Table 1 |
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|
Outcome of stability studies performed on three batches of dihydroartemisinin tablets (Dynamax, Proxi Pharma, Belgium). |
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| Time |
Assay |
Disintegration |
Dissolution |
Uniformity of mass |
Average weight |
Appearance |
|
|
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| Month |
% |
Minutes |
% |
|||
| (90-110) |
(≤15) |
(beige tablet) |
||||
|
|
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| Batch n° A - Accelerated stability studies: 40°C and 75% RH |
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|
|
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| Zero |
97.4 |
conform |
75 |
conform |
0.2728 |
conform |
| 1 |
99.3 |
conform |
81 |
conform |
0.2776 |
conform |
| 3 |
80.4 |
conform |
65 |
conform |
0.2782 |
not conform |
|
|
||||||
| Batch n° A - Real time stability studies: 30°C and 65% RH |
||||||
|
|
||||||
| Zero |
97.4 |
conform |
75 |
conform |
0.2728 |
conform |
| 3 |
95.6 |
conform |
70 |
conform |
0.2769 |
conform |
| 6 |
85.5 |
conform |
Not tested |
conform |
0.2786 |
conform |
|
|
||||||
| Batch n° B - Accelerated stability studies: 40°C and 75% RH |
||||||
|
|
||||||
| Zero |
91.7 |
conform |
73 |
conform |
0.2747 |
conform |
| 1 |
93.9 |
conform |
75 |
conform |
0.2792 |
conform |
| 3 |
77.3 |
conform |
74 |
conform |
0.2805 |
not conform |
|
|
||||||
| Batch n° B - Real time stability studies: 30°C and 65% RH |
||||||
|
|
||||||
| Zero |
91.7 |
conform |
73 |
conform |
0.2747 |
conform |
| 3 |
100.9 |
conform |
67 |
conform |
0.2775 |
conform |
| 6 |
79.1 |
conform |
Not tested |
conform |
0.2803 |
conform |
|
|
||||||
| Batch n° C - Accelerated stability studies: 40°C and 75% RH |
||||||
|
|
||||||
| Zero |
93.7 |
conform |
80 |
conform |
0.2734 |
conform |
| 1 |
95.0 |
conform |
70 |
conform |
0.2791 |
conform |
| 3 |
88.4 |
conform |
73 |
conform |
0.2805 |
not conform |
|
|
||||||
| Batch n° C - Real time stability studies: 30°C and 65% RH |
||||||
|
|
||||||
| Zero |
93.7 |
conform |
80 |
conform |
0.2734 |
conform |
| 3 |
91.2 |
conform |
68 |
conform |
0.2785 |
conform |
| 6 |
80.4 |
conform |
Not tested |
conform |
0.2806 |
conform |
|
|
||||||
|
Assay performed by HPLC with reference standard; appearance assessed by macroscopic inspection; disintegration, uniformity of mass and friability determined according to European Pharmacopoea. |
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|
Jansen Malaria Journal 2010 9:212 doi:10.1186/1475-2875-9-212 |
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