Preformulation Studies
Preformulation involves the characterization of a drug's physical and chemical properties to inform formulation development.
Critical preformulation factors for parenteral products include:
Solubility: Ensuring the drug is soluble in the chosen vehicle at therapeutic concentrations.
Stability: Assessing chemical and physical stability to prevent degradation or precipitation.
pH Compatibility: Maintaining a pH that is compatible with physiological conditions to minimize irritation.
Compatibility with Excipients: Ensuring excipients do not interact adversely with the drug or each other.
Osmolarity: Matching physiological osmolarity to prevent cell damage or discomfort.
Essential Requirements for Parenteral Dosage Forms
Sterility: Free from viable microorganisms.
Pyrogen-Free: Absence of fever-inducing substances.
Isotonicity: Similar osmotic pressure to body fluids to prevent cell lysis or crenation.
Clear and Particulate-Free: Free from visible particles to ensure safety and efficacy.
Proper Viscosity and pH: To facilitate administration and patient comfort.