Characteristics Of Aloe Vera Powder Biology Essay

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B. Estimation of Paracetamol using uv spectrophotometry

Paracetamol was estimated using phosphate buffer pH 5.8 and measured at 257nm using UV Spectrophotometry. It obeyed the Beer's law in the range of 2-10 µg/ml. Slope was found to be 0.0445, and the correlation coefficient was found to be 0.9978 and results were given in table 2.

Table 2: Estimation of Paracetamol measured at 257nm using UV Spectrophotometry.

S.No

Concentration (µg/ml)

Absorbance at 257nm

1

0

0.0000

2

2

0.1006

3

4

0.2016

4

6

0.2687

5

8

0.3622

6

10

0.4657

Fig 1: Estimation of Paracetamol measured at 257nm using UV Spectrophotometry.

c. Compatibility studies

Fig 2: IR spectrum of Paracetamol

Fig 3: IR spectrum of Aloe Vera

Fig 4: IR spectrum of Paracetamol and Aloe Vera

Table 3: IR spectrum of Paracetamol, Aloe Vera and Physical mixture

Materials

Wave number (cm-1)

Peak for functional group assignment

Standard

Test

PARACETAMOL

1501 (m)

1502.13

Aromatic C=C stretching

1350-1280

1322.93

Aromatic secondary C-N vibration

1900-1600

1652

C-O stretching

1410-1310

1371.14

OH bending

1500-1300

1436.71

Aliphatic C-H bending

1650-1550

1562.06

Secondary NH bending

840-800

800.31

Aromatic C-H bending

ALOE VERA

1900-1600

1633.41

C-O stretching

3700-3000

3654.44

OH stretching

1500-1300

1403.92

C-H bending in plane

1300-800

1079.94

C-C stretching

Materials

Wave number (cm-1)

Peak for functional group assignment

Standard

Test

PARACETAMOL

+

ALOE VERA

1900-1600

1652.7

C-O stretching

1501 (m)

1506.06

Aromatic C=C stretching

1500-1300

1438.64

Aliphatic C-H bending in one plane

840-800

804.17

Aromatic C-H bending

There was no interaction between drug and Aloe Vera gel and also no interaction was established between drug and starch as well as with other excipients. This can be predicted on the basis of no change in peak in the characteristic Fourier Transformation Infrared Spectroscopy.

II. FORMULATION OF PARACETAMOL TABLET

Table 4: Tablet formulation containing Paracetamol with Aloe Vera gel in different concentration using maize starch as disintegrating agent

Ingredients

F1

(mg)

F2

(mg)

F3

(mg)

F4

(mg)

F5

(mg)

F6

(mg)

Paracetamol

500

500

500

500

500

500

Maize starch paste

40

-

-

-

-

-

Aloe Vera gel

-

40

50

60

70

80

Maize starch powder

70

70

70

70

70

70

Lactose

38

38

28

18

8

-

Magnesium stearate

2

2

2

2

2

2

Total weight

650

650

650

650

650

650

Table 5: Tablet formulation containing Paracetamol with Aloe Vera gel in different concentration using high concentration of Sodium starch glycolate as disintegrating agent

Ingredients

F7

(mg)

F8

(mg)

F9

(mg)

F10

(mg)

F11

(mg)

Paracetamol

500

500

500

500

500

AloeVera gel

40

50

60

70

80

Sodium starch glycolate

70

70

70

70

70

Lactose

38

28

18

8

-

Magnesium stearate

2

2

2

2

2

Total weight

650

650

650

650

650

Table 6: Tablet formulation containing Paracetamol with Aloe Vera gel in different concentration using low concentration of Sodium starch glycolate as disintegrating agent

Ingredients

F12

(mg)

F13

(mg)

F14

(mg)

F15

(mg)

F16

(mg)

Paracetamol

500

500

500

500

500

AloeVera gel

40

50

60

70

80

Sodium starch glycolate

36

36

36

36

36

Lactose

72

62

52

42

32

Magnesium stearate

2

2

2

2

2

Total weight

650

650

650

650

650

III. EVALAUTION OF PARACETAMOL GRANULES

As per the results of physical characterization, batches from F1 to F16, the values ranged within that of the Pharmacopoeial limits. These physical parameters lead to the fact that such type of dosage form can be easily formulated, using the method involved, with no loss of material during packaging and transportation.

