Low Dose Capsule Formulation via Solution Filling
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Solution Overview
Problem
Formulating low dose pharmaceuticals into solid unit dosage forms with acceptable content uniformity is challenging due to difficulties in uniform mixing and segregation of components, which can impact the quality, safety, and efficacy of the dosage forms.
Innovation Solution
Preparing low dose pharmaceutical formulations by adding an active drug substance in solution directly to a capsule body, minimizing the use of pharmaceutical excipients and avoiding non-uniform mixing through methods like solvent removal and filling with non-therapeutic materials, ensuring uniform content distribution.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If active drug substance is mixed with solid pharmaceutical excipients, then the formulation can be processed into solid unit dosage forms, but uniform mixing is difficult and segregation occurs during handling leading to content non-uniformity
Solution Approach 1:
The patent changes the physical state of the drug substance from solid to solution form. By dissolving the active drug substance in a solvent and directly filling the solution into capsule bodies, the invention eliminates the mixing and segregation problems associated with solid-solid formulations, achieving content uniformity without extensive mixing operations
Solution Approach 2:
The patent introduces a solvent as an intermediary medium to carry the active drug substance. The solvent acts as a vehicle that enables uniform distribution of the drug at the molecular level within the solution, eliminating the need for mechanical mixing of solid particles and preventing segregation during handling
2Manufacturing precision
If conventional approaches are used to prevent de-mixing or maintain content uniformity, then content uniformity may be improved, but additional processing steps and additives require extensive quality control work
Solution Approach 1:
The patent extracts the active drug substance from the solid mixture context and delivers it in solution form directly into the capsule. This approach removes the need for additional processing steps and additives that would otherwise be required to maintain content uniformity in solid formulations, simplifying the overall manufacturing process and reducing quality control burdens
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 method achieves content uniformity and meets the standards for immediate release formulations, ensuring consistent drug release and compliance with quality parameters like content uniformity tests.
Implementation Method 1
removing the solvent of the drug solution from the capsule body
Data Source
AI summary
Low dose pharmaceutical formulations may be prepared to deliver consistent low doses of a variety of pharmaceuticals with minimal additives. In particular, the low dose pharmaceutical formulations are solid unit dosage forms of low dose drug substances which may be prepared by a method that provides content uniformity across prepared solid unit dosage forms.