The pharmaceutical death-ride of dihydroartemisinin

Malaria Journal

Table 1 Outcome of stability studies performed on three batches of dihydroartemisinin tablets (Dynamax, Proxi Pharma, Belgium).

Time	Assay	Disintegration	Dissolution	Uniformity of mass	Average weight	Appearance
Month	%	Minutes	%
	(90-110)	(≤15)				(beige tablet)
Batch n° A - Accelerated stability studies: 40°C and 75% RH
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.

ISSN: 1475-2875