hCG Microsphere Formulation for Sustained Release
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Solution Overview
Problem
Current hCG formulations require frequent injections and have challenges with systemic delivery due to instability and degradation, limiting their effectiveness and convenience for maintaining pregnancy and ovulation induction.
Innovation Solution
A controlled-release formulation comprising hCG or hCG variant loaded microspheres prepared using a process involving emulsification with PLGA and polyvinyl alcohol, followed by hardening and freeze-drying, which allows for sustained release over an extended period, reducing the frequency of injections and enhancing stability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional hCG formulations are used with frequent parenteral administration, then therapeutic effectiveness is maintained, but patient convenience deteriorates and administration burden increases
Solution Approach 1:
The hCG protein is segmented into multiple dosage units contained within a single injectable formulation, allowing the total therapeutic dose to be divided and released gradually over time through the microsphere matrix, reducing the frequency of administrations from multiple injections to a single injection
Solution Approach 2:
The hCG is pre-encapsulated in biodegradable polymer microspheres before administration, creating a reservoir that will release the drug automatically over time without requiring repeated dosing actions by the patient or administrator
2Productivity
If hCG is administered via conventional routes, then drug delivery is achieved, but systemic stability deteriorates due to degradation and poor bioavailability
Solution Approach 1:
Biodegradable polymer microspheres serve as an intermediary carrier between the hCG protein and the systemic circulation, protecting the protein from degradation enzymes and immune clearance while enabling controlled release into the bloodstream
Solution Approach 2:
The biodegradable polymer matrix forms a flexible protective shell around the hCG protein, shielding it from harsh systemic environments while allowing gradual degradation and release of the active ingredient over time
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The formulation provides stable and effective delivery of hCG, reducing the need for frequent injections and improving bioavailability by encapsulating the protein in a biodegradable polymer matrix, ensuring a controlled and sustained release of the drug for therapeutic efficacy.
Implementation Method 1
emulsifying an aqueous solution of hCG or hCG variant comprising 0.1 to 20% (w/v) gelatin with an organic oily phase comprising 1% to 50% low viscosity grade PLGA to obtain a primary emulsion
Implementation Method 2
emulsifying the primary emulsion with an aqueous phase comprising 0.01% to 30% (w/v) polyvinyl alcohol and 0.1 to 20% sodium chloride to obtain hCG or hCG variant loaded microsphere
Implementation Method 3
freeze drying the hCG or hCG variant loaded microsphere of step (d) using 1% to 30% w/w mannitol
Data Source
AI summary
A controlled-release formulation comprising human chorionic gonadotropin (hCG) or hCG variants, a process of preparation of thereof and use of the formulation are provided herein. The formulation as disclosed in the present invention avoids the need for repeated injections.