- Compressed tablets - Multiply Compressed Tablets - Sugar coated tablet - Film-coated tablets - Gelatin-coated tablets - Enteric-coated tablet - Buccal and Sublingual tablets - Chewable tablets - Effervescent tablets - Molded tablets - Hypodermic tablet - Tablet triturates - Dispensing tablets - Immediate-release tablets - dissolving tablets - Extended-Release tablets - Vaginal tablets

upcoming quiz Flashcards by BABAS CHRISTINE MAY

are compressed solid unit dosage forms containing medicament usually circular in shape and may be flat or biconvex.

prepared by compression with a limited number prepared by
molding

Tablets

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are mainly incorporated to enhance physical appearance, stability, disintegration, or breakup of tablet after
administration

Additives or excipients

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Some tablets are ______________, which allows them to be easily broken into two or more parts

Some tablets are scored, or grooved, which allows them
to be easily broken into two or more parts

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Advantage of Tablets

1.Accuracy in dose.
2.Increased physiological activity, physical and chemical stability.
3.The ease of administering.
4.Economic production on a large scale.
5.Simple to handle, and transport.
6.Special forms, such as sustained-release pills, help patients
comply.

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Disadvantages of Tablets

1.Unsuitable for patients who cannot swallow, including
newborns and youngsters.
2.A slower beginning of action than with liquids, oral
medications, and parenteral.

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Types of Tablets:

Compressed tablets
Multiply Compressed Tablets
Sugar coated tablet
Film-coated tablets
Gelatin-coated tablets
Enteric-coated tablet
Buccal and Sublingual tablets
Chewable tablets
Effervescent tablets
Molded tablets
Hypodermic tablet
Tablet triturates
Dispensing tablets
Immediate-release tablets
dissolving tablets
Extended-Release tablets
Vaginal tablets

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▪ Prepared by compression of powdered crystalline or granular materials by the application of high pressures using punches and die.

They do not contain special coatings.

▪ Rapid disintegration occurs which releases the drug rapidly

Compressed tablets

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_________ are fillers that provide a formulation volume it needs to create tablets of proper size.

Diluents are fillers that provide a formulation volume it needs to create tablets of proper size.

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_________________ are made with anti-adherents, glidants, lubricants & other lubricating substances that increase material flow into tablet dies, lessen wear on punches & dies, prevent fill material from adhering to punches & dies.

Sheen-coated tablets are made with anti-adherents, glidants, lubricants & other lubricating
substances that increase material flow into tablet dies, lessen wear on punches & dies,
prevent fill material from adhering to punches & dies.

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_________________ are colorants and flavorants

Miscellaneous adjuncts

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▪The loaded material is compressed more than once to create tablets that have been multiply compressed.

▪The outer tablet is shell, & inner tablet is core.

▪Due to physical and chemical incompatibilities, each layer
contains a distinct therapeutic ingredient.

Multiply Compressed Tablets

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▪ A colored sugar layer may be applied to compressed tablets.
▪ After being swallowed, the coating soon dissolves because it is water soluble.
▪ The sugarcoats shield medicine inside from outside elements & act as a defense against unpleasant tastes and odors.
▪ It enhances the appearance of the tablet.
▪ Permits imprinting of identifying manufacturers information
▪ Disadvantage: Time and expertise required in the coating process and increase in size, weight and shipping cost (May add 50% of the weight)

Sugar coated tablet

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▪ It is the actual start of the sugar coating process
▪ It provides the rapid build-up necessary to round up the tablet
edge.
▪ It also acts as the foundation for smoothing and color coats.

Subcoating

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▪ This process is for filing the irregularity/roughness on the surface generated during sub-coating.
▪ It also increases the tablet dimension to a predetermined level.
▪ usually can be accomplished by the application of a simple syrup solution of approximately 60 to 70% sugar
solid.
▪ This syrup solution generally contains pigments starch gelatin
acacia or opacifier (TiO2) if required.

