Formulation and Evaluation of Polyherbal Orodispersible Tablets for Antidiabetic Activity

Diabetes mellitus is a chronic metabolic disorder characterized by elevated blood glucose levels resulting from defects in insulin secretion, insulin action, or both. It is one of the most prevalent non -communicable diseases worldwide and is associated with serious complications such as neuropathy, nephropathy, retinopathy, and cardiovascular disorders [1,2]. The increasingprevalence of diabetes and limitations associated with conventional antidiabetic therapy have encouraged the development of safer and more effective alternative approaches including herbal formulations.

Herbal medicines have gained considerable attention due to their natural origin, reduced side effects, cost effectiveness, and therapeutic potential in the management of diabetes mellitus. Medicinal plants such as Syzygium cumini (Jamun), Phyllanthus emblica (Amla), Ocimum sanctum (Tulsi), Cinnamomum zeylanicum (Cinnamon), and Clitoria ternatea (Gokarn) possess significant antidiabetic and antioxidant activities [3 –5].

Orodispersible tablets (ODTs), also known as mouth dissolving tablets, are solid dosage forms that rapidly disintegrate or dissolve in saliva without the need for water. These formulations improve patient compliance, particularly in paediatric, geriatric, and dysphagic patients experiencing difficulty in swallowing conventional tablets [6,7]. ODTs provide rapid onset of action, improved bioavailability, and enhanced patient convenience.

The present study was aimed at formulation and evaluation of herbal orodispersible tablets for antidiabetic activity using selected herbal extracts prepared by maceration method and formulated by direct compression technique. The prepared formulations were evaluated for preformulation and post-compression parameters to identify optimized formulation with improved pharmaceutical properties.

2. MATERIALS AND METHODS

2.1 Materials

The herbal drugs used in the present study included Jamun seed, Amla, Cinnamon, Tulsi, Gokarn, Cardamom, and Stevia. Crospovidone was used as superdisintegrant, while Microcrystalline Cellulose (MCC), Mannitol, Magnesium stearate, and Talc were used as pharmaceutical excipients. All chemicals and reagents used were of analytical grade.

2.2 Preparation of Herbal Extract

The selected herbal drugs were shade dried and coarsely powdered separately. The powdered materials were extracted using hydroalcoholic solvent system (ethanol: water, 70:30 v/v) by maceration method for 5 days with occasional shaking. The obtained extracts were filtered and concentrated using water bath. The dried extracts were stored in airtight containers for further use.

2.3 Formulation of Orodispersible Tablets

Herbal orodispersible tablets were prepared by direct compression method. All ingredients were accurately weighed and passed through sieve no. 60. The ingredients were mixed uniformly and magnesium stearate was added at the final stage. The prepared powder blend was compressed into tablets of 500 mg weight using tablet compression machine.

2.4 Formulation Composition

2.5 Evaluation Parameters

The prepared powder blend was evaluated for angle of repose, bulk density, tapped density, Carr’s index, and Hausner’s ratio. The formulated tablets were evaluated for general appearance, weight variation, thickness, hardness, friability, disintegration time, wetting time, water absorption ratio, drug content, in-vitro dissolution study, and stability studies according to standard procedures.

3. RESULTS

3.1 Extraction Yield

The percentage yield of herbal extracts obtained by maceration method is shown in Table 1.

Table 1: Percentage Yield of Herbal Extracts

3.2 Preformulation Studies

The prepared powder blend was evaluated for preformulation parameters and results are shown in Table 2.

Table 2: Preformulation Study Parameters

1. 3. Evaluation of Orodispersible Tablets
      1. General Appearance

The prepared tablets showed light brown colour, round shape, smooth surface, and pleasant odour.

1. 1. 2. Weight Variation

Table 3: Weight Variation Test

Average Weight = 500 mg

1. 1. 3. Thickness

Table 4: Thickness Test

Average Thickness = 3.42 mm

1. 1. 4. Hardness

Table 5: Hardness Test

Average Hardness = 3.34 kg/cm²

1. 1. 5. Friability

Table 6: Friability Test

1. 1. 6. Disintegration Time

Table 7: Disintegration Time

1. 1. 7. Wetting Time and Water Absorption Ratio

Table 8: Wetting Time and Water Absorption Ratio

1. 1. 8. Drug Content

Table 9: Drug Content

1. 1. 9. In-vitro Dissolution Study

Table 10: In-vitro Dissolution Study

1. 1. 10. Stability Studies

The prepared formulationswere subjectedto stability studies under different storage conditions.

Table 11: Stability Studies

4. DISCUSSION

Among all formulations, F3 demonstrated superior performance with fastest disintegration time, highest water absorption ratio, and maximum drug release. The improved performance may be attributed to optimized concentration of crospovidone and suitable excipient composition. The prepared herbal orodispersible tablets showed satisfactory physicochemical characteristics and rapid drug release profile suitable for antidiabetic drug delivery.

5. CONCLUSION

The present study successfully formulated and evaluated herbal orodispersible tablets for antidiabetic activity using selected herbal extracts such as Jamun seed, Amla, Cinnamon, Tulsi, Gokarn, Cardamom, and Stevia. The tablets were prepared by direct compression method using crospovidone as superdisintegrant.

The prepared formulations showed satisfactory preformulation and post-compression parameters including hardness, friability, disintegration time, wetting time, drug content, and dissolution characteristics. Among all formulations, F3 exhibited better performance with rapid disintegration and maximum drug release.

The study concluded that herbal orodispersible tablets can serve as a promising alternative dosage form for antidiabetic therapy with improved patient compliance and rapid drug release characteristics.

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