NERDG 2026
Poster 36 Abstract
Expanding the design space of swellable core technology (SCT) for delivery of higher doses and patient centric dosage form
Ruchi Thombre, Sweta Manthena, Yuxia Mao, Brent Harrington
Pfizer
Presenting and Corresponding Author: Ruchi Thombre, [email protected]
Purpose
Osmotic systems for controlled drug-delivery applications are well established and preferred systems due to their robust performance. Swellable Core technology (SCT) based formulations consist of a core tablet that contains a drug layer and water-swellable layer, which performs robustly producing an excellent in vitro/in vivo correlation. This platform has typically been limited to a maximum unit dose of approximately 50mg, often requiring multiple tablet dosing for clinical studies. The purpose of this work was to systematically study the feasibility of increasing drug load in the SCT system and reduce patient pill burden.
Methods
Five model compounds with different aqueous solubilities were selected. Drug loading ranged from 10-50%. Coating thickness was varied to achieve different duration of release. Different dry manufacturing conditions and tablet size were also explored. The weight of the active-layer and swell-layer was kept constant for each formulation. The active-layer contained drug, PEO and lubricant. The swell-layer contained PEO, MCC, sodium chloride, lubricant, and blue dye for easy distinction from the active layer. Bilayer cores were coated using a usual CA:PEG coating in a water/acetone solvent system. Dissolution was performed on the final dosage form.
Results
The dissolution profiles were analyzed for rate and extent of dissolution. The extent of dissolution can be inverted as residual material (%) in tablet. The residual for each compound was evaluated against drug load and aqueous solubility. The impact of drug load was also evaluated across release duration, tablet size and process conditions. Drug loading coupled with aqueous solubility of the compound had the most influence on the in vitro performance of the SCT formulations. When the solubility of the compound is very high, the effect of formulation variables are minimal. On the other hand, when aqueous solubility ranges from low to medium, formulation variables may have varying levels of impact.
Conclusion
The tablets had more residual material with higher drug load and lesser solubility. High solubility compounds did not show a trend across other parameters, but for low solubility compounds % drug load and release duration had an impact on the extent of drug released from the SCT tablet.
Keywords
SCT, controlled release, osmotic technology
Poster 36 Abstract
Expanding the design space of swellable core technology (SCT) for delivery of higher doses and patient centric dosage form
Ruchi Thombre, Sweta Manthena, Yuxia Mao, Brent Harrington
Pfizer
Presenting and Corresponding Author: Ruchi Thombre, [email protected]
Purpose
Osmotic systems for controlled drug-delivery applications are well established and preferred systems due to their robust performance. Swellable Core technology (SCT) based formulations consist of a core tablet that contains a drug layer and water-swellable layer, which performs robustly producing an excellent in vitro/in vivo correlation. This platform has typically been limited to a maximum unit dose of approximately 50mg, often requiring multiple tablet dosing for clinical studies. The purpose of this work was to systematically study the feasibility of increasing drug load in the SCT system and reduce patient pill burden.
Methods
Five model compounds with different aqueous solubilities were selected. Drug loading ranged from 10-50%. Coating thickness was varied to achieve different duration of release. Different dry manufacturing conditions and tablet size were also explored. The weight of the active-layer and swell-layer was kept constant for each formulation. The active-layer contained drug, PEO and lubricant. The swell-layer contained PEO, MCC, sodium chloride, lubricant, and blue dye for easy distinction from the active layer. Bilayer cores were coated using a usual CA:PEG coating in a water/acetone solvent system. Dissolution was performed on the final dosage form.
Results
The dissolution profiles were analyzed for rate and extent of dissolution. The extent of dissolution can be inverted as residual material (%) in tablet. The residual for each compound was evaluated against drug load and aqueous solubility. The impact of drug load was also evaluated across release duration, tablet size and process conditions. Drug loading coupled with aqueous solubility of the compound had the most influence on the in vitro performance of the SCT formulations. When the solubility of the compound is very high, the effect of formulation variables are minimal. On the other hand, when aqueous solubility ranges from low to medium, formulation variables may have varying levels of impact.
Conclusion
The tablets had more residual material with higher drug load and lesser solubility. High solubility compounds did not show a trend across other parameters, but for low solubility compounds % drug load and release duration had an impact on the extent of drug released from the SCT tablet.
Keywords
SCT, controlled release, osmotic technology
