METHODS:

5. Collection of materials:

The herbal powders of neem,  bitter melon, jamun, licorice,amla  and black pepper were procured online from commercially available suppliers (Brand name:VAMIRA NATURAL , City:pali  Country: India ;  AZAMDEA,Jalgaon,India;  KAYABOOST,New Delhi,India;  ,India;NEUHERBS,Gautam buddha nagar Uttarpradesh,India; VINAYAKA AYURVEDA,New Delhi,India ;  TRIKUND,Sant ravidas nagar Uttarpradesh,India;)respectively.

5. Formulation of antidiabetic tablet

In the present study, dried powder of extract was formulated into tablet dosage form by direct compression method. Formulation has the following composition: M. charantia, A. indica, E. jambolana, P. amarus. G. glabra, P. nigrum (in ratio 1:1) Starch (15 mg), magnesium stearate (33 mg). microcrystalline stearate (2 mg), and tale (2.5 mg).

Method:

Momordica charantia (Bitter melon) Azadirachta indica (Neem), Syzygium cumini (Jamun), Glycyrrhiza glabra( Licorice), Piper nigrum (Black pepper) powder was taken in equal proportions. Pass through sive no  80.

Dry starch Magnesium stearate, Microcrystalline stearate, Talc were added to drug powder mixed and blended . Powder equivalent to 650 mg were weight and tablet was compressed in Tablet punching Machine.

Preformulation studies

 A. Angle of Repose

The angle of repose was determined using the fixed height method to evaluate the flow characteristics of the physical mixtures in all formulations. A funnel with a stem having an inner diameter of 10 mm was fixed on a platform at a height of 2 cm. Approximately 10 g of the sample was carefully allowed to flow through the funnel. The powder was poured gradually along the wall of the funnel until a conical pile was formed and its apex just touched the stem of the funnel.

The radius of the powder cone was measured by drawing a rough circle around the base of the formed pile. The angle of repose (θ) was then calculated using the following formula:

Where:

θ = Angle of repose

h = Height of the powder cone

r = Average radius of the powder cone

B.Loose Bulk Density (LBD)

Loose bulk density of the granules was determined by carefully transferring 25 g of the sample into a 100 mL graduated cylinder using a glass funnel without applying any compaction. The volume occupied by the powder was noted. The loose bulk density represents the ratio of the weight of the powder to the volume it occupies under untapped conditions.

Formula:

LBD=Weight of powderBulk volume

 

 

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Tapped Bulk Density (TBD)

Tapped bulk density of the granules was measured by placing 25 g of the sample into a 100 mL graduated cylinder through a glass funnel. The cylinder was then tapped from a height of approximately 2 inches (about 10 cm) at regular intervals until a constant volume was obtained. After tapping, the final volume of the powder was recorded. Tapped bulk density was calculated as the ratio of the mass of the powder to the volume after tapping.

Formula:

TBD=Weight of powderTapped volume

 

 

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Compressibility Index (Carr’s Index)

The compressibility index was used to evaluate the flow properties of the powder blend. It was calculated using Carr’s compressibility index, which is derived from the difference between tapped bulk density and loose bulk density.

Formula:

Compressibility Index (%)=TBD-LBDTBD×100

 

 

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Hausner’s Ratio

Hausner’s ratio is an indicator of the frictional resistance between particles and is commonly used to assess the flowability of powders. It is calculated as the ratio of tapped bulk density to loose bulk density. An ideal Hausner’s ratio generally lies in the range of 1.2–1.5.

