Manufacturing Pharmacy -[Practice Question 2]

Proverbs 16:3

B) II, III

The following recommendations as to storage conditions can be prominently indicated on the label of the product, except:
I. The use of terms such as “ambient conditions” or “room temperature” is acceptable.
II. General precautionary statements, such as “protect from sunlight” and or “store in dry place” should be included and used to conceal stability problems.
III. If applicable, recommendations should be made as to the utilization period and storage conditions after opening and dilution or reconstitution of a solution.
IV. Where applicable specific requirements should be stated particularly for drug products that cannot tolerate freezing.
*
A. I, IV
B. II, III
C. III, IV
D. I, II

D) I, II, III, IV

True about Plant Production Facility
I. Clean room is a zone with defined environmental control of particulate and microbial contamination.
II. An airlock/anteroom is an enclosed space with two or more doors between rooms that helps control airflow when people enter or move between those rooms.
III. The Grade A area is dedicated to high-risk operations such as fill/finish (filling zone), stopper bowls, open ampoules, vials, and making aseptic connections.
IV. The Grade C cleanroom spaces are for performing less stringent steps of sterile product manufacturing.
*
A. I, II, III
B. I, II, IV
C. II, III, IV
D. I, II, III, IV

E) NOTA

The following are true about theoretical considerations for suspension, except:
I. The smaller the surface free energy the more thermodynamically stable is the suspension.
II. When the interfacial energy reduces the surface free energy also decreases.
III. When the surface free energy decreased, it avoids the agglomeration of particles in the suspension.
IV. Wetting agent reduces interfacial tension by being adsorbed at the interface between solid particles and the liquid medium, making the suspension thermodynamically stable.
*
A. I, II, III
B. I, II, IV
C. II, III, IV
D. I, II, III, IV
E. NOTA

A) I, II, III

The following are true about types of filter media
I. Nylon is a superior type of filter media that is unaffected by molds/fungus.
II. Filter cloth is used for straining syrupy liquids.
III. Kraft paper is used as a pharmaceutical standard.
IV. Felt cloth is used for gelatinous solutions.
*
A. I, II, III
B. I, II, IV
C. II, III, IV
D. I, II, III, IV

C) Ultrasonifier

The use of this equipment will produce extremely fine particles for moderately viscous emulsions, but this equipment is not available for commercial scale.
*
A. Mechanical stirrer
B. Homogenizer
C. Ultrasonifier
D. LFE

A) I, II, III

Which of the following are true about granulation methods,
I. Formation of slugs: Dry granulation
II. Slugger and roller compactor: Dry granulation
III. Wet massing: Wet Granulation
IV. High energy solids: Hot Melt Granulation
*
A. I, II, III
B. I, II, IV
C. II, III, IV
D. I, II, III, IV

B) Homogenizer

This equipment can produce extremely fine droplets, depending on the viscosity and interfacial tension of the system.
*
A. Mechanical stirrer
B. Homogenizer
C. Ultrasonifier
D. LFE

D) Blooming

Coating becomes dull immediately or after prolonged storage at high temperatures
*
A. Chipping
B. Blistering
C. Cratering
D. Blooming

A) I, II, III

The following are true about glass as packaging, except:
I. Type II: Highly resistant borosilicate glass
II. Type III: Treated soda lime glass
III. Type I: General purpose soda lime glass
IV. Type IV: Soda lime glass
*
A. I, II, III
B. I, II, IV
C. II, III, IV
D. I, II, III, IV

A) Impact

Size reduction occurs when particles are struck at high speed. Ideal for brittle materials
*
A. Impact
B. Cutting
C. Compressing
D. Attrition

A) Flooding

An uncontrolled, excessive, and often unpredictable flow of material, which behaves more like a liquid than a solid.
*
A. Flooding
B. Arching
C. Funneling
D. Bridging

E) NOTA

The following are true about key factors affecting stability, except:
*
High temperature can cause hydrolysis, oxidation, and degradation of proteins.
High humidity can cause microbial growth.
Weekly acidic and basic drugs show good solubility when they are ionized, and they also decompose faster when they are ionized.
Smaller particles have a larger surface area, which can accelerate chemical degradation processes, compromising the overall stability of the drug product.
NOTA

B) Attrition

Mechanically reduce solid particles through the intense acceleration of particles against one another in a curved or flat grooved surface
*
A. Cutting
B. Attrition
C. Impact
D. Compressing

C) II, III, IV

The following statements are true about theoretical considerations for suspension, except:
I. Wetting is the ability of a liquid to maintain contact with a solid surface, resulting from intermolecular interactions when the two are brought together.
II. Hydrophilic particles float on the surface of the liquid until the layer of air is displaced completely.
III. The use of wetting agent ensures adequate wetting by allowing the entrance of air from the surface so that the adsorbed liquid is displaced from the solid surfaces by the air.
IV. Drug particles, if wetted, will tend to aggregate spontaneously to stabilize the system.
*
A. I, II, III
B. I, II, IV
C. II, III, IV
D. I, II, III, IV

A) Oil in water

Pharmaceutical emulsions which are given orally are of ____ type.
*
A. Oil in water
B. Water in oil
C. Oil in water in Oil
D. O/W/O

D) LFE

This equipment has been developed to allow for the draft-free flow of clean, filtered air over the work area.
*
A. Mechanical stirrer
B. Homogenizer
C. Ultrasonifier
D. LFE

C) Hydrophobic substances are easily wet by water or other polar liquids.

