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Stability of Oral Oxytocics in Tropical Climates - Results of Simulation Studies on Oral Ergometrine, Oral Methylergometrine, Buccal Oxytocin and Buccal Desamino-Oxytocin - EDM Research Series No. 012
(1994; 52 pages) View the PDF document
Table of Contents
View the documentAbbreviations
View the documentSummary
Open this folder and view contentsIntroduction
Open this folder and view contentsMaterials and methods
Open this folder and view contentsResults
Open this folder and view contentsDiscussion
View the documentConclusions and recommendations
View the documentReferences
Close this folderAnnexes
View the documentAnnex 1: Ergometrine 0.2 mg tablets
View the documentAnnex 2: Methylergometrine 0.125 mg tablets
View the documentAnnex 3: Buccal oxytocin 200 IU
View the documentAnnex 4: Buccal desamino-oxytocin, 50 IU
View the documentAnnex 5: Summary of results
View the documentAnnex 6: Figures 1 to 7
 

Annex 2: Methylergometrine 0.125 mg tablets

Stated amount: 95µg free base methylergometrine (= 100%) test I: D6/83

time (weeks)

mean conc/tablet (HPLC)

% HPLC

SD

SD/mean x100% CV%

n

0

0.089

93.7

0.008

9.0

20

3

0.093

97.9

0.009

9.7

4

7

0.093

97.9

0.003

3.2

4

14

0.090

94.7

0.001

1.1

4

21

0.088

92.6

0.003

3.4

4

30

0.050

52.6

0.002

4.0

4

40

0.055

57.9

0.004

7.3

4

52

0.056

58.9

0.003

5.4

11

test II: D20/75

time (weeks)

mean conc/tablet (HPLC)

% HPLC

SD

SD/mean x100% CV%

n

0

0.089

93.7

0.003

9.0

20

3

0.100

115.8

0.006

6.0

4

7

0.083

87.4

0.004

4.8

4

14

0.078

82.1

0.003

3.8

4

21

0.056

58.9

0.003

5.4

4

30

0.049

51.6

0.002

4.1

4

40

0.053

55.8

0.001

1.9

4

52

0.054

56.8

0.004

7.4

12

test III: D30/45

time (weeks)

mean conc/tablet (HPLC)

% HPLC

SD

SD/mean x100% CV%

n

0

0.089

93.7

0.008

9.0

20

3

0.089

93.7

0.007

7.9

4

7

0.072

85.2

0.013

18.1

4

14

0.059

62.1

0.001

1.7

4

21

0.042

44.2

0.002

4.8

4

30

0.046

48.4

0.001

2.2

4

40

0.056

58.9

0.001

1.8

4

52

0.050

52.6

0.003

6.0

12

Methylergometrine 0.125 mg tablets

test IV: D30/75

time (weeks)

mean conc/tablet (HPLC)

% HPLC

SD

SD/mean x100% CV%

n

0

0.089

93.7

0.008

9.0

20

3

0.079

83.2

0.009

11.4

4

7

0.075

78.9

0.005

6.7

4

14

0.077

81.1

0.001

1.3

4

21

0.061

64.2

0.001

1.6

4

30

0.047

49.5

0.000

0

4

40

0.053

55.8

0.001

1.9

4

52

0.047

49.5

0.003

6.4

12

test V: D40/25

time (weeks)

mean conc/tablet HPLC

% HPLC

SD

SD/mean x100% CV%

n

0

0.089

93.7

0.008

9.0

20

3

0.093

97.9

0.008

8.6

4

7

0.090

94.7

0.004

4.4

4

14

0.091

95.8

0.001

1.1

4

21

0.076

80.0

0.004

5.3

4

30

0.046

48.4

0.002

4.3

4

40

0.052

54.7

0.000

0

4

52

0.049

51.6

0.002

4.1

12

test VI: D40/75

time (weeks)

mean conc/tablet (HPLC)

% HPLC

SD

SD/GEM x100% CV%

n

0

0.089

93.7

0.008

9.0

20

3

0.084

88.4

0.013

15.5

4

7

0.083

87.4

0.004

4.8

4

14

0.083

87.4

0.004

4.8

4

21

0.060

63.2

0.003

5.0

4

30

0.044

46.3

0.003

6.8

4

40

0.046

48.0

0.002

4.3

4

52

0.040

42.1

0.002

5.0

12

Methylergometrine 0.125 mg tablets test VII: L20/30

time (weeks)

mean conc/tablet HPLC

% HPLC

SD

SD/mean x100% CV%

n

0

0.089

93.7

0.008

9.0

20

3

0.097

102.1

0.003

3.1

4

7

0.072

75.8

0.006

8.3

4

14

0.081

85.3

0.001

1.2

4

21

0.061

64.2

0.003

4.9

4

30

0.048

50.5

0.001

2.1

4

40

0.054

56.8

0.002

3.7

4

52

0.054

56.8

0.002

3.7

12

Methylergometrine 0.125 mg tablets

test III: D30/45; packed in aluminium foil

time (weeks)

mean conc/tablet (HPLC)

% HPLC

SD

SD/mean x100% CV%

n

12

0.042

44.2

    

7

41

0.062

65.3

    

12

test IV: D30/75; packed in aluminium foil

time (weeks)

mean conc/tablet (HPLC)

% HPLC

SD

SD/GEM x100% CV%

n

12

0.049

51.6

    

8

41

0.060

63.2

    

12

test V: D40/25; packed in aluminium foil

time (weeks)

mean conc/tablet (HPLC)

% HPLC

SD

SD/mean x100% CV%

n

20

0.049

51.6

    

4

test VI: D40/75; packed in aluminium foil

tijd (wkn)

gem. HPLC abs

% HPLC

SD

SD/GEM x100%

n

12

0.047

49.5

    

8

20

0.044

46.3

    

6

test VII: L20/30; packed in aluminium foil

time (weeks)

mean conc/tablet (HPLC)

% HPLC

SD

SD/mean x100% CV%

n

12

0.051

53.7

    

8

41

0.052

54.7

    

6

test VII: L20/30; packed in sealed poly-ethylene

time (weeks)

mean conc/tablet (HPLC)

% HPLC

SD

SD/mean x100% CV%

n

41

0.057

60.0

    

24
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