Exam 2- Lecture 1: Polymorphism/SODF intro

What does the drug product usually use?

Stable polymorph

What is polymorphism?

When a single molecule can form different arrangements of the molecules (conformations/configurations) in the solid state crystal

What happens when the form has high free energy & higher molar V?

Less interactions, more soluble, & less stable

What happens with the form that has lower free energy & lower molar volume?

More stable

What does the higher molecule on the graph w/ free energy & molar volume vs. temperature mean?

Less stable

• Lower on graph: more stable

What can temperature affect?

Form that is the most stable

What can one molecule have?

Multiple Polymorphs

What has the longest shelf life for a typical API formulation?

Tablets (solid- physically stable)

• W/ solutions & suspensions (solid but small particles exposed to water)

What is a powder?

A finely divided solid

What is a particle?

Assembly of molecules

What is a powder?

Assembly of particles

What is the micrometer for very coarse powder?

>1000

What is the micrometer for coarse powder?

355-1000

What is the micrometer for moderately fine powder?

180-355

What is the micrometer for fine powder?

125-180

What is the micrometer for very fine powder?

90-125

What does micromeritics cover?

• Particle size

• Particle shape

• Flow properties

• Other attributes

  • Particle size distribution

  • Surface area

  • Porosity

  • Density (true envelope bulk)

  • Compactibility/compressibility

What is dmax?

Maximum length

What is dmin?

Minimum length

What is dw?

Weight

What is dv?

Volume

What is ds?

Surface area

What is dsieve?

Sieve aperture

What is dsed?

Sedimentation rate

What is particle size?

• Particle size distribution (PSD)

• Particle sizing

  • Sieve

  • Sedimentation

    • Strokes’ law (distribution over time)

What does a smaller sieve number mean?

Larger hole (micrometers

What is particle size distribution (PSD)?

• Mean

• Standard deviation

• Log normal distributions

What properties of a powder are a result of particle size?

• Specific surface area

• Flow

• Density

• Compactibility

• Compressibility

• Tabletability

What API powder will dissolve the fastest?

Very fine

• More SA, fastest dissolve

What is the Hausner ratio?

HR = Pt/Pb

• Pt = tapped density

• Pb = bulk density

• Interpretation: >1.25 poor flow ability