Formulation and Evaluation of Orally Disintegrating Tablet of Atenolol by Using Ion Exchange Resin

 

Patil P.R. 1*, Thorat R.U.1, Zinjan R.V.1, Shamkuwar P.B.2, Salve V.K., P. K. Puranik

1Government College of Pharmacy, Osmanpura, Aurangabad 431 005 (M.S.), INDIA

2Government College of Pharmacy, Near Thieba Palace, Ratnagiri 415 612 (M.S), INDIA

*Corresponding Author E-mail:- prpatilgcop@gmail.com

 

 

ABSTRACT:

The present research deals with study of flow properties of Atenolol along with excipients and formulate into orally disintegrating tablets (ODT’s). Formulation of atenolol into an ODT can provide fast relief with higher bioavailability. Conventional tablets of atenolol are available in the market but as it is used in life threatning conditions like angina pectoris, hypertension in which quick action is required. ODT is desired for Patients who have difficulty in swallowing or chewing solid dosage forms. The present work describes the excipients selected shows better flow properties as compared to drug alone. The prepared fast disintegrating tablets were evaluated for weight variation, content uniformity, hardness, disintegration time, wetting time and friability of tablets. Indion-234 shows faster disintegrating action. Faster disintegration may show increased bioavailability and onset of action. Among the three promising formulations, the formulation F6 emerged as the overall best formulation based on the in-vitro drug release characteristics.

 

The ODT developed in this work will hopefully contribute to improve acceptability. As a result, ODT administration of Atenolol may appear to be a promising alternative drug delivery to conventional drug delivery.

 

KEYWORDS Orally disintegrating tablet, Atenolol, Indion 234, Direct compression etc.


 

INTRODUCTION1-9:

An orally disintegrating tablet (ODT) is defined as a solid dosage form that dissolves or disintegrates quickly in the oral cavity without the need of water for administration. After coming in contact with saliva, ODTs disintegrate immediately that can be easily swallowed by the patient. The active ingredients in solution are more rapidly absorbed through the pre-gastric route from the mouth, pharynx and esophagus and through gastrointestinal epithelium to produce the desired effect. In certain diseases or disorder such as hypertension, angina, myocardial disorder therapy, taking fast pharmacological response is an important criteria. In this case, a rapid onset of pharmacological effect is an often desired from drugs. This can effectively be achieved by parentral administration, but this method may not always be convenient for the patient. Therefore, there is growing interest in developing new, non-parentral, reliable and convenient dosage forms using administration routes where a rapidly dissolved drug is immediately absorbed into the systemic circulation

 

Atenolol is a β-blocker used for treatment of life threatning condition like angina pectoris, hypertension. Conventional tablets are available in the market but desired fast effect is expected so by formulating ODT faster effect with increased in patient compliance is achieved. Before formulating any solid dosage form its flow properties should studied which plays important role. By selecting proper excipients its flow properties can be increased as compared to drug alone.

 

MATERIAL AND METHODS:

Materials:

Atenolol is obtained as a gift sample from IPCA Pharmaceuticals, Aurangabad. Pearlitol SD-200, Prosolv Silicified Microcrystalline cellulose (SMCC), Polacrilin potassium (Kyron T -314) and Sucralose obtained as a gift sample from Lupin Research Park, Aurangabad. Indion-414, Indion-234 was obtained from Ion Exchange India, Mumbai. Magnesium stearate, talc received from Dipa Chemicals, Aurangabad. All other chemicals and reagents used were of analytical grade.

 

 


Fig 1. UV Spectrum of drug in 0.1 N HCl

 

Calibration curve for Atenolol:

 

Fig 2. Calibration curve for Atenolol


 

 


Table 1: Formula for factorial batches

Tablet Ingredient (mg)

Factorial batches

F1

F2

F3

F4

F5

F6

F7

F8

F9

Atenolol

12.5

12.5

12.5

12.5

12.5

12.5

12.5

12.5

12.5

Indion-234

1

1

1

2

2

2

3

3

3

Prosolv SMCC90

5

10

15

5

10

15

5

10

15

Sucralose

2

2

2

2

2

2

2

2

2

Magnesium Stearate

1.5

1.5

1.5

1.5

1.5

1.5

1.5

1.5

1.5

Talc

0.5

0.5

0.5

0.5

0.5

0.5

0.5

0.5

0.5

Pearlitol SD-200

77.5

72.5

67.5

76.5

71.5

66.5

75.5

70.5

65.5

Total Weight

100

100

100

100

100

100

100

100

100


 

 

Preparation of tablet10-17:

