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Storage of Ampoules Containing Pharmaceutical Formulations Using a Sealed Container Comprising an Oxygen Scavenger

a technology of ampoules and oxygen scavengers, which is applied in the field of sealing containers, can solve the problems of reducing the shelf life of ampoules, the failure of the product, and the refusal of regulatory authorities to license ampoules without safeguards, so as to reduce or prevent the oxidation of formulations

Inactive Publication Date: 2010-06-10
APTALIS PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0008]The invention is based on the use of an oxygen scavenger to reduce or prevent oxidation of formulations within ampoules sealed within containers.
[0012]In a second aspect, the invention provides a method of reducing oxidative degradation of the content of an ampoule, the method comprising sealing the ampoule in a container containing an oxygen scavenger.
[0013]In a third aspect, the invention provides a method of reducing moisture egress from a container, the method comprising sealing the container in a pouch containing an oxygen scavenger.
[0016]In a sixth aspect, the invention provides the use of an oxygen scavenger to reduce or prevent oxidation of formulations within one or more ampoules sealed within a container.

Problems solved by technology

However, a number of technical and practical difficulties exist with all such containers.
A known problem with existing ampoules is that they allow oxygen, other gases and other volatile compounds into the ampoule and allow water (moisture) to exit.
As one specific example, unacceptable amounts of vanillin have been found inside ampoules, leading to failure of the product and refusal of regulatory authorities to licence the ampoules without safeguards against this external contamination.
This pouch is regarded as an acceptable solution but the contents are still susceptible to oxidation over time.
This is particularly an issue with drug formulations containing oxygen sensitive materials.
It is, however, a problem that using nitrogen in this process requires specialised equipment or modification of existing equipment.
Health and safety precautions associated with the use of nitrogen tend to increase production costs and times and the efficiency of nitrogen entrapment within the pouch varies and is not totally efficient

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0029]Packages were prepared each containing one 4-ampoule card and one FreshPax D-50 oxygen scavenger packet (MultiSorb) and sealed in foil. The packages were prepared in normal atmospheric conditions and contained air when sealed.

[0030]The oxygen scavenging data was analysed at timed intervals using a Mocon Head Space Analyzer, the results of which can be seen below:

TimeO2 content within foil0hours19.9%16hours566 ppm23hours435 ppm8days 0 ppm14days 0 ppm28days 0 ppm84days 0 ppm

[0031]A control package with no oxygen scavenger measured 20.5% O2 at 8 days.

example 2

[0032]This study was designed to demonstrate the effectiveness of oxygen scavengers in preventing degradation of the product, thereby reducing the impurity levels present in the solution after storage.

[0033]The solutions for nebulisation were manufactured in 3 ml LDPE ampoules using blow-fill-seal technology. The strips of 5 were then sealed in a foil over wrap to prevent water loss from and external contamination of the product.

[0034]One batch of Levalbuterol / Ipratropium Bromide Solution for Nebulisation (1.25 mg / 0.5 mg / 2 ml) combination product was manufactured in 2006. Two sublots of this batch were produced and labelled Sublot 1 (ampoules were sealed in a foil pouch containing an oxygen scavenger) and Sublot 2 (ampoules were sealed in a standard foil pouch) stored for 12 months and then tested as set out below.

[0035]The related substance data summarised below is for product that has been stored for 12 months at 25° C. / 60% RH.

Batch 04906ASublot 1Sublot 2 (No(Oxygen Scavenger)Oxyg...

example 3

[0038]This study was designed to demonstrate the effectiveness of oxygen scavengers in generating and maintaining an oxygen-free environment when ampoules are stored inside a foil pouch containing an oxygen scavenger.

[0039]Ampoules were manufactured using blow-fill-seal technology in normal atmospheric conditions and contained only air when sealed. Packages were prepared each containing four empty ampoules sealed within an aluminium pouch containing one FreshPax D-50 oxygen scavenger packet (MultiSorb).

[0040]The packages were prepared in normal atmospheric conditions and the oxygen content of air inside the pouches and ampoules on sealing was 20.5%. The packages were stored for 18 months and then tested as set out below. Oxygen content inside each pouch and inside two ampoules from each pouch was measured following internal protocols SAP 392.01 and SEP 156.01.

[0041]A Systech Gaspace Advance Oxygen Micro Headspace Analyser was used to measure oxygen content. The Gaspace instrument wa...

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Abstract

Ampoules made of plastics material and containing 0.5 to 5 ml of a pharmaceutical formulation are sealed, together with an oxygen scavenger, within a pouch.

Description

FIELD OF THE INVENTION[0001]The present invention relates to the sealing of containers which can be used for storage of ampoules containing pharmaceutical formulations, and in particular to sealing ampoules within a pouch to reduce or prevent oxidation of the formulations over time. The invention relates also to the sealed containers, in particular containing such ampoules.BACKGROUND TO THE INVENTION[0002]Pharmaceutical formulations are presented in a variety of different packaging, including packaging made of glass, metal, plastic and natural materials. For liquid formulations, e.g. solutions or suspensions, the packaging must be and remain sealed to prevent leakage. However, a number of technical and practical difficulties exist with all such containers.[0003]It is known to administer drugs to the lungs of a patient using a nebuliser, allowing a patient to administer the drug whilst breathing normally. The drugs are provided in a unit dose ampoule (UDA), containing a relatively sm...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K9/00A61K31/439A61P11/08A61P11/06
CPCA61J1/067B65D81/266A61J1/10B65D81/268A61P11/06A61P11/08B65D81/26A61J1/06
Inventor MCAFFER, IAN GARDENER, CAMERONTASKO, PETER ERNEST
Owner APTALIS PHARMA
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