Development and Assessment of Naturally Derived Tamarind Kernel Powder as Disintegrant in Beta-Blocker Atenolol Tablet

1)Bulk Density:

Pouring the powder blend into a cylinder and recording its initial weight allows for calculation. Bulk volume is the starting volume. The following formula was used to determine the volume of the powder blend.

Formula:

Bulk Density:   Mass of powder

                          Volume of powder

2)Tapped      Density:

It can be defined as the ratio of a powder's tapped volume to its overall mass. The powder blend was poured into the measuring cylinder to ascertain it. On the harder surface, the cylinder was gently tapped 500 times, and the volume of powder that was tapped was recorded. The tapped volume was recorded after 1000 repetitions of tapping when there was a difference of more than 2% between two volumes. In a bulk density apparatus, tapping was carried out repeatedly until the ensuing volume differences were less than 2%. It was computed using the formula and expressed in g/ml⁵.

Formula:

Tapped density:  Mass of powder

                           Tapped volume of powder                                              

3)Angle of Repose:

To get the angle of repose, we applied the funnel approach. The mixture was run through a funnel that could be adjusted vertically until the cone's height (h) was attained. The Angle of Repose (θ) was calculated using the formula after the heap's radius (r) was measured⁶.

Formula:

Angle of Repose: Tan θ:  h

                                         r                                                        

4)Hausner’s Ratio:

HR serves as a proxy for powder flow ease. It is computed using the formula that follows⁷:

Formula:

Hausner’s Ratio: Tapped density

                             Bulk density

5)Carr’s Index:

It proves that the flow of a powder is what makes it compressible. The following is the Carr's index formula¹¹:

Formula:

Carr’s index:  D_t-D_b  × 100

                                      D_t

1)Tablet Hardness:

In a test device that applies tension or bending stress, the force needed to shatter a tablet is called "tablet hardness." The effectiveness and overall performance of a tablet are greatly influenced by its hardness, especially in relation for patients use, packaging, and shipping¹².

2)Tablet Thickness:

Tablets were measured for thickness with a Vernier caliper.

3)Weight Variation:

A test for weight variation was conducted to make sure a tablet had the right amount of medication. Analytical balances were used to determine the weight of each tablet. That was used to calculate the average weight. Next, each tablet's weight was compared to the average weight⁸.

Weight of 10 tablets (mg)

Table 5. Weight of Tablets

10 tablets average weight is 386.5 mg.

Weight variation restriction for tablets weighing <500 mg in accordance with different regulatory recommendations and pharmacopoeias:

USP (United States Pharmacopoeia):

For tablets < 250 mg: ±10%

 For tablets 250-500 mg: ±5%

Calculation :

 Average weight of 1 tablet = 395 mg

 395 x 5 / 100 = 19.75 mg

 395 ± 19.75 = 414.75 or 375.25

4)Friability:

A sample of ten to twenty tablets was tested for friability using a USP-type Roche friabilator.

Apparatus: A cylindrical drum (285 mm diameter, 190 mm depth) with a translucent plastic cover and a removable tray.

 Formula:

 Initial weight – Final weight ×100

              Initial weight

Calculation:

3865 – 3835×100 =0.7

      3865

5)In Vitro Disintegration:

The tablet disintegrating test device was used to determine the tablet's disintegration time. Each tube of the tablet disintegration testing device contained six tablets. The media was kept at 37 ± 2°C, and the amount of time needed for the complete pill to dissolve was recorded. The duration required for a tablet or capsule to disintegrate in a controlled laboratory setting that mimics physiological fluids is known as the "in vitro disintegration time."

Test Method:

Apparatus: A USP Disintegration Apparatus or the disintegration tester with baskets¹³.

Medium: Distilled Water

Procedure: Put four tablets in baskets, then immerse them in a medium that is maintained at 37°C and watch.

6)In Vitro Dissolution:

A technique used in laboratories to mimic how a pharmaceutical product might dissolve in the human body is called in vitro dissolution testing. The test assesses the active pharmaceutical ingredient's (API) rate and degree of dissolution from the dosage form⁹.

The contents of the dissolution medium are as follows: [900 milliliter Phosphate Buffer: Ph 6.8]

Test:

• Place the sample: Fill each basket with one dose unit.
• Turn on the device: Start the timer and agitation. (RPM of 50)
• Gather samples: At specified time intervals, remove samples.

(5, 10, 15, 30, 45, 60 min.)

• Examine samples: Utilize UV spectrophotometry to determine the concentration of dissolved drugs.
• Record data: Record the dissolution profile (drug release percentage vs time)
• Formula:

Amount of drug release(mg/ml):

Concentration × Dissolution volume × Dilution factor

                                      1000

Percent Drug release:

Amount of drug release ×1000                              

Total amount of drug in formulation (mg)

7)UV Absorbance:

The concept an active pharmaceutical ingredient (API)-containing solution's ability to absorb ultraviolet (UV) light is measured by the UV Absorbance test. The API's concentration and absorbance are intimately correlated.

Measurement Steps for UV Absorbance:

• Prepare sample solution
• Set the wavelength between 200 and 400 nm, or 277 nm.
• Determine the blank's (distilled water) absorbance.
• Determine sample absorbance.
• Determine the absorbance difference¹⁰.

Sr. No

Parameter

Standard Value

Observed Value

Conclusion

Hardness

4 – 12 kg/cm 2

4.1 kg/cm 2

Low

Thickness

5 – 10 mm

10 mm

Pass

Friability

0.5 – 1 %

0.7 %

Excellent

Weight Variation

>500 mg ± 5%

414.75 or 375.25

Acceptable

Disintegration

<15 min

9 min 52 sec

Good

% Drug Release T90

30 – 60 min

42.67 min

Good