Solid dosage form

Dosage form

What is the physical manifestation of a drug used to administer formulations to the proper site in the body?

excipients

A solid dosage form consists of a specific quantity of an active pharmaceutical ingredient (API) combined with _____ in a dry state.

Powders/Granules/Pellets, Capsules, Tablets, and Miscellaneous Solids.

What are the four broad categories of solid dosage forms?

Definition: The therapeutic moiety that produces pharmacological activity.

Term: Active Pharmaceutical Ingredient (API)

Excipients

What is the collective term for inactive ingredients such as additives, adjuncts, or necessities in a formulation?

Diluent (or Bulking Agent)

Which type of excipient is added specifically to increase the tablet to a manageable size?

Diluents (Bulking Agents)

Lactose, Mannitol, and Microcrystalline Cellulose are common examples of which excipient class?

It glues powders together to form granules.

What is the functional role of a binder in a solid dosage form?

Binders

Starch paste and aqueous gelatin solution are examples of which excipient type?

Flow Activator (or Glidant)

Which excipient increases the flow of materials from the hopper during compression?

Glidants (Flow Activators)

Colloidal silica (Silicon dioxide) and Talc are primary examples of which excipient?

To prevent adhesion of the mixture to dies and punches.

What is the primary purpose of a lubricant in tablet manufacturing?

lubricants

Magnesium stearate and Mineral oil are common examples of _____.

Disintegrant

Which excipient causes a tablet to break apart when placed in an aqueous environment?

disintegrants

Corn starch, Potato starch, Bentonite, and Alginic acid are examples of _____.

To hold quantities of fluids in an apparently dry state.

What is the function of an adsorbent excipient?

Adsorbents

Silicon dioxide and Magnesium carbonate are examples of which excipient class?

Sweeteners, Flavors, and Colorants.

What are three excipients used primarily to improve aesthetic value and palatability?

They have low manufacturing costs and are easy to package.

Compared to liquid forms, why are solid dosage forms generally preferred for shipping?

They are often easier to formulate.

What is a specific advantage of capsules over tablets during the development phase?

Inaccuracy of the dose.

What is a significant disadvantage of powders regarding dose administration?

Capsules

Which solid dosage form carries the risk of lodging in the esophagus?

internal; external

Powders are defined as intimate mixtures of dry, finely divided drugs and/or chemicals for _____ or _____ use.

Very Coarse

In the classification of powder particle size, what is the designation for 'no. 8'?

Very Fine

In the classification of powder particle size, what is the designation for 'no. 80'?

Aerosol Powders

Which type of powders are administered by inhalation using dry-powder inhalers?

Non-potent medicaments provided to the patient in bulk.

What are 'Bulk Powders' intended for?

Dentifrices

Which powder type is used for cleansing and polishing teeth and may contain fluoride?

insufflations

Medicated powders designed to be blown into body cavities using a specific device are called _____.

A medicinal substance ground in a mortar and pestle with sugar and milk.

What is a 'Trituration'?

Chartula

What is the traditional name for 'Divided Powders' where each dose is separately wrapped?

Waxed paper

Which powder wrapping paper is waterproof?

White bond paper

Which powder wrapping paper has no moisture-resistant properties?

Collagen

What is the primary protein constituent of connective tissues used to prepare gelatin?

acid

Gelatin A is produced through the _____ hydrolysis of porcine skin.

base

Gelatin B is produced through the _____ hydrolysis of bovine bones.

Sulfur dioxide

What substance is added (0.15%) to hard gelatin capsules to prevent decomposition during manufacture?

12-15% (or 13-16%).

What is the typical moisture content range for Hard Gelatin Capsules?

Glycerin or polyhydric alcohol (Sorbitol).

Which ingredients are added to Soft Gelatin Capsules to provide elasticity and plasticity?

5-8% (or 6-10%).

What is the typical moisture content range for Soft Gelatin Capsules?

0

Which capsule size is the largest and intended for veterinary use?

5

Which capsule size has the smallest capacity (0.13 mL)?

