Tablets


TABLETS CHARACTERISTICS OF IDEAL

‣ SOLID phar maceutical dosage for m TABLET
containing drug substances with or without ‣ FREE of defects
diluent prepared by compression or ‣ Strength to withstand the mechanical
moulding stresses of production
‣ MOST COMMON dosage form because of ‣ Chemically and Physically stable
convenience of administration ‣ Release the medicinal agent in a predictable
‣ May vary in size, shape, height, hardness, & reproducible manner
thickness, disintegration characteristics

TYPES of TABLETS based on

ADVANTAGES method of preparation
‣ Precision and low content variability 1. COMPRESSED TABLET
‣ LOW manufacturing cost ‣ LARGE SCALE
‣ Easy to package & ship ‣ Example:
‣ Simple to identify • Sugar coated
‣ Easy to swallow • Enteric Coated
‣ Lend themselves to special release forms • Sustained release
‣ Best suited to large scale production 2. MOLDED TABLET
‣ MOST STABLE of all oral dosage form ‣ Tablet triturate
‣ Essentially TAMPER proof ‣ Use of moulder
‣ Yield softer tablet
DISADVANTAGES
‣ Some drugs resist compression into tablets OTHER METHODS OF PREP
‣ Some drugs may be difficult to formulate to 1. WET GRANULATION
provide adequate bioavailability ‣ MOST COMMERCIALLY used
‣ Some drugs may require encapsulation or 2. DRY GRANULATION
entrapment ‣ MOST ECONOMICAL and STABLE
3. DIRECT COMPRESSION
‣ Blend the AI & excipient for direct
compression

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4. FLUID BED PROCESS ‣ for DISTRIBUTION of the material into
the die
DRY vs WET GRANULATION 2. DIES

‣ LESS STEPS in dry granulation ‣ controls the SIZE & SHAPE of the tablet
Suitable for moisture sensitive ingredients 3. PUNCHES
‣
‣ upper and lower punch — eject
‣ No heat exposure for dry granulation
compacting the materials with in the die
‣ Slugging method
4. CAMS
‣ GUIDING the punches
COMPRESSION MACHINE
‣ SINGLE PUNCH
COMPONENTS OF A TABLET
• Single set of tooling
• one punch & die FORMULATION
‣ MULTISTATION ROTARY PRESS 1. ACTIVE INGREDIENT
• several sets of tooling 2. TABLET EXCIPIENTS
• > 1 punch and die ‣ Essential components
• large scale • diluents
• Binders/adhesives
• Disintegrants
IDEAL CHARACTERISTICS OF
‣ Aid compression
GRANULES PRIOR TO
• Lubricant
COMPRESSION
• Glidant
‣ Ability to FLOW FREELY — glidant
• Anti-adherent
‣ Cohesiveness — binder
‣ Supplements
‣ Proper lubrication — lubricant
• Colors & dye
- REASON: NO scratches along the side
• Flavorant
of the tablet; NO screeching sound of
• Sweetener
the machine
• Adsorbent
3. DILUENT
PARTS OF A TABLETING ‣ filler
MACHINE ‣ bulking agent
1. HOPPER ‣ Factors to consider
‣ for STORING the materials to be • cost
compressed • compatibility
2. FEED FRAME/ FEED SHOE • moisture content
‣ Example

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 • Lactose ‣ EXAMPLE:
• Mannitol (water sensitive drug; • Metallic stearates 1%
chewable) - Mg stearate
• Dicalcium phosphate - Ca stearate
• Kaolin - Stearic acid
• Cellulose • Talc 5%
• Starch 6. GLIDANT
• Calcium sulfate ‣ IMPROVES the flow characteristics of the
4. BINDERS granule or powder mixture
‣ Granulator ‣ Added prior to compression to improve
‣ GLUE powder flow
‣ Promotes cohesiveness ‣ EXAMPLE:
‣ can be liquid or solid • Talc
• Liquid • Colloidal silicon dioxide
- Glucose 25-50% 7. ANTI-ADHERENT
• Semi-solid ‣ Reduce sticking
- Starch paste 10-20% 8. DISINTEGRANT
• Solid ‣ helps in the break-up of the tablet after
- Gelatin administration
- Sugar (sucrose, glucose, lactose) ‣ Together with AI during granulation and
- Acacia compression
- Veegum ‣ EXAMPLE:
‣ Overwetting — TOO much binder • Starch-/derivatives
‣ Underwetting — LACKING required • Cellulose derivatives
amount of binder • Veegum
5. LUBRICANT • Bentonite
‣ Prevents adhesion of the tablet material 9. COLORANT
to the surface of the punches and dies ‣ usually tablets are light colored
‣ Facilitates the ejection of the tablet from ‣ FD&C— water soluble pigment
the die cavity ‣ LAKE— water insoluble pigment
‣ HYDROPHOBIC material 10.FLAVORANT
‣ “BOLTING” — The method of adding ‣ for chewable, sublingual, buccal tablets
lubricant to the granulation by passing to 11.ARTIFICIAL SWEETENERS
sieve #60-100 ‣ Saccharin
‣ Xylitol/ Sorbitol

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12.ADSORBENT 3. Prepare the starch paste by dispensing the
‣ MgO starch in boiling water & mixing until a
‣ Bentonite translucent mass is obtained; cool to 70ºC
‣ Calcium 4. Add starch paste & enough water to the
triturated powders portion by portion by
PROBLEMS kneading until a moist mass is formed

1. MOTTLING 5. Screen the moist mass by foreing until a

moist mass is formed
‣ Uneven distribution of color
6. Dry the next granules in an oven at 50ºC
‣ NO dry screening
until the moisture content is not 2%
‣ Color of active ingredient & excipient is
INCONSISTENT 7. Screen the dry granules using sieve #60
8. Pass talc, Mg stearate % plaedone through
‣ Degradation product
sieve #100 with the dried granules on tray
‣ SOLUTION: add colorant
2. CAPPING as receiver

Complete or partial separation of top or 9. Blend mixture using tumbling method for
‣
5mins
bottom surface of the tablet
3. LAMINATION 10.Compress using tableting machine

‣ Separation of 2 or more distinct layer

‣ Air pressure in tablets
‣ Uneven distribution of granules
‣ Sieve again before compression
4. PICKING
‣ Adherence to UPPER punch
5. STICKING
‣ Adherence to the WALL of die cavity
6. CHIPPING
‣ separation of SMALL PIECE
‣ High moisture content
‣ SOLUTION: Reheat

PROCEDURE
1. Pass paracetamol & starch for primary
granulation through sieve #20
2. Blend paracetamol & starch for primary
granulation by trituration for 5mins
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