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hypertension > Tablet Formation > Flashcards

Tablet Formation Flashcards

1
Q

4 methods of tablet manufacturing

A

Wet granulation

Dry granulation - slugging

Roller compaction - also dry

Direct compression

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2
Q

What is wet granulation

A

Mixing API with excipients and a wet binder to form granules which are then dried

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3
Q

What is wet granulation suitable for and what does it achieve

A

Drugs with poor solubility and flow properties

Enhances uniformity of drug distribution and improves compression characteristics

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4
Q

What is dry granulation

A

Compacts drugs and excipients under high presssure to form slugs which are milled into granules

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5
Q

What is dry granulation used for and what does it achieve

A

Used when a drug cannot withstand heat or moisture

Simpler and less expensive than wet but requires drugs and excipients with cohesive properties

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6
Q

What is roller compaction

A

A dry granulation technique where powder particles are made to adhere under high pressure between two counter-rotating rollers.

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7
Q

What is roller compaction used for

A

useful for moisture- sensitive drugs. It is efficient and eliminates the need for binders or liquids.

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8
Q

What is direct compression

A

The simplest method, where the drug and excipients are blended and compressed into tablets without prior granulation.

cost- effective and efficient but requires the drug and excipients to have excellent flow and compression characteristics.

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9
Q

Factors that determine the choice of manufacturing process

A

Compression Properties of the Therapeutic Agent

Particle size of therapeutic agent

Types of Excipients

Chemical Stability of the Therapeutic Agent

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10
Q

What is Compression Properties of the Therapeutic Agent

A

The ability of the drug to form a compact mass under pressure is crucial.

Drugs with good compressibility can be easily formulated using direct compression

drugs with poor compressibility, alternative methods such as wet granulation may be necessary

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11
Q

What is Particle size of therapeutic agent

A

The size of drug particles affects the dissolution rate, bioavailability, and homogeneity of the tablet. Smaller particles may enhance dissolution but can pose challenges in flowability and uniform mixing.

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12
Q

What is Types of Excipients

A

The compatibility of excipients with the drug and the desired release profile dictates the choice of excipients the manufacturing process.

For instance, moisture- sensitive drugs may benefit from dry granulation or direct compression to avoid exposure to water during wet granulation.

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13
Q

What is Chemical Stability of the Therapeutic Agent

A

The stability of a drug under various conditions influences the manufacturing process.

Processes that involve heat or moisture may not be suitable for thermolabile or hydrolytic drugs,

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14
Q

General steps in manufacturing of tablets

A
  1. Mixing of API with the excipients
  2. Granulation of the mixed powder
  3. Mixing of powder or granules with other excipients
  4. Compression of the powder / granule mixture into tablet
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15
Q

What part of the process is the drug added

A

Milling

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16
Q

What part of the process is the excipient added

A

Blending

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17
Q

What part of the process is the binder solution added

A

Wet granulation

18
Q

What part of the process is the lubricant added

A

2nd blending after sieving

19
Q

Types of excipient

A

Diluent/filler
Binder
Disintergrant
Lubricant
Glidant
Absorbent
Sweetening agent
Colouring agent
Surface active agent

20
Q

Diluent/filler

A

Added in all manufacturing processes

Added to increases mass/bulk of tablet containing low conc of therapeutic agent

Eg. Anhydrous lactose - used in wet and dry
Eg. Spray dried lactose - used in direct compression
Eg. Starch - used as a liquid diluent
Eg. Mannitol - used in chewable tablets

21
Q

Binders

A

Polymeric components
Mainly used in wet granulation
Can be added as solution or powder
Holds components together

22
Q

Disintergrants

A

1st mechanism - Added to tablet formation to facilitate breakdown of tablet upon entry to stomach
Disintegration must occur within 15mins

Eg. Starch and MCC

2nd mechanism - Can also occur by swelling in presence of aqueous fluids, increasing the nternal pressure with the tablet

3rd mechanism - gas formation - effervescent tablets

23
Q

Lubricants

A

During compression of tablets, lubricant act at the interface between the face of the die and the face of the tablet

Insoluble (added to final mix stage but prior to compression) and soluble

24
Q

Glidants

A

Enhances the flow properties of the powders within the hopper into the tablet press

Essentially, reduces the friction between the powder/granulate and the surface of the hopper

Eg. Talc

25
Q

Absorbents

A

These materials are used whenever it’s required to include a liquid or semisolid components. E.g. a drug or a flavour

Eg. MgO

26
Q

Sweetening, colouring and surface-active agents

A

Sweetening agent – added to control the taste for bitter drugs and chewable

Colouring agent – added to improve the appearance of the tablet or to IDENTIFY the finished product.

Surface-active agents – added to enhance the wettability of hydrophobic tablets and aids the rate of disintegration.

27
Q

Adv of wet granulation

A

Reduce segregation of formulation components

Good technique for manufacturing of tablet containing low concentration of drugs

Use conventional excipient and most manufacturing plants are built around wet granulation

28
Q

Disadv wet granulation

A

Several processes are required

Solvent required in the process but may cause degradation

The drug may be solubilize in the granulation fluids

29
Q

adv dry granulation

A

Conventional excipients are required

No heat or solvent is required

This method does not cause alteration in drug morphology

30
Q

Disadv dry granulation

A

Require the use of special equipment of roller compaction

Segregation of the components may occur

There are issue regarding powder flow

Final tablet formed by dry granulation tend to be softer

31
Q

Adv of direct compression

A

Few processing and manufacturing steps

No need for granulation fluids or solvents, ideal for therapeutic agents that are degradable in presence of solvent

Lubrication is performed in the same bowel as powder mixing, reduce transfer loss or contamination

Good for small dose tablets

32
Q

DisAdv of direct compression

A

Specialist equipment is required

Segregation may occur but can be reduced by
using similar particle sizes

Issue with powder flow

Can not be used if colourant is required

33
Q

Tablet compression process

A

Step 1: Filling of the die with the granules/powder
- feed by gravity

Step 2: Compression of the powder bed
- upper punch descent and stress applied

Step 3: Tablet ejection
- upper punch elevated, shoe of hopper moves across ad push away tablet

34
Q

Types of tablet press

A

Type 1 : Single-punch presses

Type 2 : Rotary tablet presses

35
Q

Technical problems during tabletting

A

Capping

Lamination

36
Q

2 main formulations of tablet coating

A

Solutions nd emulsion

37
Q

Solution

A

Coat in coating polymers, coating solvents nd other excipients

Increases conc of coating polymer, reducing coating time

May increase viscosity of coating matters making it harder to spray

38
Q

Emulsion

A

More attractive process

Polymer dissolved in volatile organic phase

Spraying the coating emulsion followed by deposition, spreading and then evaporation of the volatile solvent. This encourages the formation of a coating film

39
Q

Coating of tablet in practise

A
  1. Pan coater
  2. Air suspension coater
40
Q

Factors affecting on fluidized air coating

A
  1. Evaporation rate of the solvent
  2. Fluidised air volume
  3. Specific humidity
  4. Coating spray rate and duration

hypertension (24 decks)

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