Lecture 2 - Intro into Medicinal Products

Question 1

What is pharmaceutics?

Answer 1

The process of turning a new chemical entity (NCE) into a medication to be used safely and effectively by patients. It is also called the science of dosage form design. Pharmaceutics is the process (and understanding) of taking a drug from discovery to dosing. It’s also the science of drug dose design.

Question 2

Steps of Pharmaceutics

Answer 2

Step 1: synthesis, scale up, production, of drug substance (or active); formulation, manufacture and supply of the medicine (the packaged form of the drug).
Step 2: Administering the medicine in the correct way (route), at the correct dose and with all the associated quality parameters.
Step 3: The way the body acts on the medicine so that the drug can get the target site without causing too many side effects.

Question 3

Drug Properties to be aware of

Answer 3

Drug properties: physcio-chemistry which includes – solubility, polarity, ionisation (acid, bases, neutral, pKa), chemical stability, chirality,
Medicine properties: formulation, chemical/physical/microbiological stability, supply/manufacture
Patient-medicine: biopharmaceutics - pharmacokinetics (how the body deals with the drug)
Patient-drug: pharmacodynamics (how the drug affects the body)

Question 4

When do medicines equal drugs?

Answer 4

only when there are no excipients present

Question 5

Onset of action variation depending on dosage forms

Answer 5

Seconds: intravenous injection
Minutes: Intramascular and subcutaneous injection, buccal tablets, aerosols, gases
Minutes to hours: solutions, suspensions, powders, granules, capsules, tablets,
Several hours: Enteric coated formulations, control release
Days to weeks: Implants, depot injections