Pre Formulation

Pre-formulation serves as the crucial foundation for drug development, often referred to as Phase 1 or pre-clinical studies. During this stage, we meticulously investigate and assess the alignment of drug ingredients with physicochemical parameters and biopharmaceutical properties. These assessments lay the groundwork for subsequent formulation development.

Key Areas of Pre-Formulation Expertise

Physical Characterization

Our pre-formulation services encompass a comprehensive range of physical characterization techniques:
  • Polymorph Screening

Identifying different crystalline forms of the drug substance.

  • Hygroscopicity Testing

Evaluating the propensity of the drug to absorb moisture.

  • Particle Size, Shape, and Surface Area Analysis

Understanding the physical attributes of drug particles.

  • Flow Properties Testing

Assessing the flow behavior of powders and granules.

Solubility Analysis

Understanding a drug’s solubility is critical for effective formulation. Our solubility analysis includes:
  • Solubilization Studies

Investigating methods to enhance drug solubility.

  • Partition Coefficient Studies:

Determining the distribution of a drug between organic and aqueous phases.

  • Dissolution Studies

Assessing drug release from dosage forms.

  • pH Solubility Profile and pKa Determination

Examining solubility across different pH conditions and determining pKa.

Stability Analysis

Ensuring drug stability is essential throughout the development process. Our stability analysis covers:
  • Solid-State Stability

Evaluating the stability of the drug substance in its solid form.

  • Solution-Phase Stability

Assessing stability in solution or suspension.

  • Excipient Compatibility Studies

Investigating interactions between the drug and excipients.

Why Choose Our Pre-Formulation Services?

Our team combines decades of pharmaceutical expertise with cutting-edge approaches. By leveraging our skillset, you’ll benefit from:
  • Efficient Decision-Making
  • Solution-Phase Stability
  • Excipient Compatibility Studies