Smoothing

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▪ It involves the multiple application of syrup solution
containing the requisite coloring matter.
▪ Water-soluble dyes were used previously in the sugar coating
as water-soluble dye migrates to the surface during drying
they are now replaced by water-insoluble pigment forms, for example, TiO2, Iron oxide, and Certified Lakes.

Coloring (Color coating)

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▪ Sugar-coated tablets use this process to achieve a final elegance.
▪ It is the application of a thin layer of glossy wax.
▪ The wax may be dissolved in warm naphtha or petroleum
benzene.

Polishing

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▪ are a particular kind of oral medicine formulation that has a compressed tablet core that is then thinly coated with a glossy, water-soluble polymer, like hydroxypropyl methylcellulose.

▪ The coating is usually colored to enhance the appearance of the tablet and facilitate identification by patients.

▪ The primary goal is to shield the tablet core from external elements including moisture, light, and air that can degrade the drug’s efficacy and stability.

▪ It can also make swallowing easier by masking
the drug’s unpleasant taste or odor.

▪ It has an advantage over sugarcoatings in that it is more durable, less bulky, and less time consuming to apply

▪ By its composition, the coating is designed to rupture and expose the core tablet at the desired location in the
gastrointestinal tract.

Film-coated tablets

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▪ Tablets that are coated in sugar are a recent innovation.

▪ The ground-breaking item, gelcap, is a compressed tablet in shape of a capsule that makes it possible for the coated product to be around one-third smaller than a capsule containing an equivalent amount of powder.

▪ In comparison to unsealed capsules, its coating makes swallowing easier and is more tamper-evident.

Gelatin-coated tablets

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have a delayed release function.

▪ They are made to be ingested through the intestines, where the tablets dissolve and allow for absorption of the medication.

▪ are employed when the drug substance is destroyed by gastric acid or is particularly irritating to the gastric mucosa or when bypass of the stomach enhances drug absorption

Enteric coated tablets

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▪ are flat, oval, and designed to
dissolve in the buccal pouch or under the tongue for oral mucosal absorption.

▪ They allow for oral absorption of medications that are either poorly absorbed by GIT & eliminated by gastric juice.

▪ are designed to erode slowly, and dissolved promptly and provide rapid drug effects

Buccal and Sublingual tablets

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▪ are designed to disintegrate quickly and smoothly when chewed and dissolved in the mouth.

▪ They typically have a creamy base, often flavored and colored with mannitol.
▪ It is especially useful for administration of large tablets to children and adults who have difficulty in swallowing solid
dosage form

Chewable tablets

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▪ Prepared by compressing granular effervescent salts that release gas when in contact with water.

▪ These tablets contain medicinal substances that dissolve rapidly when added to water.

▪ The “bubble action” can assist in breaking up the tablets and
enhancing the dissolution of the active drug

Effervescent tablets

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▪ Some tablets are prepared using a molding process, such as tablet triturates, instead of compression.

▪ These tablets are usually soft, soluble, and designed for rapid
dissolution.

Molded tablets

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▪ are small, usually cylindrical, molded, or compressed tablets containing small amounts of usually potent drugs.

▪ must be readily and completely soluble in water, only a minimal amount of pressure is applied during their manufacture.

▪ A combination of sucrose and lactose is usually the diluent

Tablet triturates

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▪ Originally used by physicians in extemporaneous preparation of parenteral solutions. ▪ The required number of tablets was dissolved in a suitable vehicle and sterilized, and the injection was performed. ▪ The tablets were a convenience, because they can be carried by the physicians medicine bag and injections prepared to meet the needs of the individual patients. ▪ However it is difficult to achieve sterility and the availability of prefabricated injectable products,

Hypodermic tablet

▪ The use of this has ended. ▪ Because pharmacists used them to compose prescriptions, they might be better known as compounding pills. ▪ They were not given to patients directly. ▪ The tablets contain large amounts of highly potent drug substances, so the pharmacist could rapidly obtain premeasured amounts for compounding multiple dosage units. ▪ These tablets had the dangerous potential of being inadvertently dispensed as such to patients.

