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PHRM 513 > Tablets > Flashcards

Tablets Flashcards

1
Q

Tablet

A

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

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2
Q

How are tablets manufactured?

A
  • 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
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3
Q

Scored or grooved tablets

A
  • 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
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4
Q

Some are not scored bc

A

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

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5
Q

Compressed tablets

A 
may include: 
Diluents
Binders or adhesives
Disintegrants or disintegrating agents
Glidants, lubricants or lubricating agents
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6
Q

Multiple compressed

A

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
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7
Q

Sugar coated tablets

A

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
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8
Q

Film coated tablets

A

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
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9
Q

Gelatin coated tablets

A
  • 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
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10
Q

Enteric coated tablets

A

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
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11
Q

Buccal and sublingual tablets

A
  • 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
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12
Q

Buccal tablets

A
  • Designed to dissolve/erode slowly
  • Bypasses the digestive tract
  • Gives prolonged release of medication
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13
Q

Sublingual tablets

A

dissolve quickly and active ingredient rapidly absorbed

- provides rapid drug effects

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14
Q

Chewable tablets

A

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

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15
Q

Effervescent tablets

A

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
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16
Q

Molded tablets

A

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

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17
Q

Tablet triturates

A

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
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18
Q

Hypodermic tablets

A

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

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19
Q

Dispensing tablets

A

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
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20
Q

Immediate release

A

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

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21
Q

Rapidly Disintegrating or Dissolving Tablets

A

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
22
Q

Lyophilized foam

A

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

23
Q

Extended release tablets

A

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

24
Q

Vaginal tablets

A
  • also called inserts, are uncoated, bullet shaped or ovoid tablets inserted for local effects
  • used for antibacterial or anti-fungal applications
25
Q

The less concave the punches,

A

the flatter the tablets and vice versa

26
Q

Controlled factors of compressed tablets

A

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

27
Q

USP Weight Variation Test

A

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

28
Q

Content Uniformity requirement

A

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

29
Q

Tablet thickness

A
  • 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
30
Q

Tablet hardness requirement

A

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
31
Q

Friabilater

A
  • 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 %
32
Q

Tablet disintegration test

A
  • 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
33
Q

Enteric coated tablet disintegration

A

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
34
Q

Tablet in vitro dissolution

A

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

35
Q

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

A

In the basket

36
Q

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

A

In the vessel

37
Q

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

A

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

38
Q

Wet granulation method

A

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
39
Q

Dry granulation method

A
  • 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
40
Q

slugging (dry gran method)

A

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

41
Q

Roller compression (dry granulation method)

A

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

42
Q

Direct compression method

A

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

43
Q

Why are tablets coated?

A

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

44
Q

Compression coating

A

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

45
Q

Steps of sugarcoating

A
  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
46
Q

Film coating tablets contain

A
  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
47
Q

Packaging and storing tablets

A

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
48
Q

Pellets

A

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

49
Q

Bolus tablets

A

Large, usually elongated tablets intended for administered to large animals

50
Q

Pills

A

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

PHRM 513 (13 decks)

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