Drug Dosage/Delivery E1

What is pharmaceutics?

The study of the formulation, manufacture, stability, and effectiveness of pharmaceutical dosage forms.

What is a dosage form?

The physical form in which a medication is given, such as a tablet, capsule, cream, solution, or injection.

What is the goal of a dosage form?

To deliver the correct drug, in the correct amount, by the correct route, safely and consistently.

What are characteristics of an ideal dosage form?

Standardization, uniformity, and consistency.

What is a route of administration?

The way a medication enters the body, such as oral, topical, intravenous, or rectal.

What is the difference between a dosage form and a route of administration?

A dosage form is the physical form of the drug; a route of administration is how the drug enters the body.

What does the Rx symbol represent?

Pharmacy or a prescription.

What does USP stand for?

United States Pharmacopeia.

What type of organization is USP?

A nongovernmental, nonprofit scientific organization.

What does USP do?

It creates objective, science-based quality standards for medications, dietary supplements, and some foods.

Are USP standards enforceable?

Yes. USP standards for medications are required by law in the United States and may be enforced by the FDA.

When was the first United States Pharmacopeia published?

1820.

How often does the USP Convention meet today?

Every 5 years.

What does NF stand for?

National Formulary.

Why was the National Formulary originally created?

Because some commonly used drugs were not included in USP standards.

When were USP and NF first published together as USP–NF?

1980.

What are USP–NF monographs?

Legal documents that set standards for drug substances and pharmaceutical ingredients.

What is found in the USP section of USP–NF?

Monographs for therapeutically active drug substances.

What is found in the NF section of USP–NF?

Monographs for pharmaceutical agents, including excipients.

Do USP–NF standards apply only to drug manufacturers?

No. They apply to both large-scale manufacturing and pharmacy compounding.

What is compounding?

Creating a customized medication or dosage form to meet the needs of a specific patient.

What does USP <795> cover?

Nonsterile compounding.

Why is USP <795> important in pharmacies?

It provides the official standards for nonsterile compounding and is used during pharmacy inspections.

What must pharmacies do with USP <795> requirements?

Include its requirements in their policies and procedures.

What does USP <797> cover?

Sterile compounding.

What is the main focus of USP <797>?

Preventing microbial contamination and verifying contamination-control practices.

what facility areas may be required for sterile compounding?

An ante-area and a clean room.

Which has more facility and contamination-control requirements: USP <795> or USP <797>?

USP <797>.

What does USP <800> cover?

Handling hazardous drugs.

What is the purpose of USP <800>?

To promote patient safety, worker safety, and environmental protection when handling hazardous drugs.

What activities are considered handling hazardous drugs?

Receiving, storing, compounding, dispensing, administering, and disposing of hazardous drugs.

What is micromeritics?

The study of small particles, especially powders.

Why is micromeritics important in pharmacy?

It helps pharmacists understand how particles behave in dosage forms given to patients.

Why is particle size important in pharmaceutical products?

It affects mixing, flow, surface area, packing, dissolution, reconstitution, and dose uniformity.

What does reconstitution mean?

Adding a specific amount of liquid, usually water, to a dry drug product to make the final preparation.

What USP chapter covers light-diffraction measurement of particle size?

USP <429>.

What USP chapter covers dynamic light scattering for particle-size measurement?

USP <430>.

What USP chapter covers particle-size distribution using sieves?

USP <786>.

What should be used when performing official sieve analysis?

USP–NF official sieves.

What is a particle-size distribution?

A description of the different particle sizes in a powder and how frequently each size occurs.

What does a histogram show in particle-size analysis?

The frequency of particles within different size ranges.

What is surface area?

The total exposed outer area of particles.

How does decreasing particle size affect surface area?

By having a greater total surface area.

What is bulk volume (Vb)?

The total volume occupied by a powder in a container, including particles and spaces between particles.

What is particle volume (Vp)?

The actual volume occupied by the solid particles themselves.

What is void volume (Vvoid)?

The volume of empty spaces between particles.

What is porosity?

The fraction of a powder’s bulk volume that consists of empty spaces, or voids.

How is porosity often expressed?

As a percentage, such as 47% voids.

What does high porosity mean?

There is more empty space between the powder particles.

Why is porosity important in pharmacy compounding?

It affects how much powder fits into a container or capsule and how much liquid is needed for reconstitution.

