Two-part capsule to accept pharmaceutical preparations for powder inhalers

Abstract

The present invention relates to capsules for holding pharmaceutical preparations for powder inhalers with increased drug safety and capsules for pharmaceutical preparations for powder inhalers with improved adaptation to their use in powder inhalers. The capsules consist of water-insoluble hydrophobic synthetic materials which do not significantly affect the pharmaceutical quality of the contents themselves, but which improve the usability of the filled capsules with regard to their function, their longevity and / or the geographic location of their use, and are advantageous at various stages from manufacture up to utilisation.

Description

[0001] The invention relates to new two-part capsules for holding pharmaceutical preparations for use in powder inhalers.THE PRIOR ART[0002] Capsules with pharmaceutical preparations are often used in the therapy and diagnosis of illnesses. The capsules can be orally administered or are used in certain medical apparatus such as powder inhalers. Generally, the capsules consist of two parts, a capsule body (body) and a capsule cap (cap), which are pushed together telescopically. However, multi-part capsules are also known. The capsules generally consist of gelatine, especially hard gelatine. In the case of some special applications, the capsules occasionally consist of water-soluble synthetic materials easily digested by humans, in order for example to release the active ingredients in certain compartments of the gastrointestinal tract in the case of oral administration. Examples of various capsule materials are listed hereinafter.[0003] EP 0143524 discloses a two-part capsule of mate...

AI Technical Summary

Benefits of technology

[0013] In one embodiment, the synthetic material of the capsule is not digestible by humans, so that the active ingredient is not released when the capsule is taken orally. This has the advantage that inadvertent swallowing of the capsule cannot lead to a detrimental effect on health. This applies especially to small children or older people.

[0014] Preferably, synthetic materials are used which can be processed using injection moulding or blow casting and / or synthetic materials where no mould release agent is necessary for their processing into capsule caps or capsule bodies, which can cause adhesion of the contents to the capsule wall. This has the advantage that the interior of the cap or the body need not be cleaned from mould separation agent, in order for example to meet the official requirements (e.g. according to DAB (Deutsches Apotheker Buch)), which restricts the use of mould release agents for primary packaging means.

[0015] In a preferred embodiment of the invention, the synthetic material does not exhibit any pronounced adhesion for pharmaceutical-chemical materials, especially for particles of lung-accessible size, so that when the capsule is used in one of the aforementioned inhalers, the entire contents of the capsule can be released. This has the advantage that exact dosage, especially of the lung-accessible fine fraction, is possible.

Problems solved by technology

The materials which are used are often not very resistant to air humidity, which is why the pharmaceutical quality of the contents cannot be guaranteed for all climatic zones.

However, these materials are not specially perfected for use in powder inhalers.

Hence materials used in construction of the capsules can alter their characteristics dependent on the ambient air humidity and / or do not always have sufficient inherent stability.

As a result, such a capsule cannot for example be used in climatic zone 4 as a result of the high air humidity, since the capsule material absorbs the humidity to such a degree that the inherent stability is seriously affected and / or the humidity penetrates into the interior of the capsule.

This has a negative effect on the pharmaceutical quality of the capsule's contents.

The said materials also have diverse disadvantages in other various stages in the life of the capsule from manufacturing up to utilisation, which affect the suitability of the capsule as a carrier for pharmaceutical preparations, the manner of administration of the contents, the perishability of the contents and / or the usability of the capsule in certain countries.

A further disadvantage of conventional capsule materials is that e.g. they tend to bind powder materials to themselves, especially when coated with a mould release agent which is often necessary for production of the capsule.

In the case of capsules for inhalation purposes, this leads to difficulty in accurately metering the fine fraction which is to enter the lungs.

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