Flavonoid-based lipid nanoparticle eye-drop and nasal spray for allergy relief
Introducing OcuHeal™, a flavonoid-based lipid nanoparticle formulation designed for effective allergy relief via eye-drops and nasal spray. This innovative solution offers antioxidant and anti-inflammatory benefits, addressing low oral bioavailability by utilizing local delivery.
Overview
OcuHeal™ presents a breakthrough in allergy relief through its innovative flavonoid-based lipid nanoparticle formulations, designed for both ophthalmic (eye-drops) and intranasal (spray) applications. Utilizing a GRAS (Generally Recognized As Safe) flavonoid, known for its antioxidant and anti-allergy properties, OcuHeal™ targets inflammation and stabilizes mast cells to alleviate symptoms like nasal discharge and ocular itching. This approach overcomes the limitations of low bioavailability seen with oral administration, maximizing therapeutic efficacy locally while ensuring safety and tolerability.
Technical specifications
Key features:
- Flavonoid encapsulation: Stabilizes the compound, preventing oxidation and enhancing penetration through nasal and ocular mucosa.
- Anti-inflammatory action: Reduces inflammatory mediators from mast cells and eosinophils, restoring immune cell balance.
- Development and formulation: Complete for ophthalmic use; ongoing optimization for intranasal application includes plume and droplet size adjustments, and viscosity enhancements.
- Safety and stability: Undergoing validation with animal models, including safety and tolerability studies, alongside long-term stability assessments.
Technology readiness level
Currently at TRL 4, OcuHeal™ is in the validation stage, focusing on refinement of the intranasal formulation and preparation for safety studies. The ophthalmic formulation is fully developed, with scale-up and stability studies in progress. Patented delivery system in 14 jurisdictions supports the global potential of this innovative solution.
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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