Novel dosage forms and regimens for sevelamer-based phosphate binders.

Area of Science:

• Nephrology and Pharmaceutical Sciences
• Biochemistry and Polymer Chemistry

Background:

• Sevelamer is a nonabsorbed, calcium- and metal-free phosphate binder with a polyallylamine polymer backbone.
• The current sevelamer hydrochloride form can lead to bicarbonate reduction due to chloride absorption.
• Phosphate binders are typically administered three times daily in tablet form.

Purpose of the Study:

• To introduce sevelamer carbonate as a new salt form to provide buffering and minimize bicarbonate reduction.
• To present novel dosage forms (tablet and powder) and regimens for sevelamer-based phosphate binders.
• To enhance patient compliance and phosphorus control in chronic kidney disease (CKD).

Main Methods:

• Development of sevelamer carbonate, replacing chloride with carbonate counter ions.
• Formulation of sevelamer carbonate into both tablet and powder forms for flexible dosing.
• Evaluation of preliminary data on once-daily dosing efficacy compared to traditional regimens.

Main Results:

• Sevelamer carbonate provides a buffering source, potentially mitigating bicarbonate level reduction.
• Novel dosage forms (tablet, powder) offer alternative, potentially more palatable administration.
• Preliminary data suggest once-daily dosing may achieve comparable phosphate control to multiple daily doses.

Conclusions:

• Sevelamer carbonate offers an improved phosphate binder with enhanced buffering capacity.
• New dosage forms and regimens increase flexibility and choice for patients and healthcare providers.
• These advancements are expected to improve compliance and phosphorus level management in CKD patients.