Pre-formulation considerations Flashcards
How do we approach formulation
By considering:
the disease state (as this alters the body’s ability to absorb and excrete compounds),
drug (how easily the drug can be incorporated into the dosage form, how the drug tastes)
and the patient (it has to be convenient for the patient group to take the medicine) concurrently
What is preformulation
The area of pharmacy surrounding:
The determination of physical and chemical characteristics of the drug
Considerations before developing the medicine
Optimisation of the administration route and dosage form
What do we use preformulation data to decide on
which is the most appropriate drug candidate
which is the most appropriate dosage form
what are the likely issues with manufacturing
Which of the following are molecule characteristics and which are material characteristics
- Solubility
- Dissolution profile
- Crystal forms
- Melting point
- Chemical and physical purity
- Chemical stability
- Chemical and physical stability
- Excipient compatibility
- Microscopy
- Powder flow
- Compression
- Excipient compatibility
Molecule
•Solubility
•Chemical stability
•Excipient compatibility
Material •Dissolution •Crystal forms •Melting point •Chemical and physical purity •Chemical and physical stability •Microscopy •Powder flow •Compression •Excipient compatibility
What is the definition of solubility
The composition of a saturated solution, which can only be achieved when solute molecules in solution and additional solid are in equilibrium. Solubility is thus an equilibrium or thermodynamic concept, which is onlu dependent on temperature and pressure in a given solvent
Does the solubility of a molecule change with its material/crystal form?
No, as it describes the concentration of solute after an indefinitely long time. This is different to ‘apparent solubility’ which can change with the crystal form