Table 7: Evaluation of Granules

Parameters

F1

F2

F3

F4

F5

F6

F7

F8

Bulk density (g/ml)

0.45

0.31

0.45

0.26

0.22

0.24

0.29

0.22

Tapped density (g/ml)

0.55

0.35

0.55

0.29

0.28

0.29

0.31

0.28

Hausners ratio

1.22

1.14

1.22

1.11

1.28

1.13

1.06

1.28

Compressibility as per Carrs index (%)

18.19

12.60

18.19

10.5

21.10

12.27

5.76

21.10

Angle of repose (0)

35.86

34.20

36.54

36.76

34.24

39.14

32.16

35.42

Parameters

F9

F10

F11

F12

F13

F14

F15

F16

Bulk density (g/ml)

0.25

0.45

0.22

0.45

0.24

0.29

0.22

0.22

Tapped density (g/ml)

0.29

0.53

0.28

0.55

0.27

0.32

0.30

0.28

Hausner ratio

1.08

1.20

1.27

1.22

1.13

1.07

1.33

1.28

Compressibility as per Carr's index (%)

7.58

18.06

21.4

18.19

12.27

6.73

25.08

22.10

Angle of repose (0)

32.16

36.86

35.42

33.60

32.14

32.28

37.21

36.19

IV. Evaluation of Paracetamol tabLETS

A. Thickness and Diameter

Table 8: Thickness and Diameter of Paracetamol tablets

S.No

Formulation code

Thickness (mm)

Diameter (cm)

1

F1

4.64

1.27

2

F2

4.64

1.28

3

F3

4.59

1.27

4

F4

4.64

1.27

5

F5

4.59

1.28

6

F6

4.59

1.26

7

F7

4.59

1.28

8

F8

4.59

1.27

9

F9

4.64

1.27

10

F10

4.59

1.26

11

F11

4.64

1.26

12

F12

4.64

1.27

13

F13

4.64

1.27

14

F14

4.59

1.25

15

F15

4.64

1.27

16

F16

4.59

1.26

B. Weight Variation Test

. In weight variation test, the Pharmacopoeial limit (United States Pharmacopoeia, 2000) for percentage deviation more than 324 mg is ±5%. The percentage deviation of all formulations was found to be within the limits, and hence all formulations passed the uniformity of weight as per official requirements of the United States Pharmacopoeia, 2000. The results were shown in table 9.

Table 9: Weight Variation of Paracetamol tablets.

S.No

Formulation code

Average weight (mg)

Limit range (±5%) (mg)

1

F1

630

599-662

2

F2

656

623-689

3

F3

653

620-686

4

F4

645

613-677

5

F5

650

618-683

6

F6

644

611-676

7

F7

630

599-662

8

F8

650

618-683

9

F9

641

609-673

10

F10

652

619-673

11

F11

633

602-665

12

F12

641

609-673

13

F13

663

629-696

14

F14

656

632-689

15

F15

655

622-687

16

F16

649

616-681

C. Hardness Test

Formulated Paracetamol tablets were tested for hardness using Pfizer hardness tester. The hardness increased as the concentration of the binder increased. Batch F11 showed a maximum hardness of 6 kg/cm2 using Aloe Vera as binding agent, whose hardness was similar to that of the reference batch F1. The results were shown in table 10.

Table 10: Hardness test of Paracetamol tablets

S.No

Formulation code

Hardness (kg/cm2)

1

F1

6.0

2

F2

3.6

3

F3

4.0

4

F4

4.6

5

F5

5.4

6

F6

6.0

7

F7

3.8

8

F8

4.4

9

F9

5.0

10

F10

5.2

11

F11

6.0

12

F12

3.2

13

F13

4.0

14

F14

4.6

15

F15

5.0

16

F16

5.6

Fig 5: Concentration of Binder versus Hardness

D. Friability Test (Banker and Ander, 1987)

Tablet hardness is not a complete indication of strength. Tablet's strength can also be measured in terms of Friability. In the present study, the percentage friability for all the tablet formulations was found to be below 1%, signifying that the friability was found to be within the specified limits. The friability decreased with increase in concentration of the binder. The results were given in table 11.

Table 11: Friability test of Paracetamol tablets.