Composition of tablet shows dose of drug taken 12.5mg in each batches. Indion-234 was used in 1% in F1, F2 and F3, 2%in F4, F5 and F6, 3% in F7, F8, F9 batches. Similarly Prosolv SMCC 90 used in 5%, 10% and 15% concentration. Uniform blends of composition per tablet as mentioned in Table were directly compressed using 6.0 mm, round flat faced tooling by 12 station LABPRESS compression machine. The tablet press setting was kept constant across all formulations. ODTs of atenolol were formulated by direct compression method using following procedure with formula given in Table 1

 

IDENTIFICATION AND AUTHENTICATION OF DRUG (ATENOLOL):

1) UV Spectrum of drug in 0.1 N HCl:

The UV spectrum of atenolol was obtained in 0.1N HCl (pH 1.2) using double beam UV visible spectrophotometer (Shimadzu UV 1700), atenolol solution of concentration 30 µg/ml was prepared in 0.1 N HCl and was scanned in the range of 400 to 200 nm. Maximum wavelength for atenolol was found to be 224.5 which match with the standard.

 

Table 2: Parameters of analytical validation

Parameters

Results

Absorption maxima

224.5 nm

Linearity range

5 – 30 µg/ml

Standard regression equation

Y = 0.03331x + 0.01182

Correlation coefficient

0.99986

Accuracy

98.02%

Precision

99.751% ( intraday precision)

 

99.491% ( inter day precision)

LOD (µg/ml)

0.349

LOQ (µg/ml)

1.058

 

2) Fourier Transform Infrared Spectrum:

The FTIR spectrum of atenolol / 4-(2-Hydroxy-3-[(1-methyl ethyl) amino] propoxy) benzeneacetamide was recorded over a range of 4000 cm-1 to 400 cm-1. The spectrum obtained was concordant with the structure as shown in fig. 3

ig 3:FTIR of Atenolol

 

Sr. No

Functional group

wave number cm-1

(Recorded)

1

=NH

3348.78 cm1

2

=OH

3171.36 cm1

3

C=O

1706.69 cm1

4

-CONH

1613.16 cm1

 

From FTIR study it can be concluded that given sample shows similar functional groups as that of standard.

 

EVALUATION OF FLOW PROPERTIES OF POWDER BLENDS OF FACTORIAL BATCHES18-31:

For each type of factorial formulation batches, blends of API and excipients were prepared and evaluated for various parameters. The characterization of flow properties of powder blends is important in tablet compression. The powder blends with good flow properties gives uniform die fill and consequently it gives the uniform tablet weight.

 

 


Fig 4: DSC of Atenolol



Table 3: Flow properties evaluation parameters

Formulation batches

Evaluation Parameters

Angle of Repose

Bulk Density (gm/cm3)

Tapped Density (gm/cm3)

Compressibility Index (%)

Hausner’s Ratio

Flowability

Atenolol

48.21

0.333

0.5001

33.4

1.501

Very poor

F1

25.43

0.4605

0.5303

13.26

1.153

Good

F2

25.13

0.4587

0.5216

11.50

1.130

Good

F3

23.23

0.4022

0.4487

9.9

1.110

Excellent

F4

25.51

0.4487

0.5162

13.11

1.151

Good

F5

25.18

0.4166

0.4666

11.26

1.127

Good

F6

23.17

0.4102

0.4586

9.09

1.100

Excellent

F7

25.34

0.4611

0.5287

12.73

1.146

Good

F8

25.13

0.4320

0.4861

10.95

1.123

Good

F9

23.13

0.4211

0.4667

8.25

1.09

Excellent

 

 


3) Differential Scanning Calorimetry:

DSC thermogram of atenolol showed endothermic peak of fusion, having peak maximum of 158.97ºC. DSC thermogram is shown in Fig.4 shows that obtained peak matches with the reference.

 

Angle of Repose:                    

The angle of repose was found to be within the range of 23º to 26º indicating good flowability for factorial batches. Flow properties are improved in formulation F3, F6 and F9, since the concentration of Prosolv SMCC increases.

 

Bulk Density:

The bulk density of powder is important parameter in the compressibility of the powder. The bulk density was between 0.4022 to 0.4611 gm / cm3 for factorial batches.

 

Tapped density:

The tapped density of powder is also important parameters in the compressibility of the powder. The tapped density was found to be 0.4487 to 0.5303 gm/cm3 for factorial batches.

 

Carr’s index:

The Carr’s index is indicator of compressibility. The value below 10 % shows excellent compressibility. It was found to be 8 to 14 % for factorial batches indicating excellent compressibility.

