intro

Question 1

Drug formulation

Answer 1

developing an appropriate dosage form accounting for physicochemical drug properties, stability, route of delivery, etc.

Question 2

Drug delivery systems

Answer 2

novel means of improving efficacy of medicine or patient compliance, reducing side-effects, targeting drug to specific cells/tissue, etc.

Question 3

Biopharmaceutics

Answer 3

Biopharmaceutics is the study of those factors which modify the performance of pharmaceutical dosage forms and how this information can be used to optimize these so-called «drug delivery systems».

understanding the absorption, distribution, metabolism and excretion of drugs following administration and applying this to the design of dosage forms.

Question 4

Quality control

Answer 4

ensuring that standards of purity, identity, dosage and safety are met throughout the process of manufacturing a medicine.

Question 5

Regulatory science

Answer 5

according to the FDA, “…the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance” of medicines.

Question 6

Development of the drug delivery system taking in to account basic drug properties including

Answer 6

MW
Lipophilicity
Ionization
Solubility vs pH
Dissolution rate
Chemical stability
Particle size, crystallinity and hygroscopicity for solid drugs
Compatibility with excipients and packaging materials

Question 7

What is a medicine?

Answer 7

“Getting the right drug to the right place at the right dose and at the right rate”.
“The right medicine/treatment for the right patient”
Rate and extent of drug absorption and the definitions of biopharmaceutics, pharmacokinetics and pharmacodynamics.
Identification of the principal barriers to oral drug absorption

Question 8

Biopharmaceutics
What is a medicine and how is one optimised?

Answer 8

Weakly acidic and basic drug molecules – the Henderson-Hasselbalch equation.
Drug solubility as a function of pH.

Optimising drug properties to ensure good oral bioavailability.
What is log P, how is it measured and why is it a useful parameter?
Lipinski’s Rule-of-5: criteria for drug molecular weight, lipophilicity and hydrogen bonding ability. Exceptions and strategies for “difficult-to-deliver” drugs

Question 9

Dogmas for the 21st Century

Answer 9

Potent drugs are only useful if they reach their site(s) of action

Drug delivery technology can optimize therapy (increase efficiency, minimize toxicity)

Drug design and development to include analysis of delivery options

Question 10

Pharmacodynamics

Answer 10

What the drug does to the body

Question 11

Pharmacokinetics

Answer 11

What the body does to the drug

Question 12

Bioavailability

Answer 12

is a quantitative measure of the amount of a drug that reaches its site of action and of the rate at which it gets there

it allows comparison of different drug delivery systems

Question 13

Determinants of pharmacokinetics

Answer 13

Dose
metabolite
drug in urine
drug concertation in plasma
LADME

Question 14

Drug absorption into the body

Answer 14

Transfer of drug from its formulation at site of administration to systemic circulation
Practically speaking, several routes of ‘delivery’ are possible:
Oral
intramuscular injection
subcutaneous, intradermal injection
implant
topical and transdermal
inhalation
ocular, nasal, buccal
rectal, vaginal

Question 15

Dose

Answer 15

Equally, high dose (low potency) drugs can be a problem to formulate
If drug has poor flow/compressability cannot make a tablet

capsule