0
Q
Aim of preform
A
Produce mathematical model for drug behaviour when formulated
1
Q
Define preformulation
A
Characterisation of physiochemical properties of compounds
2
Q
Key things we want to know 2:
A
- stability and solubility of API
- awareness of methods of inhibiting decomposition and increasing half life
3
Q
Tests we might do 6
A
Log p PKa Crystallinity Hygroscopicity Solution and solid stability Solubility
4
Q
Main problem
A
We only get 50 mg of drug
5
Q
Solubility of less that …. Indicates need for a salt
A
1mg/ml
6
Q
HTS basically
A
Dissolves the drug in loads of stuff, recrystallises with anti solvent
7
Q
In general we don’t anticipate absorption problems from things with
A
Aq sol > 1%
At 37degrees
pH 1-7
8
Q
All these tests will a help use choose 4
A
Salt polymorph solvent or hydrate
9
Q
Five tests for salt selection
A
Solubitliy Therm anal Crystal habit Solid stability Polymorphism studies
