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By :
Dr. K.B.Gabhane
Assistant Professor
Department of Pharmaceutical Chemistry,
Vidyabharti College of Pharmacy,
Amravati
PROCESSING OF TABLETS
DEFINATION
 According to the Indian Pharmacopoeia :
Pharmaceutical tablets are solid, flat or biconvex dishes, unit
dosage form, prepared by compressing a drugs or a mixture of
drugs, with or without diluents. They vary in shape and differ
greatly in size and weight, depending on amount of medicinal
substances and the intended mode of administration.
Advantages
 They are unit dosage form and offer the greatest capabilities of all oral dosage form for the
greatest dose precision and the least content variability.
 Cost is lowest of all oral dosage form.
 Lighter and compact
 Easiest and cheapest to package and strip.
 Easy to swallowing with least tendency for hang‐up.
 Sustained release product is possible by enteric coating
 Objectionable odour and bitter taste can be masked by coating technique.
 Suitable for large scale production.
 Greatest chemical and microbial stability over all oral dosage form.
 Product identification is easy and rapid requiring no additional steps when employing an
embossed and/or monogrammed punch face.
Disadvantages of Tablet dosage form are
1. Difficult to swallow in case of children and unconscious patients.
2. Some drugs resist compression into dense compacts, owing to
amorphous nature, low density character.
3. Drugs with poor wetting, slow dissolution properties, optimum
absorption high in GIT may be difficult to formulate or manufacture as
a tablet that will still provide adequate or full drug bioavailability.
4. Bitter testing drugs, drugs with an objectionable odor or drugs that are
sensitive to oxygen may require encapsulation or coating. In such cases,
capsule may offer the best and lowest cost.
General properties of Tablet dosage forms:
1. A tablet should have elegant product identity while free of defects like
chips, cracks, discoloration, and contamination.
2. Should have sufficient strength to withstand mechanical shock during its
production packaging, shipping and dispensing.
3. Should have the chemical and physical stability to maintain its physical
attributes over time
4. The tablet must be able to release the medicinal agents in a predictable and
reproducible manner.
5. Must have a chemical stability over time so as not to follow alteration of the
medicinal agents.
(A) Tablets ingested orally:
Compressed tablet, e.g. Paracetamol tablet
Multiple compressed tablet
Repeat action tablet
Delayed release tablet, e.g. Enteric coated Bisacodyl tablet
Sugar coated tablet, e.g. Multivitamin tablet
Film coated tablet, e.g. Metronidazole tablet
Chewable tablet, e.g. Antacid tablet
(B) Tablets used in oral cavity:
Buccal tablet, e.g. Vitamin‐c tablet
Sublingual tablet, e.g. Vicks Menthol tablet
Troches or lozenges
Dental cone
(c) Tablets administered by other route:
1. Implantation tablet
2. Vaginal tablet, e.g. Clotrimazole tablet
(D) Tablets used to prepare solution:
1. Effervescent tablet, e.g. Dispirin tablet (Aspirin)
2. Dispensing tablet, e.g. Enzyme tablet (Digiplex)
3. Hypodermic tablet
4. Tablet triturates e.g. Enzyme tablet (Digiplex)
Tablet Ingredients
In addition to active ingredients, tablet contains a number of inert materials
known as additives or excipients. Different excipients are:
Sr.no. Excipients
1 Diluent
2 Binder and adhesive
3 Disintegrents
4 Lubricants and glidants
5 Colouring agents
6 Flavoring agents
7 Sweetening agents
Granulation technology on large scale by various
techniques
Direct Compression Process
Wet Granulation Process
Tablet Compression Machine
Tablets are made by compressing a formulation containing a drug or drugs
with excipients on stamping machine called presses.
Tablet presses are designed with following basic components:
1) Hopper for holding and feeding granulation
2) Dies that define the size and shape of the tablet
3) Punches for compressing the granulation within the dies
4) Cam tracks for guiding the movement of the punches.
