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lecture-5

The document provides a comprehensive overview of tablets as a solid dosage form, detailing their definition, advantages, disadvantages, ingredients, and various types. It also discusses the preparation methods, processing problems, and evaluation techniques for tablets, including tests for general appearance, weight variation, content uniformity, hardness, friability, disintegration, and dissolution. Additionally, it highlights the roles of excipients and the importance of proper manufacturing practices to ensure quality and efficacy.

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taniamazumdar7
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0% found this document useful (0 votes)
6 views

lecture-5

The document provides a comprehensive overview of tablets as a solid dosage form, detailing their definition, advantages, disadvantages, ingredients, and various types. It also discusses the preparation methods, processing problems, and evaluation techniques for tablets, including tests for general appearance, weight variation, content uniformity, hardness, friability, disintegration, and dissolution. Additionally, it highlights the roles of excipients and the importance of proper manufacturing practices to ensure quality and efficacy.

Uploaded by

taniamazumdar7
Copyright
© © All Rights Reserved
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 40

Ms.

Pratiksha Jayaswal
Assistant Professor
Faculty of Pharmaceutical Sciences
Rama University, KANPUR (U.P.)
1
DEFINITION OF TABLETS

ADVANTAGES

DISADVANTAGES

TABLET INGREDIENTS

GRANULATION TECHNIQUES

PROBLEMS DURING PRODUCTION

EVALUATION OF TABLETS

2
INTRODUCTION

• Tablet is defined as a compressed solid dosage


form containing medicaments with or without
excipients.
• Tablets are solid dosage forms, prepared by
compressing a drug or a mixture of drugs, with or
without diluents.

3
ADVANTAGES
Cost is lowest of all oral dosage forms.

Lighter and compact.

Easiest and cheapest to package and strip.

No risk in choking.

Overcome unacceptable taste of drug.

Quick disintegration and dissolution of


dosage form.
4
5
Difficult to swallow in case of children and unconscious patients.

Some drugs resist compression into dense compacts, owing to


amorphous nature, low density characters.

Drugs with poor wetting, slow dissolution properties.

Bitter tasting drugs, drugs with an objectionable odour or drugs


that are sensitive to oxygen may require encapsulation or coating.

6
TABLET INGREDIENTS
• Diluents are fillers used to make
required bulk of the tablet.
1. DILUENT
• Ex: Lactose, Starch, Dextrose,
Mannitol.

2.BINDER AND • Added either in dry or wet- form to


form granules or cohesive compacts.
ADHESIVE • Ex: Acacia, Starch, CMC, PVP.

• Added to facilitate breaking or


3.DISINTEGRANTS disintegration in the GIT.
• Ex: Starch, Cellulose, Clays.
• Intended to prevent adhesion of the
tablet materials to the surface of dies
4.LUBRICANTS and punches.
• Ex: Stearic acid, Magnesium stearate,
Talc, Surfactants. 7
• Intended to promote flow of
granules or powder material by
5.Glidant reducing the friction.
• Ex: Corn Starch, Talc.

6. Colouring • Production of more elegant product.


• Ex: Brilliant blue, Indigotene,
agent Erythrosine.

7. Flavoring • To impart flavour or odour.


• Ex: Menthol, Vanilla, Liquorice, Citrus
agent fruits flavour, Anise oil, Clove oil.

8. Sweetening • To mask the bitter taste of drugs.


agent • Ex: Mannitol, Lactose,Aspartame.

8
EXCIEPIENTS
- functions
Impart weight,
accuracy, &
volume.
Facilitate
Improve
dosage form
solubility.
design.

Increase Increase
patient
acceptability. stability.

Modifying Enhance
drug bioavailability
release. .

9
(A) Tablets ingested orally:

1. Compressed tablets. e.g. Paracetamol tablets.

2. Multiple compressed tablets.

3. Repeat action tablets.

4. Delayed release tablets.

5. Sugar coated tablets, e.g. Multivitamin tablet.

6. Film coated tablets, e.g. Metronidazole tablet.

7. Chewable tablets, e.g. Antacid tablets.


10
(B) Tablets used in oral cavity
1. Buccal tablets, e.g. Vitamin-c tablet

2. Sublingual tablets.

3. Troches or lozenges.

4. Dental cone.
(c)Tablets administered by other
route
1. Implantation tablets.

2. Vaginal tablets, e.g. Clotrimazole tablets.


11
PREPARATIO
N OF
TABLETS
13
Direct
compression

14
• Milling/Screening.
1
• Pre-blending.
2
• Slugging/roller compaction.
3
• Dry screening.
4
• Blending of lubricant.
5
• Compression.
6
15
• Milling/Screening.
1
• Pre-blending.
2
• Addition of binder.
3
• Screening of wet mass.
4
• Drying of the wet granules.
5
• Screening of dry granules.
6
• Blending of lubricant (and disintegrant).
7
8 • Compression.
16
Tablet
compression
equipments
17
Single Punch
Machine
(Tablets)

Upper and
Lower Collar

Collar locker
18
19
ROTARY COMPRESSION

20
Processing
Problems
PROCESSING PROBLEMS
Various problems arise during manufacture of
tablets. They are:

Capping

Lamination

Picking

Sticking

Mottling

22
Processing Problems

1.CAPPING :
Complete or partial loss of top and bottom
crowns of a tablet from the main body is called
.
capping.

