Quality of compounded topical 2% diltiazem hydrochloride formulations for anal fissure

Table 1 Potency at prespecified locations of compounded preparations of topical 2% diltiazem that lacked content uniformity

	Percentage of label claim (prescription number, type of packaging)
Sample location1	1, jar	2, jar	4, jar	10, jar	11, jar	14, jar	19, jar	20, jar	25, jar	26, jar	27, jar	28, jar	32, tube	33, tube
Location 1	111.9%	110.8%	102.9%	97.5%	126.0%	83.3%	100.2%	71.4%	73.0%	39.9%	94.8%	83.8%	44.3%	67.4%
Location 2	108.7%	114.2%	95.7%	98.0%	117.8%	73.1%	99.3%	20.9%	58.7%	74.2%	68.9%	66.5%	15.1%	83.4%
Location 3	142.1%	112.0%	100.6%	101.1%	144.9%	93.4%	91.2%	82.3%	67.3%	52.1%	63.4%	81.1%	16.8%	80.7%
Location 4	149.1%	145.5%	99.8%	100.9%	117.1%	72.4%	99.9%	81.8%	64.9%	76.1%	57.7%	82.9%	33.8%	87.9%
Location 5	110.6%	106.5%	109.0%	92.9%	107.4%	112.4%	95.9%	69.2%	63.2%	67.9%	54.3%	71.5%	67.7%	81.5%
Location 6	106.7%	99.9%	97.1%	90.9%	116.1%	161.1%	97.3%	81.3%	59.5%	65.8%	51.5%	65.4%	29.4%	79.3%
Location 7	110.8%	103.8%	100.8%	85.9%	121.2%	211.2%	77.8%	79.9%	55.2%	72.0%	56.1%	65.6%	42.0%	83.0%
Location 8	111.7%	107.8%	231.7%	89.2%	120.6%	220.8%	91.0%	82.1%	57.6%	70.6%	52.8%	65.6%	29.4%	90.7%
Mean	119.0%	112.6%	117.2%	94.6%	121.4%	128.5%	94.1%	71.1%	62.4%	64.8%	62.4%	72.8%	34.8%	81.7%
Relative SD	14.0%	12.5%	39.6%	6.0%	9.0%	46.9%	8.0%	29.4%	9.4%	19.2%	22.9%	11.5%	48.5%	8.5%

¹Jars: 1: Top front; 2: Top left back corner; 3: Top right back corner; 4: Top center; 5: Center of jar; 6: Middle right corner; 7: Bottom left corner; 8: Bottom center. Tubes: 1: Top left; 2: Top right; 3: Middle left; 4: Middle right; 5: Random left; 6: Random right; 7: Bottom left; 8: Bottom right.

Table 2 Mean potency as percentage of label claim for 3 prescriptions of compounded topical 2% diltiazem filled by 12 retail pharmacies

Pharmacy No.	Label claim (mean ± SD)	Relative SD
1	95.9% ± 9.8%	8.7
2	107.3% ± 16.5%	15.4
3	95.9% ± 2.2%	2.2
4	103.3% ± 5.1%	4.9
5	86.5% ± 20.1%	23.2
6	106.2% ± 1.8%	1.7
7	81.6% ± 6.5%	8.0
8	100.1% ± 2.0%	1.9
9	63.2% ± 3.8%	6.0
10	70.4% ± 3.2%	4.5
11	68.8% ± 6.5%	9.4
12	102.9% ± 0.8%	0.8