 

Hausner’s ratio:

The Hausner’s ratio is another parameter indicating the flow properties. The value of ratio below 1.25 indicates good flow while above 1.25 indicates the poor flow. It was found 1.09 to 1.53 for factorial batches indicating good flowability.

 

RESULTS AND DISCUSSIONS:

Evaluation of Factorial Formulation Batches32-41:

All the tablet formulations were subjected for organoleptic, physical and chemical evaluations as shape, thickness, hardness, friability, weight variation, in vitro disintegration time, wetting time, water absorption ratio, drug content and in vitro dissolution studies.

Appearance:                                                                                

Randomly picked tablets from each formulation batch examined for shape and in presence of light for color. Tablets showed circular shape and white colour, tablets shape with more surface area generally was a faster disintegration time than a tablets shape having less surface area, all other factors being equal.

 

Weight Variation Test:

All the tablets passed weight variation test as the % weight variation was within the Pharmacopoeial limits. The weight of all the tablets was found to be uniform. Uniform weight due to uniform die fill with acceptable variation as per USP standards were obtained since blend of material was free-flowing.

Hardness:

Tablet crushing strength, the critical parameter was controlled as the resistance of tablets to capping, abrasion or breakage under conditions of storage, transportation and handling before usage depends on its hardness. The hardness for all formulation batches was found between 3 to 3.5 Kg/cm2 for factorial design batches i.e. F1 to F9.

 

Thickness:

The thickness of the tablets was measured by using Vernier caliper by picking the tablets randomly. The values were almost uniform in all formulations. Thickness for all formulation batches i.e. F1 to F9 was found to be between 2.43 to 2.54 mm.

 

Friability:

To achieve percent friability within limits for oral disintegrating tablets was challenge to the formulator since all methods of manufacturing of oral disintegrating tablets was responsible for increasing the % friability values. The % friability values found to be between 0.2589 to 0.6912 % for factorial design batches. The friability of all the formulation was found to be less than 1.0 %. The results reveal that as the amount of Prosolv SMCC increases, the percent friability decreases.

 



Fig 5.Disintegration time of factorial batches

 

Drug Content::

Drug content for all factorial design batches i.e. F1 to F9 showed in the range of 99.78 % to 100.61 %. The results indicated that in all the formulations the drug content was uniform.

 

Wetting Time:

Since the dissolution process of a tablet depends upon the wetting followed by disintegration of the tablet, it could be assumed that wetting was the only cause of disintegration. Wetting time for factorial design batches i.e. F1 to F9 showed wide variation in the range of 19.27 to 30.22 sec.

 

Disintegration Time:

The factorial design batches F1, F2, F3 comprised of Pearlitol SD as directly compressible filler, 1 % w/w Indion-234 and 5 %, 10 %, 15 % w/w Prosolv SMCC respectively, in vitro disintegration time was found 31.69, 30.48, 27.34 sec respectively. However, the factorial design batches F4, F5, F6 comprised of Pearlitol SD as directly compressible filler, 2 % w/w Indion-234 and 5 %, 10 %, 15 % w/w Prosolv SMCC respectively, in vitro disintegration time was found 28.42, 25.45 and 15.56 sec respectively. Moreover, the factorial design batches F7, F8, F9 comprised of Pearlitol SD as directly compressible filler, 3 % w/w Indion-234 and 5 %, 10 %, 15 % w/w Prosolv SMCC respectively, in vitro disintegration time was found 24.35, 19.18 and 15.38 sec respectively. The factorial batches F6 and F9 showed disintegration time very close to each other i.e. 15.56 sec and 15.38 sec respectively. Following graph shows  graphical representation of disintegration of all factorial batches.

 

In Vitro Dissolution Study42-44:

The solubility of the active ingredient is one of the key aspects in the screening of possible dissolution media. Dissolution studies of Atenolol ODTs were carried out in three different dissolution media.

 

Drug Release Study in Simulated Salivary Fluid45-47:

Drug percent dissolved in one min (Q15) for all factorial design batches i.e. F1 to F9 showed wide variation in the range of 71.54 to 86.37. Batch F6 shows 85.59%drug release in 15 min which is the best batch.

