Package and device for simultaneously maintaining low moisture and low oxygen levels

a technology of oxygen level and moisture, applied in the direction of packaging foodstuffs, packaged goods types, pharmaceutical containers, etc., can solve the problems of unmarketable drugs, candidate to be excluded from development, reformulation and addition of standard antioxidants can take considerably more time and money

Inactive Publication Date: 2007-07-19
BEND RES
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0013] The present invention provides a pharmaceutical package comprising an oxygen permeable bottle containing therein at least one sub-container containing a self-activated oxygen absorber and at least one sub-container containing a desiccant. The sub-containers can be separate units or unitary, i.e., fabricated together as separate compartments within a single unit, termed herein a “cartridge”, containing the self-activated oxygen absorber in one compartment and the desiccan

Problems solved by technology

In the case of drugs that are highly oxygen-sensitive, such degradation may render a drug unmarketable or cause a candidate to be excluded from development.
At such later stages of development, reformulation and addition of standard antioxidants can require considerably more time and money.
European Patent Application Nos. 864630A1 and 964046A1 describe the use of iron iodide and bromide to allow oxygen absorption in a low humidity environment without the need to bring in water; however, commercial application of this technology has not been realized.
In the pharmaceutical industry, there have been some limited reports of using oxygen absorbers to stabilize drugs.
Although these systems perform well for many pharmaceutical applications, they cause the humidity in the bottle en

Method used

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  • Package and device for simultaneously maintaining low moisture and low oxygen levels
  • Package and device for simultaneously maintaining low moisture and low oxygen levels
  • Package and device for simultaneously maintaining low moisture and low oxygen levels

Examples

Experimental program
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Effect test

example 1

[0076] A 20 mm Flurotec® Teflon stopper (West Pharmaceutical Services, Jersey Shore, Pa.) was drilled through the center with a 1.0 mm drill bit. HPLC tubing (Upchurch Scientific, Oak Harbor, Wash.) was cut to 2 cm in length and forced through the drilled hole in the stopper. The tubing used included model 1520 (762 μm inner diameter), model 1532 (508 μm inner diameter), model 1531B (254 μm inner diameter), model 1535 (127 μm inner diameter) and model 1560 (64 μm inner diameter), all from Upchurch Scientific (a division of Scivex Inc., Oak Harbor, Wash.).

[0077] For the measurement of water vapor uptake, a 1 gram Sorb-It® canister (Süd-Chemie, Belen, N. Mex.) was cut open and the silica gel contents poured into a 10-cc tubular flint Type I glass vial (Wheaton Science Products, Syracuse, Nebr.). The stopper with tubing was crimp-sealed to the vial and the initial weight recorded. The test units were then placed in a 40° C. / 75% RH stability chamber and periodically weighed over two we...

example 2

[0079] A cartridge is made by injection molding polyethylene into two compartments with cylindrical shape of diameter 0.5 inches (1.3 cm) and wall diameters of approximately 1 mm. The top compartment has a single 600 μm diameter hole with a lattice (diameter of openings of 25 μm) on the side as part of the mold. The bottom compartment is 0.25 inches in height (0.63 cm). The top compartment is 0.5 inches in height (1.3 cm). Into the bottom compartment is filled 0.5 g of silica gel. A cap of sintered polyethylene (porosity of 0.1) is adhered to the bottom compartment to seal in the powder. Magnesium nitrate (1.0 kg) is slurried with 800 g of water to give a 44% (w:w) slurry. The top compartment is filled with a combination of 300 mg of fine iron powder (as described in U.S. Pat. No. 5,725,795) and 450 mg of the magnesium nitrate slurry. A cap is formed by injection molding polyethylene into a cylinder with a wall and a top having a high porosity (0.4). The cap is 0.55 inches in diamet...

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PUM

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Abstract

The present invention relates to a device for reducing the oxygen content of the air surrounding pharmaceutical dosage forms contained within an oxygen-permeable bottle, while also maintaining a relatively low moisture level in said air during the shelf-life of the product. Accordingly, a pharmaceutical package contains a dessicant in a first sub-container and a self-activated oxygen-absorber in a second sub-container.

Description

FIELD OF THE INVENTION [0001] The present invention relates to a device for reducing the oxygen content of the air surrounding pharmaceutical dosage forms contained within an oxygen-permeable bottle, while also maintaining a relatively low moisture level in said air during the shelf-life of the product. BACKGROUND OF THE INVENTION [0002] Oxygen induced drug degradation is a factor that can limit the shelf life, usually as indicated by the expiration date, of a drug product. In the case of drugs that are highly oxygen-sensitive, such degradation may render a drug unmarketable or cause a candidate to be excluded from development. [0003] In some cases, oxygen sensitivity occurs only in the presence of certain excipients. Since oxidation is often not accelerated by standard Arrhenius-based increased temperature studies (known in the art as “accelerated aging studies”), instances can occur in which the oxygen sensitivity of the drug is not recognized until drug development has progressed...

Claims

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Application Information

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IPC IPC(8): B65D85/42
CPCB65D81/268A61J1/00
Inventor FRIESEN, DWAYNE T.WATERMAN, KENNETH C.
Owner BEND RES
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