Solutions comprising polyethylene glycol and electrolytes

Abstract

The invention provides a solution in water comprising the following components at the following concentrations: (a) N×(70 to 130) g / L polyethylene glycol (PEG) having an average molecular weight of 2500 to 4500; (b) N×(1.6 to 4.0) g / L sodium chloride; (c) N×(0.2 to 0.6) g / L potassium chloride; (d) N×(0.6 to 2.2) g / L sodium bicarbonate; (e) N×an amount of preservative; (f) optionally N×an amount of flavouring; and (g) optionally N×an amount of sweetener where N is in the range of 2 to 8. The solution is a concentrate for dilution. In use it is diluted N-fold with water to provide a solution for administration to a subject for the treatment of constipation or faecal impaction. Also provided are solutions, kits, unit doses and methods that comprise or use the solutions.

Description

[0001]The present invention relates to solutions for the treatment of constipation or faecal impaction. In particular it relates to concentrates for use in the preparation of solutions comprising polyethylene glycol (PEG) and electrolytes.[0002]Constipation is a widespread condition which generally gives rise to discomfort. The physical presence of faeces retained in the colon and / or the rectum gives rise to a feeling of malaise and headaches. In extreme cases of prolonged constipation, dyschezia may result from the presence of scybala or faecaliths in the rectum.[0003]Numerous treatments of constipation have been developed, including dietary manipulation (e.g. increasing the fibre content of the diet and removing foods considered to be constipation causing), laxatives and enemas. Laxatives are agents that promote and assist defecation. Osmotic laxatives act to retain water in the colonic lumen thereby counteracting the normal dehydrating action of the colon. By suppressing the dehy...

AI Technical Summary

Benefits of technology

[0003]Numerous treatments of constipation have been developed, including dietary manipulation (e.g. increasing the fibre content of the diet and removing foods considered to be constipation causing), laxatives and enemas. Laxatives are agents that promote and assist defecation. Osmotic laxatives act to retain water in the colonic lumen thereby counteracting the normal dehydrating action of the colon. By suppressing the dehydration action of the colon, the osmotic laxative produces a faecal stream which is softer, bulkier and easier to expel.

[0151]Solutions of the invention optionally comprise one or more flavourings. Flavourings assist in making the solutions in their diluted form for ingestion more palatable to certain patients.

Problems solved by technology

Constipation is a widespread condition which generally gives rise to discomfort.

The physical presence of faeces retained in the colon and / or the rectum gives rise to a feeling of malaise and headaches.

It is found that dissolution can, in practice, take some time.

The time taken for the powder to dissolve causes inefficiency in the care-home or hospital setting where solutions are prepared by professional care-providers.

In the self-administration domestic setting, it can cause frustration in the patient and risks the patient taking an incompletely dissolved preparation, which would reduce the efficacy of the treatment.

Some patients have difficulties manipulating and tearing open the sachets.

The sachets are not re-usable.

The large amount of space taken up by the necessary multi-pack boxes can be costly and cause difficulties.

Despite there being scope for practical improvements in use for the powder PEG / electrolye compositions on the market, no concentrated solutions of PEG / electrolyes for dilution to PEG-containing laxatives have been developed to commercialisation.

Concentrated solutions of PEG / sodium sulphate lavage solutions have been proposed (see WO 2005 / 049049 and JP 1-11-132527), but no such solutions have been commercialised.

However, and in contrast to those publications, the current inventors have found that a concentrated solution of PEG, sodium chloride, potassium chloride and sodium bicarbonate (and no sodium sulphate), supports microbial growth to an unacceptable extent.

A re-closable closure may be tamper-evident.

Such a container can potentially be re-used or recycled, something that is not possible with sachets.

Particularly in the domestic setting, very accurate dilution is not generally possible or convenient.

The 1B solution did not achieve the required log reduction for yeast.

The 1A solution did not achieve the required log reduction for either yeast or mould.

Accordingly, the solutions without any preservative were found not to be suitable for use as concentrates for the preparation of oral medicaments.

The 2F solution did not achieve the required log reduction for bacteria (S. aureus) or mould (A. niger) at the 14 day time point.

Likewise, the 2G solution did not achieve the required log reduction for bacteria (S. aureus) or mould (A. niger) at the 14 day time point.