Characteristics of “Hard-to-Use” Press-Through-Package Sheets: An Analysis of Information Collected by Marketing Specialists of a Japanese Medical Wholesaler

Figures & data

Figure 1 Breakdown of negative PEM-MS reports regarding press-through packages (PTPs). As multiple problems were often included in one report, the sum is not equal to the total number of reports.

Figure 2 Measured thickness of PTP pockets.

Figure 3 Parameters relating to the inside of PTP pockets.

Figure 4 Measurement of press-out force. (A) (left): Base for measurement, (B) (right): Method of measurement.

Table 1 Parameters Relating to the Inside of PTP Pockets

Term	Problem Group (n=39)	Control Group (n=97)
Drug major axis [mm]	9.02 ± 3.82	8.50 ± 2.21
Drug minor axis [mm]	6.16 ± 1.27	7.60 ± 1.24
Pocket major axis [mm]	11.67 ± 4.31	9.69 ± 2.28
Pocket minor axis [mm]	8.59 ± 2.32	8.78 ± 1.31
Major axis ratio	0.78 ± 0.13	0.87 ± 0.05
Minor axis ratio	0.74 ± 0.14	0.87 ± 0.05
Drug projected area [mm^2]	46.85 ± 24.75	51.68 ± 16.36
Pocket projected area [mm^2]	79.45 ± 41.06	67.17 ± 19.62
Projected area ratio	0.63 ± 0.18	0.77 ± 0.08

Note: Mean ± standard deviation.

Table 2 Results of Logistic Regression

Term	β Estimate	Standard Error	P value
Drug major axis [mm]	0.056	0.061	0.363
Drug minor axis [mm]	−0.743	0.166	<0.001
Pocket major axis [mm]	0.178	0.059	0.002
Pocket minor axis [mm]	−0.069	0.111	0.933
Major axis ratio	−12.362	3.057	<0.001
Minor axis ratio	−15.584	3.424	<0.001
Drug projected area [mm^2]	−0.011	0.010	0.263
Pocket projected area [mm^2]	0.014	0.007	0.030
Projected area ratio	−8.552	1.980	<0.001

Note: Bold rows represent the significant terms.

Table 3 Cross Table and Adjusted Residuals for PTP Materials

Material	Problem	Control	Sum
Aluminum	7 (4.11)	0 (−4.11)	7
PCTFE	4 (3.07)	0 (−3.07)	4
PE	1 (1.52)	0 (−1.52)	1
PP	11 (−1.59)	39 (1.59)	50
PVC	18 (−1.61)	56 (1.61)	74
PVDC	3 (0.74)	4 (−0.74)	7
COC	0 (−0.94)	2 (0.94)	2
Sum	44	101	145

Notes: Number of products, (Adjusted residual); Bold values show adjusted residuals whose absolute values are larger than 1.96, meaning significance.

Abbreviations: PCTFE, polychlorotrifluoroethylene; PE, polyethylene; PP, polypropylene; PVC, polyvinyl chloride; PVDC, polyvinylidene chloride; COC, cyclic olefin copolymer.

Table 4 Shapes of PTP Pocket Sections

Figure	Problem	Control
Very round	7	18
Slightly round	8	15
Slightly flat	10	21
Very flat	11	34
Others	2	0

Table 5 PTP Pocket Wall Thickness

Part	Problem (n=31)	Control (n=89)	P value
Top [µm]	106.45 ± 35.64	109.94 ± 40.43	0.652
Side [µm]	103.23 ± 36.64	110.45 ± 27.09	0.320
Bottom [µm]	25.16 ± 5.98	24.66 ± 4.11	0.670

Note: Mean ± standard deviation.

Figure 5 Distribution and mean value of press-out force in each group. n=31 (Problem), 89 (Control). Each dot represents the press-out force of a product. Bold bars indicate the mean values. The P value for the difference of the means is shown.