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PC IV > TABLETS > Flashcards

TABLETS Flashcards

1
Q

What are Tablets?

A

1) Solid dosage forms containing medicinal substances prepared with the aid of suitable excipients
2) May vary in characteristics based on intended use and method of manufacture

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2
Q

advantages of tablets

A

1) Accurate dosage/minimum variability
2) Absence of alcohol
3) Concentration variability
4) Elegance
5) Patient acceptance
6) Convenience (light and compact)
7) Tamper resistant
8) Low cost
9) Easiest/cheapest to package and ship
10) Production identification
11) Ease of administration
12) Special release profiles possible
13) Suited for large-scale production

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3
Q

Tablet Disadvantages

A

1) Difficult to extemporaneously prepare
2) Difficult for some patients to swallow
3) Some drugs resist compression
4) Difficulty to formulate some agents - poorly wetting drugs, slow-dissolving drugs, intermediate to large dosages

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4
Q

Types of Tablets

A 
Compressed
Multiple Compressed 
Sugar-coated
Film-coated
Gelatin-Coated
Enteric-Coated
Buccal and Sublingual
Chewable
Effervescent
Molded/Triturates
Immediate Release
Rapidly Disintegrating or Dissolving
Extended Release
Vaginal Tablets
Hypodermic
Dispensing
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5
Q

Multiple Compressed Tablets (Layered tablets)

A

1) Prepared by subjecting the powder blend to multiple compression operations
2) The result may be a multiple-layer tablet or a tablet within a tablet, the inner tablet being the core and the outer portion being the shell

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6
Q

What are Sugar-Coated Tablets ?

Disadvantage?

A

1) Water soluble sugar coating that dissolves quickly after swallowing
2) Protects drug from environment and masks objectionable tastes or odors
3) Disadvantages: increases the weight and size of tablet

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7
Q

What are Film-Coated Tablets? What are features?

A

1) compressed tablets coated with a thin layer of a polymer capable of forming a skin-like film
2) usually colored and usually more durable, less bulky, and easier to apply than sugar-coat
3) Ruptures and exposes content at desired location in the GIT

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8
Q

Gelatin-Coated Tablets

A

1) gelcap: is a capsule-shaped compressed tablet that allows the coated product to be about one-third smaller than a capsule filled with an equivalent amount of powder
2) Gelatin coating facilitates swallowing
3) more tamper evident than unsealed capsules

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9
Q

Enteric-Coated Tablets

A

1) Delayed-release properties
2) Designed to pass unchanged through the stomach to the intestines
3) Useful when the drug substance is destroyed by gastric acid or is particularly irritating to the gastric mucosa or when bypass of the stomach substantially enhances drug absorption

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10
Q

Buccal and Sublingual Tablets

A

1) Buccal – tabletsintended to erode slowly in the buccal pouch
2) Sublingual – tablets intended to dissolve quickly under the tongue
3) Enhance oral absorption of drugs destroyed by gastric fluids and/or poorly absorbed from the GIT
4) Lozenges

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11
Q

Chewable Tablets

A

1) rapid disintegration when chewed or allowed to dissolve in the mouth
2) have a creamy base, usually of specially flavored and colored mannitol
3) useful for administration of large tablets to children and adults who have difficulty swallowing solid dosage forms

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12
Q

Effervescent Tablets

A

1) Prepared by compression of granular effervescent salts that release gas when in contact with water.
2) bubble action” can assist in breaking up the tablets and enhancing the dissolution of the active drug

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13
Q

Molded Tablets/Tablet Triturates

A

1) Molded – Softsoluble tablets designed for rapid dissolution that are prepared by molding instead of compression
2) Tablet triturates – small, usually cylindrical, molded, or compressed tablets containing small amounts of usually potent drugs ( minimal amount of pressure is applied)

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14
Q

Immediate-Release Tablets

A

Disintegrate and release the active ingredient with no special rate-controlling features, such as special coatings and other techniques

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15
Q

What are Rapidly Disintegrating or Dissolving Tablets ( Rapid release tablets) and disadvantage?

A

1) Disintegrated or dissolve to release active ingredient in the mouth rapidly – within 1 minute
2) Might be prepared using lyophilization or direct compression
3) Water-soluble excipients wick water into the tablet for rapid disintegration or dissolution
4) Disadvantages: drug loading, taste masking, friability, manufacturing costs, and stability of the product
5) Making it more firm and less friable may increase dissolution time. A balance generally must be achieved between friability and the speed of dissolution.

