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Solid > Tablet Quality > Flashcards

Tablet Quality Flashcards

1
Q

What are some tablets quality control evaluations we would look at?

A
  • chemical: assay, stability
  • biological: bioavailability, drug performance
  • physical: dimensional, weight, hardness, friability, disintegratability, dissolution
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2
Q

What are some pharmacopeia tests for tablets evaluation?

A
  • content
  • mean weight and weight variation
  • dimension
  • friability
  • hardness
  • disintegration test
  • dissolution/release studies
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3
Q

What is the tablet dimensions specifications for tablet thickness?

A

< or = 5% of standard value (20 tablets)

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4
Q

What are some causes of thickness variation?

A
  • compressive loads
- die fill --> factors:
~ raw materials
~ punch length
~ machine operation
~ granule properties
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5
Q

What is the purpose for manufacturer’s production to check for tablet thickness?

A
  • important for packaging

- should be part of in-process quality control (thickness, diameter)

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6
Q

Why should tablets should comply to tablet weight test?

A
  • compliance with this test helps to ensure uniformity of dosage is achieved (of biopharmaceutical consequence)
  • not required for tablets/capsules that have to comply with the test for uniformity of content for all active ingredients
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7
Q

What could be some variations to tablet weight?

A
  • dimensions of die cavity
  • amount of fill
  • density of material: determines tablet weight
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8
Q

What is the methodology (pharmacopeia) for tablet weight?

A

weigh 20 tablets individually and determine average mass

Not more than 2 of the individual masses should deviate from the average mass by more that the percentage deviation shown

none should deviate by more than 2x

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9
Q

What are the % deviation acceptable for Tablets (uncoated and film coated)?

A

BP pharmacopeia:

Average mass
80mg or less: 10%
>80 & <250mg: 7.5%
250mg or more: 5%

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10
Q

What are the % deviation acceptable for Capsules, granules and powders?

A

BP pharmacopeia:

<300mg: 10%
300mg or more: 7.5%

Capsule: weigh, subtract weight of shell, for weight of content

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11
Q

What are the % deviation acceptable in USP?

A

130mg or less: +/- 10%
>130mg and <325mg: +/- 7.5%
325mg and more: +/- 5%

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12
Q

What is friability?

A

Determine friability, abrasion properties

  • tumble in container, may contain beads to increase abrasion
  • originated as Roche friabilator
  • let it drop 100 time?
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13
Q

What is the friability test?

A

Compliance ensure tablets can withstand mechanical shocks and abrasion during manufacturing, packaging and transportation processes

Specified amt of tablets being subjected to a tumbling action for a specified time, tablets then collected, dusted and weighed again

USP: each tablet weight should be about = or < 650mg. take as near as possible to 6.5g
if weight more than 650mg, take 10 tablets

Run once, tablets visually damaged –> is a fail

Loss, not greater than 1.0% (=< 1%) –> is a pass

If >1%, repeat twice or more and mean of 3 tests, should not be greater than 1%

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14
Q

Why the word ‘hardness’ is misleading?

A

It’s rather a breaking force; not crushing strength and not about hardness

hardness has different meaning from “breaking” which is: resistance of a surface to penetration or indentation by a small probe

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15
Q

What is the hardness test?

A

Tablets are tested either across the diameter or parallel to the longest axis. –> Provides info about strength along the weakest point in the structure

If flat-faced round tablets (right circular cylinders) FAIL in tension, as indicated by a CLEAN SPLIT into HALVES under diametric compression, the breaking force maybe used to compute the tensile strength by (Applies only to cylindrical tablets):

sigma x = 2F / (pi X D X H)
where sigma x is tensile strength
F is breaking force
D is tablet diameter
H is tablet thickness
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16
Q

What are the pharmacopeia BP requirements for hardness test?

A
  • measurement on 10 tablets
  • report: mean, minimum and maximum in newtons

Impt: type of apparatus and orientation of shaped particles

Break line is a weak point; would need to specify how you place tablet for testing

17
Q

Why do we need to comply with disintegration test?

A
  • compliance helps to ensure that tablets / capsules break up after ingestion, to ensure rapid dissolution of drug
  • test not required for chewable tablets, lozenges, and modified release capsules or tablets
18
Q

What is the methodology for disintegration test?

