In vitro Comparison of Pancreatic Enzyme Preparations Available in the Indian Market

Figures & data

Table 1 Overview of Pancreatic Enzyme Products Investigated

Brand Name (Manufacturer)	Label Claim^a (L, A, P)	Batch	Manufacturing Date	Expiry Date	Capsule Content
Creon^® 10,000 (Abbott Laboratories, Germany)	10,000	CNA9046	Sep 2019	Aug 2021	150 mg Pancreatin IP
	8000
	600
Creon^® 25,000 (Abbott Laboratories, Germany)	25,000	CNB9013	Oct 2019	Sep 2021	300 mg Pancreatin IP
	18,000
	1000
Creon^® 40,000 (Abbott Laboratories, Germany)	40,000	CNC9011	Aug 2019	Jul 2021	400 mg Pancreatin IP
	25,000
	1600
Agna™ 10,000 (Hetero Labs Limited, India)	10,000	GNA190905	Sep 2019	Aug 2021	170 mg Pancreatin IP
	8000
	600
Agna™ 25,000 (Hetero Labs Limited, India)	25,000	GNB190302	Mar 2019	Feb 2021	350 mg Pancreatin IP
	18,700
	1000
Enzar™ 10,000 (Torrent Pharmaceuticals, India)	10,000	TOREA9002	Jul 2019	Jun 2021	Unknown
	6000
	350
Enzar™ 25,000 (Enzar HS) (Torrent Pharmaceuticals, India)	25,000	WBC39013	Aug 2019	Jul 2021	250mg^b Pancreatin IP
	18,000
	1000
Enzar™ 40,000 (Torrent Pharmaceuticals, India)	40,000	TOREB9001	May 2019	Apr 2021	Unknown
	24,000
	1600
Panlipase^® 10,000 (Sun Pharmaceutical Industries, India)	10,000	BSU1310	Sep 2019	Feb 2021	150 mg Pancreatin IP
	33,200
	37,500
Panlipase^® 25,000 (Sun Pharmaceutical Industries, India)	25,000	ESU1875	Nov 2019	Apr 2021	300 mg Pancreatin IP
	74,700
	62,500

Notes: ^aAll values are in EP units except for Panlipase^® 10,000 and Panlipase^® 25,000 which are in USP units; ^bAccording to website http://www.1mg.com.

Abbreviations: A, amylase enzyme; IP, Indian pharmacopeia; L, lipase enzyme; P, protease enzyme.

Figure 1 Particle size of pancreatic enzyme preparations. Feret maximum diameter (X₅₀) for Creon^®, Agna™, Enzar™ and Panlipase^® pancreatic enzyme products. The continuous line at 2000 µm represents the largest particle size recommended in clinical guidelines for the treatment of PEI.

Table 2 Water Content of Pancreatic Enzyme Products

Product	Water Content (%)
Creon^® 10,000	4.3
Creon^® 25,000	4.1
Creon^® 40,000	4.1
Agna™ 10,000	5.7
Agna™ 25,000	5.8
Enzar™ 10,000	5.2
Enzar™ HS	5.2
Enzar™ 40,000	4.5
Panlipase^® 10,000	8.0
Panlipase^® 25,000	8.3

Table 3 Comparison of Actual Lipase Activity to Label Claim in Various Pancreatic Enzyme Products

Product	Label Claim (Activity per Capsule)	Activity Found (Activity per Capsule)	% Label Claim
Creon^® 10,000	10,000 EP units	12,031 EP units	120
Creon^® 25,000	25,000 EP units	27,661 EP units	111
Creon^® 40,000	40,000 EP units	41,654 EP units	104
Agna™ 10,000	10,000 EP units	6,748 EP units	67
Agna™ 25,000	25,000 EP units	19,217 EP units	77
Enzar™ 10,000	10,000 EP units	8178 EP units	82
Enzar™ HS	25,000 EP units	23,320 EP units	93
Enzar™ 40,000	40,000 EP units	43,221 EP units	108
Panlipase^® 10,000	10,000 USP units	7943 USP units	79
Panlipase^® 25,000	25,000 USP units	13,760 USP units	55

Abbreviations: EP, European pharmacopoeia; USP, United States pharmacopoeia.

Figure 2 Dissolution of pancreatic enzyme preparations. Dissolution of the different products at 20 min (solid bars) and 30 mins (patterned bars). Test items (pellets from capsules) were first incubated in simulated gastric fluid (pH 1) for 2 h and then transferred to phosphate buffer pH 6 and stirred for 30 min. Individual points indicate mean (standard deviation) at each time point (n = 6 for Creon^®, Agna™, Enzar™ products and Panlipase^® 25,000 and n = 4 for Panlipase^® 10,000).

Figure 3 Enzyme release kinetics of pancreatic enzyme preparations. Enzyme release kinetics for (A) Creon^® 10,000, Agna™ 10,000, Enzar™ 10,000, and Panlipase^® 10,000 (B) Creon^® 25,000, Agna™ 25,000, Enzar™ HS and Panlipase^® 25,000 (C) Creon^® 40,000 and Enzar™ 40,000. Test items were incubated in phosphate buffer pH 5 for 60 min and then phosphate buffer pH 6 for 60 min. The vertical dashed line represents the transition between the pH 5 and pH 6.