Wet granulation, Dry granulation, and Direct compression.

What are the three main methods used to manufacture compressed tablets?

50%

How much bulk is typically added to a tablet by sugar coating?

Mannitol

Which diluent is used in chewable tablets for its cooling sensation and sweetness?

In the intestinal fluid.

Where do enteric-coated tablets typically disintegrate?

Layered has multiple layers; Press-coated is a tablet within a tablet.

What is the difference between Layered and Press-coated multiple compressed tablets?

Citric acid and Tartaric acid.

Effervescent tablets are composed of sodium bicarbonate combined with which two acids?

Under the tongue.

Where are sublingual tablets intended to be dissolved?

delayed release

Modified-release tablets that release medication at a time other than promptly after administration are called _____.

A tablet containing two single doses, one for immediate release and one for delayed release.

What is a 'Repeat Action' tablet?

Definition: Also known as compounding tablets, used for extemporaneous compounding.

Term: Dispensing Tablets

The difficulty in achieving sterility.

Why are hypodermic tablets no longer used?

Bullet or ovoid shaped.

What is the shape of a vaginal tablet (vaginal insert)?

Troches are compressed; Pastilles are molded and softer.

What is the difference between a Troche and a Pastille?

Implants (or Pellets)

Which solid dosage form consists of a concentrated drug for subcutaneous implantation for continuous long-term release?

0.2-4 mm

What is the typical particle size range for granules?

fluidity; compressibility

Granules must possess two key properties for tablet manufacturing: _____ and _____.

The mixture becomes sticky.

What happens if only citric acid is used in the preparation of effervescent granulated salts?

The granules will crumble.

What happens if only tartaric acid is used in the preparation of effervescent granulated salts?

Starches

Which diluent is favored for stabilizing hygroscopic drugs?

It is very hygroscopic above 65% relative humidity.

What is a disadvantage of Sorbitol when used for direct tableting?

It is somewhat hygroscopic and turns brown with acidic/basic substances.

Why should sucrose only be used in a small ratio as a diluent?

Avicel

What is the brand name for Microcrystalline Cellulose used for direct compression?

It needs a lubricant and is expensive.

What are two disadvantages of using Microcrystalline Cellulose (Avicel)?

10-20% w/w

What is the typical concentration range for Starch Paste when used as a binder?

Aqueous glucose solution

Which binder is used at a concentration of 25-50% w/w?

Clays

Bentonite and Veegum are examples of which type of disintegrant?

Algins

Alginic acid and sodium alginate are categorized as which type of disintegrant?

Lakes (Al(OH)3

Which type of colorants are insoluble in water and are the colorants of choice to prevent mottling?

They are volatile.

Why are flavoring oils never added during wet processing of tablets?

Chocolate, anise, cherry mint, nut, or fennel.

Which flavor is typically used to mask a bitter taste?

Butterscotch, maple, peach, melon, or raspberry.

Which flavor is typically used to mask a salty taste?

250-500x

What is the sweetening potency of Saccharin compared to sucrose?

200x

What is the sweetening potency of Aspartame compared to sucrose?

A disadvantage where the sugar causes the cap of the container to stick.

What is 'cap-locking' in the context of sucrose use?

50%

How much water can Silicon dioxide hold relative to its own weight?

Magnesium carbonate, Bentonite, and Kaolin.

Identify three examples of adsorbents other than silicon dioxide.

no. 40

A powder designated as 'Moderately Coarse' corresponds to which sieve number?

no. 60

Powders designated as 'Fine' correspond to which sieve number?

Excipients (Additives/Adjuncts)

Which excipient type is specifically defined as 'inactive ingredients' used for safety and convenience?

Lozenge

Which type of tablet is designed to dissolve slowly in the mouth and contains a flavored, sweetened base?

Lollipop

Which tablet type contains fentanyl citrate and is sugar-based on a stick?

100-120 (Sieve size/grade)

What moisture content range is unique to Spray-dried lactose?

A form directed towards a specific region, tissue, or site of absorption.

What is a 'Targeted Release' dosage form?