Industrial Exam 4 Review

What are the two major types of capsules?

Hard gelatin capsules, Soft gelatin capsules (softgels)

What dosage forms are typically filled into hard gelatin capsules?

Powders,Granules,Pellets,Mini

What dosage forms are typically filled into soft gelatin capsules?

Oils,Liquids,Suspensions

Hard gelatin capsules consist of what two parts?

Cap,Body

Are soft gelatin capsules one piece or two?

one

What happens to gelatin when exposed to water?

Swells,Softens,Dissolves at warm temperatures,Releases drug contents

What happens first after swallowing a capsule?

The gelatin shell swells and ruptures before drug release.

What effect does excessive water have on a gelatin capsule shell?

Makes the shell soft and may cause deformation.

What effect does a hygroscopic drug have on a gelatin capsule shell?

Removes moisture from the shell, making it brittle and susceptible to cracking.

What does "hygroscopic" mean?

A material that readily absorbs moisture.

What is capsule cross-linking?

Chemical bonding between gelatin protein chains that decreases shell solubility and slows dissolution.

What compounds commonly cause gelatin cross-linking?

Aldehydes

What is the major consequence of gelatin cross-linking?

Poor dissolution and delayed drug release.

What is lactose primarily used for?

Diluent (filler).

What is magnesium stearate primarily used for?

Lubricant.

What is colloidal silicon dioxide primarily used for?

Glidant (improves powder flow).

What is croscarmellose sodium primarily used for?

Disintegrant.

Name three common diluents used in capsule formulations.

Lactose,Starch,Microcrystalline cellulose (MCC)

What is the purpose of a glidant?

To improve powder flow during manufacturing.

What is the purpose of a lubricant?

To reduce friction between the formulation and manufacturing equipment.

What is the largest capsule size?

000

What is the smallest capsule size?

5

What is the volume of a size 000 capsule?

1.36 mL

What is the volume of a size 00 capsule?

0.95 mL

What is the volume of a size 0 capsule?

0.67 mL

What is the volume of a size 1 capsule?

0.48 mL

What is the volume of a size 2 capsule?

0.37 mL

What is an aerosol?

A system in which solid or liquid particles are dispersed in a gas.

What is the major advantage of pulmonary drug delivery?

Rapid drug delivery directly to the lungs with reduced systemic side effects.

What does pMDI stand for?

Pressurized Metered Dose Inhaler.

What are the major components of a pMDI?

Drug, Propellant (HFA), Canister, and Metering valve

What is the major disadvantage of a pMDI?

Requires coordination between actuation and inhalation.

What accessory can be added to a pMDI to improve coordination?

Spacer.

What does DPI stand for?

Dry Powder Inhaler.

Does a DPI require a propellant?

No. DPIs are breath-actuated.

What is meant by "breath-actuated"?

The patient's inhalation provides the energy needed to disperse and deliver the drug.

What type of inhalation should be used with a DPI?

Fast, forceful inhalation.

What type of inhalation should be used with a pMDI?

Slow, deep inhalation followed by breath-holding.

What is a nebulizer?

A device that converts liquid formulations into an inhalable mist.

Which patients benefit most from nebulizers?

Children, Elderly patients, and Patients who have difficulty using inhalers properly

What determines where aerosol particles deposit in the respiratory tract?

Aerodynamic diameter.

What particle size is ideal for deep lung deposition?

1-3 µm.

What happens to particles larger than 5 µm?

They deposit in the mouth, throat, and upper airways by inertial impaction.

What deposition mechanism occurs with particles larger than 5 µm?

Inertial impaction.

What deposition mechanism occurs with particles 1-5 µm?

Gravitational sedimentation.

What deposition mechanism occurs with particles less than 1 µm?

Brownian diffusion.

What often happens to particles smaller than 0.5 µm?

They are exhaled before deposition.

Which particle size range is most likely to reach the bronchioles and alveoli?

1-5 µm.

What is inertial impaction?

Deposition of large particles that cannot follow airflow around airway bends and collide with airway walls.

What is gravitational sedimentation?

Deposition caused by particles settling under gravity.

What is Brownian diffusion?

Random movement of very small particles caused by collisions with gas molecules.

Why is lactose added to DPI formulations?

Improves powder flow, Improves manufacturability, and Improves dose uniformity

What is the role of lactose in a DPI?

It acts as a carrier particle for micronized drug particles.

What size are typical DPI drug particles?

Approximately 2-5 µm.

What size are typical lactose carrier particles in DPIs?

Approximately 30-150 µm.

What happens to the drug particles during DPI inhalation?

Drug particles detach from lactose and continue into the lungs.

What happens to the lactose carrier during DPI inhalation?

It impacts and deposits in the throat.

What propellant was historically used in pMDIs?

Chlorofluorocarbons (CFCs).

What propellant is used in modern pMDIs?

Hydrofluoroalkanes (HFAs).

Why did HFAs replace CFCs?

Environmental concerns related to ozone depletion.

What is hygroscopic growth?

Particle growth caused by water absorption in the humid respiratory tract.

What is the approximate relative humidity inside the lungs?

About 99%.

What clears particles from the conducting airways?

Mucociliary clearance.

What cells remove particles from the alveoli?

Alveolar macrophages.

What type of aerosol device is Advair HFA?

pMDI.

What type of aerosol device is Spiriva HandiHaler?

DPI.

What formulation aid is found in the Spiriva HandiHaler capsule formulation?

Lactose carrier particles.

Ideal deep lung deposition size?

1-3 µm.

>5 µm = ?

Inertial impaction.

1-5 µm = ?

Gravitational sedimentation.

<1 µm = ?

Brownian diffusion.

<0.5 µm = ?

Often exhaled.

pMDI = ?

Press + Breathe.

DPI = ?

Breath-actuated.

Nebulizer = ?

Mist + Normal Breathing.

New propellant = ?

HFA.

Lactose in DPI = ?

Carrier particle that improves flow and dose uniformity.