Saudi Prometric Pharmacist Pharmaceutical Sciences 2 — Questions and Answers
Question 1: What is a controlled-release formulation and what are its advantages?
- A drug that is controlled by the government
- A dosage form designed to release drug slowly over time, maintaining therapeutic levels with fewer daily doses (Correct answer)
- A drug that controls a disease
- A fast-release tablet
Correct answer: A dosage form designed to release drug slowly over time, maintaining therapeutic levels with fewer daily doses
Controlled-release (CR/SR/XR) formulations release drug gradually to maintain steady plasma levels, reduce dosing frequency (improving compliance), minimize peak-trough fluctuations (reducing side effects), and provide sustained therapeutic effect. They must NOT be crushed or chewed.
Question 2: What is the role of excipients in pharmaceutical formulations?
- They are unnecessary additives
- Inactive ingredients that aid in drug stability, absorption, appearance, taste, and manufacturing — such as binders, fillers, and preservatives (Correct answer)
- They are the active drug ingredient
- They only add color to medications
Correct answer: Inactive ingredients that aid in drug stability, absorption, appearance, taste, and manufacturing — such as binders, fillers, and preservatives
Excipients serve critical functions: binders (hold tablets together), fillers (provide bulk), disintegrants (help tablet break apart), lubricants (aid manufacturing), coatings (protect from moisture/light), preservatives (prevent microbial growth), and flavoring agents. Some patients may have excipient allergies (e.g., lactose, gluten).
Question 3: What is pharmacovigilance and why is it important in Saudi Arabia?
- A type of security system for pharmacies
- The science of monitoring, detecting, assessing, and preventing adverse drug reactions post-marketing (Correct answer)
- Marketing surveillance of drug prices
- A pharmacy inventory system
Correct answer: The science of monitoring, detecting, assessing, and preventing adverse drug reactions post-marketing
Pharmacovigilance monitors drug safety after market approval. SFDA's National Pharmacovigilance Center (NPC) collects adverse drug reaction (ADR) reports from healthcare professionals. Saudi pharmacists have a legal obligation to report ADRs and medication errors to SFDA.
Question 4: What is the Henderson-Hasselbalch equation used for in pharmacy?
- Calculating drug costs
- Predicting the ionization state of drugs at different pH values, affecting absorption and distribution (Correct answer)
- Measuring drug potency
- Determining expiry dates
Correct answer: Predicting the ionization state of drugs at different pH values, affecting absorption and distribution
The Henderson-Hasselbalch equation (pH = pKa + log [A-]/[HA]) predicts drug ionization at different pH levels. Un-ionized drugs cross membranes better. Weak acids absorb better in acidic environments (stomach), while weak bases absorb better in alkaline environments (intestine).
Question 5: What is the significance of drug polymorphism in pharmaceutical manufacturing?
- It has no significance
- Different crystal forms of the same drug can have different solubility, stability, and bioavailability, affecting therapeutic efficacy (Correct answer)
- It refers to different colored tablets
- It means the drug works in multiple diseases
Correct answer: Different crystal forms of the same drug can have different solubility, stability, and bioavailability, affecting therapeutic efficacy
Polymorphism means a drug substance can exist in multiple crystal forms with different physical properties. Different polymorphs may have different solubility (affecting absorption), melting points (affecting stability), and dissolution rates (affecting bioavailability). Manufacturing must control polymorphic form.
Question 6: What is the role of the SFDA in regulating pharmaceutical products in Saudi Arabia?
- SFDA only regulates food
- SFDA registers, evaluates, and monitors the safety, efficacy, and quality of all pharmaceutical products marketed in Saudi Arabia (Correct answer)
- SFDA has no role in pharmacy
- SFDA only handles import/export
Correct answer: SFDA registers, evaluates, and monitors the safety, efficacy, and quality of all pharmaceutical products marketed in Saudi Arabia
The Saudi Food and Drug Authority (SFDA) is responsible for: drug registration and market authorization, manufacturing facility inspection (GMP compliance), post-marketing surveillance, pharmacovigilance, controlled substance regulation, and ensuring drug quality throughout the supply chain.
Saudi Prometric Pharmacist Pharmaceutical Sciences 2
What is a controlled-release formulation and what are its advantages?