L32 Development Process in Industry TJ and GT Flashcards
what is crospovidone
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
What are the two main focuses of pharmaceutical companies in drug development
Product line extensions and New Chemical Entities
What general tests are done to make the compound available
preformulation testing
formulation testing
dissolution testing
stability testing
What takes place in analytical development?
Stability of samples are analysed and the shelf-life can be justified in liaison with chemical development and pharmaceutical development
What takes place at the GMP pilot plant
plants used to prepare the product for human administration. They take responsibility for the interface with manufacturing, and for the commercial batches.
QC
Quality Control
QA
Quality Assurance
GMP
Good Manufacturing Practice
cGMP
Current Good Manufacturing Practice
QbD
Quality by Design
What do tablets consist of generally?
API Binders Fillers Glidants Lubricants Other Excipients involved in colouring and flavouring
What is Filler and state characteristics of a good one
Provides the bulk volume in a tablet.
Good Compressibility Good Flow Small Particle size Good Bulk Density Moisture Content Solubility Good Compatibility
Example of a good filler/binder?
Microcrystalline Cellulose, MCC
How do lubricants work?
Lowering ejection force and preventing the tablet from sticking the the tools
Example of a good lubricant?
Mg Stearate or Calcium Stearate
Example of a soluble lubricant?
SLS
Glidants role and example
Improve flow of powder or granules e.g Talc or Magnesium Stearate
Two types of disintegrants. name them
Intra and Extragranular disintegrants
How do disintegrants work?
Break up the tablet to increase the SA:Volume ratio so this enhances dissolution
Disintegration step produces
Granules from tablets
Disaggregation step produces
Fine Particles from granules
Why is disintegration important? and what is the consequence of a drug that struggles to enter solution? I know i’m being repetitive..
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.
State examples of super disintegrants
cross linked sodium and crospovidone
