Single-Unit PRAX-944 Tablets for Easier High-Dose Handling
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Solution Overview
Problem
Current PRAX-944 modified release formulations for treating essential tremor are challenging for patients with movement disorders due to their small size and multiple tablets, leading to difficulties in handling and increased risk of dosing errors.
Innovation Solution
Development of single-unit dosage forms of PRAX-944, which are bioequivalent to existing 20-mg tablets, with larger and non-round shapes to improve usability and reduce the number of tablets needed, ensuring consistent drug release over a 24-hour period.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If multiple small tablets are used to achieve the required dose strength, then the total drug delivery is sufficient, but the ease of operation deteriorates due to handling difficulties and increased dosing errors
Solution Approach 1:
The patent combines multiple individual tablets into a single unit dosage form that delivers the equivalent total dose. This merging approach maintains the required drug delivery quantity while eliminating the handling difficulties associated with multiple small tablets, directly resolving the contradiction between total drug delivery and ease of operation.
2Quantity of substance
If multiple tablets are required to achieve the therapeutic dose, then the dose strength is sufficient, but the device complexity increases due to multiple dosage units
Solution Approach 1:
The invention merges multiple dosage units into a single integrated tablet or capsule that provides the equivalent dose strength. This reduces the number of separate tablets a patient must handle and administer, thereby reducing device complexity while maintaining the required therapeutic dose strength.
3Ease of operation
If a larger single-unit dosage form is used, then the ease of operation improves due to easier handling, but the manufacturing precision becomes more challenging
Solution Approach 1:
The patent employs segmentation strategies in formulation development, creating a single-unit dosage form with optimized dimensions and physical properties that balance ease of handling with manufacturability. The dosage form is segmented in design to achieve optimal size for patient comfort while remaining within manufacturing capabilities.
Solution Approach 2:
The invention utilizes parameter changes in the formulation process, adjusting factors such as tablet size, shape, coating, and physical properties to create a dosage form that is both easy to handle and manufacturable. By optimizing these parameters, the patent resolves the contradiction between ease of operation and manufacturing precision.
Data Source
AI summary
Described herein, in part, are single-unit dosage forms, comprising the compound of Formula (I) or a pharmaceutically acceptable salt thereof (e.g., the compound of Formula (II), e.g., PRAX-944 HCl), wherein the composition is bioequivalent to a reference composition of the same dosage strength administered as multiple small, round tablets. The present invention further comprises methods useful for treating a disease or condition relating to aberrant function or activity of a T-type calcium channel, such as tremor (e.g., essential tremor).