Pharmaceutical preparation for topical administration of antigen

Details Pharmaceutical preparation for topical administration of antigen Pharmaceutical preparation for topical administration of antigen

1995-10-06

1999-08-24

Caputa, Anthony C.

Drug, bio-affecting and body treating compositions

Nonspecific immunoeffector, per se ; or nonspecific...

4242341, 4241841, 4242801, 4242831, 568623, 536115, 554 1, 562606, 436 71, A61K 3939, A61K 910, A61K 9113, A61K 906

Patent

active

059422378

DESCRIPTION:

BRIEF SUMMARY
The present invention relates to novel pharmaceutical preparations for topical administration of antigens and/or vaccines to mammals, including humans, via a mucosal membrane. The invention also relates to the use of certain compounds (to be defined in more detail below) as adjuvants or vehicles in such preparations.
The parenteral (intramuscular and subcutaneous) administration of antigens and/or vaccines is normally regarded as the most convenient way of administration. However, the administration by injection presents a range of disadvantages. Thus it requires the use of sterile syringes and may cause pains and irritations, particularly in the case of repeated injections, including the risk of infection. More significantly, in the case of intramuscular injections there is also a risk of the infection being poorly tolerated. There is likely to be an induration (hardening of tissue), haemorrhage (bleeding) and/or necrosis (local death of tissue) at the injection site. Besides, injections cannot be administered satisfactorily by untrained persons.
Administration of attenuated virus, bacteria or parasites has been attempted intranasally as well as through other mucosal surfaces. The elicitation of an immune response by such antigens through mucosal surfaces cannot be considered unexpected in such cases, because the modified live pathogens of the vaccine is following the natural route of infection of the wild-type pathogen creating immunity through a sub-clinical infection. The use of modified live pathogen to effect immunization entails a certain risk, however, because the more purified antigens are very poor immunogens and thus require effective formulations and adjuvants to produce a clinically protective immune response.
Mucosal administration is currently receiving special interest, attempting to stimulate locally produced antibodies (secretory IgA antibodies) and also to avoid the inconveniences caused by the direct intervention into the organism in connection with parenteral administration. Additionally, this route of administration may conveniently be used as an alternative to parenteral injection, since it may well be performed by an untrained person. Furthermore, small children will avoid the psychological irritation during injection (vaccination).
In order to be an attractive alternative to parenteral administration, the intranasal administration should be capable of stimulating humoral and cellular immune factors both systemically (mainly of the IgG isotype) and at mucosal surfaces where most pathogens enter the host by locally produced antibodies of the secretory IgA (IgA.sub.s) isotype. Several oral vaccines have been shown to induce appropriate IgA.sub.s responses in remote secretions including saliva, lachrymal fluid and fluids obtained from nasal and gastrointestinal washes. Such intranasally administered vaccines and/or antigens may not cause any considerable pain or irritation to the patient nor any irreversible damage or irritation to the mucosal surfaces.
In nasal administration, the antigen and/or vaccine must be applied to the mucosa in such a condition that it is able to penetrate or to be absorbed through the mucosa. In order to penetrate the mucus the vehicle must be biocompatible with the mucus and hence have a certain degree of hydrophilicity.
Vaccines and/or antigens are not able to be administered in pure form. It is necessary to blend them with other components to obtain a preparation which is ready for use. Dependent on the chemical properties of the antigen and/or vaccine it will be necessary to take various considerations into account before a pharmaceutical preparation for humans or animals can be produced.


BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a phase diagram of a composition according to the present invention.
It has now surprisingly been found that the topical administration of antigens and/or vaccines to mammals via mucosal membranes can be performed in a new and significantly improved manner by using a novel type of formulation, said preparation being

REFERENCES:
patent: 4315925 (1982-02-01), Hussain et al.
patent: 4985242 (1991-01-01), Sekine et al.
Sveinbjorn Gizurarson (1990) Acta Pharm. Nord. 2(2), 105-122. "Animal models for intranasal drug delivery studies".
Two abstract pages, Abstracts 27347n --27367u, Chemical Abstracts, 106:13-14 (1987).

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