 

Table 4: Pharmacopoeial tests of evaluation

Parameters

Factorial batches

F1

F2

F3

F4

F5

F6

F7

F8

F9

Wt.Variation (mg)

100±3

100±3

100±3

100±3

100±3

100±3

100±3

100±3

100±3

Hardness (Kg/cm2)

3-3.5

3-3.5

3-3.5

3-3.5

3-3.5

3-3.5

3-3.5

3-3.5

3-3.5

Thickness (mm)

2.45±

0.25

2.47±

0.23

2.45±

0.19

2.46±

0.22

2.48±

0.25

2.43±0.21

2.54±0.23

2.49±

0.20

2.47±

0.21

Friability (%)

0.4726

0.3263

0.2589

0.6503

0.3711

0.2945

0.6912

0.5523

0.3537

Drug Content (%)

99.78

98.94

100.1

100.45

100.67

99.88

101.05

100.61

100.37

Wetting Time (Sec)

35.22±

1.57

30.65±

1.45

28.16±

1.46

26.44±

1.64

24.67±

1.75

19.78±1.26

26.36±1.48

23.15±

1.64

19.27±

1.23

In vitro DT (sec)

31.69±

1.48

30.48±

1.26

27.34±

1.39

28.42±

1.52

25.45±

1.49

15.56±1.33

24.35±1.44

19.18±

1.13

15.38±

1.45


Table 5: Dissolution Profile of Factorial Batches in Simulated Salivary Fluid

Time (min)

F1

F2          

F3

F4

F5

F6

F7

F8

F9

1

9.07

14.26

14.90

17.12

20.00

23.94

20.61

21.66

24.16

5

25.83

26.87

28.67

31.64

34.52

45.19

38.14

38.87

46.07

10

48.97

53.03

54.18

65.72

65.74

70.76

67.56

69.14

70.49

15

71.54

74.89

76.18

75.77

82.06

85.59

84.61

86.01

86.37

20

81.29

82.44

84.25

89.13

89.16

91.29

89.37

90.02

90.24

25

91.77

93.41

93.41

100.46

100.6

100.63

99.50

99.98

100.57

30

99.54

99.7761

99.761

94.587

97.18

97.14

95.82

98.28

97.38

 

 

Table 6: Dissolution Profile of Factorial Batches in Simulated Gastric Fluid

Time (min)

F1

F2

F3

F4

F5

F6

F7

F8

F9

2

27.88

31.36

35.30

35.1

41.78

53.45

38.34

42.61

49.34

5

42.08

46.99

56.90

71.16

71.49

81.26

80.34

80.17

81.02

10

65.51

70.36

80.95

83.34

84.75

86.85

85.74

85.86

87.02

15

81.32

84.41

86.15

86.97

88.47

95.95

93.35

94.98

96.52

20

96.22

100.2

99.83

99.96

100.44

100.11

100.60

101.10

100.47

25

99.89

97.00

95.64

96.39

97.517

98.797

98.97

97.84

97.65

30

95.74

93.73

93.33

94.85

95.28

97.18

97.87

93.74

90.54

 

 


From above table it is observed that Batch F6 shows 95.95% drug release in 15 min in gastric fluid media.

 

Drug Release Study in Simulated Gastric Fluid (0.1 N HCl) 48-50:

Dissolution Profile of Factorial Batches in Simulated Gastric Fluid .The percent drug release after 15 min (Q15) for all factorial design batches i.e. F1 to F9 showed in the range of 81.32 to 96.52 %.

 

Fig 6. Drug Release Study in Simulated Salivary Fluid

 

Statistical Analysis by Design Expert Software:

The 32 full factorial designs was selected to study the effect of independent variables Indion-234 (X1) and Prosolv SMCC (X2) on dependent variables disintegration time (DT), percent friability (F), percent drug release in 15 min (Q15) in SSF, SGF.

 

CONCLUSION:

In the present study orally disintegrating tablet of Atenolol was prepared by direct compression technique. The prepared tablets were found to be within the official limits with respect to all parameters of evaluation. The disintegration time and dissolution studies were performed for the F1-F9 formulations. Among these two formulations F6 and F9 showed the least disintegration time and maximum cumulative percentage drug release after 15 min. But formulation batch F6 was found to be less friable and also requires less amount of Indion-234 as compared to batch F9. Therefore batch F6 was most robust formulation and considered to be optimum batch. As a result, orally fast disintegrating tablet administration of Atenolol may appear to be a promising alternative drug delivery to conventional drug delivery.

 

Fig7.Drug Release Study in Simulated Gastric Fluid

 

ACKNOWLEDGEMENT:

Authors are highly thankful to Dr. S. S. Khadabadi, Principal, Government College of Pharmacy, Aurangabad for providing all necessary support and guidance at every hours of work.

                                                                                               

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Received on 17.04.2013          Modified on 30.04.2013

Accepted on 20.05.2013         © RJPT All right reserved

Research J. Pharm. and Tech 6(7): July 2013; Page 753-760