What are the two ideal packing arrangements of uniform spheres?

Closest packing (rhombohedral) and loosest packing (cubic).

What is closest packing also called?

Rhombohedral packing.

What is loosest packing also called?

Cubic packing.

What is bulk density

The mass of powder divided by its bulk volume.

What is bulkiness(Fluffy)?

The reciprocal of bulk density.

How are bulkiness and bulk density related?

The more dense a powder is, the less bulky it is.

What is the angle of repose?

A measurement used to assess a powder’s ability to flow.

What does a lower angle of repose indicate?

Better powder flow

What is the theoretical lower limit for angle of repose?

25°.

What does an angle of repose above 50° indicate?

Poor powder flow.

What two forces reduce powder flow?

Cohesion and friction.

What is cohesion?

The attraction of particles to each other.

How can moisture affect powder flow?

Moisture can cause particles to stick together, reducing flow; want content as dry as possible

How can electrostatic attraction affect powder flow?

It causes particles to cling to each other or to equipment, reducing flow.

What is bridging?

When particles form an arch over an opening, blocking powder flow.

What is rat-holing?

When powder flows only through a narrow channel in the center while powder remains stuck along the sides of the container.

What is an excipient?

Any component of a drug product other than the active ingredient.

Why are excipients used in medications?

They help form, stabilize, manufacture, deliver, protect, flavor, color, or improve the performance of the dosage form.

Can inactive ingredients matter to patients?

Yes. Some patients may have allergies or sensitivities to inactive ingredients.

What is the purpose of microcrystalline cellulose in tablets?

It is a cellulose derivative that acts mainly as a bulk former; it adds bulk and shape and is easily compressed.

What are common cellulose derivatives used as excipients?

Microcrystalline cellulose, croscarmellose, hydroxypropyl cellulose, carboxymethylcellulose, and hypromellose.

What is croscarmellose used for?

It is a disintegrant.

What is crospovidone used for?

It is a disintegrant.

What is a disintegrant?

An excipient that helps a tablet or capsule break apart after administration.

What is sodium lauryl sulfate?

A surfactant.

What is a surfactant?

A “surface acting agent” that lowers the surface tension of water.

Why can surfactants work with both polar and nonpolar substances?

They have an affinity for both polar and nonpolar solvents.

What does HLB stand for?

Hydrophilic-lipophilic balance.

What does a higher HLB value indicate?

Greater hydrophilicity, or greater attraction to water.

What is the HLB range for defoamers?

1–3; not dispersible in water

What is the HLB range for water-in-oil (W/O) emulsifiers?

3–6;poor dispersion in water

What is the HLB range for wetting agents?

7–8; milky dispersion after shaking

What is the HLB range for oil-in-water (O/W) emulsifiers?

9–10; stable milky dispersion

What is the HLB range for detergents?

11–13; opaque dispersion

What is the HLB range for solubilizers?

14–16; clear solution

What is an emulsifying agent?

A type of surfactant that maintains the dispersion of substances that are normally immiscible.

What examples of emulsifying agents?

Acacia, stearates, oleates, glyceryl monostearate, and sorbitan monooleate

What is magnesium stearate used for in tablets?

It is a lubricant that reduces friction during tablet compression.

How does magnesium stearate help manufacturing?

It prevents the preparation from sticking to dies, punches, and other machinery.

What is talc used for in tablet manufacturing?

It is a glidant that improves powder flow during tablet compression.

What is a glidant?

An excipient that improves powder flow.

What is an adsorbent?

A substance that can physically or chemically hold other molecules on its surface.

What is sodium metabisulfite used for?

It is an antioxidant.

How does an antioxidant protect an active ingredient?

It is oxidized more readily than the active ingredient, helping prevent active-ingredient oxidation.

What are colorants used for?

They give dosage forms a recognizable color and improve appearance.

What is a humectant?

An excipient that retains moisture and prevents a preparation from drying out.

What is a levigating agent?

A liquid ingredient used to reduce particle size and begin solubilizing an active ingredient before mixing it into another vehicle.

What is a solvent?

An agent in which the active ingredient is dissolved.

What are examples of solvents used in pharmacy?

Alcohols, vegetable oils, nut oils, oleic acid, water, and saline.

What are stiffening or thickening agents commonly used in?

Ointment preparations.