Amorphous

Solid

Dispersions

Objectives:

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This course provides an in-depth understanding of theoretical aspects and processing technologies for the development of amorphous solid dispersions. Thecase studies presented in the course provide onanalytical characterization methods as well as on stability evaluationand regulatory requirements. The attendees will learn about cutting edge manufacturing technologies including the coupling of PAT tools and scale – up approaches. The course includes advanced screening techniques and polymer selections approaches.

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The Course is of interest to:

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• Pharmaceutical Technology R&D

• Principle Scientists

• Research Fellow

• Pre-formulation

• Formulation

• Analytical Development

• Researchers in R&D

DAY 1

Introductions and Aims of the Session

Solubility of Water Insoluble Drugs

• Theoretical Consideration.

• A Definition of Solubility

• pH Effect on Solubility: pH-Solubility Profile

• Temperature Effect on Solubility

• Determination of Solubility

• Biopharmaceutical Classification System

• Prediction of solubility

• Various approaches for increasing solubility (cosolvents, cyclodextrines etc)

Theory of solid dispersions

• What is solid dispersion

• Importance of solid dispersion

• Challenges in the development of solid dispersions

• SD vs PM

• Thermodynamics and miscibility in solid dispersions

• Free energy, enthalpy and entropy of mixing

• Clarification of solid dispersions

Polymer selection

• Theoretical approaches – Hansen solubility parameters

• Screening approaches for solid dispersions

• Examples of advance screening technologies

Stability evaluation

• Chemical instability

• Physical instability

DAY 2

Processing Technologies for SolidDispersions: Part A

• Hot Melt Extrusion

• Scale- up studies

• In-line monitoring

Processing Technologies for SolidDispersions: Part B

• Spray – drying

• Mechanochemical grinding

• Examples of solid dispersions

Material Characterisation

• Description and examples of thermal techniques

• X-ray diffraction

• SEM

• TGA

• FTIR

• NIR

• Drug release

Regulatory aspects of solid dispersions

• QbD

• CPP, CQA, Design space

• Manufacturing process

• NDA and ANDA