Understanding the Roles of Excipients in Moisture Management in Solid Dosage Forms

Area of Science:

• Pharmaceutical Sciences
• Materials Science

Background:

• Excipients are crucial for pharmaceutical product quality and stability.
• Moisture sensitivity in drugs poses significant stability challenges during storage.
• Excipients that interact with moisture can potentially enhance product stability.

Purpose of the Study:

• To augment the moisture-interactive behavior of maize starch.
• To investigate the effect of coprocessing starch with sodium chloride (NaCl) or magnesium nitrate hexahydrate on moisture interactions and drug stability.
• To assess the efficacy of coprocessed excipients compared to physical mixtures.

Main Methods:

• Maize starch was coprocessed with NaCl or Mg(NO3)2·6H2O at 5% and 10% (w/w).
• Acetylsalicylic acid was used as a model moisture-sensitive drug to assess formulation impact.
• Drug degradation and tablet tensile strength changes were evaluated during storage.

Main Results:

• Coprocessing altered the number of water molecule binding sites on starch and moisture distribution.
• Coprocessed excipients significantly reduced drug degradation and changes in tablet tensile strength.
• Physical mixtures of starch and salts did not provide comparable stability benefits.

Conclusions:

• Coprocessing common excipients like starch with salts offers a synergistic strategy to enhance moisture management.
• This approach effectively mitigates adverse moisture effects on sensitive drugs, promoting product stability.
• Findings contribute to understanding moisture-excipient interactions for judicious excipient selection in drug formulation.