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PHRM 100 – PDD > PDD 09: Solid Oral Dosage Forms – Tableting > Flashcards

PDD 09: Solid Oral Dosage Forms – Tableting Flashcards

1
Q

How are tablets formed?

A

by applying a force to a powder between two die punches

  • during this process, compression and consolidation occur
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2
Q

What is compression?

A

reduction powder volume by gas displacement from the powder blend

  • reversible, non-destructive
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3
Q

What is consolidation?

A

increasing the mechanical strength of the tablet due to interaction between particles during compression

  • destructive
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4
Q

What is the predominant factor for tablet strength?

A

increased particle-particle interaction due to van der Waals forces

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5
Q

What are the two types of tablet presses for tablet production?

A
  • single-punch press (eccentric press)
  • rotary press (multistation press)
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6
Q

What is a single-punch press (eccentric press)?

A
  • one die and one pair of punches
  • output is up to 200 tablets per minute
  • force is applied from upper punch only
  • primary use is in the production of small batches of tablets in R&D stage (formulation development or clinical trials)
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7
Q

Single-Punch Press (Eccentric Press)

What are the stages of tableting? (3)

A
  1. die filling
  • powder flows into the die from the feeder by gravity
  • the bottom of the die is closed off by the lower punch
  1. tablet formation
  • the upper punch enters the die and compresses the powder blend until the tablet is formed
  • after maximum force application, the upper punch leaves the die
  1. tablet ejection
  • tablet is ejected from the die
  • the lower punch rises to push the tablet out of the die
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8
Q

Why is flowability of powders in solid drug formulations so important?

A

–

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9
Q

What is a rotary press (multistation press)?

A
  • primary use is for scale-up and for large-scale production
  • possesses a number of dies and sets of punches
  • output of over 10,000 tablets per minute
  • force is applied from upper AND lower punch
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10
Q

Rotary Press (Multistation Press)

What are the stages of tablet formation? (4)

A
  1. compression
  • upper punch enters die and gas is displaced
  1. consolidation
  • particle/particle interactions occur
  1. decompression
  • tablet ‘relaxes’ as upper punch leaves die
  • tablet expands axially during this process
  • if bonding between particles is not
    strong enough, the tablet will laminate
  1. ejection
  • tablet undergoes radial expansion
  • if lamination occurs, it will occur around the upper edge of the tablet – this is called capping
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11
Q

Tablet Defects

When can lamination and capping occur?

A

if particles are not compressed enough or if air is entrapped in powder bed during compression

  • force transmission is not uniform throughout powder bed
  • reduce compression speed
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12
Q

Tablet Defects

What can lead to lamination?

A

low density zones

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13
Q

Tablet Defects

What can lead to capping?

A

high density zones

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14
Q

Tablet Defects

What are flowability defects?

A
  • weight and dose variation
  • powder sticking
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15
Q

Tablet Defects

What are compactability defects?

A
  • low mechanical strength
  • lamination and capping
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16
Q

Tablet Defects

What are friction and adhesion properties defects?

A
  • excessive wear
  • tablet picking – sticking of tablets to each other or tools
17
Q

When can tablet defects occur?

A

from various stages during the manufacturing process

  • the whole process has to be optimized from start to finish
18
Q

Tablet Defects

What is insufficient mixing?

A

mottling: uneven distribution of colorants on surface coating

19
Q

Tablet Defects

What are chemical incompatibility and non-optimized formulations?

A
  • cracking: splitting of tablet coating due to excessive expansion or poor mechanical stress resistance of coating
  • peeling: insufficient adhesion between tablet core and coating
20
Q

What are the quality attributes of tablets?

A
  • tablet should contain correct dose of drug
  • appearance should be elegant and consistent
  • drug should release from the tablet in a controlled and reproducible way
  • tablet should be biocompatible
  • tablet should be of sufficient mechanical strength to withstand fracture and erosion during handling
  • tablet should be chemically, physically, and microbiologically stable during the lifetime of the product
21
Q

What are the tests performed to ensure tablet matches specifications?

A
  • uniformity of content (amount of active ingredient(s))
  • uniformity of mass
  • disintegration testing
  • dissolution testing
  • mechanical strength testing – attrition testing (friability testing), fracture resistance testing
22
Q

Tablet Testing

What is the uniformity of content (amount of active ingredient(s)) test?

A
  • collect 10 tablets and measure active ingredient(s) by an appropriate analytical method
  • should be within ±15% of the average amount of active drug
23
Q

Tablet Testing

What is the uniformity of mass testing?

A

weigh 20 tablets and calculate average mass

deviation of individual masses should not exceed the following limits:

  • less than 80 mg: ± 10%
  • 80-250 mg: ± 7.5%
  • greater than 250 mg: ± 5%
24
Q

Tablet Testing

What is disintegration testing?

A

test is carried out by agitating tablets in an aqueous medium at a defined temperature and the time to reach the endpoint of the test is recorded

  • basket rack assembly with 6 open ended tubes
  • mesh screen at bottom of tube
  • basket raised and lowered between 29-32 cycles per minute in immersion fluid at 37°C until tablet is disintegrated
25
Q

Tablet Testing

What must disintegration time be?

A

within specified range in Pharmacopoeia (usually 30 minutes)

26
Q

Tablet Testing

What is dissolution testing?

A

important way to study the release of a drug from a solid dosage form in vitro

  • during a dissolution test, cumulative amount of drug that passes into solution is measured as function of time
27
Q

Tablet Testing

Why are dissolution tests carried out to do?

A
  • evaluate the potential effect of the formulation and process variables on the bioavailability of the drug
  • ensure that preparations comply with product specifications
  • indicate the performance of the preparations under in vivo conditions (must be experimentally verified)
28
Q

Tablet Testing

Describe the dissolution test.

A

tablet is placed in a chamber containing dissolution medium – depends on application

  • ensures sink conditions
  • concentration gradient between diffusion layer and bulk solvent is assumed to be constant (solubility lecture)
  • stirred vessel methods or continuous flow methods are common
29
Q

Tablet Testing

What is mechanical strength testing?

A

set of tests to determine the hardness and friability of the tablet

  • different sets of equipment are in use
30
Q

Tablet Testing

What does the mechanical strength of a tablet affect?

A
  • disintegration and dissolution rates
  • physical stability – breaking/chipping upon shipping and handling
  • ability to break tablets if needed (splitting)
31
Q

Tablet Testing

What are the two most common methods of mechanical strength testing?

A
  • attrition resistance tests (friability testing)
  • fracture resistance tests
32
Q

Tablet Testing

What is attrition testing (friability testing)?

A

test meant to mimic the kind of forces to which a tablet is subjected during handling between its production and its administration

33
Q

Tablet Testing

What are the methods of attrition testing (friability testing)?

A
  • most common method of attrition testing involves rotation of tablets in a cylinder followed by the determination of weight loss after a given number of rotations
  • another method is to shake tablets intensively in a jar
34
Q

Tablet Testing

What is required during an attrition test (friability test)?

A

weight loss of less than 1%, along with an absence of physical abnormalities such as capping, cracks, or fractures

35
Q

Tablet Testing

What is fracture resistance testing?

A

application of a load on the tablet and determination of the force needed to fracture or break the tablet along its diameter

  • particularly important for blister packaged medications to ensure the tablets remain intact during their removal from the packaging

PHRM 100 – PDD (14 decks)

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