Formulation and Evaluation of Oral Dispersion Tablet of Atorvastatin

 

Raman S.G.

1Department of Pharmaceutics, School of Pharmaceutical Sciences,

Vels Institute of Science Technology and Advanced Studies, Pallavaram, Chennai- 600117 India.

*Corresponding Author E-mail: pgmahesh83@gmail.com

 

ABSTRACT:

AIM: Atorvastatin is used along with a proper diet to help lower bad cholesterol and fats and raise good cholesterol in the blood. Objective: Difficulty in swallowing (dysphasia) is a common problem of all age groups, especially the elderly and pediatrics, because of physiological changes associated with these groups.

 

KEYWORDS: Atorvastatin, Starch sodium glycolate, Croscarmellose sodium, Direct compression method.

 

 


INTRODUCTION:

Recent developments in technology have presented viable alternatives for the patients who may have difficulty in swallowing tablets or liquids1. In certain cases like ill, sudden allergic issues and poor intake of water in such cases swallowing conventional tablets may be difficult2. Especially by old age and pediatrics patients. To overcome these issues Fast dissolving tablet is prepared3. In such cases bioavailability of drug is significantly greater than those absorbed from conventional dosage form4. ODT are suitable for all kind of patients. When we kept on the tongue it dissolves instantly within a few seconds without intake of water5. ODT released drugs in the mouth for absorption through local oral mucosal tissues and through pregastric as well as postgastric6,7. In certain cases the bioavailability of drugs may be increased due to absorption of drugs in oral cavity. The dispersed drugs that passes down significantly greater than those absorbed8,9. ODT's are also known as fast dissolving, mouth dissolving tablets10.

 

EXPERIMENTAL METHODS:

Pre-Formulation Studies:

Pharmaceutical methods substances.

Standard Curve of Atorvastatin:

Sodium hydroxide solution, 0.2M:

8gm of sodium hydroxide was dissolved in 1000ml distilled water and it gives 0.2M solution55.

 

Standard Curve of Atorvastatin:

Table No.1: Standard curve of Atorvastatin Phosphate buffer (pH 6.8)

S. No

Concentration (μg /ml)

Absorbance (290nm)

1

0

0.00

2

2

0.238

3

4

0.466

4

6

0.689

5

8

0.927

6

10

1.126

 

Figure No.1: Standard curve of Atorvastatin in Phosphate buffer (pH 6.8)

 

Method of Preparation:

Preparation of Atorvastatin tablets:

Direct compression technique:

Each tablet weight = 100mg

 

Precompression Studies of Powder Blends:

Angle of repose

θ = Tan-1 (h/r)

Where,

θ = Angle of repose,

h = Height of the powder cone,

r = Radius of the powder cone.

RESULTS AND DISCUSSION:

Pre-Formulation Studies:

The present study was undertaken to formulate Atorvastatin oral dispersible tablets with three polymers namely., CCS and SSG and in combination of three Super disintegrants and by dry granulation technique. (Table-3).

 

Table No.2: Different Formulation of Atorvastatin Oral Dispersible Tablets

S. No

Formulations

Hardness Test (kg/cm)

Thickness Test

(cm)

Friability Test (%)

% of Weight variation test

Estimation of Drug Content

1

F1

2.36

0.32

0.187

99.6

98.27

2

F2

2.37

0.39

0.209

99.7

96.34

3

F3

3.26

0.34

0.236

99.7

96.66

4

F4

2.56

0.36

0.266

99.8

97.58

5

F5

2.27

0.38

0.238

99.9

95.77

 

Table no: 3 Pre compression studies of powder blend

S. No

Formulation Code

Drug

SSG

CCS

Mannitol

Sodium Saccharin

Magnesium Stearate

Mint flavor

1

F1

10

-

10

73

5

2

q. s

2

F2

10

-

5

78

5

2

q. s

3

F3

10

5

5

73

5

2

q. s

4

F4

10

10

-

73

5

2

q. s

5

F5

10

5

-

78

5

2

q. s

 

Table no: 4 post compression studies of  Atorvastatin oral dispersion tablet

S. No

Formulations

Bulk Density

(gm/cm3)

Tapped Density

(gm/cm3)

Angle of Repose

(θ)

Carr's Index (%)

Hausner's Ratio

1

F1

0.384

0.377

31.35

10.15

1.327

2

F2

0.357

0.368

35.27

6.37

1.175

3

F3

0.356

0.365

32.98

9.28

1.205

4

F4

0.389

0.314

32.43

6.14

1.167

5

F5

0.337

0.363

34.05

9.27

1.008

 

Table No.5: Disintergration studies of Atorvastatin oral dispersible Tablets

S. No

Formulations

Disintegration time (sec)

Wetting time (sec)

1

F1

21

19

2

F2

22

18

3

F3

27

15

4

F4

25

19

5

F5

23

15

 

 

Figure No.2: FTIR spectrum of Atorvastatin

 

Figure No. 3: FTIR spectrum of SSG

 


In vitro Drug Release Study:

Tablets of all the formulations were subjected for invitro release studies. The results are presented in Table-5.

 

Fig no: 4 formulation-1(F1)

 

DISCUSSION:

Oral dispersible tablets of Atorvastatin were prepared by direct compression method. The prepared Oral dispersible tablets are round in shape.

 

CONCLUSION:

In the present work it has been observed from all formulations of Pre compression and post compression studies were given within the limit of values.

 

REFERENCE:

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2.      Indurwade, N. H., Rajyaguru, T. H. and Nakhat, P.D. Fast Dissolving drug delivery systems: A Brief overview. Indian Drugs. 2002; 39(8): 405-09.

3.      Devrajan, P.V, Gore, S.P. Fast Dissolving Tablets: The Future Compaction. Express Pharma Pulse. 2000: 23, 7(1), 16.

4.      Habib W, Khankari R, Hontz J. Fast-dissolving Drug Delivery Systems”, Critical Reviews. Therapeutic Drug Carrier Systems. 2000, 17(1), 61-72.

5.      Rowe. R.C, Shestey P.J, Weller P.J. Hand book of Pharmaceutical Excipients, 6th Edition, London, Chicago: Pharmaceutical Press, American Pharmaceutical Association; 2009.

6.      www.drugbank.ca

7.      Rajeshree Panigrahi. Effect of Combination of Natural Superdisintegrants on Fast Dissolving Tablets of Lisinopril. International Journal of Pharmaceutical Research and Allied Sciences. 2012; 1 (3): 73-78.

8.      Sunada, H., Bi Y. Preparation, evaluation and optimization of rapidly disintegrating tablets, Powder Technol. 2002; 122(23): 188-198.

9.      Goyani Sandip, M, Shah Pranav, Vyas Bhavin, Shah D.R, Formulation and evaluation of Orally disintegrating tablets of Meclizine hydrochloride. Int Res J Pharm. 2012; 3(3): 196- 199.

10.   Brahmaiah Bonthagarala. A comparative study on natural super disintegrents and synthetic super disintegrents. Int. J. Res. Ayurveda Pharm. 2014; 5(2): 185-192 http://dx.doi.org/10.7897/2277-4343.05237

 

 

 

Received on 04.04.2020           Modified on 14.09.2020

Accepted on 11.12.2020         © RJPT All right reserved

Research J. Pharm. and Tech. 2021; 14(9):4702-4704.

DOI: 10.52711/0974-360X.2021.00817