Exam 1 Tablets Flashcards by Darren Jacks

Advantages of tablets for the manufacturer

Simplicity and economy of production

Convenience in packaging, shipping, and dispensing

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Advantages of tablets for patient

Accuracy of dosage
Compactness
Portability
Blandness
Ease of administration

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Simplest form of tablet; no special coating, that is made from powdered, crystalline, or granular materials with or without inactive ingredients. Include a VAST majority of tablets either coated or uncoated

Compressed tablets

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Purpose of sugar coating

Covers up taste/odor

Protects against oxidation

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What has sugar coating been replaced by mainly?

Film-coating

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Compressed tablets that are covered with a thin water-soluble material usually made from polymers and require shorter operation than sugar-coated tablets. For example, Flagyl tablets include the use of PEG, hydroxypropylmethylcellulose, HPMC

Film-coated tablets

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Compressed tablets coated with substances that resist dissolution in gastric fluid, but disintegrate in the intestine that are used for drugs that may decompose in the stomach, irritate the mucosa, or intended for delayed release in the intestine

Enteric-coated tablets

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What type of tablets are used to separate active ingredients for stability purposes if they are incompatible, or if the uniform distribution of two or more drugs is not guaranteed during the mixing process?

Multiple-compressed tablets

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What are the two types of multiple-compressed tablets?

Layered tablets

Press-coated tablets

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Type of tablet that compresses additional tablet granulation on a previously compressed granulation

Layered-tablets

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Type of tablet where a layer of granulation is compressed AROUND an already compressed tablet, that results in a dry-coated tablet that can be used to mask the taste of the drug in the core tablet

Press-coated tablets

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Tablets that release drug in response to a physiological condition

Enteric coated

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Tablets that release the drug slowly at a relatively steady controlled rate over a period of time, and include extended release, sustained-release, and prolonged-release tablets

Modified release tablets

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Tablets that release pulses of drug through a combination of mechanism

Repeat action, pulse-release, pulsatile-release

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Halazone tablets are an example of this, and must be labled with NOT TO BE SWALLOWED

Tablets for solution

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Contain sodium bicarbonate and an organic acid (tartaric or citric) and when added to water, the carbon dioxide released serves as a disintegrant. Includes Alka-Seltzer which contains primarily antacid sodium citrate and analgesic sodium acetysalicylate

Effervescent tablets

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These tablets usually use lactose as a diluent because it is soluble in water and can be inserted into vagina without causing pain from grittiness of particles left behind

Vaginal tablets

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Small, flat, and require sufficient pressure to produce hard tablet that is placed between lip and gum where it can dissolve or erode slowly.
Example includes ORAVIG

Buccal tablets

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These tablets are used for patients with dysphagia that require a low compression force and generally use mannitol that allows it to dissolve on the tongue
Example includes Claritin RediTabs

Orally disintegrating tablets

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Small flat tablets that are placed under the tongue that dissolve rapidly and drug is absorbed readily.
Examples include Nitroglycerin, and Nitrostat

Sublingual tablets

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What are the characteristics needed to enable compression?

Ability to flow freely
Cohesiveness
Lubrication

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How is the weight of a tablet determined?

By the volume of the material that fills the die cavity

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What are the three methods of preparation for tablets?

Wet granulation
Dry granulation
Direct compression

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What does API stand for?

Active Pharmaceutical Ingredient

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True or False: Most excipients used in tablets have one function

False: many have more than one function

What is cornstarch PASTE used for?

Binder

What is cornstarch in a DRY or SUSPENDED state used for?

Disintegrant

Inactive group that helps with processing and compression of tablets

Group 1

Inactive group that helps to impart desirable physical qualities to the finished tablet

Group 2

What group of inactives include disintegrants, surfactants, colors, and antioxidants that help improve stability?

Group 2

What group of inactives include diluents, binders, glidants, and lubricants?

Group 1

Increase the bulk to make compression possible, and include material such as calcium phosphate, calcium sulfate, lactose, cellulose, and dry starch

Diluents

True or False: With an API with low water solubility, use water-soluble diluents

True

Why are Kaolin and bentonite avoided in tablets with small dosages?

Adsorption, because the drug gets stuck to the surface of bentonite and can't be used

What are two uses of hydroxypropyl methylcellulose?

Incorporated to prolong release from tablets | Used in film coatin

What are membranes made of?

