Investigation of potential substandard dry powder inhalers on EU and North African markets – evaluation of the delivered and fine particle doses

Figures & data

Table 1. Delivered dose of 8 studied drugs (n = 3).

	Delivered dose (DD – µg)
	A (Foradil)	B	C	D	E	F	G	H
Test 1	8.31	9.57	9.38	8.56	8.79	9.23	9.41	9.42
Test 2	8.86	9.53	9.30	8.08	8.59	9.16	9.25	9.73
Test 3	8.41	9.51	9.37	8.35	8.81	9.02	9.63	9.92
Mean	8.53	9.54	9.35	8.33	8.73	9.14	9.43	9.69
DD versus Foradil		111.8%	109.6%	97.7%	102.3%	107.2%	110.6%	113.6%

Table 2. Fine particle dose of 8 studied drugs (n = 3).

	Fine particle dose (FPD – µg)
	A (Foradil)	B	C	D	E	F	G	H
Capsule	Gelatin	HPMC	HPMC	HPMC	HPMC	Gelatin	Gelatin	HPMC
Packaging	PA/Alu/PVC/Alu blister	HDPE container PP screw cap with desiccant	HDPE container PP screw cap with desiccant	Alu/Alu blister	Alu/Alu blister	PVC/PVDC/Alu blister	PVC/PVDC/Alu blister	PVC/PVDC/Alu blister
Test 1	2.74	3.18	3.31	3.04	3.07	2.01	2.25	2.70
Test 2	3.05	3.26	3.40	2.99	3.01	1.93	2.49	2.58
Test 3	2.76	3.32	3.33	3.07	3.31	1.66	2.64	2.93
Mean	2.85	3.25	3.35	3.03	3.13	1.86	2.46	2.74
FPD versus Foradil		114.2%	117.4%	106.4%	109.8%	65.5%	86.3%	96.0%

Figure 1. Nominal decomposed dose in non-delivered dose (in orange), non-respirable dose (in blue) and respirable dose (in grey).

Table 3. Evaluation of freezing-thawing cycles’ impact on sample stability (n = 3).

	Delivered dose of product B samples (µg)
	first freezing-thawing cycle	Second freezing-thawing cycle
Test 1	9.57	9.51
Test 2	9.53	9.44
Test 3	9.51	9.35
Mean	9.54	9.43

Data availability statement

Upon a reasonable request, the datasets of this study are available from the CONTACT.