PHA 338 - Oral Dosage Forms (Tablets) L21

What are tablets?

Solid dosage forms prepared by compression of a drug with excipients.

What are the advantages of tablets?

Most common, least expensive, easy to manufacture, and may be scored for breaking.

What are immediate-release tablets?

Tablets that release the drug rapidly after administration.

What are sugar-coated tablets?

Tablets coated with a thick sugar layer to improve appearance, taste, and stability.

What are film-coated tablets?

Tablets coated with a thin polymer film for protection and appearance.

What are enteric-coated tablets?

Tablets coated to resist stomach acid and dissolve in the intestine.

Why are enteric-coated tablets used?

To protect acid-sensitive drugs or protect the stomach from irritating drugs.

What are multiple compressed tablets?

Tablets made of two or more compressed layers.

What are layered tablets?

Multiple compressed tablets containing separate layers of ingredients.

What are press-coated tablets?

Tablets with one tablet compressed around another.

What are chewable tablets?

Tablets designed to be chewed before swallowing.

What are buccal tablets?

Tablets placed between the cheek and gum for absorption.

What are sublingual tablets?

Tablets placed under the tongue for rapid absorption.

Why are sublingual tablets used?

To bypass first-pass metabolism and provide rapid onset.

What is an example of a sublingual tablet?

Nitroglycerin.

What are controlled-release tablets?

Tablets designed to release drug slowly over time.

What are extended-release tablets?

Tablets formulated to prolong drug release and reduce dosing frequency.

What excipients are commonly used in extended-release tablets?

Poly(methyl methacrylate), carnauba wax, EC, HEC, and Eudragit.

What are effervescent tablets?

Tablets that release carbon dioxide when dissolved in water.

What ingredients create the effervescent reaction?

Sodium bicarbonate with citric acid or tartaric acid.

What gas is released by effervescent tablets?

Carbon dioxide.

What are rapid-dissolving tablets?

Tablets that dissolve in the mouth within about 15-30 seconds.

What does RDT stand for?

Rapid-dissolving tablet.

What does ODT stand for?

Orally disintegrating tablet.

How long do ODTs typically dissolve?

About 15-30 seconds.

How are ODTs manufactured?

Soft direct compression, fast-dissolving excipients, effervescent excipients, or lyophilized foam.

How should ODT blister packages be opened?

Peel back the foil rather than pushing the tablet through.

What are molded tablets?

Small molded tablets made from rapidly soluble powders.

What are tablet triturates?

Another name for molded tablets.

How are molded tablets prepared?

By geometric dilution, moistening with alcohol or water, molding, drying, and removal.

What are lozenges?

Tablets that dissolve slowly in the mouth for localized effects.

What is another name for a lozenge?

Troche.

What are vaginal tablets?

Tablets intended for vaginal administration.

What are orally dissolving films?

Thin films that dissolve in the mouth and release medication.

What does ODFS stand for?

Orally dissolving film strips.

What does RDF stand for?

Rapidly dissolving films.

What were dissolving films originally developed for?

Breath freshening.

What percentage of API may dissolving films contain?

Up to 30%.

Why is taste masking important in dissolving films?

Because the drug dissolves directly in the mouth.

What polymer is commonly used in dissolving films?

HPMC (Hydroxypropyl Methylcellulose).

How can dissolving films be modified for buccal absorption?

By changing polymer composition or making thicker films.

What manufacturing technology can produce customized tablets?

3D printing.

What equipment compresses tablets?

Tablet presses.

What materials are compressed to form tablets?

Powders or granules.

What components form one tablet station?

Two punches and one die.

What is the function of the die?

Holds the powder during compression.

What is the function of the upper punch?

Compresses the powder into a tablet.

What is the function of the lower punch?

Supports the powder and ejects the finished tablet.

What type of punches produce convex tablets?

Concave punches.

What controls tablet weight?

Amount of die fill.

What controls tablet thickness?

Amount of die fill and compression pressure.

What types of tablet presses exist?

Single-station and rotary presses.

How does tablet compression occur?

Granules fill the die, upper punch compresses, then lower punch ejects the tablet.

What is the advantage of rotary tablet presses?

Very high production rates.

What supplies powder to the die cavities in rotary presses?

Hopper and feed frame.

What is needed for successful tablet manufacture?

Proper size, good powder flow, lubrication, cohesiveness, drug release, and aesthetics.

Which excipient provides bulk?

Diluent.

Which excipient improves flow?

Glidant.

Which excipient reduces sticking to punches?

Lubricant.

Which excipient provides cohesiveness?

Binder.

Which excipient helps tablets break apart?

Disintegrant.

Which excipient improves appearance?

Colorant.

What is the function of a diluent?

Provides bulk to make tablets practical for compression.

What are examples of diluents?

Lactose, microcrystalline cellulose, dicalcium phosphate, powdered sucrose.

What is the function of a binder?

Imparts cohesiveness to the tablet.

What are examples of binders?

Starch, gelatin, povidone, natural gums, and synthetic gums.

What is the function of a lubricant?

Prevents adhesion of powder to punches and dies.

What are examples of lubricants?

Magnesium stearate and talc.

What is a secondary purpose of lubricants?

They may improve powder flow.

What happens if too much lubricant is used?

Poor disintegration and delayed dissolution.

What is the function of a glidant?

Improves powder flow.

What are examples of glidants?

Colloidal silicon dioxide and talc.

What is another name for colloidal silicon dioxide?

Aerosil or Cab-O-Sil.

What is the function of a disintegrant?

Helps tablets break apart after administration.

What is an example of a disintegrant?

Starch.

What are superdisintegrants?

Disintegrants that work effectively at low concentrations.

What are examples of superdisintegrants?

Croscarmellose, crospovidone, and sodium starch glycolate.

What is the brand name for croscarmellose?

Ac-Di-Sol.

What is the brand name for crospovidone?

Polyplasdone.

What is the function of colorants?

Distinguish doses and improve aesthetics.

What colorants are approved for tablets?

FD&C dyes and lakes.

What are the three methods of tablet manufacture?

Wet granulation, dry granulation, and direct compression.

Why is granulation performed?

To improve powder flow into the dies.

What is a granule?

An agglomerate of powder particles bound together.

What are the first steps of granulation?

Weigh and blend powders.

How does wet granulation differ from dry granulation?

Wet granulation uses a binder solution; dry granulation uses compression.

When is wet granulation used?

When powders require a binder to improve cohesion.

What happens after binder addition in wet granulation?

Screening, drying, dry screening, lubrication, and compression.

When is dry granulation preferred?

For moisture-sensitive or heat-sensitive drugs.

Does dry granulation use a binder?

No.

How are dry granules formed?

Compressed into slugs, broken apart, and screened.

What occurs during fluid-bed granulation?

Granulation and drying occur in the same equipment.

What else can a fluid-bed processor be used for?

Tablet coating.

When is direct compression used?

When powders already have good flow and compressibility.

What advantage does direct compression provide?

Granulation is unnecessary.

What excipients are commonly used for direct compression?

Spray-dried lactose, Avicel, pregelatinized starch, and compressible sugar.

What is a common tablet manufacturing defect?

Capping.

What is capping?

The top of the tablet separates from the body.

What causes capping or splitting?

Excess fines, insufficient starch, worn punches, deep punch markings, soft granulation, or excessive compression pressure.

What can excessive lubricant cause?

Reduced disintegration and delayed dissolution.