Kahar Method: A Novel Calculation Method of Tonicity Adjustment.

Area of Science:

• Pharmaceutical Science
• Formulation Development

Background:

• Hypertonic and hypotonic conditions negatively impact drug absorption, bioavailability, and can cause tissue damage.
• Existing methods effectively manage hypotonic preparations but lack solutions for hypertonic issues without dose division complications.

Purpose of the Study:

• To develop a novel calculation method based on the cryoscopic principle to resolve both hypotonic and hypertonic pharmaceutical preparation challenges.
• Specifically target hypertonic preparations by reducing the need for additional ingredients.

Main Methods:

• Developed the Kahar method through substitution and simplification of the cryoscopic method's fundamental equation.
• Evaluated the method by applying it to 42 sterile formula preparations.
• Compared the Kahar method against White-Vincent, cryoscopic, equivalent NaCl, and milliequivalent methods for similarity and reliability.

Main Results:

• The Kahar method demonstrated high similarity with other established methods (similarity > 0.880).
• Achieved the highest similarity (1.0) when compared with the cryoscopic method.
• Exhibited excellent reliability, indicated by a Cronbach's alpha value of 0.990.

Conclusions:

• The Kahar method provides a dependable and comprehensive solution for managing both hypotonic and hypertonic pharmaceutical preparations.
• Offers an efficient approach to formulation challenges, potentially enhancing drug product quality and patient safety.