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16
Q

Extended-Release Tablets

A

1) Release the active ingredient in a predetermined manner over an extended period
2) Also called controlled-release

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17
Q

Vaginal Tablets

A

1) Uncoated, bullet-shaped, or ovoid tablets inserted into the vagina for local effects
2) Prepared by compression and shaped to fit snugly on plastic inserter devices that accompany the product
3) Also called vaginal inserts

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18
Q

Hypodermic and Dispensing Tablets

A

1) No longer in use in the US
2) Hypodermic tablets were used in the extemporaneous preparation of parenteral solutions
3) Dispensing tablets ( compounding tablets) contained large amounts of highly potent substances that the pharmacist could quickly obtain premeasured amounts for compounding

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19
Q

Compressed Tablets

A

1) Solid dosage forms prepared with suitable excipients and tablet machines capable of exerting great pressure in compacting the powdered or granulated material
2) Tablet diameters and shapes are determined by the die and punches used in compression

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20
Q

Diluents or Fillers

A

Add the necessary bulk to a formulation to prepare tablets of the desired size

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21
Q

Diluents or Fillers examples

A 
Dibasic calcium phosphate
Lactose
Sucrose
Mannitol
Microcrystalline cellulose
Powdered cellulose
Starch
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22
Q

Binders or Adhesives

A

Promote adhesion of the particles

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23
Q

Binders or Adhesives examples

A

Acacia, Alginic acid, Carboxymethylcellulose, Gelatin, Liquid glucose
Methylcellulose, hydroxy methylcellulose, Povidone
Pregelatinized starch

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24
Q

Disintegrants

A

swell or expand on exposure to moisture
effect the rupture or breakup of the tablet in the gastrointestinal tract
Promote breakup of tablets after administration to smaller pieces for ready drug availability

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25
Q

Disintegrants examples

A

Microcrystalline cellulose
Sodium starch glycolate
Starch

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26
Q

Glidants

A

Improve powder flow

Colloidal silica, Cornstarch, Talc

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27
Q

Lubricants/Antiadherents

A

1) Reduce friction to punch/die during tablet compression and facilitate tablet ejection
2) Prevent tablet components from sticking to machinery during production
3) Reduce punch/die wear
4) Improve powder flow properties

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28
Q

Lubricants/Antiadherents examples

A 
Calcium stearate 
Magnesium stearate
Stearic acid
Zinc stearate
Talc
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29
Q

Preparation of Compressed Tablets

A

Wet Granulation
Dry Granulation
Direct Compression

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30
Q

Wet Granulation

A

Components mixed with granulating fluid, dried and milled to produce granules with good flow and compression properties

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31
Q

Steps in Wet Granulation Process

A

1) Powders dry blended
2) Blended material wetted with a binder solution
3) Wet milling (optional)
4) Granulation dried
5) Dried granulation milled to size
4) Granules blended with remaining excipients
5) Tablet blend compressed

32
Q

Key Variables For Wet Granulation Processes

A

1) Amount of Binder: Increase binder, increased granule density
2) Method of Binder Addition: Fine spray applied uniformly over moving bed to avoid over-wetting areas
3) Granulating (Wet Massing) Time:
Increase time, increases granule density
If too much, paste formation could result

33
Q

Dry Granulation

A

Powder blend is compacted into large slugs or compacts and subsequently broken down into granules

34
Q

Steps Involved in Dry Granulation Process

A

1) Milling and mixing of active ingredient and excipients
2) Compression into slugs or roll compaction
3) Milling and screening of slugs and compacted powder
4) Mixing with lubricant and disintegrant
5) Compression

35
Q

Direct Compression

A

Compression without the need for granulation

36
Q

Steps Involved in Direct Compression

A

1) Milling and mixing of active ingredient and excipients

2) Compression

37
Q

Precompression Force

A

1) Small amount of force applied to material to remove entrapped air, forming a loose compact
2) Decreases the chance of lamination and capping
3) Weight adjustment often performed at precompression stage by measuring punch displacement

38
Q

Main Compression Force

A

1) Larger amount of force applied to material, bonding particles together to form the tablet

39
Q

Main Compression Force: Compression profiles

A

performed to determine the effect of increasing force on the physical properties of the tablets

40
Q

Main Compression Force: Over-Compression

A

excessive force applied resulting in reduced hardness, lamination and capping

41
Q

As Compression Force Increases

A 
Thickness decreases
Hardness increases
Friability decreases
Disintegration time increases
Dissolution rate decreases
Tablet density increases
42
Q

Tablet Press Speed

A

The time that the die is under the feedframe varies with press speed: Affects die fill, Increase feeder paddle speed or fill depth as press speed increases

43
Q

Tablet Press Speed: Dwell time

A

Press speed affects dwell time: Duration that the force is applied to material, short dwell times lead to capping/lamination

44
Q

As Tablet Press Speed Increases

A

1) Weight variability may increase (especially for poor flowing blends)
2) Dwell time decreases, which could exacerbate lamination and capping
3) Results in decreased hardness and increased friability

45
Q

Tablet Coating benefits

A

1) Protect medicinal agent against destructive exposure to air and/or humidity
2) Mask the taste of the drug
3) Provide special characteristics of drug release
4) Provide aesthetics or distinction to the product