Formula:

Hausner’s Ratio=TBDLBD

 

 

E. Hausner’s Ratio

Hausner’s ratio is used to evaluate the interparticle friction and flow characteristics of the powder blend. It provides an indication of the resistance of particles to movement. Generally, a value in the range of 1.2–1.5 suggests acceptable flow properties of the powder. The ratio is calculated using the following equation:

Formula:

Hausner’s Ratio=TBDLBD

 

 

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F. Loss on Drying (LOD)

Loss on drying of the granules was determined by placing 1 g of well-mixed granules into a shallow weighing bottle fitted with a dry glass stopper. The sample was evenly spread inside the bottle and then placed in a moisture balance (Sartorius drying chamber). The stopper was removed, and the sample was dried for a specified period until a constant weight was achieved. The percentage loss on drying was then calculated using the following formula:

Formula:

Loss on Drying (%)=Initial weight – Final weightInitial weight×100

 

 

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Evaluation of Tablets

All prepared tablet formulations were evaluated using the following quality control parameters.

a. Color and Appearance

The prepared tablets were visually inspected to assess their colour, surface characteristics, and overall appearance.

b. Weight Variation Test

A total of 20 tablets were randomly selected and weighed collectively to determine the average tablet weight. Each tablet was then weighed individually. The percentage deviation of individual tablet weights from the average weight was calculated. According to pharmacopeial limits, not more than two tablets should deviate from the average weight by the specified percentage, and none should deviate by more than twice that percentage.

c. Hardness and Friability Test

Tablet hardness was measured using a calibrated Monsanto hardness tester to determine the mechanical strength of the tablets. Friability was evaluated using a Roche friabilator, where tablets were rotated for 4 minutes at 25 rpm to assess their resistance to abrasion and mechanical stress.

d. Disintegration Test

The disintegration test was carried out using a glass or plastic tube (80–100 mm in length) with an internal diameter of about 28 mm and an external diameter of 30–31 mm, fitted with a rust-proof wire mesh at the lower end. Six tablets were placed inside the tube, which was then moved up and down in the testing medium at a rate of 28–32 cycles per minute. Disintegration was considered complete when no tablet residue remained above the 10-mesh screen, allowing particles to pass freely through the mesh.

e. Thickness

The thickness of the tablets was measured using Vernier calipsers to ensure uniformity in tablet dimensions.

f. Stability Studies

Stability studies of the formulated tablets were conducted in a stability chamber maintained at 40°C and 75% relative humidity. The tablets were stored under these conditions for a period of two months, and their stability was evaluated over this duration.

RESULTS AND DISCUSSION

The prepared granules were evaluated for their physical characteristics, including bulk density, tapped density, angle of repose, Carr’s index, and Hausner’s ratio. The obtained values were found to be within acceptable limits, indicating that the granules possessed satisfactory flow properties suitable for tablet compression. The values for Carr’s index and Hausner’s ratio were observed within the ranges of 21–24%, 11.45–14.42%, and 1.10–1.17, respectively, demonstrating good flowability of the granules.

The formulated polyherbal antidiabetic tablets were further evaluated for several quality parameters such as color, average weight, hardness, friability, and disintegration time. All results complied with the pharmacopeial specifications. The hardness of the tablets ranged from 9.00 ± 0.02 to 12.50 ± 0.003 kg/cm², indicating adequate mechanical strength. Friability values were found to be less than 1%, suggesting that the tablets had sufficient resistance to mechanical stress. In addition, the disintegration time for all tablet batches was recorded between 100.012 and 380.011 minutes. Based on the evaluation of these parameters, one formulation was identified as the optimized batch according to the required criteria (Table 5).

Stability studies indicated that the physical properties of the optimized formulation remained largely unchanged during the storage period. A minor increase in moisture content and hardness was observed; however, friability values remained unaffected. These variations were found to be within the acceptable pharmacopeial limits (Table 5).

CONCLUSION

From the findings of the preformulation studies and evaluation parameters of the prepared tablets, it can be concluded that all measured characteristics were within the acceptable range. The physical evaluation confirmed that the formulation exhibited adequate hardness, low friability, and suitable disintegration time. Overall, the developed polyherbal tablet formulation demonstrated satisfactory quality characteristics. However, further investigations are required to better understand the mechanism of action and to conduct long-term toxicity studies to confirm its safety and effectiveness.

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