Sequential Release ADHD Compositions for Reduced Side Effects
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Solution Overview
Problem
Conventional ADHD treatments with stimulants and non-stimulants often result in significant side effects such as appetite suppression, insomnia, abdominal pain, and growth issues due to high doses needed for prolonged effects, and slow absorption and onset of action.
Innovation Solution
The development of pharmaceutical compositions that include a subtherapeutic dose of a stimulant and a non-stimulant, formulated for sequential release, with the stimulant released early and the non-stimulant released later, using nanoparticulate formulations for rapid onset and reduced side effects, and incorporating peppermint oil to minimize gastrointestinal pain.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of moving object
If high doses of stimulants are administered to provide prolonged therapeutic benefit, then the duration of action is improved, but side effects such as appetite suppression, insomnia, and abdominal pain worsen
Solution Approach 1:
The patent segments the stimulant dose into multiple smaller releases throughout the day using different formulation types (immediate-release, delayed-release, extended-release, sustained-release). This segmentation allows the total therapeutic dose to be delivered over time without requiring a single large morning dose, thereby reducing peak-related side effects while maintaining prolonged duration of action.
2Duration of action of moving object
If high doses of stimulants are administered to achieve longer lasting benefits, then the duration of action is improved, but gastrointestinal pain worsens
Solution Approach 1:
The patent introduces peppermint oil as an intermediary substance that mediates between the stimulant formulation and the gastrointestinal tract. Peppermint oil has known gastroprotective properties that reduce abdominal pain and gastrointestinal discomfort, allowing the stimulant to be administered at therapeutic doses without exacerbating GI side effects.
3Duration of action of moving object
If large morning doses of stimulants are administered to provide sufficient therapeutic benefit throughout the day, then the duration of action is improved, but insomnia worsens
Solution Approach 1:
The patent segments the stimulant dosing schedule to avoid concentrated morning administration. By distributing the total daily dose across multiple release mechanisms that deliver smaller amounts at intervals throughout the day, the formulation reduces the risk of stimulant-induced insomnia while maintaining adequate coverage through evening hours.
4Reliability
If high doses of stimulants are administered, then the therapeutic effectiveness is improved, but loss of appetite worsens
Solution Approach 1:
The patent segments the stimulant dose delivery to avoid large single doses that cause significant appetite suppression. By using multiple release mechanisms that deliver smaller amounts at different times, the formulation maintains therapeutic effectiveness while reducing the intensity of appetite-related side effects.
5Ease of manufacture
If conventional formulations are used, then ease of manufacture is improved, but onset of action is slow
Solution Approach 1:
The patent segments the formulation into multiple components with different release characteristics, including an immediate-release portion that provides rapid onset of action. This segmentation allows the formulation to achieve fast therapeutic effect while maintaining manufacturability using established pharmaceutical technologies for each release type.
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
This approach reduces adverse side effects while maintaining therapeutic effectiveness by administering lower doses of stimulants and non-stimulants, providing rapid action and extended symptom relief without the drawbacks of conventional treatments.
Implementation Method 1
The development of pharmaceutical compositions that include a subtherapeutic dose of a stimulant and a non-stimulant, formulated for sequential release, with the stimulant released early and the non-stimulant released later, using nanoparticulate formulations for rapid onset and reduced side effects
Implementation Method 2
administering a pharmaceutical composition comprising: an immediate- or early-release pharmaceutical formulation comprising an amount of stimulant pharmaceutical agent that is subtherapeutic for once daily administration; and a delayed-release pharmaceutical formulation
Data Source
AI summary
The present invention provides drug therapy formulations. In some embodiments, the present invention provides combinations of pharmaceutical agents (e.g., stimulant and non-stimulant), pharmaceutical formulations (e.g., nanoparticualte, non-nanoparticualte, etc.), and release profiles (e g, immediate release, delayed release, sustained release, etc.) to provide therapeutic benefit with reduced side effects.