Syringeability of morphine ARER, a novel, abuse-deterrent, extended-release morphine formulation

Figures & data

Table 1. Mean difficulty ratings and syringeable volume for syringeability tests on a scale of 1 (very easy to draw into a syringe) to 10 (impossible to draw into a syringe).

	Incubation Time, min
	1		5		10		30
Condition (Number of repetitions)	Mean difficulty	Syringeable volume, mL	Mean difficulty	Syringeable volume, mL	Mean difficulty	Syringeable volume, mL	Mean difficulty	Syringeable volume, mL
ER morphine (N = 3)
10 mL, crushed, room temperature, 100 rpm	3.7	10	3.3	10	3	10	3.3	10
Morphine ARER (N = 5)
Condition: Room temperature, 100 rpm
Intact tablet (27-gauge needle)*
1 mL	1	1	1	1	1	1	1.8	1
5 mL	3.4	5	3.2	5	3.4	5	2.6	5
10 mL	3.4	10	3.6	10	3.2	10	3.4	10
Cut tablet (18-gauge needle)
1 mL	10	N/A	10	N/A	10	N/A	10	N/A
5 mL	10	N/A	10	N/A	10	N/A	10	N/A
10 mL	6.4	4	6.8	4	6.2	4	6.6	4
Crushed tablet (18-gauge needle)
1 mL	10	N/A	10	N/A	10	N/A	10	N/A
5 mL	10	N/A	10	N/A	10	N/A	10	N/A
10 mL	8.6	4	8.4	4	8.4	4	8.6	4
Condition: 90°C, 100 rpm
Intact tablet (27-gauge needle)*
1 mL	1	1	1	1	1	1	1.4	1
5 mL	1	5	1	5	1	5	2.6	5
10 mL	2.4	10	2.6	10	2.4	10	2.4	10
Cut tablet (18-gauge needle)
1 mL	10	N/A	10	N/A	10	N/A	10	N/A
5 mL	10	N/A	10	N/A	10	N/A	10	N/A
10 mL	6.6	2	6.2	2	6.6	2	6.2	2
Crushed tablet (18-gauge needle)
1 mL	10	N/A	10	N/A	10	N/A	10	N/A
5 mL	10	N/A	10	N/A	10	N/A	10	N/A
10 mL	8.4	2	8.4	2	8.6	2	8.4	2

Note. Tests were completed in an iterative fashion. Data for the smallest-bore needle that allowed liquid to be drawn into a syringe are shown. Tests were completed after 10 minutes of agitation for each condition. A rating of 1 = very easy to pull into a syringe; a rating of 10 = impossible to pull into a syringe. rpm = revolutions per minute. Syringeable volume was “N/A” if it was not possible to draw liquid into the syringe.

*The liquid around intact morphine ARER tablets was deemed “very easy” to syringe; however, extraction data indicate that only trace amounts of morphine were pulled into the syringe.

Figure 1. Representative samples of (a) intact, (b) cut, and (c) crushed morphine ARER tablets after a 10-min incubation in 5 mL room temperature water with agitation.

Notes: Panels on the left show the resulting mixture; panels on the right illustrate the attempts to draw the resulting solution into a syringe.

Figure 2. Mean percentage of morphine released from crushed ER morphine after 1, 5, 10, and 30 min of 100 rpm agitation in 10 mL roomtemperature water.

Notes: Error bars = standard deviation; ER = extended-release; SD = standard deviation.

Figure 3. Mean percentage of morphine released after 1, 5, 10, and 30 min in 1 mL, 5 mL, or 10 mL room temperature water with 100 rpm agitation for (a) intact, (b) cut, or (c) crushed morphine ARER tablets. Notes: Error bars = standard deviation; ER = extended-release; SD = standard deviation.

Figure 4. Mean percentage of morphine released after 1, 5, 10, and 30 min in 1 mL, 5 mL, or 10 mL 90°C water with 100 rpm agitation for (a) intact, (b) cut, or (c) crushed morphine ARER tablets. Notes: Error bars = standard deviation; ER = extended-release; rpm = revolutions per minute; SD = standard deviation.