Introduction to DFDM

Question 1

What is the difference between drug vs medicine?

Answer 1

Drug - Biologically active molecules, pharmacological action (API)
Medicine - Drugs given in dosage form for treatment, includes drug and excipients

Question 2

What is a dosage form?

Answer 2

The final form of a drug (the tablet itself not just the API within)

Question 3

Name examples of dosage forms

Answer 3

Gels, cream, tablet/suspensions, ointment, eye drops, solution, patch, nasal spray, buccal lolly pop

Question 4

What is a suspension?

Answer 4

Formed when drug can’t dissolve in water, suspension placed in H2O as powder so final form is solution

Question 5

What is an excipient?

Answer 5

Chemicals added for function in dosage form, sometimes biologically active (Everything except API)

Question 6

What is the purpose of dosage forms?

Answer 6

Protect drug from atmospheric O2, humidity, gastric acid
Conceal bitter, salty taste/odour
Provide liquid forms either insoluble/unstable in other forms

Question 7

Define pre-formulation

Answer 7

Development stage where physicochemical prop of drug are characterised
(Btw drug selection and development)

Question 8

What is analysed during pre-formulation?

Answer 8

Physicochemical prop, dosage forms for drug, solubility, stability, dissolution, pka, solid state prop profile (shelf life)

Question 9

What to consider when designing drugs?

Answer 9

Therapeutic prop of disease (dosage form, onset)
Physicochemical prop
Biopharmaceutical (rate/extent of abs)
Product safety
Regulatory issues
Consumer

Question 10

What are the product attributes?

Answer 10

Effectiveness, safety, quality, stability, appearance, organoleptic prop, convenience (ease, dosing, acceptance)