Cause: Improper/Deep concave punches.


Remedy: Better to use flat
punches.

23
2.LAMINATION:
The separation of a tablet into two or more
distinct layers is called lamination.
Cause: Air entrapment , Deep concave punch.
Remedy: By pre-compression ,Reducing final
compression force ,Using flat punch ,Using
hygroscopic materials to maintain proper
moisture level.

24
3.Picking :
Surface materials of the tablet stick to
the punch and get removed from the
tablet surface. This is known as
picking.

Cause:
•Because of engraving on the punch
tips like small enclosed areas in the
letters like “A”, “B”, “D”, “O”, “Q” etc

Remedy:
•Lettering should be designed as large
as possible, even the tablet size can be
increased by reformulation

25
4.Sticking:
Sticking refers to the condition in which tablet
materials adhere to the die wall.
Cause: over wetting or excessive film tackiness
Remedy: Reduction in liquid application rate

26
5.Mottling:
It is an unequal distribution of colors on a
tablet with light and dark areas on tablet

surface.
Cause: 1. Use of a drug whose color differs
from tablet excipients.
2. Use of a drug whose dehydration
products are colored.
Remedy: 1. The use of colorant.
2. Disperse a dry colour additive during
powder binding steps.
27
EVALUATION OF TABLETS

28
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1.GENERAL APPEARANCE :

The general appearance of a tablet is essential for consumer


acceptance. it involves:
➢ Size & Shape : Tablet thickness should be controlled
within a ± 5% variation of standard value.
➢ Unique identification marking: These markings include
company name or symbol, product code, product name etc.
➢ Organoleptic properties: Color distribution must be
uniform in comparison with the color of the standard.

30
2.WEIGHT VARIATION TEST:

weigh randomly 20 tablets individually in a batch.

Determine the average weight of 20 tablets.

Compare individual tablet weight to average weight


• As per I.P. ,
❑ If the tablet weight is,
❑ < 80mg , % deviation allowed up to 10%
80-250mg , % deviation allowed up to 7.5%
> 250mg , % deviation allowed up to 5%
If any of the tablet deviates, another 10 tablets are selected
from the same batch and the procedure is repeated.

Of 30 tablets , not more than 1 tablet should deviate.


31
3.Content uniformity test:
It is used to ensure that every tablet contains the amount of drug
substance intended with little variation.

Procedure:
o 10 tablets are assayed,
o 9 tablets should have % limit of 85-115%.
o If more than 1 tablet deviates from 85-115%,
o Another 20 tablets are assayed
o Not more than 1 tablet should have the % limit of 75-125%

32
4. Hardness test:
It is defined as the force required to break a tablet in a
diametric compression . Tablet requires a certain amount of
strength or hardness and resistance to friability to withstand
mechanical shocks of handling in manufacture, packaging and
shipping
Types of hardness testers used.
1. Monsanto hardness tester .
2. Strong cob tester.
3. Pfizer tester.
For, Conventional tablets hardness : 2.5- 5 kg/cm2
Dispersible/ chewable tablets hardness: 2.25- 2.5 kg/cm2
Extended release tablets hardness : 5- 7.5 kg/cm2

33
5. Friability test:
The instrument used is Roche friabilator.
It consists of a drum having 280-290mm diameter with a
thickness of 30mm. A drum is mounted on a horizontal axis
of a drive motor.
Drum is operated at a speed of 25rpm.&Allowed revolutions
for each tablet is 100.
Allowable range: loss 0.5 - 1% weight

34
6.Disintegration test:
Disintegration is the breakdown of tablet crust into
finely divided particulate matter or into granules
once the tablet is exposed to the gastric fluids .

Type of tablets Time Of disintegration

uncoated conventional tablets 15min

sugar coated tablets 60 min.

film coated tablets 30 min

35
7.Dissolution Test (U.S.P.): It is the solubilization of the drug or

active moiety in to the dissolution media.

Different types of dissolution apparatus:


Apparatus -I-Rotating Basket type.
Apparatus -II- Rotating Paddle type.
Apparatus-3-Reciprocating cylindrical type.
Apparatus-4-Flow through cell.
Apparatus-5-Paddle over disk.
Apparatus-6-Cylindrical apparatus.
Apparatus-7-Reciprocating disc apparatus.

36
REFERENCES

Page no: 293 to 334.


Page no:88 to 121

37
REFERENCES

page No: 751 to 754 Page No:889 to 913.

38
Page No:558 to 629.
Page No:225to 256.

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