Lecture 2 - Pharmaceutics

Question 1

What is involved in the discovery phase (1st phase) of drug development?

Answer 1

Isolation/synthesis of a chemical entity which shows some specific pharmacological action

Question 2

What is involved in the pharmaceutics phase (2nd phase) of drug discovery?

Answer 2

• Pharmaceutical characterization of drug
• Fabrication of suitable dose form
• Testing & evaluation of the finished product in terms of stability and bioavailability

Question 3

What general areas are included within pharmaceutics?

Answer 3

1) Physical pharmaceutics
2) Dose form design
3) Fabrication
4) Microbiology

Question 4

What must be considered when designing a dose form?

Answer 4

• Physicochemical properties of the drug
• Biopharmaceutical aspects
• Therapeutic considerations of the disease state, the nature or situation of the patient

Question 5

Define preformulation

Answer 5

Gather information and anticipate problems

Question 6

What can be some possible formulation problems?

Answer 6

• Poor water solubility
• Drug may degrade in stomach acid
• Drug may be affected by digestive enzymes
• Drug may degrade when exposed to light, heat, or oxygen

Question 7

What must a pharmacist ensure that the patient understands? (7 things)

Answer 7

• Purpose of medication
• Goals and timelines of treatment
• What to do if goals not being met
• Dose and how to measure and administer it
• Auxiliary labels (ex: shake well, keep in fridge)
• Possible adverse effects and what to do if one occurs
• Storage of medication

Question 8

Describe compounding

Answer 8

• Sometimes available dose form is not appropriate for a situation (mostly in children and elderly)
• Pharmacist will have to change dose form
• Must be concerned and knowledgeable about stability and bioavailability of compounded product

Question 9

Define compatibility

Answer 9

Mixing drug products for injections

Question 10

Define stability

Answer 10

Product stored under temperature conditions other than what is recommended