A

USP

mesh aperture, 2mm (#10 mesh);

cycles: 28-32 cycles/min over 50-60mm;
media: 37oC +/- 2oC

Pass: all particles must pass through the 10 mesh screen in the time specified (15min). If any residue remains, it must be a soft mass without core (e.g. hydrogel)

if hard core that is visible - tablets have not disintegrated –> fail

If 1 or 2 tablets or capsules fail, repeat with additional 12 units; pass only if not less than 16 out of the 18 tablets/capsules tested have disintegrated.
(16-18/18 –> pass)

19
Q

What are the reasons for doing release testing?

A
  • optimise manufacturing processes
  • reassure constant manufacturing quality:
    ~ within lot
    ~ lot-to-lot
    meeting compendial/regulatory requirements, if any
    design extended/ delayed release products
    predict biopharmaceutical performance

Many pharmacopeia methods available but apparatuses 1-4 are most commonly encountered for solid dosage forms.

20
Q

What does an In Vitro Dissolution apparatus consists of?

A
  • an inert vessel which contains the dissolution solvent

- a rotating spindle which provides the hydrodynamic flow of the solvent across the surface of the dosage form

21
Q

What are USP Apparatus 1 and 2?

A

Apparatus 1: Basket Method (can keep hydrophobic molecules from climbing up the spindle)

Apparatus 2: Paddle method (most popular)

22
Q

What is Apparatus 3 (Bio-Dis II)?

A

Reciprocating cylinder

  • versatile apparatus
  • for in-vitro assessment of release characteristics of product by subjecting to different dissolution media and agitation speeds in a single run
  • different pH aq media; keep water bath temp at 37oC +/- 0.5oC
  • moves from one vessel to another in different pHs
  • However, cumbersome (difficult to carry out), there is no specified duration that vessel stays in media; settings to be adjusted accordingly; can also check whether drug can be available for control release product
23
Q

What is USP Apparatus 4?

A
  • Flow-through cell
  • consists of reservoir containing dissolution/release medium, a pump that forces medium upwards through the vertically positioned flow-cell, and a water bath to control temp in cell
  • medium can be changed during experiment (change pH with time)
  • can be used for testing tablets, powders, supp, hard and soft gelatin capsules, implants, semisolids and drug-eluting stents
  • using different types of cells, if needed
24
Q

What is the driving force fore release kinetics by Noyes-Whitney Equation?

A

Diffusion gradient

Cc (saturated drug conc at core) = S (Solubility)
Hence, Cs ~= S

Solubility Cs is also the driving force

25
Q

What is the Noyes-Whitney Equation?

A

dm/dt = A X (D/L) X (Cs- Cb)

dm/dt - mass of dissolved material over time taken

A - Surface Area (constant)
D - Diffusion Coefficient (Constant)
L - Length - as thickness increases, dm/dt decreases (distance for drug to travel out will become longer)

Cs - drug almost at saturation (surface conc)
Cb - most of the time at sink condition (bulk conc)

26
Q

Why is there lag time?

A

Take time to establish equilibrium

27
Q

Why is there a depletion zone?

A

interior of drug drop below saturation

28
Q

The release profile of dissolution flow is what kind or order release?

A

zero-order release (after lag time and before depletion zone)

Diffusion barrier is constant
A and D are constant

29
Q

What is the burst effect?

A

when drying a soluble drug, some drug pulled to surface, thus some release of drug already at the start

30
Q

What kind of drug shows a first order model?

A

Matrix; hydrogel system

Surface already start to release drug as surface decreases

31
Q

What kind of drug shows a diffusion model?

A

Reservoir (drug in the core) - coat semi-permeable that does not erode

32
Q

What kind of drug shows diffusion model with erosion (pseudo-zero order release)?

A

Hydrogel that encourage erosion

Erosion front will reduce thickness of gel

Rate of erosion = reducing the barrier thickness to be equivalent

Erosion keeps L (thickness) constant
- rate proportional to 1/L

33
Q

Diffusion model with erosion is the same as

A

pseudo-zero order release

Solid (16 decks)

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