Basics of MDM Flashcards
What is bioavailability?
The rate and extent of drug absorption
What medications are 100% bioavailable?
IV medications
What are factors to consider in dosage form?
Indication
Target population
Patient compliance
Drug availability
What are the principle objectives of medicine design?
To achieve predictable therapeutic response to a drug included in a formulation
To be able to manufacture the medicine on a large scale with reproducible product quality
What is preformulation?
The part of the drug journey where pure crystalline drug substance is transformed to a safe and usable medicine
What does preformulation indicate?
The feasibility of potential new dosage forms and the suitability of potential excipients
What are the 5 categories of routes of administration?
Oral, Rectal, parenteral, topical and respiratory
What are biopharmaceutical considerations?
Absorption
Metabolism
Excretion
Relationship between physical, chemical and biological sciences that are applied to drugs
What are therapeutic considerations?
clinical indications
disease/illness
systemic or local therapy
delivery system
duration of action
emergent or non-emergent
What are the drug factors in basics of MDM?
Particle size
Surface area
Solubility
Dissolution
pKa
Partition co-efficient
How are different polymorphs produced?
Manipulation of conditions of particle formulation during crystallisation
What conditions can be manipulated in polymorph production?
temperature
cooling rate
choice of solvent
How do polymorphs differ?
melting point
solid state stability
dissolution
What happens to metastable polymorphs?
They convert at different rates to the stable form
What are 4 crystal properties?
Amorphous
Anhydrous
Solvate
Hydrate
What happens to amorphous crystals?
no molecular symmetry so fall out of solution
What is an anhydrous crystal?
No water in the crystal structure
What is a solvate crystal?
Solvent in the crystal structure
What is a hydrate crystal?
Water in the crystal structure
What is theobroma oil?
polymorphous natural fat consisting of a single glyceride that melts over a narrow range
Exists in 4 polymorphic forms
Highest mp is the most stable polymorph (β form)
What is theobroma oil used for?
Suppositoires as it melts at physiological pH
Why can’t metastable form of theobroma oil be used for suppositories?
They melt at room temperature
What are factors of chemical stability?
Hydrolysis
Oxidation
Dimerisation
Photodegredation
Excipient compatibility
What are factors of physical stability?
Crystal ripening
Sorption to container
Precipitation of drug
Creaming and cracking
