Microneedle system for applying a hepatitis vaccine
Inventors
Henning, Andreas • SPILGIES, Heiko
Assignees
Ltd Lohmann Therapie Systems Ag • LTS Lohmann Therapie Systeme AG
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Publication Number
US-12168053-B2
Publication Date
2024-12-17
Expiration Date
Abstract
The present invention relates to a microneedle system (MNS for short) for the intradermal application of a hepatitis vaccine, namely the antigen HBsAg.
Core Innovation
The invention relates to a microneedle array for use in the intradermal application for hepatitis vaccination, in which the microneedle array consists of HBsAg. The microneedle array further comprises polyvinylpyrrolidone (PVP) in a weight percentage of 1 to 95%, trehalose in a weight percentage of 0.1 to 50%, an auxiliary polysorbate in a weight percentage of 0.01 to 10%, and an auxiliary glycerol in a weight percentage of 0.1 to 10%.
A microneedle array/system is described with microneedles that can be hollow microneedles with channels/bore and tapered tips, and optional structural features including barb hooks or helically shaped microneedles that are rotatably arranged. Carrier materials for the microneedles are described using examples such as metal, ceramic, semiconductors, polymer, or composites, and the microneedle geometry includes microneedle diameter and passage diameter ranges and microneedle length ranges.
Preclinical guinea-pig in-vivo data are presented to support intradermal delivery using microneedle array (MAP) for hepatitis vaccination, including prime/boost/boost schedules at 0/1/3 months. The results report strong anti-HBsAg antibody titres after MAP delivery across different HBsAg doses, including comparison to a reference group of intramuscular injection.
Claims Coverage
The independent claims cover 3 inventive features. Coverage centers on intradermal hepatitis-vaccination microneedle arrays with defined excipient weight percentages, an embodiment with a ceramic or semiconductor carrier, and a device with an applicator and a triggering device so a plunger can implement sufficient impact energy with microneedles of different diameters and/or different lengths.
Intradermal hepatitis vaccination microneedle array formulation with HBsAg plus defined excipient ranges
A microneedle array for use in the intradermal application for hepatitis vaccination, wherein the microneedle array consists of HBsAg, and polyvinylpyrrolidone, trehalose, polysorbate, and glycerol in the stated weight ranges.
Ceramic or semiconductor carrier with HBsAg and defined excipient ranges
A microneedle array for use in the intradermal application for hepatitis vaccination, wherein the microneedle array consists of HBsAg, trehalose, polysorbate, and glycerol, and a carrier made of a ceramic material or a semiconductor.
Device with applicator triggering device and microneedle dimensional variation
A device comprising a microneedle array consisting of HBsAg and the stated excipients, and an applicator with a plunger and a triggering device comprising a pump, a syringe, or a spring, so that sufficient impact energy can be implemented and the microneedles have different diameters and/or different lengths.
Across the independent claims, coverage centers on intradermal hepatitis vaccination using a microneedle array with HBsAg and specified PVP, trehalose, polysorbate, and glycerol weight ranges, optionally combined with a carrier made of ceramic or semiconductor, and implemented in a device having an applicator with a pump, syringe, or spring triggering device.
Stated Advantages
Strong anti-HBsAg antibody titres after microneedle array delivery are reported.
No meaningful differences between adjuvant and non-adjuvant formulations are reported, supporting effectiveness without adjuvants.
Anti-HBsAg antibody titres are discussed as achieving or relating to a WHO protective titre threshold (>10 mLU/mL).
Documented Applications
Intradermal hepatitis vaccination using a microneedle array/system delivering HBsAg, evaluated in a guinea-pig preclinical in-vivo study with prime/boost/boost schedules at 0/1/3 months.
Comparison to intramuscular injection is documented via a reference group in the preclinical guinea-pig data.
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