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Pharmacy Year 2 > Tablet Testing > Flashcards

Tablet Testing Flashcards

1
Q

What are HGCs?

A

Hard Gelatine Capsules Gelatine, colours, water

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2
Q

Why are capsules used?

A

Taste masking
Ease of administration
Easy to formulate
Stability enhancement

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3
Q

Why is gelatine used in capsules?

A

non toxic, easily pepared, soluble in gastric fluids, good film former, reversible phase change at just above ambient

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4
Q

What materials can be used in capsules?

A

V-caps Hypromellose
Hydroxypropylmethylcellulose
Plant based (used for vegetarians)
6% moisture
nutritional products

NPcaps Pullulan
Polysaccharide (from corn syrup)
12% moisture (approx)
Japanese market only

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5
Q

Example of hard shell capsule

A

capsugel

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6
Q

What can a capsule be filled with?

A

Anything which does not react with gelatine.
Water and aldehydes CANNOT be used.
Requirements:
Must be able to accurately dose into capsule shell
Formulation must release active in a bioavailable form.
Types - solids (powders, granules, pellets, tablets), liquids, semi-solids.

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7
Q

What must the powder be like for HGC hard gelitin capsules only?

A

Formulation must flow well.
Degree of cohesiveness required but must not stick to equipment.
Flooding technique – dose contained within full capacity of capsule body.
All other techniques – dose contained in less than full capacity of capsule.

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8
Q

What is the equation for max capsule fil weight?

A

Tapped bulk density of formulation (g/mL) X Capsule volume (mL)

Tapped bulk density is only used for powder, granulation or bead filled capsules. Liquid capsules require the acual density of the formulation to be used

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9
Q

What is the capsule volume required (mL)?

A

Is the required fill weight (g) Tapped bulk density of formulation (g/mL)

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10
Q

What are other formulations instead of capsules?

A

Granule/ Pellets
As spherical as possible
pellets formed by extrusion/spheronisation process

Tablets
Blinded clinical trial materials
Special release dosage forms
Produce tamper evident dosage forms
Separate incompatible ingredients
Characteristics - smooth, suitable diameter and shape sometimes film coated

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11
Q

What are factors which affect bioavailability?

A

API factors
Formulation factors
Type of formulation filled
Specific excipients used in the formulation

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12
Q

What are API factors?

A

Dose
Physical characterisitics
Wettability
Solubility
Rate of dissolution
Flowability

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13
Q

Examples of Excipients?

A

Granulating agents - for granulations, pellets and tablets onlt
Diluent - Dose, solubility
Wetting agents - Hydrophobic ADI
Lubricanr - for fully automated equipment
Disintegrants - necessary to break up plug quickly
Glidant - for high dose drugs
small amounts to improve flow

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14
Q

if the API has a poor solubility what is used?

A

SOLUBLE DILUENT
creates porous plug when in contact with GI fluids
Increased dissolution rates
Lactose, mannitol

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15
Q

if the API has a high solubility what is used

A

INSOLUBLE DILUENT
Avoid competition for GI fluids
Dicalcium phosphate

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16
Q

What are examples of glidants and lubricants?

A

Glidant - colloidal silicon dioxide
Lubricant - magnesium stearate

HYDROPHOBIC and use at minimum levels

Formulation factor 2

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17
Q

When are wetting agents used?

A

Used when necessary to promote penetration of fluids into powder plug e.g sodium lauryl sulphate (sodium dodecyl sulfate)

Disintegrants to break up plug of powder
Ac-Di-Sol or Explotab

Granulating agents
May necessitate the use of wetting agents and disintegrants
PVP (povidone and polyvinylpyrrolidone)

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18
Q

How are powders, pellets/granulations, liquids and PCCAL filled into capsules?

A

For powders - dosator type, auger type, tamping finger / dosing disc, flooding.
For pellets/granulations – slide / piston method
For liquids and semi-solids – fluid dosing method
PCCAL package “Methods of Filling of hard gelitin capsules”

19
Q
  1. Define ‘TABLET’ (1) Part 1 – Overview
A
20
Q
  1. Discuss the advantages and disadvantages of the dosage form.(1)
A
21
Q
  1. Discuss the properties of each of the immediate release tablet types (giving examples for each)(1)
A
22
Q
  1. Explain each stage of the tablet manufacturing process(1)
A
23
Q
  1. Explain the choice of excipients, their roles and their effect on tablet properties. (1)
A
24
Q
  1. Discuss problems that can occur during tableting(1)
A
25
Q
  1. Discuss the reasons for coating tablets and compare and contrast the different type of coatings available (2) Part 2 – Coating, Attributes & Quality Testing
A
26
Q
  1. Discuss tablet attributes
A
27
Q
  1. Describe the tests undertaken to ensure tablet quality, the purpose of each test and the limits for each stipulated by the BP.

Resources:

A
28
Q
  1. What are the normally accepted limits for crushing strength / hardness? (2)
A
29
Q
  1. Why is hardness an important tablet attribute?
A
30
Q
  1. What is the usual acceptable maximum weight loss during
    friability testing?
A
31
Q
  1. What are the limits for standard release tablets for disintegration?
A
32
Q
  1. What media is used for tablet disintegration and what temperature should this be heated to?
A
32
Q
  1. What media is used for tablet disintegration and what temperature should this be heated to?
A
33
Q
  1. What are the two main instruments used for B.P. dissolution testing?
A
34
Q

Discuss the properties of an ‘ideal’ tablet blend and discuss how these effect a tablet’s attributes.

A
35
Q

Outline the stages of the tablet manufacturing process for both directly compressed and granulated blends and discuss the advantages and disadvantages of each method.

A
36
Q

Discuss the importance of the following excipients within a tablet blend and give examples of each:

a. Glidant

b. Lubricant

c. Filler

d. Binder

A
37
Q

Describe the key differences between single – punch and rotary tablet presses.

A
38
Q

Discuss the reasons for coating tablets and the types of coatings available.

A
39
Q

Discuss the process of sugar-coating tablets with regard to each of the 6 coating stages.

A
40
Q

Identify the types of immediate release tablets available and give examples of each.

A
41
Q

Discuss each of the following tablet tests with regard to their importance, method and BP limits:

a. Disintegration

b. Dissolution

c. Friability

A
42
Q

Discuss each of the following technical issues / problems that can occur during the tabletting process and suggest how these may be rectified.

a) ‘Capping’

b) ‘Lamination’

c) ‘Picking’

A
43
Q

Discuss the process by which the drug is release from the tablet and absorbed in the GI tract

A

Pharmacy Year 2 (33 decks)

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