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Tablet Reproducibility Study

Background

16 standard generic Aspirin tablets were (with one exception) each measured 16 times, using the new, multiple tablet capability of the Version 4 Solid Fraction Measurement System. The true (pore-free) density of the powder was input as 1.42, based on the value cited by Hancock et al 2003.

 

Results

1) The average solid fraction of the 347 measurements was 0.924, in excellent agreement with the value of 0.93 cited by Hancock et al.

2) The very low standard deviation of the automated measurements demonstrate the excellent reproducibility of the measurement system.

 

Sample #

1st Meas

2nd Meas

3rd Meas

4th Meas

5th Meas

6th Meas

7th Meas

8th Meas

9th Meas

1

0.924

0.921

0.924

0.918

0.922

0.921

0.919

0.923

0.915

2

0.916

0.914

0.920

0.917

0.915

0.913

0.913

0.919

0.924

3

0.920

0.920

0.923

0.920

0.921

0.919

0.921

0.922

0.926

4

0.931

0.931

0.935

0.932

0.933

0.930

0.929

0.940

0.932

5

0.925

0.920

0.926

0.926

0.923

0.922

0.922

0.926

0.925

6

0.922

0.917

0.923

0.916

0.924

0.925

0.920

 N/A

 N/A

7

0.935

0.931

0.933

0.933

0.930

0.929

0.927

0.936

0.938

8

0.930

0.930

0.931

0.929

0.925

0.927

0.929

0.925

0.935

9

0.927

0.928

0.929

0.929

0.927

0.927

0.927

0.928

0.930

10

0.922

0.922

0.926

0.924

0.923

0.922

0.921

0.925

0.927

11

0.924

0.926

0.930

0.929

0.928

0.923

0.925

0.930

0.929

12

0.921

0.924

0.924

0.922

0.920

0.921

0.920

0.921

0.916

13

0.916

0.918

0.921

0.918

0.917

0.915

0.916

0.920

0.925

14

0.918

0.918

0.921

0.919

0.918

0.918

0.920

0.922

0.921

15

0.926

0.923

0.929

0.924

0.924

0.927

0.921

0.927

0.920

16

0.928

0.931

0.934

0.931

0.931

0.930

0.932

0.930

0.931


Sample #

10th Meas

11th Meas

12th Meas

13th Meas

14th Meas

15th Meas

16th Meas

Mean

Std Dev

1

0.916

0.919

0.920

0.917

0.919

0.917

0.919

0.920

0.003

2

0.915

0.917

0.916

0.917

0.917

0.915

0.918

0.917

0.003

3

0.923

0.921

0.919

0.920

0.919

0.917

0.919

0.921

0.002

4

0.934

0.934

0.930

0.930

0.934

0.929

0.936

0.932

0.003

5

0.926

0.921

0.928

0.927

0.933

0.923

0.924

0.925

0.003

6*

N/A

N/A

N/A

N/A

N/A

N/A

N/A

0.921

0.004

7

0.932

0.936

0.934

0.933

0.931

0.932

0.935

0.933

0.003

8

0.925

0.922

0.925

0.924

0.924

0.925

0.926

0.927

0.003

9

0.927

0.926

0.926

0.924

0.927

0.928

0.930

0.927

0.002

10

0.925

0.924

0.924

0.923

0.924

0.924

0.924

0.924

0.001

11

0.929

0.928

0.926

0.928

0.928

0.925

0.926

0.927

0.002

12

0.921

0.921

0.918

0.919

0.924

0.922

0.920

0.921

0.002

13

0.916

0.921

0.916

0.914

0.915

0.922

0.914

0.918

0.003

14

0.919

0.918

0.916

0.921

0.918

0.919

0.919

0.919

0.001

15

0.926

0.924

0.922

0.926

0.925

0.925

0.924

0.925

0.002

16

0.932

0.930

0.930

0.928

0.928

0.926

0.929

0.930

0.002

6* Note: Sample 6 was misplaced during the one week interval between the 7th and 8th measurements. Hancock, Bruno C., Joshua T. Colvin, Matthew P. Mullarney, and Andrey V. Zinkchuk, "The Relative Densities of Pharmaceutical Powders, Blends, Dry Granulations, and Immediate-Release Tablets", Pharmaceutical Technology, April 2003, 64-80

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