Soft Gel Capsule Suspension Formulation for Cold and Flu Medications
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Solution Overview
Problem
Current cold and flu medications face challenges in reducing dosage form size without compromising therapeutic effectiveness or stability, particularly due to issues with suspension-based formulations like phase separation and instability of active ingredients.
Innovation Solution
Development of a soft gel capsule with a suspension-based inner fill containing a combination of acetaminophen, dextromethorphan HBr, phenylephrine HCl, and optional antihistamines, stabilized by polyethylene glycol and povidone, which allows for a smaller capsule size while maintaining therapeutic efficacy and stability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If traditional liquid gel formulations are used, then therapeutic effectiveness is maintained, but capsule size becomes too large for comfortable swallowing
Solution Approach 1:
The patent changes the physical state of the formulation from a liquid gel to a semi-solid suspension with higher viscosity. This parameter change allows the same therapeutic dose to be contained in a smaller volume, reducing capsule size from traditional large gel capsules to a more swallowable size while maintaining all active ingredients at therapeutic concentrations
Solution Approach 2:
The patent uses a composite suspension system combining multiple active ingredients (acetaminophen, dextromethorphan HBr, phenylephrine HCl, and optional antihistamines) suspended in a polyethylene glycol-based vehicle with povidone stabilizer. This composite formulation achieves space efficiency and therapeutic effectiveness simultaneously
2Volume of stationary object
If suspension-based formulations are used to reduce capsule size, then capsule size is reduced, but phase separation and instability occur
Solution Approach 1:
The patent introduces povidone as an intermediary stabilizing agent in the suspension formulation. This hydrophilic polymer acts as a protective colloid that adsorbs to the surface of suspended particles, preventing aggregation and phase separation, thereby maintaining formulation stability in the reduced-volume semi-solid suspension
Solution Approach 2:
The patent changes the viscosity parameter of the suspension vehicle (polyethylene glycol base) to a semi-solid consistency. This increased viscosity parameter slows particle settling and maintains uniform distribution of active ingredients, preventing phase separation while enabling smaller capsule size
3Reliability
If multiple active ingredients are combined to treat multiple symptoms, then therapeutic effectiveness is improved, but formulation complexity and manufacturing difficulty increase
Solution Approach 1:
The patent merges multiple active ingredients (acetaminophen for pain/fever, dextromethorphan HBr for cough suppression, phenylephrine HCl for decongestion, and optional antihistamines) into a single semi-solid suspension formulation. This unified formulation maintains therapeutic effectiveness for multiple symptoms while simplifying manufacturing through a single-dosage-form approach
Solution Approach 2:
The patent uses a polyethylene glycol-based suspension vehicle with controlled viscosity parameters that allows multiple active ingredients to remain stably suspended without complex stabilization systems. This parameter optimization simplifies manufacturing while maintaining the multi-ingredient therapeutic regimen
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 solution enables the creation of smaller, stable, and visually appealing soft gel capsules that maintain the therapeutic effect of traditional liquid gel capsules, addressing the challenges of size reduction and stability in suspension-based formulations.
Implementation Method 1
a suspension, wherein the suspension has a total volume of between 0.50 mL and 0.90 mL and the suspension comprises: between 300 mg and 400 mg acetaminophen; between 5 mg and 20 mg dextromethorphan HBr; between 2.5 mg and 10 mg phenylephrine HCl; optionally between 1 mg and 10 mg antihistamine; between 400 mg and 500 mg polyethylene glycol; and between 25 mg and 75 mg povidone
Data Source
AI summary
The present disclosure provides for suspension-based pharmaceutical formulations for cold and flu medications, specifically suspension formulations and soft gel capsule dosage forms having reduced size. The present disclosure also provides methods of preparing the suspensions and soft gel capsule dosage forms.