FORMULATION AND EVALUATION OF CHEWABLE TABLETS OF MEBENDAZOLE BY DIFFERENT TECHNIQUES

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(d.) Bulk density (BD)
Bulk density (BD) was measured by slowly pouring a powder sample into a 100 ml graduated cylinder at a 45 degree angle. Care was taken not to shake the sample. BD was calculated by dividing the sample weight with its volume. The bulk density of different Mebendazole tablets were calculated and shown in Table III.

(e.) Tapped density (TD)[10]
To measure tapped density (TD), a powdered sample was poured into a 100 ml graduate cylinder at a 45 degree angle. The sample was mechanically tapped 1500 times. TD was calculated by dividing the sample weight by its final volume. The Tapped density of different Mebendazole tablets were calculated and shown in Table III.

(f.) Carr’s Index[11]
The compressibility of mebendazole tablet was determined by the Carr’s Index.

Compressibility index (%) = DT-DB x 100

Where,
DT= Tapped density
DB= Bulk density

(g.) Hausner Ratio
The Hausner Ratio of Mebendazole tablet was determined by the following equation.

Hausner Ratio = Tapped density / Bulk density

Value less than 1.25 indicates good flow, while greater than 1.25 indicates poor flow.

(h.) Hardness test
Hardness is a force required to break a tablet across the diameter. The hardness of a tablet is an indication of its strength. The hardness was measured using Monsanto Hardness tester. The values were expressed in Kg/cm2.

(i.) Friability test
The friability of tablets were determined by using Roche Friabilator. Ten tablets were weighed and placed in friabilator and rotated at 25 rpm for 4 minutes. Then the tablets were taken out, dusted and reweighed. The percentage friability of the tablets were calculated by the formula,

Percentage Friability = [(Initial Weight – Final Weight)/ Initial Weight] × 100 

(j.) Disintegration test[12]
For a drug to be absorbed from a solid dosage form after oral administration, it must first be in solution, and the first important step toward this condition is usually the break-up of the tablet; a process known as disintegration. The disintegration test is a measure of the time required under a given set of conditions for a group of tablets to disintegrate into particles which will pass through a 10 mesh screen. The disintegration test is carried out using the disintegration tester which consists of a basket rack holding 6 plastic tubes, open at the top and bottom, the bottom of the tube is covered by a 10-mesh screen. The basket was immersed in a bath of suitable liquid held at 37 0C, preferably in a 1L beaker. For compressed uncoated tablets, the testing fluid was usually water at 37 0C but some monographs direct that simulated gastric fluid be used. If one or two tablets fail to disintegrate, the test was repeated using 12 tablets. For most uncoated tablets, the BP (British Pharmacopoeia) requires that the tablets disintegrate in 15 minutes (although it varies for some uncoated tablets). The individual drug monographs specify the time disintegration must occur to meet the Pharmacopoeial standards.

(k.) Content Uniformity test
Weighed accurately quantity of the powder containing about 0.1 g of Mebendazole. Add about 150 ml of 0.1 M Methanolic Hydrochloride acid, Shaked for 15 min and dilute to 250 ml with 0.1 M Methanolic Hydrochloride acid, Mixed and Filtered and diluted 5.0 ml of the filtrate to 250.0 ml with 0.1M Sodium hydrochloride measured the absorbance of the resulting solution at the γ max of 308 nm, Calculated the content of Mebendazole taking 742 as the specific absorbance at 308 nm.

(l.)In-vitro dissolution test[13]
The in vitro drug release studies were performed using USP dissolution apparatus Type II (paddle) using 900 ml of 0.1N hydrochloric acid as the dissolution medium. The temperature of the dissolution medium was maintained at 37±0.5oC and the paddle was rotated at 50 rpm. Aliquots were withdrawn at different time intervals of 10, 20 and 30 minutes and replaced by adding equal volume of fresh dissolution medium. The samples were suitably diluted and absorbance of the solutions was determined at the wavelengths of maximum and minimum absorbance at about 308 nm and 350 nm, in a UV- visible spectrophotometer.

(m.) Drug content[14]
Five tablets were powdered and the blended equivalent to 200 mg of Mebendazole was weighed and dissolved in suitable quantity of water. The solution was filtered, suitably diluted and drug content was analysed spectrophotometrically at 309 nm. Each sample was analyzed in triplicate.

RESULTS AND DISCUSSION
All the prepared batches of tablets were within the range. Using Monsanto hardness tester, the strength of the tablets was tested. All the tablets showed good hardness. Batch ‘AG’ had minimum hardness (5.1±0.10) while ‘DC’ had maximum hardness (5.5±0.09). The friability was carried out for all the batches of tablets. The friability was less than 0.2% for all the blends and was satisfactory. Assay value of all prepared batches of Mebendazole tablets were within the range of 90% to 110% of stated amount of Mebendazole. From the data obtained it was found that 87% of drug was released for the trial ‘DC’ at 30 min while other trials ‘NG’& ‘AG’ had shown 81% & 80.5% drug re-lease at 30 min respectively. The variation in the dissolution rate of Mebendazole tablets was in the following order AG<NG<DC. The dissolution profile of batches of tablets prepared by direct compression method has shown better results compared to the tablets prepared by other methods as well as marketed product as showed in fig I.

Result of comparative evaluation of tablet using different parameters are shown in Table III.

CONCLUSION
All the tablets showed satisfactory results with respect to hardness, friability, assay and in vitro dissolution studies. The trial ‘DC’ i.e. tablet prepared by direct compression method had the better dissolution rate when compared to trial ‘NAQ’ and ’AQ’ i.e. prepared by non aqueous and aqueous methods, respectively.

ACKNOWLEDGEMENT
I pay my sincere thanks to sequent scientific Ltd, Bangalore, India for providing gift sample of Mebendazole. I would also like to express my gratitude towards my family members and the supreme soul.

Fig. 1: Comparison of dissolution profiles of three batches of tablets and marketed product

Table I: Manufacturing formulas for preparation of Tablet

S.No.

Name of the ingredients

Nonaqueous Granulation

(mg/tablet)

Aqueous Granulation

(mg/tablet)

Direct Compression

(mg/tablet)

1.

Mebendazole

200

200

200

2.

Lactose mono.

100

100

100

3.

Starch

50

39.2

78.4

4.

Sodium starch glycolate

25.23

25.23

25.23

5.

Starch

20

39.2

--

6.

Isopropyl alcohol

q.s

--

--

7.

Purified water

--

q.s

--

8.

Mannitol

90

90

90

9.

Sodium saccharide

5

5

5

10.

Carmofine color

0.5

0.5

0.5

11.

Pineapple flavor

3

3

3

12.

Magnesium stearate

5

5

5

13.

Talc

5

5

5

14.

Aerosol

10

10

10

Table IIGrading of the powder for their flow properties according to Carr’s index

Percent

Compressibility

Type of flow

5-15

Excellent

12-16

Good

18-21

Fare passable

23-25

Poor

33-38

Very poor

>40

Extremely poor

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