Preformulation 2

Question 1

Solid State Property

Answer 1

Particle Size, Particle Surface Area, Flow Properties, Crystallinity (shelf life), Polymorphism, Melting Point, Compressibility, Hygroscopicity (solubility) and Drug-Excipient Compatability

Question 2

Surface Area of a Sphere

Answer 2

(Pi)(r^2)

Question 3

Methods of Analysing Particle Size

Answer 3

Sieve analysis, sedimentation and laser diffraction

Question 4

Methods of Analysing Surface Area

Answer 4

Microscopy

Question 5

Methods of Analysing Crystallinity & Polymorphism

Answer 5

X Ray Diffraction, Thermal ANalysis

Question 6

Methods of Analysing Melting Point

Answer 6

Thermal Analysis and Hot Stage Microscopy

Question 7

Methods of Analysing Hygroscopicity

Answer 7

Thermal Analysis

Question 8

Methods of Analysing Drug-Excipient Compatibility

Answer 8

Thermal ANalysis

Question 9

Sieving Advantages

Answer 9

Simple, wide range, inexpensive

Question 9

Sieving Outline

Answer 9

Particle Size Analysis (50-150 mcm). Particles pass through mesh holes

Question 9

Optical Microscopy Outline

Answer 9

Particle size analysis (0.2-100 mcm). Camera takes photographs of exact shape and size. 2 Types: Transmission, Scanning, Manual (picture + ruler) and Automatic

Question 9

Sieving Disadvantage

Answer 9

Easy to damage, requires large sample size

Question 10

Relationship between size, solubility, surface area, cohesion and flow

Answer 10

smaller size = greater surface area = greater surface area = greater cohesion = less flow

Question 11

Laser Diffraction (Mastersizer) Outline

Answer 11

Particle size measure (0.02mcm and 2,000 mcm). Light source passes through powder flow surrounded by detectors

Question 12

Angle of diffraction and particle size

Answer 12

Smaller angle diffraction = larger particle

Question 13

D(0.9) Outline

Answer 13

90% of particles measured in sample are smaller then D(0.9) values

Question 14

D(0.5) Outline

Answer 14

Median particle size of sample

Question 15

Particle Span Calc

Answer 15

(D0.9 - D0.1)/D0.5

Question 16

Thermal Analysis Outline

Answer 16

Physicochemical material properties/changes as a function of temp. Egs; Host Stage Microscopy, DSC & DTA

Question 17

Endothermic Reactions (Heat Graph Peak)

Answer 17

Melting, Glass Transition

Question 18

Exothermic Reactions (Heat Graph Trough)

Answer 18

Crystallisation, Cross-linking, oxidation

Question 19

Thermal Analysis Quantitaive

Answer 19

Purity measure and polymorph ratio

Question 20

How Drug_excipient Compatibility id Measured in Thermal Analysis

Answer 20

Changes in glass transition temp and appearance of new thermal events

Question 21

Thermogravemetric Analysis (TGA) Outline

Answer 21

Measuures smaple’s weight change as a function of temp (hook w/ sample pan and mass balance). Calllibrated with 200mg and 1,000mg weights. Reference: empty (Aluminium/tin) sample pan

Question 22

Reasons for heat induced weight loss

Answer 22

removed surface mositure, removed solvent, decomposition, sublimation

Question 23

Reasons for heat induced weight gain

Answer 23

hygroscopicity

Question 24

Hygroscopicity Outline

Answer 24

Material ability to absorb/adsorb moisture ynder defined temp and humidity

Question 24

Results of absorbing water

Answer 24

stavility changes, hydrate crystallisation, polymorphic changes, crystalline form changes, microbiological, flow properties

Question 25

Humidity Control Effects

Answer 25

Drying, Mixing, Granulation, Tabletting and Storage

Question 26

Differential Scanning Calorimetry Outline

Answer 26

Measures Heat flow (exothermic vs endothermic) as a function of temp. Standard metal (eg Indium used to measure) using heat blocks

Question 27

RAMP Setting

Answer 27

+10 degrees C/min to 250 degrees C

Question 28

Bragg's Kaw

Answer 28

(number of rotations(n))(lamda(wavelength)) = 2 (distance between 2 molecules) sin (light diffraction angle). Used in X-ray diffraction