Formulation, characterization and physicochemical evaluation of potassium citrate effervescent tablets

Area of Science:

• Pharmaceutical Technology
• Nephrology
• Materials Science

Background:

• Kidney stones, including calcium oxalate and urate types, are a significant health concern.
• Current treatments for kidney stones often involve managing underlying causes and facilitating stone passage.

Purpose of the Study:

• To design and formulate potassium citrate effervescent tablets for the reduction of calcium oxalate and urate kidney stones.
• To evaluate the efficacy of different formulation and manufacturing methods for potassium citrate effervescent tablets.

Main Methods:

• Prepared 13 formulations of potassium citrate effervescent tablets using direct compression, fusion, and wet granulation methods.
• Evaluated powder flowability, granule properties, and tablet characteristics (hardness, friability, effervescence time, pH, content uniformity).
• Assessed taste acceptability using a panel test with flavoring agents and the Latin Square method.

Main Results:

• Direct compression and fusion methods resulted in good flow but poor tablet hardness.
• Wet granulation enhanced flowability and physicochemical properties, yielding tablets with acceptable hardness, rapid effervescence (≤3 min), suitable pH (<6), low friability (<1%), minimal water content (<0.5%), and accurate content uniformity.
• Combination flavors (orange-lemon, strawberry-raspberry) were well-accepted by volunteers.

Conclusions:

• Wet granulation, particularly using PVP solution, produced potassium citrate effervescent tablets with superior hardness and desirable physicochemical properties.
• This reproducible wet granulation process is suitable for manufacturing effervescent tablets with enhanced properties due to larger agglomerate formation.