Dispensing tablets

▪ It is designed to disintegrate and release their medication with no special rate-controlling features, such as special coatings and other techniques

Immediate-release tablets

▪ Characterized by disintegrating or dissolving in the mouth within 1 minute, some within 10 seconds. ▪ Tablets of this type are designed for children and the elderly or for any patient who has difficulty in swallowing tablets. ▪ It liquefies on the tongue, and the patient swallows the liquid

Rapidly disintegrating or dissolving tablets.

▪Sometimes called CRT are designed to release their medication in a predetermined manner over an extended period

Extended-Release tablets

▪ Uncoated, bullet shaped, or ovoid tablets inserted into the vagina for local effects. ▪ They are prepared by compression and shaped to fit snugly on plastic inserter devices that accompany the product. ▪ They contain antibacterials for the treatment of nonspecific vaginitis caused by Haemophilus vaginalis or antifungals for the treatment of vulvovaginitis candidiasis caused by Candida albicans.

Vaginal tablets

▪ Also known as fillers or bulking agents. ▪ Used for making up of required bulk for a tablet ▪ Mostly used when dose of drug is too small to formulate as a tablet. If the dose is high, bulking agents are avoided. ▪ Properties of an ideal diluent: physiologically inert, non-toxic, physically and chemically stable, easily available, free from microbial contamination, and does not affect the bioavailability of drug.

DILUENTS

Examples of diluents:

▪ Example: Lactose, Spray dried lactose, Mannitol, Dextrose, Starch, Sorbitol, Sucrose, and Microcrystalline cellulose

▪Most widely used diluent ▪Available in hydrous and anhydrous form ▪Preferred because of pleasant taste ▪Readily dissolvable in water ▪Low cost and less disintegration time ▪Disadvantage: Undergo discoloration when in contact with amine drugs

Lactose

▪ Can be used for direct compression due to its **cohesive nature and good flow characteristics.** ▪ In presence of moisture, it may undergo darkening

Spray dried lactose

▪ Widely used as a diluent in chewable tablet ▪ Non-hygroscopic and non-carcinogenic ▪ Disadvantage: Expensive

Mannitol

▪Available in hydrous and anhydrous form ▪When **combined with spray dried lactose**, its darkening can be avoided

Dextrose

▪Very occasionally used as diluent ▪USP grade of this can be used due to its free flowing nature and direct compressibility

Starch

▪Suitable for direct compression

Sucrose

▪two main grades are available but they are expensive, so used in combination with other diluents.

Microcrystalline cellulose

- Adhesives ▪ When mixed with powders, they are used to produce granules ▪ Enhance the free flowing capacity of granules of desired size and hardness ▪ Selection of binders depends on the type of tablets ▪ For example: Lozenges requires more binders than tablets ▪ Gum acacia ▪ Tragacanth ▪ Starch paste ▪ Sucrose solution ▪ Polyvinylpyrolidine ▪ Gelatin Cellulose derivatives like HPMC and HEC

Binders

-used alone in a concentration of 10-25% or in combination

Gum acacia and tragacanth

-should be prepared fresh and added in warm condition to avoid solidification

Gelatin

-is prepared by dispensing starch into cold purified water, warming the mixture by continuous stirring until a translucent paste is formed.

Starch paste

-is used as a wet binder which is cheap, produces hard but brittle granules. Disadvantage: susceptible to microbial contamination

Sucrose solution

-used in aqueous or alcoholic solution and suitable for moisture sensitive drugs

PVP

-natural polymer as binder

Cellulose derivatives

▪They are intended to reduce the friction between the walls of the tablet and walls of the die cavity during the ejection of the tablet. ▪Concentration and time of mixing of it should be optimized. ▪If the concentration is more, mechanical strength of the tablet is reduced

Lubricants

▪ Act by inter-crossing the intermediate layer between the tablet material and the die cavity. ▪ Such lubricants are intended to act on tablet surface or on tablet coating surface, so added in the last stage before compression. ▪ Example: Calcium or magnesium stearate, light mineral oil, paraffins ▪ Optimum concentration: 1-4%

