L3: Developability Flashcards
Preclinical and clinical testing is regulated from
ICH guidelines
What is one of the main purposes of the CMC phase?
Process development and scale-up
Small molecule drugs include?
Organic molecule (< 900 dalton)
Which of the following is not a commonly-used technique for drug screening?
Electron microscopy
What is/are the main challenge(s) in oral drug delivery (from a formulation p.o.w)
Solubility and permeability
How many classes are the biopharmaceutical classification system divided into:
4
The classes are:
(1) Class I, high-solubility high-permeability drugs, indicate the easier and straightforward development process and complete absorption is expected;
(2) Class II, low-solubility high-permeability drugs, indicate that a solubility/dissolution limitation is expected;
(3) Class III, high-solubility low-permeability drugs, indicate that the permeability rate will limit the intestinal absorption of this class of drugs;
(4) Class IV, low-solubility low-permeability drugs. Since Class IV drugs suffer from inadequate solubility and permeability, they have very poor oral bioavailability and are inclined to exhibit very large inter- and intrasubject variability
What are the main property of ‘grease ball’ and ‘brickdust’ molecules?
Poorly soluble
You can improve the solubility of a compound by changing on a molecular, colloidal or particulate level
Yes
What is the goal of the developability phase:
Collect and summarize info from preclinical studies on formulation
What could the developability assessment consists of?
Physico-chemical characterization
The stability of a compound is an important factor. How can this be investigated?
E.g. using heat, light and various pH values.
What is the most convenient formulation type for early formulations?
Solution
What is the goal of the biopharmaceutics phase:
Increase drug product understanding
Which method can you use to determine solubility
Shake flask
In the developability phase, you have:
Many compounds, low precision
