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 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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