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 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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