30-day sustained release fluticasone propionate micropatch for allergic rhinitis treatment
A 30-day sustained release nasal micropatch delivering fluticasone propionate to provide consistent therapeutic effects without daily intranasal sprays. The design aims to improve drug absorption while minimizing common local side effects and reducing systemic bioavailability. The micropatch is self-administered using a sterile, preservative-free applicator and is fully biodegradable over 4–6 weeks.
Overview
A sustained release nasal micropatch delivers fluticasone propionate directly to the nasal cavity for allergic rhinitis. The formulation is designed to provide consistent therapeutic effects over an extended period without the need for daily intranasal sprays. By maintaining a steady release profile, the approach targets improved drug absorption and prolonged symptom relief, while aiming to minimize common local side effects such as nasal ulcerations and epitaxis and to reduce systemic bioavailability, which can be associated with complications such as glaucoma and cataracts.
Technical specifications
- Micropatch dimensions: 10 mm diameter, 300–500 microns thick
- Drug content: Contains 6 mg of fluticasone propionate, releasing 200 mcg daily
- Biodegradability: Fully biodegradable in 4–6 weeks
- Administration: Self-administered using a sterile, preservative-free applicator
- Platform flexibility: The micropatch platform supports modification to adjust drug release durations from days to weeks
Technology readiness level
Currently at TRL 3, the micropatch is under development with ongoing in-vitro testing. Future steps include refinement of dosing compositions, sterilization, and in-vivo testing, followed by additional R&D, applicator development, and clinical testing to advance to higher TRLs.
About Integral BioSystems, LLC
Integral BioSystems is a contract research organization (CRO) specializing in the development of complex drug formulations and specialty delivery systems. Founded in 2009 and based in Bedford, Massachusetts, the company provides high-end R&D and cGLP technical services, including analytical method development, preformulation studies, and process scale-up. Its core expertise lies in designing biocompatible formulations for diverse routes of administration, such as ophthalmic, injectable, dermal, intranasal, and otic, with a particular focus on sustained-release technologies like lipid nanoparticles, microspheres, and nano-/micro-crystals. The company differentiates itself through its translational medicinal approach, helping clients transition research concepts from laboratory feasibility through to clinic-ready products for first-in-man trials.
By serving as an extended R&D arm for start-ups, mid-size companies, and large pharmaceutical organizations, Integral BioSystems addresses critical formulation challenges that can impede drug development pipelines. Beyond its fee-for-service CRO model, the company maintains a proprietary portfolio of patented delivery platforms, including OcuHeal and NanoM Wafer, which are available for licensing to enhance the bioavailability or delivery performance of client molecules. The team provides comprehensive CMC planning and cGLP support, ensuring rigorous adherence to scientific standards while maintaining the nimbleness required for early-stage development. With extensive experience supporting various clinical applications, the company acts as a strategic partner in navigating complex regulatory and technical requirements for drug product design.
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