Water soluble polymers

Class of inactives that include binding agents, granulators, and granulating agents that impart cohesive properties to the powdered material in tablet formulation where the formulation of granules helps to improve flow properties and keep the tablet intact after compression

Binders

What happens if too much binder is used or if the binder is too strong?

Hard tablet that is not disintegrating that can also cause damage to the punches and dies of the tablet press

True or False: Materials with strong cohesive properties require a stronger binder

False: materials with no cohesive properties require a stronger binder

True or False: Binders are used in solution or dry form depending on the formulation

True

True or False: Cellulosics such as HPMC are more soluble in cold than hot water

True

True or False: Gelatin is added to warm water to hydrate, and then cooled to permit dissolution

False: gelatin is added to COLD water to hydrate, and then WARMED to permit dissolution

Class of inactives that prevents adhesion to the surface of dies and punches, because immediately after compression, the tablet expands and sticks to the die walls. They also reduce interparticle friction and improve rate of flow of tablet granulation. Include Talc, and a wide amount of stearates

Lubricants

True or False: Most lubricants are mostly hydrophobic

True

What happens when excessive amounts of lubricants are used?

Leads to waterproofing, resulting in poor disintegration or delayed dissolution of API

How is a lubricant added?

Finely divided in a 60 to 100-mesh nylon cloth because the finer the particle, the better they can fit on the surface. Then the granulation is mixed gently, so the lubricant is distributed evenly

Class of inactives that improve flow characteristics of a powder mixture, and are added prior to compression. The most commonly used is colloidal silicone dioxide

Glidants

Talc may serve as both a _______ and a ________.

Lubricant and glidant

Class of inactives that facilitates the breakup of the tablet and is added to the tablet following administration that is required for rapid dissolution of API. The most popular include cornstarch and potato starch.

Disintegrants

Class of disintegrants that are used in very low levels (2-4%), and include cross-linked polymers, cellulose and starches

Superdisintegrants

How is the disintegrant added?

Usually mixed with API PRIOR to granulation Sometimes the starch is divided into two portions 1. Starch is incorporated prior to granulation 2. Remainder is mixed with the lubricant and added prior to compression

What is the point of added disintegrants, such as starch, in two parts?

Part 2 breaks down the tablet into granules | Part 1 causes granules to disintegrate into smaller particles

Main purposes of coloring agents

1. Makes dosage more esthetic 2. SAFETY: helps differentiate strengths of same API 3. Serves as a mean of identification

True or False: All colorants must be approved and certified by the FDA

True

True or False: Only colorants approved for oral dosage forms are used

True

How is the colorant added?

1. Dissolve the dye in the binding solution 2. Allow dye to adsorb on starch or calcium sulfate from aqueous solution, and then dry the powder and blend with other ingredients

What is a problem that can occur with colorants during wet granulation?

A mottled appearance due to uneven distribution of dye

True or False: There is no migration problems with lakes

True because solids don't move

What is the remedy for mottled appearance with wet granulation and coloring agents?

Dry the granulation slowly at a low temperature while stirring it

What is tablet friability?

Indicator of cohesiveness

What is used to measure tablet cohesiveness?

Tablet hardness or tensile strength

True or False: As the applied force decrease, elastic and plastic deformation of the particles occurs, leading to a reduction in inter and intraparticle void spaces

False: As the applied force INCREASES, elastic and plastic deformation of the particles occurs, leading to a reduction in inter and intraparticle void spaces

True or False: The inherent cohesiveness of most drugs and excipients by itself is insufficient to manufacture a compact

True

True of False: Nitrogen adsorption is useful to estimate changes in surface area during compression, but isn't a good tool in assessing the tendency of the compact to laminate

False: Nitrogen adsorption is useful in assessing changes in surface area, AND the tendency of the compact to laminate

The duration of the period in which the compression is held at maximum force

Dwell time

When dwell time increases, _______ _______ and tablet ________ increase.

When dwell time increases, plastic flow and tablet strength increase

Most widely used granulation method where the resultant granulation will more likely meet the requirements for compression of good tablets, but has a major drawback of the number of separate steps involved, as well as time and labor needed

Wet granulation

What is the result of an over-wet, wet granulation?

Granules will be hard and considerable pressure is then needed to form the tablets

What is the result of an under-wet, wet granulation?

Granules will be too soft and break down during lubrication

True or False: During wet granulation, the mass should have the consistence of brown sugar or damp snow

True

A residual amount of _______ is desirable following drying during wet granulation, to maintain hydration of ingredients such as gums, a reduce static electricity on particles

Moisture

Why must you use a finer dry granulation to fit a smaller tablet?

