Tablets

Question 1

Tablet

Answer 1

solid dosage form usually prepared with the aid of suitable pharmaceutical excipients
-May vary in size, shape, weight, hardness, thickness, disintegration, dissolution and in other aspects

Question 2

How are tablets manufactured?

Answer 2

• Tablets are prepared by compression and some by molding
• Molded tablets are prepared on a large scale by tablet machinery or on a small scale by manually forcing dampened powder material into a mold from which the formed tablet is then ejected allowed to dry

Question 3

Scored or grooved tablets

Answer 3

• Allows tablets to be easily broken into two or more parts; this enables the patient to swallow smaller portions
• It also allows the tablet to be taken in reduced or divide dosage

Question 4

Some are not scored bc

Answer 4

certain drugs have special coatings and/or drug features that would be compromised by altering the tablets the tablets physical integrity

Question 5

Compressed tablets

Answer 5

may include: 
Diluents
Binders or adhesives
Disintegrants or disintegrating agents
Glidants, lubricants or lubricating agents

Question 6

Multiple compressed

Answer 6

prepared by subjecting the fill material to more than a single compression which can result in a multiple layer tablet or a tablet within a tablet. Inner tablet being the core and the outer component the shell

• each layer may contain a different medicinal agent

Question 7

Sugar coated tablets

Answer 7

Compressed tablets may be coated with a colored or uncolored sugar layer

• Coating is water-soluble and quickly dissolves after swallowing
• Coating: Protects enclosed drug from environment (humidity) and improves taste/odor
• Enhances appearance and permits imprinting of manufacturers info
• Coating is usually thick, increase in size, weight and shipping cost
• May add 50% to weight and bulk

Question 8

Film coated tablets

Answer 8

Coated with a thin layer of a polymer capable of forming a skin-film

• May be water-soluble or water-insoluble (aqueous or non-aqueous)
• More durable, less bulky and less time consuming to apply compared to sugar coating
• Provide taste masking
• Improve stability of the drug
• Designed to rupture and expose core tablet at desired location in the GI tract

Question 9

Gelatin coated tablets

Answer 9

• Capsule-shaped compressed tablet
• Coated product is about 1/3 smaller than a capsule filled with = amount of powder
• coating facilitates swallowing and is tamper evident

Question 10

Enteric coated tablets

Answer 10

Has delayed released features

• Designed to pass through the stomach to the intestines without damage
• Used when drug is destroyed by acid or can irritate gastric mucosa
• pKa is 4.5-7.5
• Based on pH
• Some are designed to dissolve at pH 4.8 and greater
• Coating may be aqueous or nonaqueous

Question 11

Buccal and sublingual tablets

Answer 11

• Flat, oval tablets
• intended to be dissolved in the buccal pouch or beneath tongue for absorption through the oral mucosa
• bypasses stomach acid destruction
• includes lozenges

Question 12

Buccal tablets

Answer 12

• Designed to dissolve/erode slowly
• Bypasses the digestive tract
• Gives prolonged release of medication

Question 13

Sublingual tablets

Answer 13

dissolve quickly and active ingredient rapidly absorbed

- provides rapid drug effects

Question 14

Chewable tablets

Answer 14

Smooth, rapid disintegration when chewed or allowed to dissolve in the mouth, have a creamy base, usually of specially flavored and colored mannitol
- Useful for children and adults with trouble swallowing solid dosage forms

Question 15

Effervescent tablets

Answer 15

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

• Generally contain medicinal substances that dissolve rapidly when added to water
• “Bubble action” can assist in breaking up the tablets and enhancing the dissolution of the active drug

Question 16

Molded tablets

Answer 16

Can be made from tablet triturates prepared by molding rather than by compression
- the resultant tablet is very soft and soluble and are designed for rapid dissolution

Question 17

Tablet triturates

Answer 17

Small, usually cylindrical, molded, or compressed tablets containing small amounts of usually potent drugs

• must be readily and completely soluble in water
• combination of sucrose and lactose is usually the diluent

Question 18

Hypodermic tablets

Answer 18

No longer available in US(contamination issues)
- Originally were used by physicians in extemporaneous preparation of parenteral solutions
Tablets were dissolved in solution and injected

Question 19

Dispensing tablets

Answer 19

Tablets That Are No Longer in use

• Used By Pharmacists to Compound Prescriptions
• Contained large amounts of Potent Drug
• Had dangerous potential of being inadvertently dispensed to patients

Question 20

Immediate release

Answer 20

Designed to disintegrate and release medication with no special rate-controlling features, such as special coating and other techniques

Question 21

Rapidly Disintegrating or Dissolving Tablets

Answer 21

Characterized by disintegrating or dissolving in the mouth within 1 minute, some within 10 seconds

• For children and elderly who has difficulty swallowing tablets
• Liquify on the tongue and then liquid is swallowed

Question 22

Lyophilized foam

Answer 22

Prepared by foaming a mixture of gelatin, sugar or sugars, drug and any other components and by pouring the foam into a mold
The foam is lipophilized and the tablets in the mold packaged

Question 23

Extended release tablets

Answer 23

designed to release their medication in a predetermined manner over an extended period

Question 24

Vaginal tablets

Answer 24

• also called inserts, are uncoated, bullet shaped or ovoid tablets inserted for local effects
• used for antibacterial or anti-fungal applications