Insoluble lubricants

▪ Not effective as insoluble lubricant ▪ Example: Adipic acid, magnesium lauryl sulfate, sodium lauryl sulfate, Polyethylene glycol 4000, 6000, 8000

Soluble lubricants

▪Intended to break up a tablet to smaller pieces upon administration, when it comes in contact with the GI tract. ▪ is important for the further dissolution of the drug and attaining the drug bioavailability. ▪Example: Starch (mainly used since cheaper cost, ease of availability, and compatibility with drugs), Cellulose and cellulose derivatives ▪Optimum concentration-5-20%

Disintegrants

▪ Prevents sticking of the tablet material to the face of the punch or to the die cavity. ▪ All lubricants can be used except for water soluble lubricants. ▪ Example: Talc, magnesium stearate, colloidal silica

Anti-adhesives

▪ Used to facilitate or promote flow of granules from hopper to die cavity by reducing friction between particles. ▪ Example: Talc ▪ Optimum concentration: 4-5%

Glidants

▪Usually agents that can retain large quantities of liquid ▪Example: Anhydrous calcium phosphate, magnesium carbonate, kaolin

Adsorbants

▪Added to maintain the required pH ▪Example: sodium bicarbonate, sodium citrate

Buffers

▪Added to protect drug from oxidation ▪it undergoes oxidation instead of the drug ▪Example: ascorbic acid, sodium bisulphite

Antioxidants

▪Tend to form complexes with trace amount of heavy metal ions ▪Example: EDTA (ethylenediamine tetra-acetic acid);citric acid

Chelating Agents

▪Prevents the growth of microorganism that can lead to contamination ▪Example: parabens like methylparaben, propylparaben

Preservatives

▪Alter the molecular forces between the ingredients to enhance the dissolution process leading to faster therapeutic action ▪Example: Surfactants

Dissolution Enhancers

▪Incorporated into tablets that are intended for controlled or delayed release ▪Example: Waxy material like **stearic acid and their esters**

Dissolution Retardants

- is the process in which small powder particles adhere together by forming bonds between them, resulting in the formation of large aggregates called granules. ▪The bonds are formed either by compression or by using binding agents

Tablet granulation

is a dry process where in the powdered material is compressed directly into the tablets without the physical nature being modified.

Direct compression

▪To remove traces of loose powder adhering to tablets following compression, the tablets are conveyed directly from the tableting machine to a deduster. ▪The compressed tablets may then be coated.

Tablet dedusting

Problems encountered during direct compression:

-capping -cracking -lamination

Other tablet defects:

-chipping -sticking -picking -edging/flashing of tablet -mottling -double impression -blistering -flaking -blooming/dull film -blushing -cratering -color variation -pitting -twinning

include the top of the tablet breaking off, causing it to separate. ▪ This is related to air entrapment within the powder ▪ Caused by punches that are not immaculately clean and perfectly smooth or a granulation with too much fines or fine powder. ▪ Tablets that have aged or been stored improperly may exhibit splitting or other physical deformations.

Capping

have film cracks or splits throughout the tablet batch. ▪ Typically, **occurs when there are high internal stresses in the coating formulation.** ▪ To prevent tablet from this defect, use lower molecule weight polymers or blends and adjust the plasticizer type and concentration.

Cracking

happens when the product separates Into horizontal layers. ▪ It is very similar to capping, but occurs in the main body of the tablet, not at the top, and it can occur immediately after compression or during the storage period.

Lamination

is the breaking of tablet edges during the pressing process or during the subsequent handling and coating.

Chipping

is a defect of the tablet where the tablet surface sticks to the punch face or adhesion of tablet material to the die wall during compression. ▪ is the adherence of material to the faces of tablet press punches or dies after compression.

Sticking

is the term used when a small amount of material from a tablet is sticking to and being removed from the tablet surface by a punch. ▪In other words, the **removal of material from the surface of the tablet**, and its adherence to the face of the punch.

