L32 Development Process in Industry TJ and GT

Question 1

what is crospovidone

Answer 1

it is a superdisintegrant that enables water to enter the tablet quicker causing the tablet to swell. This in turn causes the tablet to break apart by the process of wicking

Question 2

What are the two main focuses of pharmaceutical companies in drug development

Answer 2

Product line extensions and New Chemical Entities

Question 3

What general tests are done to make the compound available

Answer 3

preformulation testing
formulation testing
dissolution testing
stability testing

Question 4

What takes place in analytical development?

Answer 4

Stability of samples are analysed and the shelf-life can be justified in liaison with chemical development and pharmaceutical development

Question 5

What takes place at the GMP pilot plant

Answer 5

plants used to prepare the product for human administration. They take responsibility for the interface with manufacturing, and for the commercial batches.

Question 6

QC

Answer 6

Quality Control

Question 7

QA

Answer 7

Quality Assurance

Question 8

GMP

Answer 8

Good Manufacturing Practice

Question 9

cGMP

Answer 9

Current Good Manufacturing Practice

Question 10

QbD

Answer 10

Quality by Design

Question 11

What do tablets consist of generally?

Answer 11

API
Binders
Fillers
Glidants
Lubricants
Other Excipients involved in colouring and flavouring

Question 12

What is Filler and state characteristics of a good one

Answer 12

Provides the bulk volume in a tablet.

Good Compressibility 
Good Flow
Small Particle size
Good Bulk Density 
Moisture Content
Solubility
Good Compatibility

Question 13

Example of a good filler/binder?

Answer 13

Microcrystalline Cellulose, MCC

Question 14

How do lubricants work?

Answer 14

Lowering ejection force and preventing the tablet from sticking the the tools

Question 15

Example of a good lubricant?

Answer 15

Mg Stearate or Calcium Stearate

Question 16

Example of a soluble lubricant?

Answer 16

SLS

Question 17

Glidants role and example

Answer 17

Improve flow of powder or granules e.g Talc or Magnesium Stearate

Question 18

Two types of disintegrants. name them

Answer 18

Intra and Extragranular disintegrants

Question 19

How do disintegrants work?

Answer 19

Break up the tablet to increase the SA:Volume ratio so this enhances dissolution

Question 20

Disintegration step produces

Answer 20

Granules from tablets

Question 21

Disaggregation step produces

Answer 21

Fine Particles from granules

Question 22

Why is disintegration important? and what is the consequence of a drug that struggles to enter solution? I know i’m being repetitive..

Answer 22

Because disintegrating agents increases the surface area of poorly soluble drugs. Slow dissolution may decrease the amount of drug that is eventually absorbed in vivo.

Question 23

State examples of super disintegrants

Answer 23

cross linked sodium and crospovidone