DHA Pharmacist Sterile & Non-Sterile Preparations 2

Question 1

What is the standard technique for performing aseptic transfer of a drug from a vial into an IV bag?

Accepted Answer

Swab the vial top with 70% isopropyl alcohol, use a sterile needle and syringe, and transfer inside the laminar flow hood

Answer

Aseptic technique requires alcohol disinfection of the vial septum and the use of sterile equipment inside an ISO 5 environment to prevent microbial contamination of the final product.

Question 2

Which emulsifying agent is commonly used in oral non-sterile pharmaceutical preparations to create stable oil-in-water emulsions?

Accepted Answer

Polysorbate 80 (Tween 80)

Answer

Polysorbate 80 is a non-ionic surfactant widely used as an emulsifying agent in oral and topical preparations to reduce interfacial tension and stabilise oil-in-water emulsions.

Question 3

What is the importance of tonicity in ophthalmic preparations?

Accepted Answer

Ophthalmic preparations must be isotonic (~0.9% NaCl equivalent) to avoid eye irritation, tearing, and corneal damage

Answer

Isotonic ophthalmic preparations match the osmolality of tear fluid (~285–310 mOsm/kg), preventing cell shrinkage or swelling and avoiding irritation or damage to the delicate ocular surface.

Question 4

Which test is used to check the uniformity of drug content across tablets in a batch?

Accepted Answer

Content uniformity test (USP <905>)

Answer

The content uniformity test (USP <905>) measures the drug content in individual dosage units to ensure each tablet delivers a consistent and accurate drug amount within specified limits.

Question 5

What is the primary purpose of using a viscosity-enhancing agent in ophthalmic preparations?

Accepted Answer

To increase contact time of the drug with the eye surface, improving bioavailability

Answer

Viscosity enhancers such as hydroxypropyl methylcellulose (HPMC) slow the drainage of eye drops from the ocular surface, prolonging drug contact and improving therapeutic bioavailability.

DHA Pharmacist Practice Test

DHA Pharmacist Practice Test

DHA Pharmacist Sterile & Non-Sterile Preparations 2