Picking

is a defect of tablets in which burrs (raised edges)/ sharp edges appear on the final compressed tablet. ▪This type of tablet defect also known as **collaring of the tablet**

Edging/Flashing of tablet

is the term used to describe an unequal distribution of color on a tablet, with light or dark spots standing out on an otherwise uniform surface. ▪This type of tablet defect occurs in tablet formulation with a dry coloring agent. ▪ is a tablet defect where dark and light patches on the tablet surface occur.

Mottling

is a machine related tablet defect where a monogram or engraving shape or break line/ score line or imprint or logo appears twice on the tablet surface.

Double impression

occurs when the **film coating becomes detached** from the substrate, forming a blister on the tablet. ▪ The most common cause is overheating during the air spraying process at the end of a run. ▪ You can mitigate by selecting milder, more appropriate drying conditions for your film-coated tablets.

Blistering

occurs when film coating flakes off, exposing the tablet surface. ▪ usually happens when an initial cracking issue isn’t resolved. ▪ To reduce, indefinitely, resolve any cracking problems by analyzing the internal stresses in the coating formulation. ▪ Then, adjust the spray rate with the drying temperature.

Flaking

▪It is a coating defect where the coating becomes dull immediately or after prolonged storage at high temperatures. ▪In other words, it is the fading of a coated tablet color after a prolonged period of storage at a high temperature.

Blooming/Dull film

▪It is a coating defect where whitish specks or haziness in the film appear. ▪In other words, it is a haziness or appearance of white specks in the film-coated tablet.

Blushing

▪It is a coating defect of the film where volcanic-like craters appear on the tablet surface. ▪In other words, it is a defect in the film’s coating that results in craters appearing on the tablet which in turn results in the exposure of the tablet’s surface.

Cratering

is a coating defect where visible differences in color of film are found from tablet to tablet.

Color variation

▪It is a coating defect where pits appear on the surface of a tablet core without any visible disruption of the film coating. ▪In other words, it is the **deformation of the core of the tablet without any visible signs of disruption** of the film coating.

Pitting

▪It is a coating defect where tablets stick together especially when two tablets stick together.

Twinning

___________________ is the **most conventional, versatile, and widely used** techniques for the manufacture of compressed tablets. ▪This technique involves the usage of liquid to form compact masses.

Wet or moist granulation

is used to form granules without using a liquid solution because the product to be granulated may be sensitive to moisture and heat

Dry or double compression

The techniques of dry granulation of powdered material can be accomplished by 2 methods:

-Slugging -Roller Compaction method

-formation of extra large tablets first then broken into granules which are again recompressed. Example: Aspirin

▪Slugging

-achieved by feeding powder through a set of directly opposed counter rotating rollers

Roller compaction method

-holds and feed granules to be compressed

Hopper

-define size and shape of tablet

Dies

-compresses granules within the dies

Punches

-guides the movement of punches

Cam tracts

-moving mechanism of the granules from the hopper to the dies

Feeding mechanism

▪ Also called as **eccentric press** ▪ Ideal for **small scale productions** ▪ This tablet press **include a die and a pair of upper and lower punch along with the basic components** ▪ The machine has 2 more components ▪ Capacity regulator-adjust lower punch to allow the required quantity of granules by the die ▪ Ejection regulator-facilitates ejection of tablet from die cavity after compression

Single Punch Tablet Machine

___________________________________ are termed as “rotary” because the head that holds the die, upper and lower punches in place rotates. ▪ As the head rotates, the punches are guided up and down by fixed cam tracts ▪ The portion of the head that holds the upper punches are called upper turrets, and the portion that hold the lower punches are called lower turrets ▪ The portion holding the dies are called die table. ▪ Along with the basic components, additional components are

Multistation rotary presses

-facilitates ejection of tablet from die

Ejection cam

-helps to push tablet to a discharge chute, which is collected in a container

Take off blades

Multi Station Rotary Process has an output of ___________

1,200 tablets per minute

Single punch station has an output of ______________

200 tablets per minute

▪ A machine where, **two rotary machines work simultaneously**, therefore core tablet is prepared in one machine, and then transferred to another machine for compress coating ▪ Preferred for **multi-compressed, multi-colored, and press coated tablets** ▪ Allow manufacture to manufacture a wide variety of tablet shapes

Dry Cota Tablet Machine

-they serve as the principal defense against the stomach's severe circumstances. ▪ Enteric coating commonly employs cellulose acetate phthalate (CAP), hydroxypropyl methylcellulose phthalate (HPMCP), and polyvinyl acetate phthalate (PVAP). ▪ These were developed specifically to tolerate the acidic environment of the stomach and dissolve in the alkaline environment of the small intestine.

