Prolonged release matrix tablet of pyridostigmine bromide: formulation and optimization using statistical methods.

Area of Science:

• Pharmaceutical Technology
• Drug Delivery Systems

Background:

• Pyridostigmine bromide is crucial for treating myasthenia gravis and nerve gas poisoning.
• Developing sustained-release formulations is key to improving therapeutic efficacy and patient compliance.

Purpose of the Study:

• To design and optimize a prolonged-release matrix formulation of pyridostigmine bromide.
• To utilize a D-optimal experimental design for efficient formulation development.
• To evaluate the drug release kinetics and stability of the optimized formulation.

Main Methods:

• Employed hydrophilic (HPMC) and hydrophobic (carnauba wax) polymers with tricalcium phosphate in a wet granulation technique.
• Utilized a D-optimal experimental design to identify optimal formulation parameters.
• Assessed drug release at 1, 4, and 8 hours as dependent variables.
• Performed accelerated stability studies for six months.

Main Results:

• The optimal formulation contained 12.8% HPMC, 24.4% carnauba wax, and 26.7% tricalcium phosphate.
• Drug release followed the Higuchi model, with close agreement between observed and predicted values.
• The D-optimal design effectively optimized the prolonged-release matrix tablet.
• Accelerated stability studies confirmed the formulation's integrity over six months.

Conclusions:

• D-optimal design is a valuable tool for optimizing pyridostigmine bromide prolonged-release matrix tablets.
• The developed formulation exhibits suitable prolonged-release characteristics and good stability.
• This optimized formulation holds promise for improved management of myasthenia gravis and related conditions.