MPharm Master of Pharmacy Master of Pharmacy: Pharmaceutical Formulations and Dosage Forms 5

Question 1

Which sterilization method is preferred for heat-sensitive parenteral formulations and is validated by sterility assurance level (SAL) of 10⁻⁶?

Accepted Answer

Aseptic filtration through 0.22 µm membrane

Answer

Aseptic filtration through a validated 0.22 µm filter removes microorganisms from heat-sensitive solutions, achieving SAL 10⁻⁶ when combined with aseptic filling.

Question 2

In nanotechnology-based drug delivery, which system consists of a drug-loaded solid lipid core stabilized by surfactants?

Accepted Answer

Solid lipid nanoparticle (SLN)

Answer

SLNs comprise a solid lipid matrix (solid at body temperature) that entraps drug and is stabilized by surfactant shell, offering controlled release and physical stability.

Question 3

Accelerated stability studies (40 °C/75% RH for 6 months) are used under ICH Q1A guidelines primarily to:

Accepted Answer

Predict long-term stability and identify potential degradation products in less time

Answer

Accelerated conditions speed degradation kinetics, allowing early prediction of stability profile, though real-time data are required for official shelf-life claims.

Question 4

Which rheological property describes a material that flows when stress exceeds a yield value but behaves as a solid below it — important for semisolid formulations?

Accepted Answer

Plastic (Bingham) behavior

Answer

Plastic flow (Bingham body) requires a minimum yield stress before flow begins, characteristic of structured semisolids like certain ointments and gels.

Question 5

Poorly water-soluble drugs formulated as nanosuspensions exhibit enhanced dissolution primarily due to:

Accepted Answer

Increased surface area-to-volume ratio as particle size decreases to nanometer range

Answer

Reducing particle size to the nanometer range dramatically increases surface area, accelerating dissolution rate according to the Noyes-Whitney equation.

MPharm Master of Pharmacy Practice Test

MPharm Master of Pharmacy Practice Test

MPharm Master of Pharmacy Master of Pharmacy: Pharmaceutical Formulations and Dosage Forms 5