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 3: Buccal oxytocin 200 IU

Stated amount: 200 IU oxytocin (= 100%)

test I: D6/83

time (weeks)

mean conc/tablet (HPLC)

% HPLC

SD

SD/mean x100% CV%

n

0

211.135

105.6

17.070

8.1

20

3

227.125

113.6

39.854

17.5

4

7

217.825

108.9

15.956

7.3

4

14

195.500

97.8

2.858

1.5

4

23

197.550

98.8

3.077

1.6

4

33

164.050

82.0

4.397

2.7

4

45

158.825

79.4

3.144

2.0

4

53

164.988

82.5

4.618

2.8

20

test II: D20/75

time (weeks)

mean conc/tablet (HPLC)

% HPLC

SD

SD/mean x100% CV%

n

0

211.135

105.6

17.070

8.1

20

3

170.825

85.4

2.952

1.7

4

7

105.675

52.8

9.064

8.6

4

14

197.727

98.9

3.23

1.63

4

23

35.000

17.5

2.899

8.3

4

33

3.743

1.9

0.217

5.8

4

45

1.637

0.8

0.091

5.6

4

53

3.062

1.5

0.911

29.7

4

test III: D30/45

time (weeks)

mean conc/tablet (HPLC)

% HPLC

SD

SD/mean x100% CV%

n

0

211.135

105.6

17.070

8.1

20

3

203.033

101.5

2.914

1.4

3

7

208.725

104.4

16.201

7.8

4

23

2.393

1.2

0.230

9.6

3

33

6.903

3.5

9.732

14.1

4

45

2.023

1.0

0.136

6.7

4

72

124.000

62.0

13.966

11.3

16

Buccal oxytocin 200 IU

test III: D30/45; packed in sealed aluminium package

time (weeks)

mean conc/tablet (HPLC)

% HPLC

SD

SD/mean x100% CV%

n

0

211.135

105.6

17.070

8.1

20

3

202.600

101.3

8.675

4.3

4

14

194.738

97.4

7.636

3.9

4

23

197.965

99.0

3.183

1.6

4

33

160.725

80.4

3.235

2.0

4

45

157.675

78.8

0.855

0.5

4

72

159.142

79.6

8.024

5.04

12

test IV: D30/75; no package

time (weeks)

mean conc/tablet HPLC

% HPLC

SD

SD/mean x100% CV%

n

0

211.135

105.6

17.070

8.1

20

3

188.4750

94.2

12.048

6.4

4

7

190.850

95.4

8.368

4.4

4

14

151.283

75.6

8.982

5.9

4

23

128.478

64.2

9.041

7.0

4

33

82.338

41.2

1.971

2.4

4

45

67.420

33.7

1.137

1.7

4

53

65.045

32.5

2.802

4.3

20

test IV: D30/75; packed in sealed aluminium package

time (weeks)

mean conc/tablet HPLC

% HPLC

SD

SD/mean x100% CV%

n

0

211.135

105.6

17.070

8.1

20

3

188.900

94.4

10.280

5.4

4

7

196.825

98.4

13.909

7.1

4

14

205.665

102.8

9.318

4.5

4

23

198.843

99.4

1.607

0.8

4

33

161.450

80.7

2.475

1.5

4

45

104.568

52.3

66.613

63.7

4

53

132.709

66.4

56.711

42.7

19

Buccal oxytocin 200 IU

test V: D40/25; no package

time (weeks)

mean conc/tablet HPLC

% HPLC

SD

SD/GEM x100% CV%

n

0

211.135

105.6

17.070

8.1

20

3

201.500

100.8

14.332

7.1

4

7

204.375

102.2

19.652

9.6

4

14

142.405

71.2

7.383

5.2

4

23

144.735

72.4

5.898

4.1

4

33

163.725

81.9

4.757

2.9

4

45

162.723

81.4

1.764

1.1

4

53

165.593

82.8

3.497

2.1

20

test V: D40/25; packed in sealed aluminium package

time (weeks)

mean conc/tablet (HPLC)

% HPLC

SD

SD/mean x100% CV%

n

0

211.135

105.6

17.070

8.1

20

3

191.550

95.8

3.541

1.8

4

7

187.2

93.6

2.462

1.3

4

14

207.210

103.6

7.130

3.4

4

23

208.110

104.6

4.998

2.4

4

33

117.975

59.0

2.849

2.4

4

45

139.170

69.6

24.271

17.4

4

53

120.069

60.1

1.983

1.7

8

72

121.925

61.0

19.227

15.8

12

test VI: D40/75; no package

time (weeks)

mean conc/tablet (HPLC)

% HPLC

SD

SD/mean x100% CV%

n

0

211.135

105.6

17.070

8.1

20

3

204.625

102.3

29.545

14.4

4

7

206.850

103.4

7.824

3.8

4

14

178.805

89.4

2.858

1.6

4

23

164.075

82.0

4.347

2.6

4

33

127.325

63.7

2.934

2.3

4

45

128.430

64.2

4.036

3.1

4

53

2.927

1.5

0.120

4.1

13

Buccal oxytocin 200 IU

test VII: L20/30; no package

time (weeks)

mean conc/tablet (HPLC)

% HPLC

SD

SD/mean x100% CV%

n

0

211.135

105.6

17.070

8.1

20

3

227.775

113.9

14.973

6.6

4

7

210.650

105.3

4.812

2.3

4

14

176.904

88.5

19.563

11.1

5

23

185.740

92.9

3.833

2.1

4

33

175.650

87.8

4.608

2.6

4

45

174.958

87.5

1.763

1.0

4

53

169.960

85.0

4.960

2.9

20

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