Question 25

The less concave the punches,

Answer 25

the flatter the tablets and vice versa

Question 26

Controlled factors of compressed tablets

Answer 26

weight, weight variation, content uniformity, thickness, hardness, disintegration and dissolution

Question 27

USP Weight Variation Test

Answer 27

10 tablets are weighed individually and the average is calculated, the tablets are assayed and the content of active ingredient in each tablet is calculated assuming homogenous drug distribution

Question 28

Content Uniformity requirement

Answer 28

Amount of active ingredient in each dosage form range of 85% to 115% of the label claim and the SD is less than 6% - If one or more dosage forms do not meet these criteria, additional tests are prescribed

Question 29

Tablet thickness

Answer 29

- Determines by the diameter of the die, the amount of fill permitted in the die - May be measured by hand gauge during production or by automated equipment

Question 30

Tablet hardness requirement

Answer 30

4 kg of force is the minimum requirement for satisfactory tablet - The greater the pressure applied, the harder the tablets - Tablets intended to dissolve slowly are intentionally made harder, while those for immediate release are made soft

Question 31

Friabilater

Answer 31

- determines the tablets friability, or tendency to crumble - tablets are weighed before and after and any weight loss is determine - A max weight loss of not more than 1 %

Question 32

Tablet disintegration test

Answer 32

- Conducted in vitro using a testing apparatus that consists of a basket and a rack assembly containing six-open-ended transparent tubes - Tablets must disintegrate within the times set forth in the individual monograph, usually 30 minutes, but can vary from 2 minutes to 4 hours, depending on the specific tablet

Question 33

Enteric coated tablet disintegration

Answer 33

Enteric coated tablets are tested in simulated gastric fluid for 1 hr - After no sign of disintegration, cracking or softening must be seen - Then, they are actively immersed in the simulated intestinal fluid for the time stated in the monograph

Question 34

Tablet in vitro dissolution

Answer 34

Equipment consists of a. Variable speed stirrer motor b. Cylindrical stainless steel basket on a stirrer shaft or a paddle as the stirring element c. 1,000 mL vessel of glass or other inert temperature material fitted with a cover having a center port for the shaft of the stirrer and three additional ports, two for removal and one for a thermometer d. Water bath to maintain temperature of the dissolution medium in the vessel

Question 35

For USP Apparatus 1, the dosage unit is placed where?

Answer 35

In the basket

Question 36

For USP Apparatus 2, the dosage unit is placed where?

Answer 36

In the vessel

Question 37

The tablet or capsule must meet the stated monograph requirement for rate of dissolution which is

Answer 37

not less than 85% of the labeled amount is dissolved in 30 minutes

Question 38

Wet granulation method

Answer 38

Most widely used 1. weighing and blending ingredients 2. Preparing a dampened powder or damp mass 3. Screening the dampened powder or damp mass into pellets or granules 4. Drying the granulation 5. Sizing the granulation by dry screening 6. Adding lubricant and blending 7. Forming tablets by compression

Question 39

Dry granulation method

Answer 39

- Powder mixture is compacted in large pieces and subsequently broken down or sized into granules - Either the active ingredient or the diluent must have cohesive properties - Especially applicable to materials that cannot be prepared by wet granulation because they degrade in moisture

Question 40

slugging (dry gran method)

Answer 40

after weighing and mixing, the powder mix is slugged or compressed into large flat tablets or pellets about 1 inch in diameter • slugs are broken up by hand or mill and passed through a screen mesh for sizing lubricant is added and then made into tablets by compression

Question 41

Roller compression (dry granulation method)

Answer 41

powder compactors may be used to increase the density of a powder by pressing it between rollers at 1-6 tons of pressure, the compacted material is broken up, sized, and made into tablets

Question 42

Direct compression method

Answer 42

Some granular chemicals, like potassium chloride, possess free-flowing and cohesive properties that enable them to be compressed directly in a tablet machine without any granulation - 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 can then be coated

Question 43

Why are tablets coated?

Answer 43

protect the medicinal agent, mask taste, provide special characteristics of drug release, provide aesthetics or distinction to product, can protect individuals from drug if harmful to special populations

Question 44

Compression coating

Answer 44

Core tablets may be sugarcoated with compression - more uniform and uses less material than sugarcoating using pans, results in tablets that are lighter, smaller, and easier to swallow and less expensive to pack and ship

Question 45

Steps of sugarcoating

Answer 45

1. Waterproofing and sealing if needed 2. Subcoating 3. Smoothing and final rounding 4. Finishing and coloring if desired 5. Must be imprinted per FDA mandate 6. Polishing

Question 46

Film coating tablets contain

Answer 46

1. Film-forming polymer 2. Plasticizer 3. Colorant and opacifier 4. Vehicle (water, to make 100% - Favor the use of aqueous solutions however, they evaporate slowly

Question 47

Packaging and storing tablets

Answer 47

Stored in tight containers, in place of low humidity, and protected from extreme temps - Product prone to disintegration by moisture generally are packed w a desiccant packet - Drugs adversely affected by light are packaged in light-resistant containers - W few exceptions, tablets that are properly stored will remain stable for several years or more

Question 48

Pellets

Answer 48

Dosage form composed of small, solid particles of uniform shape sometimes called beads; may be administered orally or parenterally

Question 49

Bolus tablets

Answer 49

Large, usually elongated tablets intended for administered to large animals

Question 50

Pills

Answer 50

Small, round solid dosage forms containing medicinal agent and intended to be administered orally