Chemical Properties in Pre-formulation Studies

• Chemical Properties in Pre-formulation Studies help identify drug stability, reactivity, and interactions crucial for safe formulation.
• Chemical Properties in Pre-formulation Studies involve the evaluation of how a drug chemically interacts with excipients and environmental conditions to ensure product safety and efficacy.

Hydrolysis

1. Definition:

   • Hydrolysis is the decomposition or breakdown of a compound due to its reaction with water.
   • It is the most common form of chemical degradation in pharmaceuticals, especially for drugs containing esters, amides, lactones, and lactams.

2. Mechanism:

   • The drug molecule reacts with water, leading to cleavage of chemical bonds (e.g., ester bonds) and formation of degradation products.

Examples:

1. Example Reaction (Ester Hydrolysis):

   • RCOOR’ + H2O →[H+ or OH−] RCOOH + R’OH
     

2. Example Reaction (Amide Hydrolysis):

   • RCONH2 + H2O →[H+ or OH−] RCOOH + NH3

Prevention Strategies:

• • Use of buffers to maintain optimal pH.
  • Incorporation of anhydrous solvents.
  • Packaging in moisture-proof containers (e.g., blister packs).
  • Addition of desiccants to adsorb moisture.

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