The following parameters are evaluated during the preformulation process:

- Solubility in different media and solvents
- Dissolution of the active pharmaceutical ingredient (API) 
- Accelerated Stability Services
- Solid state properties (ex. polymorphs, particle size and shape)
- Formulation services and capabilities
- Formulation development of new chemical entities (NCE)
- Optimization of existing formulations
- Process development for selected dosage forms
- Novel  formulations  for  improved  delivery  of  existing dosage forms
- Controlled release and sustained release formulations 
- Self-emulsifying drug delivery systems
- Colloidal drug delivery systems
- Sub-micron and nano-emulsions

Preformulation Parameters

The characterization of physicochemical properties of active pharmaceutical ingredients (APIs), with the purpose of producing an optimal drug dosage that is also bioavailable and stable. This also covers the path of intake.

Calvin College

- 1: Target Identification
- 2: Target Validation
- 3: Lead Identification
- 4: Lead Optimization 
- 5: Product Characterization
- 6: Formulation and Development

Steps in Drug Discovery and Development

Deore, A., Dhumane, J., Wagh, R., & Sonawane, R. (2019). The Stages of Drug Discovery and Development Process. Asian Journal of Pharmaceutical Research and Development, 7(6), 62-67. https://doi.org/https://doi.org/10.22270/ajprd.v7i6.616

The Stages of Drug Discovery and Development Process

The process of determining a chemical lead.

3: Lead Identification

The process of determining a drug target. The methods behind this process can draw from disciplines like biology, biochemistry, genetics, or biophysics.

1: Target Identification

The process of certifying a target of a small molecule. In other words, it is looking into the functional role of a target and seeing if a drug works in a clinical setting. 

2: Target Validation

The characterization of a new drug molecule after it shows potential. Properties of characterization are based on early stages of pharmacological studies. Characterization covers molecule size, shape, strength, weakness, use, toxicity, and biological activity. 

5: Product Characterization

6: Formulation and Development

The iterative process of designing and refining a drug candidate after identifying a chemical lead. The purpose is to keep favorable properties in lead compounds while filtering out or improving upon unfavorable ones.

Learn Before

Related

Learn After