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. A microneedle array for use in the intradermal application for hepatitis vaccination, wherein the microneedle array consists of HBsAg, and 1 to 95% by weight of polyvinylpyrrolidone and trehalose 0.1 to 50% by weight as an auxiliary polysorbate 0.01 to 10% by weight as an auxiliary and glycerol 0.1 to 10% by weight as an auxiliary.

2. The microneedle array according to claim 1, wherein the HBsAg content is 0.1 g to 100 g per microneedle array.

3. A product comprising the microneedle array according to claim 1 for use in the intradermal application for hepatitis vaccination.

4. A medicinal product comprising the microneedle array according to claim 1 for use in the intradermal application for hepatitis vaccination.

5. A product for use in the intradermal application for hepatitis vaccination, wherein the product comprises the microneedle array according to claim 1 and an applicator together with triggering device.

6. A method comprising performing an intradermal application for vaccination of HbsAg antigen utilizing the microneedle array according to claim 1.

7. A microneedle array for use in the intradermal application for hepatitis vaccination, wherein the microneedle array consists of HBsAg and trehalose 0.1 to 50% by weight polysorbate 0.01 to 10% by weight as an auxiliary glycerol 0.1 to 10% by weight and a carrier made of a ceramic material or a semiconductor.

8. A device comprising: a microneedle array consisting of HBsAg and polyvinylpyrrolidone 1 to 95% by weight, trehalose 0.1 to 50% by weight polysorbate 0.01 to 10% by weight as an auxiliary and glycerol 0.1 to 10% by weight; and an applicator together with a plunger and a triggering device and wherein the triggering device comprises a pump, a syringe or a spring, so that the plunger impact with sufficient energy can be implemented and the microneedles have different diameters and/or different lengths.

9. The microneedle array according to claim 1, wherein microneedles have a shaft with a triangular or a polygonal cross-section.

10. The microneedle array according to claim 1, wherein one or more of the microneedles having barb hooks.

11. The microneedle array according to claim 1, wherein the microneedles are helically shaped and rotatably arranged.

12. The microneedle array according to claim 1, wherein the microneedle has a diameter between 10 m and 100 m.

13. The microneedle array according to claim 8, wherein the microneedles have different diameters.

Description

EXAMPLES AND DRAWINGS

A Brief Description of the Figure

(1) The FIGURE illustrates 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).

(2) 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.

(3) 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.

(4) The study design includes a prime/boost/boost (0/1/3 months) in 4 groups12 animals, of which 3 are MAP groups with (20/40/60 g HBsAg/MNA) and one is a reference group with intramuscular injection, i.m. with 20 g HBsAg/i.m.). The primary endpoint is 4 months with follow-up titres after 6 and 12 months.

(5) 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.

(6) 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.