Pulmonary Drug Delivery

Question 1

Why use pulmonary drug delivery?

Answer 1

Large surface area
Thin exchange surface
Most direct route of entry to the bloodstream
Access to all parts of the body including the brain

Question 2

What is pulmonary drug delivery?

Answer 2

Formulation of a drug for infusion to the body by pulmonary inhalation route

Question 3

List 3 drivers for growth in the inhalator market

Answer 3

1. Rising incidence in respiratory disorders (Asthma/COPD)
2. Increasing importance for self administration in chronic conditions
3. Potential for protein/peptide delivery

Question 4

What is a an aerosol?

Answer 4

Stable dispersion
Of solid/ liquid particles in a gaseous medium

Question 5

List 3 common aerosol types

Answer 5

Nebuliser devices
Metered dose inhalers
Dry powder inhalers

Question 6

What are some factors considered for developing pulmonary delivery devices?

Answer 6

Easy to use
Economical
High lung penetration
Facilitate multiple dosing
Consistent drug delivery

Question 7

Name an example of inhalator insulin devices

Answer 7

Exubera
Novo norodisk
Afrezza

Question 8

What is the indication for the Afrezza device?

Answer 8

Adults with Type 1 or Type 2 diabetes

Question 9

How does the Afrezza device work?

Answer 9

After inhalation technosphere insulin particles reach the lung
Insulin particles dissolve on contact
Then are absorbed into systemic circulation

Question 10

What is the onset of action of the Afrezza insulin device?

Answer 10

12-15 minutes
Considered ultra rapid acting insulin

Question 11

What is technosphere technology?

Answer 11

A drug delivery platform which allows pulmonary delivery of injectable drugs

Question 12

What molecule is technosphere technology based on?

Answer 12

FDKP

Question 13

What are the characteristics of FKDP?

Answer 13

Highly soluble in water
Neutral-basic pH
Crystalline plates which form microspheres

Question 14

How is insulin formulated in the Afrezza device?

Answer 14

Insulin (positive charge) is precipitated on to Technosphere surface (negative charge)
Charge device and high surface area promote insulin adsorption

Question 15

Why are insulin monomers used despite their instability compared to insulin hexamers?

Answer 15

Technosphere particles stabilise monomeric insulin
Provides delivery advantage without affecting stability

Question 16

What are the characteristics of technosphere particles

Answer 16

Uniform size distribution
2.5um
Optimal for deep lung delivery

Question 17

Describe the delivery of Afrezza insulin

Answer 17

Single use cartridges
Inserted into Medtone inhaler
Powder is discharged into oral cavity after inhalation
Particles dissolve rapidly at surface of the lung

Question 18

Why did Afrezza have more success that exubera?

Answer 18

Afrezza delivered monomeric insulin which was faster acting that exuberas hexameric insulin
Leading to shorter time to peak insulin levels
Monomeric formulation is closer to natural insulation response
Smaller device
Lower cost