S.No

Formulation code

Friability (%)

1

F1

0.157

2

F2

0.399

3

F3

0.334

4

F4

0.316

5

F5

0.284

6

F6

0.214

7

F7

0.468

8

F8

0.327

9

F9

0.204

10

F10

0.175

11

F11

0.126

12

F12

0.666

13

F13

0.458

14

F14

0.419

15

F15

0.256

16

F16

0.125

Fig 6: Concentration of Binder versus Friability

E. Wetting Time

The wetting time of the tablets were given in table 12.

Table 12: Wetting time of Paracetamol tablets

S.No

Formulation code

Wetting time (min)

1

F1

3

2

F2

5

3

F3

7

4

F4

8

5

F5

9

6

F6

12

7

F7

2

8

F8

4

9

F9

6

10

F10

8

11

F11

8

12

F12

6

13

F13

8

14

F14

9

15

F15

10

16

F16

14

C:\Users\Anila\Desktop\ani proj\photos\Image077.jpg

Fig 7: Wetting time of F1

C:\Users\Anila\Desktop\ani proj\photos\Image079.jpg

Fig 8: Wetting time of F11

Fig 9: Concentration of Binder versus Wetting Time

F. Disintegration Test

Disintegration test was carried out for formulated tablets using disintegration test apparatus as prescribed in USP, 2000. The disintegration time increased with increase in concentration of Aloe Vera gel. The disintegration time was more with maize starch when compared to sodium starch glycolate. The results of the disintegration test were given in table 13.

Table 13: Disintegration test of Paracetamol tablets

S.No

Formulation code

Disintegration time (min)

1

F1

4

2

F2

6

3

F3

9

4

F4

10

5

F5

11

6

F6

14

7

F7

3

8

F8

6

9

F9

8

10

F10

9

11

F11

10

12

F12

7

13

F13

9

14

F14

10

15

F15

12

16

F16

15

Fig10: Concentration of Binder versus Disintegration Time

G. Drug Content Uniformity

Paracetamol tablets are tested for drug content as prescribed in IP, 2007. Good uniformity in content was found among different formulations. Percentage of drug content present in the tablets was given in table 14.

Table 14: Drug content test for Paracetamol tablets

S.No

Formulation code

Amount of Paracetamol

Amount in mg

Amount in percentage

1

F1

486

97.2

2

F2

500

100

3

F3

494

98.8

4

F4

498

99.6

5

F5

496

99.2

6

F6

484

96.8

7

F7

495

99

8

F8

494

98.8

9

F9

498

99.6

10

F10

499

99.8

11

F11

500

100

12

F12

501

100.2

13

F13

512

102.4

14

F14

489

97.8

15

F15

490

98

16

F16

496

99.2

H. IN-VITRO DISSOLUTION STUDIES

Figure 9 shows the dissolution profile of the prepared Paracetamol formulations. In-vitro drug release from the tablets was major governing criteria to decide whether Aloe Vera gel or the commercially used binder (starch as in reference batch) is good binding agent. The release profile for the drug was taken for a period of one an half hour which can best be depicted by graph between percentage drug release and time. Batch F16 containing Aloe Vera gel as binder showed minimum release of 82.8% as compared to other batches of Aloe Vera gel and against the tablets of reference batch (Figure 11).

Table 15: In-vitro Dissolution test of Paracetamol tablets

Time (min)

% Release F1

% Release F2

% Release F3

% Release F4

% Release F5

% Release F6

% Release F7

% Release F8

10

45

32

29.7

22.5

22.5

20.7

36.4

39.6

20

63

46.8

32.4

39.6

30.6

26.1

41.4

45

30

75

54

45.6

48.8

39.6

37.8

45

58.5

40

88.2

64.8

55.8

57.6

45

46.8

55.8

62.1

50

99.9

72

67.5

63

55.8

59.4

66.5

69.3

60

-

79.2

73.8

75.6

61.2

63

72

79.2

70

-

88.2

84.6

79.2

66.6

72

79.2

88.2

80

-

93.6

93.6

88.2

75.6

77.4

84.6

93.6

90

-

97.2

96.3

94.6

87.3

84.6

98

98.2

Time (min)

