Moisture-resistant effervescent tablet formulation via hot melt extrusion
A hot melt extrusion-based formulation technology for solid effervescent tablets that controls moisture content and masks bitter taste of active pharmaceutical ingredients. The process enables stable, scalable tablet production with validated quality and release profiles comparable to marketed products.
Overview
This solution addresses two persistent challenges in effervescent tablet manufacturing: moisture sensitivity and the unpleasant taste of active pharmaceutical ingredients (APIs). By applying hot melt extrusion (HME) to solid effervescent formulations, the technology produces tablets with controlled moisture content and effective taste masking, while improving the release profile of the API. The approach is designed to be scalable and has already been benchmarked against a marketed product, making it attractive for pharmaceutical partners seeking differentiated, patient-friendly dosage forms.
Technical specifications
Process workflow:
- Solid components are weighed and pre-mixed in a V-blender to achieve uniform solid dispersion
- The blend is processed through hot melt extrusion to create an extruded matrix of polymer and drug
- The extruded material is milled to achieve optimal particle size for tabletting
- Tablets are compressed and subjected to quality control evaluation
Quality control parameters validated (per USP specifications, minimum 20 samples per test):
- Weight variation
- Hardness
- Thickness
- Friability
- Disintegration study
- Release profile comparison against a marketed reference product
Key advantages:
- Moisture-resistant formulation suitable for humid storage and transport conditions
- Taste masking of bitter APIs, improving patient compliance
- Enhanced release characteristics in a stable dosage form
- Scalable process ready for commercial production
Technology readiness level
The formulation has completed preliminary laboratory studies and has been validated against a marketed comparator product across all standard in-process quality checks. The technology is ready to scale up. Remaining steps include accelerated stability testing, patent filing in collaboration with a partner, and clinical studies to support commercialization. The full pathway to market is estimated at one to two years and requires additional resources and partnership support to complete.
About University of Malaya
University of Malaya is Malaysia’s oldest comprehensive public research university with broad disciplinary depth and a strong national role. Its Kuala Lumpur campus places corporate partners minutes from regional headquarters and supply‑chain nodes, while specialized labs and shared core facilities support contract R&D, testing, and validation. Integration with an on‑campus teaching hospital enables clinical studies and translational work, and industry liaison and professional education groups streamline access to talent and upskilling. Research is supported by competitive funding from Malaysian government agencies and international sponsors, complemented by direct industry collaborations. A dedicated technology transfer office manages IP, licensing, and startup formation with clear pathways for rapid engagement.
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