MICRONEEDLE SYSTEM FOR APPLYING A HEPATITIS VACCINE

Abstract

The present invention relates to a microneedle system (MNS for short) for the intradermal application of a hepatitis vaccine, namely the antigen HBsAg.

Claims

1.-8. (canceled)

9. A microneedle array comprising a formulation of polyvinylpyrrolidone and HBsAg for use in the intradermal application for hepatitis vaccination, wherein the formulation contains disaccharide, non-ionic surfactants and polyalcohol with polyvinylpyrrolidone 1 to 95% by weight, trehalose 0.1 to 50% by weight polysorbate 0.01 to 10% by weight and glycerol 0.1 to 10% by weight.

10. The microneedle array according to claim 9, wherein the HBsAg content is 0.1 μg to 100 μg per microneedle array.

11. A product comprising the microneedle array according to claim 9 for use in the intradermal application for hepatitis vaccination.

12. A medicinal product comprising the microneedle array according to claim 9 for use in the intradermal application for hepatitis vaccination.

13. A microneedle array or agent for use in the intradermal application for hepatitis vaccination according to claim 9, wherein the formulation contains up to 95% by weight of polyvinylpyrrolidone and further auxiliaries and additives.

14. A microneedle array or product for use in the intradermal application for hepatitis vaccination according to claim 9, wherein the microneedle array does not comprise any adjuvants.

15. A microneedle array or product for use in the intradermal application for hepatitis vaccination according to claim 9, wherein the microneedle array comprises an applicator.

16. A microneedle array or product for use in the intradermal application for hepatitis vaccination according to claim 9, wherein the microneedle array comprises an applicator together with triggering device.

17. A method for performing an intradermal application for vaccination of HbsAg antigen having a microneedle array comprising a formulation of polyvinylpyrrolidone and HBsAg according to claim 9.

Description

[0030] EXAMPLES AND DRAWINGS

[0031] For the production of the microneedles according to the invention, the known methods can be applied, such as McCrudden M T, Alkilani A Z, McCrudden C M, McAlister E, McCarthy H O, Woolfson A D, et al. Design and physicochemical characterisation of novel dissolving polymeric microneedle arrays for transdermal delivery of high dose, low molecular weight drugs. J Control Release. 2014; 180: 71-80.

[0032] In a preclinical in-vivo study (guinea pigs), the above formulation showed excellent results of the resulting antibody titres in the blood of the vaccinated animals after application of the micro(needle)array patches (MAP); see FIG. 1.

[0033] The study design includes a prime/boost/boost (0/1/3 months) in 4 groups×12 animals, of which 3 are MAP groups with (20/40/60 μg HBsAg/MNA) and one is a reference group with intramuscular injection, i.m. with 20 μg HBsAg/i.m.). The primary endpoint is 4 months with follow-up titres after 6 and 12 months.

[0034] The results of the study show that in all MNA and injection groups a sufficiently strong (>red line) formation of anti-HBsAg antibodies serologically relevant for the evaluation of the vaccination success was achieved.

[0035] Furthermore, the experimental groups did not show any relevant differences between adjuvant (see FIG. 1, hatched) and non-adjuvant formulations (see FIG. 1, not hatched), as well as intradermal administration of the antigen by means of microarray and conventional application by injection needle.