Transmucosal Solid Dosage Form for Fast Oral Mucosal Uptake
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Solution Overview
Problem
Conventional oral administration of therapeutic agents often leads to gastrointestinal side effects and is challenging for patients with swallowing difficulties, particularly in pediatric and adult populations, and there is a lack of suitable dosage forms that provide target doses with minimized side effects.
Innovation Solution
A solid dosage form for oral transmucosal delivery comprising a therapeutically effective amount of an active pharmaceutical ingredient (API), a water-soluble polymer, and a surfactant with a combined HLB value ranging from about 6 to about 15, which facilitates buccal and sublingual delivery, enhancing patient compliance and minimizing side effects.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If conventional oral administration is used, then the therapeutic agent can be delivered to the patient, but gastrointestinal side effects occur and patient compliance is compromised
Solution Approach 1:
The patent introduces an intermediary delivery pathway through the oral mucosa (buccal and sublingual tissues) that mediates between the therapeutic agent and the gastrointestinal system. By delivering the API through the mucosal barrier in the mouth, the formulation avoids direct contact with the gastrointestinal tract, thereby eliminating gastrointestinal side effects while maintaining patient compliance through convenient oral administration.
Solution Approach 2:
The patent extracts the delivery pathway from the gastrointestinal tract and relocates it to the oral mucosa. By taking out the API from the conventional swallowing route and delivering it directly through the buccal and sublingual mucous membranes, the formulation removes the source of gastrointestinal side effects while preserving effective drug delivery.
2Quantity of substance
If high drug loading is used to achieve desirable therapeutic effect, then the therapeutic effect is improved, but suitable dosage forms with minimized side effects become unavailable
Solution Approach 1:
The patent changes the delivery parameter from gastrointestinal absorption to oral transmucosal absorption. By altering the delivery pathway parameter, the formulation achieves high drug loading (therapeutically effective amounts) without the harmful side effects associated with conventional oral administration, as the API bypasses the gastrointestinal tract entirely.
3Ease of operation
If solid dosage form is used for oral administration, then the formulation is convenient, but swallowing difficulties arise in pediatric and adult populations
Solution Approach 1:
The patent applies local quality by designing a solid dosage form that dissolves or disintegrates at a specific location (in the oral cavity on the tongue or buccal mucosa) rather than requiring swallowing. This localized action allows patients with swallowing difficulties to receive the therapeutic agent through simple placement in the mouth, maintaining convenience while improving adaptability to patient needs.
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 dosage form enables fast uptake of therapeutic agents through sublingual, buccal, and gingiva delivery, improving patient compliance and reducing non-compliance issues, especially for patients with compromised motor skills, while maintaining efficacy and extending shelf life.
Implementation Method 1
The dosage form enables fast uptake of therapeutic agents through sublingual, buccal, and gingiva delivery
Implementation Method 2
a surfactant; wherein the surfactant and the fatty acid if present are so combined that their HLB value ranges from about 6 to about 15
Data Source
AI summary
A solid dosage form for oral transmucosal delivery of an active pharmaceutical ingredient (API) is disclosed. Also provided are methods of treating a disease with the solid dosage form.