% Release F9

% Release F10

% Release F11

% Release F12

% Release F13

% Release F14

% Release F15

% Release F16

10

32

27

22.5

27

26.1

21.6

19.8

17.1

20

39.6

36.4

33.2

32.4

30.6

27

26.1

29

30

45

45.9

42.3

39.6

39.6

32

33.2

37.8

40

59.4

52.2

48.6

45

48.6

45

41.4

50.4

50

63

58.5

53.1

59.4

59.4

50.4

57.6

55.8

60

73.8

68.4

64.8

64.8

63

62

63

64

70

81

79.2

72

73.8

75.6

75.6

70.2

70.2

80

88.2

82.8

81

88.2

84.6

82.8

77.4

77.4

90

95.4

89.1

86.4

96.3

94.6

89.1

85.5

82.8

Fig 11: In- vitro dissolution of Paracetamol tablets

I. KINETICS OF DRUG RELEASE

Various models such as Zero order kinetics (cumulative percentage amount of drug release against time), First order kinetics (log cumulative percentage of drug remaining to release against time), Higuchi (cumulative percentage amount of drug unreleased against square root of time) and Korsermeyer-Peppas (log cumulative percentage of drug released against log time) were applied to assess the kinetics of drug release from prepared Paracetamol tablets. Most suited model for drug release was predicted on the basis of regression coefficient i.e. nearer the value of regression coefficient towards 1, greater the suitability of best fitted release mechanism. In table 16, the kinetic parameters for Paracetamol release using Aloe Vera gel as binding agent were presented. As clearly indicated in table 16, the in- vitro drug release from all the formulation follows Zero order kinetics.

Table 16: Drug Release Kinetics of Paracetamol Tablets

Formulation code

Zero Order

R2

First Order

R2

Higuchi Plot

R2

Korsemeyer Plot R2

F1

0.993

0.973

0.997

0.998

F2

0.980

0.924

0.996

0.996

F3

0.987

0.9083

0.973

0.956

F4

0.980

0.922

0.994

0.993

F5

0.993

0.904

0.973

0.983

F6

0.987

0.973

0.985

0.980

F7

0.985

0.666

0.948

0.927

F8

0.990

0.868

0.979

0.970

F9

0.970

0.976

0.896

0.993

F10

0.993

0.957

0.983

0.988

F11

0.994

0.946

0.980

0.991

F12

0.986

0.806

0.939

0.940

F13

0.993

0.849

0.956

0.958

F14

0.988

0.925

0.951

0.954

F15

0.989

0.957

0.971

0.971

F16

0.985

0.984

0.996

0.998

Fig 12: DISSOLUTION KINETICS OF F1

Fig 13: DISSOLUTION KINETICS OF F2

Fig 14: DISSOLUTION KINETICS OF F3

Fig 15: DISSOLUTION KINETICS OF F4

Fig 16: DISSOLUTION KINETICS OF F5

Fig 17: DISSOLUTION KINETICS OF F6

Fig 18: DISSOLUTION KINETICS OF F7

Fig 19: DISSOLUTION KINETICS OF F8

Fig 20: DISSOLUTION KINETICS OF F9

Fig 21: DISSOLUTION KINETICS OF F10

Fig 22: DISSOLUTION KINETICS OF F11

Fig 23: DISSOLUTION KINETICS OF F12

Fig 24: DISSOLUTION KINETICS OF F13

Fig 25: DISSOLUTION KINETICS OF F14

Fig 26: DISSOLUTION KINETICS OF F15

Fig 27: DISSOLUTION KINETICS OF F16

STABILITY STUDIES

Among all formulated Paracetamol tablets, formulation F6, F11 and F16 were selected and tested as per international conference on Harmonization guidelines. The formulations were stored at real time 30±20C/65±5% RH test conditions in stability chambers for 6 months. At thethird month, the tablets were evaluated.

Table 17: Stability study data of Paracetamol tablet

Formulation code

Thickness

(mm)

Hardness

(kg/cm2)

Friability

(%)

Disintegration

(min)

Drug content(%)

Increase in weight (%)

F6

F11

F16

4.61

4.66

4.62

5.8

5.8

5.4

0.318

0.334

0.284

12

8

13

96

99.8

98.8

0.523

1.213

0.923

. When tablets were kept at real time 30±20C/65±5% RH storage condition, the hardness and disintegration time decreased indicating that the tablets were susceptible to friability loss. Therefore, the tablets must be protected from atmospheric moisture.

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