46
Q

Sugar Coating

A

Multi-step process, usually adds significant size and weight to finished tablets

47
Q

Film Coating

A

Places a thin plastic-like material over the compressed tablet, more resistant to destruction than sugar-coated tablets, Aqueous or nonaqueous film coating solutions

48
Q

Enteric Coating

A

Intended to pass intact through the stomach to disintegrate and release drug content for absorption along the intestines, design may be based on transit time or pH

49
Q

Enteric Coating examples

A

pharmaceutical shellac, hydroxypropyl methylcellulose phthalate, polyvinyl acetate phthalate, diethyl phthalate, cellulose acetate phthalate

50
Q

Fluid Bed Coating

A

Spray coating of powders, granules, beads, pellets, or tablets suspended by a column of air

51
Q

Compression Coating

A

1) Similar to multiple compressed tablets
2) core tablets may be sugarcoated by compression
3) Can minimize contact area between two incompatible drugs
4) Can encase moisture sensitive substances

52
Q

evaluation of tablets: Tablet Weight and USP Weight Variation

A

1) Weigh 10 uncoated tablets individually
2) calculate an average weight
3) The tablets are assayed
4) contents of active ingredient in each of the 10 tablets is calculated

53
Q

Content Uniformity

A

USP method –10 units are individually assayed for their content

54
Q

Content Uniformity: requirement

A

met if amount of active is between 85% and 115% of the label claim and the RSD<6%

55
Q

Tablet Thickness measured how?

A

Thickness of 5-10 tablets measured using a thickness gauge at defined intervals throughout the run

56
Q

Indicative of tablet hardness and weight

A

Thin tablets: May imply hard or light tablets

Thick tablets: May imply soft or heavy tablets

57
Q

Specification of tablet thickness should be based on

A

the desired tablet hardness and disintegration times

58
Q

what is important specification for packaging operation?

A

tablet thickness

59
Q

How is hardness measured?

A

Hardness of 5-10 tablets measured using a hardness tester throughout compression run

60
Q

Increased variability in hardness may imply ?

A

weight variability or variable punch length

61
Q

As hardness increases,

A

Disintegration time increases
Dissolution rate decreases
Friability decreases

62
Q

Decreasing press speed can do what to hardness?

A

increase hardness

63
Q

Friability

A

Indicator of how well tablets will hold up during coating, packaging, or shipping

64
Q

Friability process

A

1) Typically, 6 g of tablets (or at least 20 tablets) Tablets put in friabilator and tumbled for 4 minutes at 25 RPM
2) Tablets removed from friabilator, dedusted and reweighed
3) Percentage of weight loss is calculated; maximum weight loss of not more than 1% is generally acceptable for most products

65
Q

Tablet Disintegration

A

Tablet must first disintegrate and discharge the drug to the body fluids for dissolution in order for the medicinal agent to become fully available for absorption

66
Q

Tablet Disintegration important for what?

A

tablets containing medicinal agents that are intended to act locally within the gastrointestinal tract

67
Q

how is enteric coated Tablet Disintegration tested?

A

Enteric-coated tablets tested in simulated gastric fluid, then simulated intestinal fluid

68
Q

Tablet disintegration advantages?

A

1) Indicator of potential dissolution problems

2) Release test for some old products that might lack dissolution test protocols

69
Q

Disintegration Testing process

A

1) Basket and rack assembly
2) 6 open-ended transparent tubes with 10 mesh screen on bottom
3) Basket raised and lowered at 29 to 32 cycles/min
4) Discs may be used for tablets that float

70
Q

Dissolution Testing

advantages

A

1) Provides a prediction of or correlation with the drug product’s in vivo bioavailability
2) Helps in formulation and product development
3) Monitoring manufacturing process
4) Assessing batch-to-batch bioequivalence
5) Regulatory requirements

71
Q

Dissolution Testing process

A

1) Seven different apparatus designs
2) Dissolution media placed in vessel and allowed to come to 37°C ± 0.5°C
3) Stirrer is rotated at specified speed and samples of the media are withdrawn and analyzed at stated intervals

72
Q

Processing Factors That Can Affect Dissolution

A 
1) Milling Conditions
Drug substance and granulation
2) Granulation Process
Amount of binder, wet massing time, shear
3) Lubrication Time
4) Compression Parameters
Compression forces and press speed
73
Q

Biopharmaceutics Classification System goal

A

to provide a reasonable prediction of or correlation with the product’s in vivo bio availability
relates combination of a drug’s solubility and its intestinal permeability as a possible basis for predicting the likelihood of achieving a successful in vivo-in vitro correlation

74
Q

Biopharmaceutics Classification System process

A

The system relates combinations of a drug’s solubility and its intestinal permeability as a possible basis for predicting the likelihood of achieving a successful in vivo–in vitro correlation

75
Q

Chewable Tablets

A

formulated to disintegrate smoothly in the mouth with or without chewing

prepared by wet granulation and compression, using only minimal degrees of pressure to produce a soft tablet

Generally, chewable tablets do not contain disintegrants,

PC IV (4 decks)

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