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Gastro-resistant enzyme pharmaceutical compositions

A composition and gastric juice-resistant technology, applied in drug combination, drug delivery, pharmaceutical formulation, etc.

Inactive Publication Date: 2013-01-16
APTALIS PHARMA CANADA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, patients must swallow several of these dosage forms each day

Method used

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  • Gastro-resistant enzyme pharmaceutical compositions
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  • Gastro-resistant enzyme pharmaceutical compositions

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0082] Example 1: Digestive Enzyme Tablets Without Excipients

[0083] Table I

[0084] Excipient-free tablet (500 mg tablet)

[0085] (obtained by direct compaction at 2.5T)

[0086]

[0087]

[0088] Tablets without excipients were prepared by direct compression of 500 mg of active substance (with lipase, protease and amylase enzyme activities as mentioned in Table 1 ) in a mold with a diameter of 9.7 mm.

[0089] Smaller tablets were also prepared as indicated below. Smaller tablets of each size were prepared in sufficient numbers such that they together had a total mass of approximately 500 mg (equivalent to one 9.7 mm tablet).

[0090] Tablet 2.0mm (34 small tablets)

[0091] Tablet 4.0mm (8 tablets)

[0092] Tablet 6.0mm (4 tablets)

[0093] Tablet 9.7mm (1 tablet)

example 2

[0094] Example 2: Evaluation of Pancreatic Enzyme Tablets Without Excipients and Reference Tablets Containing 40% w / w Excipients in Simulated Gastric and Intestinal Fluids

[0095] The excipient-free tablets of Example 1, as well as the uncoated reference formulation containing excipients, were evaluated for enzymatic activity in simulated gastric fluid (SGF) and simulated intestinal fluid (SIF) as described below. The reference formulation contained 8,000 USP units of lipase, 30,000 USP units of amylase, and 30,000 USP units of protease and approximately 40% w / w pharmaceutically acceptable excipients. Reference preparations were prepared by direct compression. Results are shown in Tables II-V.

[0096] method

[0097] Tablets were maintained in a solution of SGF (50 mL) at pH 1.2 or SIF (50 mL) at pH 6.8 at room temperature with constant rotary agitation (50 rpm). The lipase, amylase, and protease activity of each sample was measured over time using the inner portion of th...

example 3

[0112] Example 3: Evaluation of whole tablet lipase activity measured after exposure to SGF for various time intervals.

[0113] Tablets prepared in Example 1 and a reference preparation as described in Example 2 were exposed to SGF for 30, 60 and 120 minutes and the lipase activity of the whole resulting tablets was evaluated. The results are shown in Table V below.

[0114] Table V

[0115] Tablets containing no excipients containing 500 mg tablets obtained by direct compression at 2.5T

[0116]

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Abstract

The present invention generally relates to compacted pharmaceutical compositions (such as tablets) comprising one or more enzymes, where the composition is monolithic or multiparticulates (such as mini-tablets, micro-tablets, or prills), or where the composition has multiple layers with the outermost layer containing one or more enzymes.

Description

[0001] This application claims the benefit of US Provisional Application No. 61 / 315,814, filed March 19, 2010, which is hereby incorporated by reference. field of invention [0002] The present invention generally relates to pharmaceutical compositions (eg, tablets) comprising one or more enzymes (eg, pancreatic enzymes), wherein the composition is a monolithic or monolayered multiparticulate (eg, minitablet, minitablet agent or pellet), or wherein the composition has multiple layers, the outermost layer containing one or more enzymes. Background technique [0003] Various disease states of the pancreas create a situation in which insufficient pancreatic enzymes are available for the digestive process. Enzyme deficiencies associated with, for example, pancreatitis, pancreatectomy, steatorrhea, and cystic fibrosis can disrupt the breakdown and absorption of nutrients, leading to malnutrition. [0004] Exogenously administered pancreatic enzymes can be used to treat pancreati...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K38/46A61K9/16A61K9/24A61K9/48A61P1/14A61J3/00
CPCA61K9/0053A61K38/465A61K38/47A61K38/46A61K9/2095A61K38/48A61K45/06A61P1/14A61P1/18A61P11/00A61P25/32A61K2300/00A61K9/209A61K9/20A61K9/48
Inventor 米尔恰·亚历山德鲁·马泰埃斯库英格里·珍妮特·布斯托斯伊夫·迪穆兰蓬皮利娅·伊斯帕斯·萨博
Owner APTALIS PHARMA CANADA
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