If you have a small cavity, you need fine material to fit inside of it and reduce inter and intraparticle space

Type of granulation where powder blend is suspended in a vertical column, with a rising air stream, and solution or solvent is sprayed onto the suspended particles, resulting in a gradual and controlled particle buildup that is compressible following the administration of a lubricant

Fluid-bed granulation

True or False: Less-dense particles are produced in fluid-bed granulation compared with conventional methods

True

When is dry granulation used?

1. API sensitive to moisture 2. API unable to stand elevated drying temperature 3. Powder blend has sufficient inherent cohesive properties

What are two other names dry granulation is referred as?

Precompression and double compression

Process during dry granulation where the blend is compressed to form large, dense compacts using flat-face punches

Slugging

Why are large compacts used to create slugs?

Fine powders flow better in large die cavities

True or False: The more time under pressure when making a slug, the more air is able to escape, resulting in a better slug

True

A method of tablet manufacture for a small group of crystalline chemicals possessing the required characteristics for formulation of good tablets, but has now become more universally applicable due to additives possessing the necessary properties.

Direct compression

True or False: In the case of drugs possessing physical characteristics for direct compression, the API shouldn't account for a major portion of the tablet weight.

False: The API should account for a major portion of the tablet weight, if not (25% or less), then direct compression is still possible by adding a suitable diluent to act as a carrier vehicle

______ sugar and _______ are used in the direct compression of chewable tablets

Compressible sugar and mannitol

Direct compression ________ must have good flow and cohesion characteristics

Diluents

_________ _________ is obtained by subjecting cellulose to special treatment, and is water insoluble, meaning it draws fluid in the table by capillary action and acts as a disintegrant. It is extensively used in direct compression

Microcrystalline Cellulose

Granulation process that takes a wet granulation containing API, diluent, and binder to form a rod-shaped cylindrical segment, which are then shaped into spheres and compressed into tablets for consistency in shape, size, and low friability

Spheronization

Granulation process where highly dispersed liquid comes in contact with hot air to dry the liquid droplets, forming approximately spherical, uniform sized, and hollow particles. It is suitable for drying-heat sensitive materials because the evaporation is fast and the product is kept cool

Spray drying

Granulation process where solids are melted and sprayed into a stream of air or other gas where it is reduced to beads or powder and cool air is used depending on the freezing point of the material.

Spray-congealing

Tablet punches with ridges make ______ tablets

Scored tablets

Machine that makes less than 100 tablets per minute, and the weight of the tablet is determined by the volume of the cavity, which is adjusted by the lower punch

Single punch machine

Machine that can make up to 100,000 tablets per minute, and a head carrying the punches and dies revolves continuously, while compression occurs as the upper and lower punches pass between two sets of rollers

Rotary tablet machine

Machine capable of producing layered tablets such as time-delayed tablets, where the first layer is compressed, granulation for the second layer is added, and a second compression stroke is then applied. It allows for separation of incompatible drugs or enteric coating

Multilayer rotary tablet machine

What is the weakest point of the tablet?

Top (cap)

What can cause the capping (damage) of the top of the tablet?

Worn dies Too much pressure (more pressure applied = more relaxation) Unsuitable formula Moist or soft granulation

Also called tablet triturates, they use vehicles that are rapidly soluble such as mannitol and dextrose, and are generally softer than compressed tablets

Molded tablets

When making molded tablets, drug and diluent are moistened with a mixture of ______ and ________.

Water and alcohol

If too much solvent mixture is added in a molded tablet preparation, a ______ mass is produced, which will result in a finished tablet that is hard and slowly soluble.

Soggy mass

True or False: If an insufficient amount of moistening agent is used, proper cohesion of the mass will be lacking and a firm tablet cannot be produced

True

Diluents, binders, glidants and lubricants are part of what group of inactives?

Group 1

Disintegrants, surfactants, colors, and antioxidants are part of what group of inactives?

Group 2

Calcium phosphate, calcium sulfate, lactose, and dry starch are examples of ________.

Diluents

Wet cornstarch, gelatin, HPMC, and sugars are used as ______

Binders

Talc, PEG, magnesium stearate, calcium stearate, and stearic acid are used as _______

Lubricants

Colloidal silicone dioxide is a commonly used _______

Glidant

Corn and potato starch, cellulose, and cross-linked polymers are commonly used _________

Disintegrants