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
PDDS 2022 Speakers
Speaker at Pharmaceutics and Drug Delivery Systems 2022 - Alena Korbut

Alena Korbut

IHS/Cherokee Nation, United States
Speaker at Pharmaceutics and Drug Delivery Systems 2022 - Victoria Demina

Victoria Demina

NEUWAY Pharma GmbH, Germany
Speaker at Pharmaceutics and Drug Delivery Systems 2022 - Samir Haddouchi

Samir Haddouchi

Sotax Pharma Services, France
Speaker at Pharmaceutics and Drug Delivery Systems 2022 - Miroslav Radenkovic

Miroslav Radenkovic

University of Belgrade, Serbia
Speaker at Pharmaceutics and Drug Delivery Systems 2022 - Mirjana B. Colovic

Mirjana B. Colovic

University of Belgrade, Serbia
Speaker at Pharmaceutics and Drug Delivery Systems 2022 - Madhav Bhatia

Madhav Bhatia

University of Otago, New Zealand

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