Polymers

▪ Use to increase the polymer's flexibility and adherence ▪ They aid in the adhesion of the coating to the tablet's surface and its integrity during the manufacturing process. ▪ Example: triethyl citrate, dibutyl sebacate, and diethyl phthalate

Plasticizers

-items to be coated are fed into a vertical cylinder and are supported by a column of air that enters from the bottom of the cylinder.

Wurster process

-coating solution is sprayed downward onto the particles to be coated as they are suspended by air from below

Top spray method

▪ This process is slightly different from the other two fluid bed processes in the sense that • Nozzle is positioned on the side of product container • It has a spinning, variable disc

Tangential spray method

- Provides immediate relief as the drug starts being absorbed in the mouth and start to work within minutes but its effect last for 15 minutes ▪ Example: **Fentanyl actiq**-for the management of breakthrough cancer pain ▪ Concern: accidentally used by children

Lollipops

▪ Small, solid particles of uniform shape sometimes called beads ▪ They can be used to provide physical separation for chemically or physically incompatible materials, extended release of an active pharmaceutical ingredient (API), or delayed release to protect an acid labile API from degradation in the stomach or to protect stomach tissues from irritation. ▪dosage forms can be formulated as single or multiple entities.

Pellets

▪Large, elongated tablets intended for administration to large animals

Bolus Tablets

▪ By definition, _________ are small, round solid dosage forms containing a medicinal agent and intended to be administered orally. ▪ The medicaments are mixed with excipients to form a firm plastic mass ▪ are spherical in shape and produced by rolling them under wooden rounder

Pills

▪ Take with a glass of water ▪ Explain whether to chew, crush or swallow whole ▪ Discuss the frequency and onset of action ▪ Explain what to do if a dose is missed ▪ Store in the least humid environment available at room temperature

Tablets

▪ Chew the tablet thoroughly before swallowing ▪ Swallow all the contents and saliva to get the full dose ▪ Confirm the frequency and timing of use ▪ Store in the least humid environment available at room temperature

Chewable tablets

▪ Tablet should be placed under the tongue. ▪ Do not chew or swallow the tablet ▪ Allow to dissolve and remain in the mouth for a time to be absorbed ▪ Avoid drinking or eating for several minutes until the drug has been absorbed ▪ Confirm the frequency and timing of use ▪ Store in the least humid environment available at room temperature

Sublingual tablets

▪ Tablet should be placed between the cheek and the gum ▪ Do not chew or swallow the tablet ▪ Allow time to dissolve or for the drug to be released ▪ Confirm if the tablet should be removed or it will dissolve and erode away ▪ Rotate the site of application to minimize irritation ▪ Confirm the frequency and timing of use ▪ Store in the least humid environment available at room temperature

Buccal tablets

▪ Open the single dose/ use container with dry hands by peeling back the foil layer. Do not push the tablet through the foil as it may be fragile and crush ▪ Remove the tablet from the blister and place in the mouth ▪ The tablet will disintegrate quickly in the saliva so it can be easily swallowed without drinking a liquid. ▪ Store in the least humid environment available at room temperature

Orally disintegrating tablets

designed to provide a slow, continuous release of drug over a prolonged period of time and should not be chewed but allowed to slowly dissolve ▪ Store in the least humid environment available at room temperature

Hard lozenges

▪ They should be taken only as directed and should not be considered a candy. Keep out of reach of children ▪ Store in the least humid environment available at room temperature

Soft and Chewable Lozenges

is a substance we use in tablet and capsule formulations in order to reduce the friction.

Lubricant

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