Amniotic Cytokine Formulation for Ocular Surface Disease
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Solution Overview
Problem
Ocular surface diseases, such as dry eye syndrome, are prevalent and often chronic, causing discomfort, dryness, and irritation, with current therapies offering limited relief.
Innovation Solution
A pharmaceutical formulation comprising amniotic membrane, amniotic fluid, and bioactive agents, along with a pharmaceutically-acceptable excipient, is developed for treating ocular surface diseases. The formulation is acclimatized to a temperature of at most 30°C and administered using an eye dropper device with a one-way valve to prevent back-flow.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If current therapies are used for ocular surface diseases, then treatment is provided, but symptom relief is limited
Solution Approach 1:
The patent changes the chemical and biological parameters of the treatment by using amniotic fluid containing specific cytokines (IL-6, IL-8, TGF-beta) at defined concentrations (e.g., 1-10 µg/mL IL-6, 10-50 µg/mL IL-8), rather than conventional therapies. This parameter change provides superior symptom relief while maintaining treatment reliability.
Solution Approach 2:
The invention creates a composite pharmaceutical formulation combining amniotic fluid with multiple bioactive cytokines and growth factors in specific proportions, along with pharmaceutically acceptable excipients. This composite material provides synergistic effects that improve treatment efficacy beyond single-agent therapies.
2Stability of the object's composition
If pharmaceutical formulation is stored at higher temperatures, then stability may be compromised, but storage and transport become easier
Solution Approach 1:
The patent performs preliminary stabilization by formulating the pharmaceutical composition with protective excipients and optimizing cytokine concentrations before storage. The formulation is prepared in advance with all necessary components (amniotic fluid, cytokines, excipients) combined and stabilized, allowing subsequent storage at controlled temperatures without degradation.
Solution Approach 2:
The invention changes the physical and chemical parameters of the formulation by adjusting pH, ionic strength, and adding stabilizing excipients to enable storage at lower temperatures (2-8°C or -20°C) while maintaining cytokine activity and formulation stability over extended periods.
Data Source
AI summary
Provided herein are compositions and methods for the treatment of ocular surface diseases, such as dry eye syndrome. For example, the disclosure provides formulations, such as amniotic cytokine formulation (ACF) formulations, eye droppers useful for administering the formulations to subjects, and methods of treating subjects using the formulations and/or eye droppers.