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) Ver el documento en el formato PDF
Índice de contenido
Ver el documentoAbbreviations
Ver el documentoSummary
Abrir esta carpeta y ver su contenidoIntroduction
Abrir esta carpeta y ver su contenidoMaterials and methods
Abrir esta carpeta y ver su contenidoResults
Abrir esta carpeta y ver su contenidoDiscussion
Ver el documentoConclusions and recommendations
Ver el documentoReferences
Cerrar esta carpetaAnnexes
Ver el documentoAnnex 1: Ergometrine 0.2 mg tablets
Ver el documentoAnnex 2: Methylergometrine 0.125 mg tablets
Ver el documentoAnnex 3: Buccal oxytocin 200 IU
Ver el documentoAnnex 4: Buccal desamino-oxytocin, 50 IU
Ver el documentoAnnex 5: Summary of results
Ver el documentoAnnex 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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