Name of the project:
Research and development of innovative nasal therapy with an improved safety profile (INSPIRA)
Project code: PK.1.1.12.0354
Applicant: JADRAN – GALENSKI LABORATORIJ d.d.
Partners on the project:
Amelia d.o.o.
Sample Control d.o.o.
University of Zagreb, Faculty of Pharmacy and Biochemistry
Program:
Competitiveness and cohesion 2025. – 2027.
Call:
IRI S3 – Increasing the Development of New Products and Services Resulting from Research and Development Activities
Project implementation period: October 1, 2025 – October 1, 2028.
Total value of the project: EUR 2,422,473.66
Total eligible costs: EUR 2,032,805.71
Total approved grants: EUR 1,150,021.46
Project summary:
The project is focused on research and development of an innovative nasal spray for the treatment of moderate to severe allergic rhinitis. The project aims to develop a formulation with an improved safety profile while maintaining appropriate microbiological stability, quality and therapeutic equivalence to the reference therapy. This is to respond to patients’ needs for effective and safe therapies.
The project includes industrial research and experimental development activities: development and selection of formulation, optimization of particle size and distribution, development of production process, selection of primary packaging, development and validation of analytical methods, stability and efficiency tests, scale-up, process validation and preparation of regulatory documentation. The development is directed towards a result at the level of TRL 7, validated in industrially relevant conditions. The project contributes to the specific goal of RSO 1.1. and the thematic priority area of the Smart Specialization Strategy “Personalized health care”.
Goals and results of the project:
The main goal of the project is to develop a stable, high-quality and regulatory-acceptable nasal spray without preservatives, with the potential to provide the same therapeutic effect with an improved safety profile compared to existing products. Special emphasis was placed on the development of an innovative suspension formulation and the process of obtaining particles, optimization of drug deposition in the nasal cavity, and ensuring dose uniformity and stability during the shelf life and application of the product.
The project is implemented through effective cooperation between industrial and academic partners with complementary expertise in pharmaceutical technology, analytics, microbiology, regulatory sciences, patent protection and quality control.
The project will result in:
- the development of an innovative nasal spray without preservatives for the treatment of allergic rhinitis, validated in industrially relevant conditions;
- the selection of the leading formulation and appropriate primary packaging and establishing an optimized production process, including scale-up and validation activities;
- the development and validation of analytical methods and implementation of product quality, stability, safety and pharmaceutical equivalence tests;
- the preparation of documentation for scientific advice and future product registration, including a regulatory assessment of the possibility of applying the biowaiver approach;
- the submission of at least one patent application and request for trademark and/or design protection in order to protect the developed knowledge and market potential of the product;
- the strengthening of research and development capacities, transferring knowledge and continuing cooperation between applicants, business partners and the academic community, while creating prerequisites for commercialization and placement of products on international markets;
- the application of horizontal activities of non-discrimination and equality, reasonable and universal design, and sustainable development.
Contact person for more information:
Name: Maša Safundžić Kučuk
E: masa.safundzic@jglpharma.com
Phone: +385 (0)51 660 700
Co-financed by the European Union
The views and opinions expressed are solely those of the author and do not necessarily reflect the official views of the European Union or the European Commission. Neither the European Union nor the European Commission can be held responsible.