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TABLETS
TABLETS
13.10.2016
LEARNING OBJECTIVES
Describe the advantages and limitations of tablets as dosage forms
Describe the quality attributes of tablets
List and describe different types of tablets
List and describe different excipients used in tablets
Describe three methods of tablet preparation
CONTENTS
INTRODUCTION
ADVANTAGES/ DISADVANTAGES
CHARACTERISTICS
TYPES
FORMULATION ADDITIVES
METHOD OF PREPARATION
TABLETS (Latin tabuletta, Tab.)
Tablet is defined as a compressed solid dosage form
containing medicaments with or without excipients.
1. Effervescent tablet
2. Hypodermic tablet
3. Dispensing tablet
4. Compressed tablet triturates
TYPES OF ORAL TABLETS
Compressed Tablets
Multiple compressed tablets
Layered Tablet
Compression coated tablet or Repeat action tablets
Diluent
Binder and adhesive
Disintegrents
Lubricants and glidants
Colouring agents
Flavoring agents
Sweetening agents
DILUENTS
Diluents or fillers; used to increase the mass of tablet,
Anhydrous lactose
Lactose monohydrate
Spray dried lactose
Sucrose
Glucose
Starch
Sorbitol
Microcrystalline cellulose (Avicel)
Mannitol
Dibasic calcium phosphate, etc
Calcium carbonate
BINDER
Binders; used in case of wet granulation method,
added in the form of solution or as a solid in the
powder mix.
SOLUTION BINDER DRY BINDER
• Gelatin • Cellulose
• PVP • Methyl cellulose
• HPMC • PVP
• PEG • PEG
• Sucrose
• Starch
DISINTEGRANT
Disintegrants; facilitates breakdown of tablets when taken orally
Starch
MCC
Sodium starch glycolate
Sodium carboxymethyl cellulose
Crosslinked PVP
GLIDANTS
Glidants; enhance the flow property of the bulk powders within the
hopper and into the die in the tablet press
Silica
Avicel (colloidal silicon dioxide)
Talc
Magnesium stearate
LUBRICANTS
Lubricants; facilitates tablet ejection by reducing the friction between
the walls of machine and tablet surface
•Magnesium stearate
•Stearic acid
•PEG
•Sodium lauryl sulfate
•Sodium stearyl fumarate
•Liquid paraffin
ADSORBENTS
Kaolin
Magnesium oxide
COLORING AGENTS
Masking of off color drugs
Product Identification
Production of more elegant product
COLORING AGENTS
All coloring agents must be approved and certified by FDA
FD & C
D & C dyes
Two forms of colors are used in tablet preparation;
solution in the granulating agent or
Lake form of these dyes
Lakes are dyes absorbed on hydrous oxide and employed as dry powder coloring.
FLAVORING AGENTS
For chewable tablet‐flavor oil are used
SWEETENING AGENTS
For chewable tablets
Sugar
Mannitol
Saccharine (artificial): 500 time’s sweeter than sucrose
Disadvantage: Bitter after taste and carcinogenic
Aspartame (artificial)
Disadvantage: Lack of stability in presence of moisture.
METHOD OF
PREPARATION
25.10.2016
METHOD OF PREPARATION
Direct compression
Wet granulation
Dry granulation
DIRECT COMPRESSION
Direct compression (DC) is by far the simplest means of production of a
pharmaceutical tablet
It requires only that the active ingredient is properly blended with appropriate
excipients before compression
reduced capital, labour and energy costs for manufacture
the avoidance of water for granulation for water sensitive drug substances
DRY GRANULATION METHOD
The ingredients in the formulation are intimately mixed and pre-compressed on
heavy duty tablet machines.
The slug which is formed is ground to a uniform size and compressed into the finished
tablet.
DRY GRANULATION METHOD
SLUGGING
Compression of powder or powder mixture into large tablets or slugs on a
compressing machine
8000-12000 pounds of pressure
Flat-faced
2.5cm (1 inch) in diameter
SLUGGING
ROLLER COMPACTION
WET GRANULATION METHOD
has more operational manipulations
more time-consuming
not suitable for drugs which are thermolabile or hydrolyzable by the presence of
water in the liquid binder
STEPS
1. The powdered ingredients are weighed and mixed intimately by geometric dilution
2. The granulating solution or binder is prepared
3. The powders and the granulation solution are kneaded to proper consistency
4. The wet mass is forced through a screen or wet granulator
5. The granules are dried in an oven or a fluidized bed dryer
6. The dried granules are screened to a suitable size for compression
7. A lubricant and a disintegrating agent are mixed with the granulation
8. The granulation is compressed into the finished tablet
SINGLE PUNCH TABLET PRESS
MULTIPLE STATION TABLET
ROTARY PRESS
CONCLUSION
Among the oral pharmaceutical dosage forms, tablets are
the most popular one, accounting for some 70% of all
ethical pharmaceutical preparations produced (Rubinstein,
2000).
REFERENCE
Ansel’s Pharmaceutical Dosage form and drug delivery systems, 8th edition, Ch# 8
Aulton’s Pharmaceutics, the design and manufacture of medicines, 3rd edition, Ch# 31