The following are true about wettability, except:
*
A. When a strong affinity exists between a solid and liquid, the liquid will easily form a film over the surface of the solid.
B. When there is a weak affinity, the liquid has difficulty in displacing air surrounding the liquid.
C. Hydrophobic substances are easily wet by water or other polar liquids.
D. Hydrophobic substances do not alter the viscosity of an aqueous suspension.

A) Mechanical stirrer

This equipment is ideal for slow mixing of finished emulsions, which have been prepared by melting the waxes.
*
A. Mechanical stirrer
B. Homogenizer
C. Ultrasonifier
D. LFE

B) Blushing

Whitish specks or haziness in the film
*
A. Chipping
B. Blushing
C. Cratering
D. Blooming

C) Cutting

Size reduction occurs by fracture of particles between two sets of knives.
*
A. Compressing
B. Impact
C. Cutting
D. Attrition

D) I, II, III, IV

Why is there a need for aging the solution prior to filtration?
I. Aging allows entrapped air to escape.
II. Ensures complete dissolution
III. Helps stabilize the solution
IV. Improves clarity and consistency
*
A. I, II, III
B. I, II, IV
C. II, III, IV
D. I, II, III, IV

E) NOTA

Which of the following statements is/are incorrect?
I. When the salt concentration decreases, the repulsive interaction between the particles increases.
II. A system with a wide particle size distribution gives more compact packing than a system with narrower particle size distribution.
III. In a pharmaceutical suspension a surfactant serves two purposes: to increase the wettability of the drug substance and to prevent particles from aggregating.
IV. If all the particles in suspension have a large negative or positive zeta potential then they will tend to repel each other and there will be no tendency for the particles to come together.
*
A. I, II, III
B. I, II, IV
C. II, III, IV
D. I, II, III, IV
E. NOTA

B) I, II, IV

The following are true about filtration, except:
I. Gravity filtration is used for very large quantities.
II. Pressure filtration provides slow filtration
III. Parallel filtration uses more than one filter
IV. Series filtration provides fast filtration to achieve highly polished product.
*
A. I, II, III
B. I, II, IV
C. II, III, IV
D. I, II, III, IV

A) Chipping

A problem in tablet coating where films becomes dented, usually at the edges.
*
A. Chipping
B. Blistering
C. Cratering
D. Blooming

A) I, II, III

The following are true about liquid filling methods, except:
I. Gravimetric method is only used in very large containers, highly viscous products, or for mobile and frothy solutions.
II. Volumetric method pumps liquid at constant pressure.
III. Volumetric fillers are ideal for containers with different interior sizes because they deliver the same volume even if the container shapes vary.
IV. Constant level method fill each container to the same level, so it is frequently called the “fill-to-a-level” method.
*
A. I, II, III
B. I, II, IV
C. II, III, IV
D. I, II, III, IV
E. NOTA

D) I, II, III, IV

Which of the following statements is/are true?
I. Both o/w and w/o emulsions may be applied to the surface of the skin and the mucous membranes.
II. A w/o emulsion can be applied more evenly because the skin is covered with a film of sebum, and this surface is more readily wetted by oil than by water.
III. W/O emulsion is more softening to the skin because it resists drying out and removal by contact with water
IV. O/W emulsions are widely used in topical formulations as creams and lotions
*
A. I, II, III
B. I, II, IV
C. II, III, IV
D. I, II, III, IV

E) NOTA

The following statements are true about theoretical considerations for suspension, except:
I. If the zeta potential is reduced below a certain value, the attractive forces between particles due to van der Waals’ force, overcome the forces of repulsion and the particles come together to form floccules.
II. In a deflocculated system, the liquid remains cloudy after shaking because very small particles settle very slowly and stay suspended even after the larger particles have already settled.
III. Flocculation occurs at the secondary energy minimum when the particles are far apart from each other upon the addition of a small amount of electrolyte which reduces the zeta potential of the deflocculated system.
IV. A deflocculated system has a zeta potential higher than the critical value when the repulsive forces supersede the attractive forces.
*
A. I, II, III
B. I, II, IV
C. II, III, IV
D. I, II, III, IV
E. NOTA

C) Funneling

A non-ideal flow pattern where an active channel of moving material forms only in the center of the hopper, while the material near the walls remains stationary or “dead”.
*
A. Flooding
B. Arching
C. Funneling
D. Bridging

C) Cratering

This refers to a coating defect in which volcanic-like craters appear, exposing the tablet surface.
*
A. Chipping
B. Blistering
C. Cratering
D. Blooming

A) I, II, III

True about blending powders
I. V-blenders are used for gentle and uniform blends.
II. Ribbon blenders are used for cohesive powders.
III. High-shear mixers are used for more intensive blending and wet granulation.
IV. There is no such thing as over-mixing. Lubrication increases with an increase in agitation time which has no effect in stability of tablet.
*
A. I, II, III
B. I, II, IV
C. II, III, IV
D. I, II, III, IV