Tablet formulation
Badrostat tablets are manufactured using CDC with a specific formulation of microcrystalline cellulose, anhydrous lactose, croscarmellose sodium, and magnesium stearate, addressing the challenge of content uniformity and flowability in low-drug-loaded tablets, resulting in high-quality, commercially viable products.
Patent Information
- Application Number
- TW114147664
- Authority / Receiving Office
- TW · TW
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-12-06
- Filing Date
- 2025-12-05
- Publication Date
- 2026-08-01
AI Technical Summary
Achieving content uniformity and good flowability in low-drug-loaded tablets of badrostat using continuous direct compression (CDC) is challenging, particularly due to the balance between large particle size for improved flowability and small particle size for content uniformity, exacerbated by the nature of APIs like badrostat.
Manufacturing badrostat tablets using CDC with a formulation comprising 1 to 2 wt% badrostat, 48 to 59 wt% microcrystalline cellulose, 35 to 43 wt% anhydrous lactose, 4 to 6 wt% croscarmellose sodium, and 0 to 2 wt% magnesium stearate, without colloidal silica, to achieve good content uniformity and flowability, meeting European, Japanese, and United States Pharmacopoeia standards.
The CDC process produces badrostat tablets with excellent content uniformity and dissociation properties, suitable for immediate-release tablets, meeting pharmacopoeial standards and enabling large-scale commercial production.