North American Pharmacist Licensure Examination (NAPLEX) Pharmaceutics, Compounding, and Drug Delivery Syllabus

Pharmaceutics, Compounding, and Drug Delivery syllabus — full chapter and topic list

Expand any chapter to see its topics and sub-topics. This is the whole examinable outline for Pharmaceutics, Compounding, and Drug Delivery in North American Pharmacist Licensure Examination (NAPLEX), not a summary of it.

1. 1

   Dosage Forms and Biopharmaceutics

   4 topics

   • Solid, liquid, and semisolid dosage forms
   • Modified-release and enteric-coated formulations
   • Dissolution, solubility, and bioavailability
   • Routes of administration and absorption
2. 2

   Sterile and Nonsterile Compounding

   4 topics

   • USP <795> nonsterile compounding standards
   • USP <797> sterile compounding and beyond-use dating
   • USP <800> hazardous drug handling
   • Aseptic technique and contamination control
3. 3

   Stability, Storage, and Formulation

   4 topics

   • Chemical and physical degradation pathways
   • Excipients and their functions
   • pH, buffers, and preservatives
   • Storage conditions and cold chain
4. 4

   Parenteral and Specialized Delivery

   3 topics

   • IV admixture and compatibility
   • Total parenteral nutrition components
   • Transdermal, inhalation, and ophthalmic delivery

Pharmaceutics, Compounding, and Drug Delivery flashcards for North American Pharmacist Licensure Examination (NAPLEX)

22 of 50 cards from the Pharmaceutics, Compounding, and Drug Delivery deck — real questions with worked answers.

1. What are the three major classifications of dosage forms by physical state, and give an example of each?

   Solid (tablets, capsules, powders), liquid (solutions, suspensions, emulsions), and semisolid (ointments, creams, gels, pastes).

2. Differentiate a solution, a suspension, and an emulsion.

   Solution: drug fully dissolved (one phase). Suspension: solid drug particles dispersed in a liquid (settle over time, require shaking). Emulsion: two immiscible liquids dispersed with an emulsifier (oil-in-water or water-in-oil).

3. Compare ointments, creams, and gels by composition.

   Ointment: oleaginous/greasy base, low water (occlusive). Cream: semisolid emulsion (o/w or w/o), spreads easily, washable if o/w. Gel: semisolid with a gelling agent in an aqueous or hydroalcoholic vehicle, non-greasy.

4. What is the difference between an enteric-coated and an immediate-release tablet?

   An enteric coating resists dissolution in acidic gastric pH and dissolves in the more alkaline small intestine, protecting acid-labile drugs or the stomach; immediate-release dissolves promptly in the stomach.

5. List the main types of modified-release oral formulations.

   Delayed-release (e.g., enteric-coated), extended-release (sustained/controlled-release), and pulsatile/targeted-release. Extended-release maintains drug levels over a prolonged period to reduce dosing frequency.

6. Why should most extended-release and enteric-coated tablets not be crushed?

   Crushing destroys the rate-controlling or protective coating/matrix, causing dose dumping (toxicity), loss of acid protection, or degradation of the drug.

7. State the Noyes–Whitney equation for dissolution rate and define its terms.

   $$\frac{dC}{dt} = \frac{D \cdot A \cdot (C_s - C)}{h}$$ where $D$ is the diffusion coefficient, $A$ is surface area, $C_s$ is saturation solubility, $C$ is bulk concentration, and $h$ is the diffusion layer thickness.

8. According to the Noyes–Whitney equation, how does particle size affect dissolution rate?

   Smaller particles have larger total surface area $A$, which increases the dissolution rate $\frac{dC}{dt}$. This is why micronization improves dissolution of poorly soluble drugs.

9. Define bioavailability ($F$) and give its formula for an oral dose relative to IV.

   $F$ is the fraction of an administered dose reaching systemic circulation unchanged. $$F = \frac{AUC_{oral} / Dose_{oral}}{AUC_{IV} / Dose_{IV}}$$ IV bioavailability is defined as $F = 1$ (100%).

10. What does the Biopharmaceutics Classification System (BCS) classify drugs by, and name the four classes?

    By aqueous solubility and intestinal permeability. Class I: high solubility/high permeability; Class II: low solubility/high permeability; Class III: high solubility/low permeability; Class IV: low solubility/low permeability.

11. How does the USP define a 'very soluble' versus 'practically insoluble' substance?

    Very soluble: less than 1 part of solvent needed per part solute. Practically insoluble (or insoluble): more than 10,000 parts of solvent needed per part of solute.

12. What is first-pass metabolism and which routes avoid it?

    First-pass metabolism is hepatic (and gut) metabolism of an orally absorbed drug before it reaches systemic circulation, reducing bioavailability. IV, sublingual, buccal, transdermal, rectal (partially), and inhalation routes largely bypass it.

13. Rank these routes by typical onset of action (fastest to slowest): oral, IV, subcutaneous, intramuscular.

    IV (immediate) > intramuscular (rapid) > subcutaneous (slower) > oral (slowest, requires absorption and survives first-pass).

14. What property of a drug favors passive absorption across GI membranes?

    A nonionized, lipophilic form. Weak acids are more nonionized (absorbed) in acidic stomach; weak bases are more nonionized in the alkaline small intestine.

15. Use the Henderson–Hasselbalch equation to determine ionization of a weak acid.

    $$pH = pK_a + \log\frac{[A^-]}{[HA]}$$ When $pH = pK_a$, the drug is 50% ionized. Below $pK_a$, a weak acid is mostly nonionized (better absorbed).

16. What does USP <795> govern?

    Standards for nonsterile compounding — including facilities, personnel training, components, documentation, and assignment of beyond-use dates for nonsterile preparations.

17. Under USP <795>, what are the default beyond-use dates (BUDs) for nonsterile preparations?

    Nonaqueous formulations: up to 180 days. Aqueous (water activity ≥ 0.6) dosage forms: up to 14 days refrigerated for oral, up to 90 days for solid/semisolid topical/mucosal — not exceeding the shortest component expiration.

18. What does USP <797> govern and what is its primary goal?

    USP <797> governs sterile compounding (compounded sterile preparations, CSPs). Its goal is to prevent patient harm from microbial contamination, endotoxins, excessive particulates, and chemical/physical errors.

19. Define beyond-use dating under USP <797> for Category 1 versus Category 2 CSPs.

    Category 1 CSPs (compounded in lower-quality environment, e.g., SCA): shorter BUDs (≤12 h room temp, ≤24 h refrigerated). Category 2 CSPs (cleanroom suite): longer BUDs based on sterility testing and storage, up to 45+ days frozen.

20. What ISO classification air quality is required for the primary engineering control (PEC) in sterile compounding?

    ISO Class 5 (e.g., a laminar airflow workbench or biological safety cabinet) provides the direct compounding area where critical sites are exposed.

21. What does USP <800> address?

    Standards for safe handling of hazardous drugs (HDs) to protect personnel, patients, and the environment — covering receipt, storage, compounding, dispensing, administration, and disposal.

22. What type of containment device and room pressure are required for compounding sterile hazardous drugs under USP <800>?

    A containment primary engineering control (C-PEC, e.g., BSC or CACI) inside a negative-pressure ISO Class 7 buffer room (C-SEC) with at least 12 air changes per hour and external venting.

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