Dispersible HIV Tablet Formulation for Pediatric Swallowing
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Solution Overview
Problem
Current pediatric formulations for HIV treatment, such as TRIUMEQ, are not suitable for patients who have difficulty swallowing tablets, necessitating alternative oral drug delivery systems that are both effective and palatable.
Innovation Solution
Development of a dispersible tablet formulation comprising dolutegravir or its pharmaceutically acceptable salt, abacavir or its salt, lamivudine, and at least one taste masking agent, which can be administered directly in the mouth and is stable in water, improving palatability and compliance.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a tablet formulation is used for HIV treatment in pediatric patients, then the treatment effectiveness is maintained, but the difficulty in swallowing tablets worsens compliance
Solution Approach 1:
The patent changes the physical form parameter from solid tablet to dispersible tablet that can be dissolved in water, transforming it into an oral suspension suitable for pediatric patients who have difficulty swallowing tablets. This parameter change maintains treatment effectiveness while improving ease of administration.
2Ease of operation
If the active ingredients are administered in a dispersible formulation, then the ease of administration to pediatric patients is improved, but the unpleasant taste worsens compliance
Solution Approach 1:
The patent introduces taste-masking agents as intermediary substances that interact with the active ingredients to mask their unpleasant taste. These agents serve as a mediator between the bitter active ingredients and the pediatric patient's taste receptors, improving compliance while maintaining ease of administration.
Solution Approach 2:
The patent creates a composite formulation combining the active ingredients (dolutegravir, abacavir, and lamivudine) with excipients and taste-masking agents. This composite material approach allows the formulation to maintain therapeutic effectiveness while masking unpleasant tastes through the combined properties of its components.
3Reliability
If a fixed dose combination tablet is used, then the treatment efficacy is maintained, but the suitability for pediatric patients with swallowing difficulties is reduced
Solution Approach 1:
The patent changes the dosage form parameter from conventional tablet to dispersible tablet, enabling the fixed-dose combination to be adapted for pediatric patients. This parameter change allows the same therapeutic regimen to be delivered in a form suitable for children who cannot swallow tablets, thereby improving adaptability while maintaining treatment efficacy.
Data Source
AI summary
The present invention relates to formulations comprising dolutegravir or a pharmaceutically acceptable salt thereof, abacavir or a pharmaceutically acceptable salt thereof and lamivudine, processes for making such formulations, and the use of such formulations in the treatment of HIV infection, in particular in the treatment of HIV infection in pediatric patients.