Semi-solid Gel Formulation for Low-dose Content Uniformity
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Solution Overview
Problem
Conventional pharmaceutical formulations of Compound I face challenges in achieving homogeneity and content uniformity at lower dosage strengths, making it difficult to produce stable and effective low-dose capsules that comply with pharmacopoeia standards.
Innovation Solution
A semi-solid pharmaceutical formulation of Compound I is developed by combining it with a semi-solid diluent, such as Vitamin E polyethylene glycol succinate, which allows for encapsulation in gelatin capsules, ensuring homogeneity and stability at low doses.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If conventional solid blend formulation is used for Compound I, then higher dosage strengths (5.0 mg, 10.0 mg, 20.0 mg, 40.0 mg) can be achieved, but homogeneity and content uniformity deteriorate at lower dosage strengths (0.5 mg, 1.0 mg)
Solution Approach 1:
The patent changes the physical state parameter of the formulation from solid blend to semi-solid gel formulation. This parameter change enables better distribution and homogeneity of Compound I at low dosage strengths (0.5 mg, 1.0 mg) while maintaining manufacturing feasibility, resolving the contradiction between low dosage quantity and manufacturing precision
Solution Approach 2:
The patent creates a composite semi-solid gel formulation by combining Compound I with gelatin and other excipients in specific ratios. This composite material approach ensures uniform distribution of the active ingredient throughout the formulation, achieving both low dosage strength and high content uniformity (90-110% of label claim)
2Reliability
If lower dosage strengths (0.5 mg, 1.0 mg) are required, then therapeutic effectiveness is improved, but manufacturing homogeneity and content uniformity become more difficult to achieve
Solution Approach 1:
By changing the formulation from solid to semi-solid gel state, the patent enables reliable delivery of low doses (0.5-1.0 mg) with consistent bioavailability while maintaining manufacturing homogeneity through the gel matrix structure
Solution Approach 2:
The gelatin-based semi-solid matrix acts as an intermediary carrier that uniformly distributes Compound I throughout the formulation, ensuring both therapeutic reliability and manufacturing precision at low dosage strengths
Data Source
AI summary
This invention relates to pharmaceutical formulations and a method of making a pharmaceutical formulation. In particular, the invention relates to pharmaceutical formulations and a method of making a pharmaceutical formulation comprising Compound I and a diluent.