Pancrelipase (Amylase; Lipase; Protease) – Pancreaze

Status: NDA approved in 2010; long on the market before recent formal approval Organizations involved:

Johnson & Johnson Co. (J&J) - R&D; Tech.; World mark.

Nordmark Arzneimittel GmbH – Manuf.

Cross ref: See the entry for Pancreatic Enzyme Products

Description: PANCREAZE is a pancreatic enzyme preparation consisting of pancrelipase, an extract derived from porcine pancreatic glands. Pancrelipase contains multiple enzyme classes, including porcine-derived lipases, proteases, and amylases. Each capsule for oral administration contains enteric-coated microtablets that are each approximately 2 mm in diameter.

The active ingredient evaluated in U.S. clinical trials was lipase. PANCREAZE is dosed by lipase units. Other active ingredients include protease and amylase. Inactive ingredients in PANCREAZE include cellulose, colloidal anhydrous silica, crospovidone, magnesium stearate, methacrylic acid ethyl acrylate copolymer, montan glycol wax, simethicone emulsion, talc and triethyl citrate.

PANCREAZE is available in four color coded strengths. Each PANCREAZE capsule strength contains the specified amounts of lipase, protease, and amylase as follows:
4,200 USP units of lipase; 10,000 USP units of protease; 17,500 USP units of amylase. The hard gelatin capsules have a yellow opaque body and clear cap imprinted with “McNEIL” and “MT 4”. The capsule shell contains gelatin, titanium dioxide, sodium lauryl sulfate, sorbitan monolaurate, iron oxide, and gelatin capsule imprint ink.
10,500 USP units of lipase; 25,000 USP units of protease; 43,750 USP units of amylase. The hard gelatin capsules have a pink opaque body and clear cap imprinted with “McNEIL” and “MT 10”. The capsule shell contains gelatin, titanium dioxide, sodium lauryl sulfate, sorbitan monolaurate, iron oxide, and gelatin capsule imprint ink.
16,800 USP units of lipase; 40,000 units of protease; 70,000 USP units of amylase. The hard gelatin capsules have a salmon opaque body and clear cap imprinted with “McNEIL” and “MT 16”. The capsule shell contains gelatin, titanium dioxide, sodium lauryl sulfate, sorbitan monolaurate, iron oxide, and gelatin capsule imprint ink.
21,000 USP units of lipase; 37,000 units of protease; 61,000 USP units of amylase. The hard gelatin capsules have a white opaque body and cap imprinted with “McNEIL” and “MT 20”. The capsule shell contains gelatin, titanium dioxide, sodium lauryl sulfate, sorbitan monolaurate, and gelatin capsule imprint ink.

The pancreatic enzymes in PANCREAZE are enteric-coated to minimize destruction or inactivation in gastric acid. PANCREAZE is expected to release most of the enzymes in vivo at pH greater than 5.5. Pancreatic enzymes are not absorbed from the gastrointestinal tract in appreciable amounts.

Like other pancrealipases, the pancreatic enzymes in PANCREAZE catalyze the hydrolysis of fats to monoglyceride, glycerol and free fatty acids, proteins into peptides and amino acids, and starches into dextrins and short chain sugars such as maltose and maltriose in the duodenum and proximal small intestine, thereby acting like digestive enzymes physiologically secreted by the pancreas. Companies: Marketed by Janssen, a subsidiary of Johnson & Johnson (J&J). The finished product is manufactured by Nordmark Arzneimittel GmbH & Co. KG, Uetersen, Germany. FDA class: Drug NDA Approvals: Date = 20100412; full NDA (022523) Indications: [Full text of the "INDICATIONS AND USAGE" section of the product insert/labeling]:
PANCREAZE (pancrelipase) is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.

Status: In April 2010, full NDA approval was granted following standard review. Chemical Type" is classified by FDA as "Drug already marketed, but without an approved NDA."

This was the third pancrealipase product to receive FDA full approval, after Creon and Zenpep.

Trials: The short-term safety and efficacy of PANCREAZE were evaluated in two studies conducted in 57 patients with exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF).

"Medical: PANCREAZE is orally administered. PANCREAZE is not interchangeable with other pancrelipase products.