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 1: Ergometrine 0.2 mg tablets

Stated amount: 147µg free base ergometrine (=100%) test I: D6/83

time (weeks)

mean conc/tablet (HPLC)

% HPLC

SD

SD/mean x100% CV%

n

0

0.142

96.6

0.008

5.6

20

3

0.148

100.7

0.014

9.5

4

7

0.125

85.1

0.005

4.0

4

14

0.130

88.4

0.005

3.8

4

21

0.096

65.3

0.002

2.1

4

30

0.096

65.3

0.003

3.1

4

40

0.085

57.8

0.002

2.4

4

52

0.079

53.7

0.004

5.1

16

test II: D20/75

time (weeks)

mean conc/tablet (HPLC)

% HPLC

SD

SD/mean x100% CV%

n

0

0.142

96.6

0.008

5.6

20

3

0.104

70.7

0.022

21.1

4

7

0.108

73.5

0.002

1.9

4

14

0.095

64.6

0.008

8.4

4

21

0.049

33.3

0.003

6.1

4

30

0.045

30.6

0.002

4.4

4

40

0.032

15.3

0.001

3.1

4

52

0.023

15.6

0.002

8.7

20

test III: D30/45

time (weeks)

mean conc/tablet (HPLC)

% HPLC

SD

SD/mean x100% CV%

n

0

0.142

96.6

0.008

5.6

20

3

0.093

63.3

0.014

15.1

4

7

0.120

81.6

0.008

6.7

4

14

0.099

67.3

0.001

1.0

4

21

0.074

50.3

0.003

4.1

4

30

0.067

45.6

0.003

4.5

4

40

0.059

40.1

0.000

0

2

52

0.054

36.7

0.003

5.6

20

Ergometrine 0.2 mg tablets test IV: D30/75

time (weeks)

mean conc/tablet (HPLC)

% HPLC

SD

SD/mean x100% CV%

n

0

0.142

96.6

0.008

5.6

20

3

0.124

84.4

0.013

10.5

4

7

0.084

57.1

0.005

8.5

4

14

0.058

39.5

0.004

6.9

4

21

0.034

23.1

0.002

5.9

4

30

0.031

21.1

0.002

6.5

4

40

0.019

12.9

0.001

5.3

3

52

0.013

8.8

0.002

15.4

20

test V: D40/25

time (weeks)

mean conc/tablet (HPLC)

% HPLC

SD

SD/mean x100% CV%

n

0

0.142

96.6

0.008

5.6

20

3

0.095

64.4

0.012

12.6

4

7

0.113

76.9

0.010

8.8

4

14

0.102

69.4

0.003

2.9

4

21

0.078

53.1

0.005

6.4

4

30

0.077

52.4

0.005

6.5

4

40

0.074

50.3

0.001

1.4

4

52

0.066

44.9

0.010

15.0

20

test VI: D40/75

time (weeks)

mean conc/tablet (HPLC)

% HPLC

SD

SD/mean x100% CV%

n

0

0.142

96.6

0.008

5.6

20

3

0.039

26.5

0.008

20.5

4

7

0.018

12.2

0.006

33.3

4

14

0.005

3.4

0.001

20

4

21

0.002

1.4

0.000

0

4

30

0.001

0.7

0.000

0

4

40

0.002

1.4

0.000

0

4

52

0.001

0.7

0.001

100

8

Ergometrine 0.2 mg tablets

test VII: L 20/30

time (weeks)

mean conc/tablet (HPLC)

% HPLC

SD

SD/mean x100% CV%

n

0

0.142

96.6

0.008

5.6

20

3

0.090

61.2

0.010

11.1

4

7

0.095

64.6

0.008

8.4

4

14

0.077

52.4

0.009

11.7

4

21

0.073

49.7

0.006

8.2

4

30

0.073

49.7

0.003

4.1

4

40

0.068

46.3

0.002

2.9

4

52

0.065

44.2

0.003

4.6

18

Ergometrine 0.2 mg tablets

test VII: L 20/30; packed in aluminium foil

time (weeks)

mean conc/tablet (HPLC)

% HPLC

SD

SD/mean x100% CV%

n

0

0.142

96.6

   

20

12

0.095

64.6

   

4

20

0.087

59.2

   

2

41

0.087

59.2

   

4

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

time (weeks)

mean conc/tablet (HPLC)

% HPLC

SD

SD/mean x100% CV%

n

41

0.079

54.4

   

11

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