Preformulation Studies
  • Organoleptic and Bulk Characters
  • Solubility analysis
  • Stability analysis

It is a phase of research and development to characterize the physical and chemical properties of a drug molecule in order to develop a safe, effective, and stable dosage form.

Usually, Preformulation studies are laboratory studies which are used to determine the characteristics of active substance and excipients that may influence the formulation and process design and performance. It has been described as “Learning before doing”.

A major area of Preformulation studies includes:

Organoleptic and Bulk Characters: These include

  • Crystallinty and Polymorphism
  • Hygroscopicity
  • Fine particle characterization
  • Powder flow properties

Solubility analysis: This includes:

  • Ionization constant-PKa
  • pH solubility profile
  • Common ion effect-Ksp
  • Thermal effects
  • Solubilization
  • Partition co-efficient
  • Dissolution

Stability analysis: This includes:

  • Stability in toxicology formulations
  • Solution stability
  • pH rate profile
  • Solid-state stability
  • Bulk stability
  • Compatibility
Committee Members
Speaker at Drug Delivery Events - Vladlen Slepak

Vladlen Slepak

University of Miami, United States
Speaker at Drug Delivery Events - Yong Xiao Wang

Yong Xiao Wang

Albany Medical College, United States
Speaker at Pharmaceutical Conference - Axel H Schonthal

Axel H Schonthal

University of Southern California, United States
Speaker at Pharmaceutical Conference - Consolato M Sergi

Consolato M Sergi

Universities of Alberta and Ottawa, Canada
PDDS 2026 Speakers
Speaker at Pharmaceutical Conference - Madhav Bhatia

Madhav Bhatia

University of Otago, New Zealand
Speaker at Pharma Conferences - Luis Jesus Villarreal Gomez

Luis Jesus Villarreal Gomez

Universidad Autónoma de Baja California, Mexico
Speaker at Pharma Conferences - Saad Tayyab

Saad Tayyab

UCSI University, Malaysia
Speaker at Pharmaceutical Conference - Lan Wang

Lan Wang

Paretor LLC, United States
Speaker at Drug Delivery Events - Ravi P Sahu

Ravi P Sahu

Wright State University, United States
Speaker at Drug Delivery Events - Kunal Sharma

Kunal Sharma

University of Bern, Switzerland

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