5) A feeding mechanism for moving granulation from hopper into the dies
Tablet Compression Machine
Die Filling and tablet ejection process
Evaluation of Tablet
General Appearance Weight variation test
Size and shape Content Uniformity test
Unique Identification marking Disintegration test
Organoleptic Properties Dissolution test
Hardness
Friability
Tablet Coating
To mask the taste of unpalatable drugs, protect the drug from
deterioration due to light, oxygen or moisture, separate in compatible
ingredients, control there lease of medicament in the gastrointestinal
tract, and provide an elegant or distinctive finish to the tablet.
Types of Coating:
1. Pan Coating
2. Fluid bed Coating
3. Compression Coating Machine
Pan Coating
Spray nozzle for tablet coating
Fluidised Bed Coating
Tablet Deffects
1. Capping
2. Lamination/Laminating
3. Chipping
4. Cracking
5. Sticking/Filming
6. Picking
7. Binding
8. Mottling
9. Double impression
Capping : (Upper or lower segment of tablet separates horizontally)
Large amount of fines in the granulation
Too dry or very low moisture content (leading to loss of proper binding action).
Not thoroughly dried granules
Insufficient amount of binder or improper binder.
Insufficient or improper lubricant.
Granular mass too cold to compress firm
Poorly finished dies
Deep concave punches or beveled‐edge faces of punches.
Lower punch remains below the face of die during ejection.
High turret speed.
LAMINATION: (Separation of tablets into two or more distinct horizontal layers )
Rapid relaxation of the peripheral regions of a tablet, on ejection from a die
Rapid decompression. Use pre‐compression step.
CHIPPING : (breaking of tablet edges while the tablet leaves the press)
Sticking on punch faces
Too dry granules
Too much binding causes chipping at bottom
Groove of die worn at compression point
Barreled die (center of the die wider than ends)
Edge of punch face turned inside/inward
Concavity too deep to compress properly
High degree of attrition associated with coating process
Sticking : (Adherence of tablet material to die)
Granules not dried properly
Too little or improper lubrication
Too much binder
Too soft or weak granules
Cracking (Small fine cracks observed on upper and lower surface of tablets)
Large size of Granules
Too dry granules
Granulation condition too cold
Tablet expansion during ejection due to entrapment of air
Deep concavities in dies and punches
Picking (Product sticking only within letters,logos,or designs on punch faces)
Low melting point substances may soften due to heat of compression
Too warm granules when compression
Too much amount of binder
Dividing lie too deep
Pressure applied is not enough
Rough punch faces
Binding (Sticking of tablet to the die and does not eject properly out of die)
Too moist granules
Insufficient or improper lubricant
Too coarse granules
Too hard granules for the lubricant to be effective
Poorly finished dies
Rough dies due to abrasion or corrosion
Undersized dies
MOTTLING (unequal distribution of color on tablet)
Colored drug used along with colorless or white colored excipients
Dye migration to surface of granulation while drying
Improper mixing of dye during “Direct Compression”
Improper mixing of color binder solution
Blistering (Detachment of film from the substrate forming a blister)
Effect of temperature on the strength, elasticity and adhesion of the film
Overheating during spraying coating solution
Cratering (Defect of film coating:- volcanic like craters appears exposing tablet surface )
Penetration of coating solution into the surface of tablet
Inefficient drying
Pitting (Pits occurs on the surface of tablet)
Incontinous spreading of film
Temperature of core is greater than melting point of material used in tablet
Blooming (Polish of tablet show dull appearance)
Prolong storage
Surface roughness
ORANGE PEEL (Coating texture that resembles orange peel surface)
Shows “Orange peel” effect of the coating film
Rapid Drying
High Coating solution viscosity
Some important facts
 India’s cost of production is nearly 33 per cent lower than that of the US
 Labour costs are 50–55 per cent cheaper than in Western countries.
 Cost of setting up a production plant in India is 40 per cent lower than in Western countries
 India has a skilled workforce as well as high managerial & technical competence in
comparison to its peers in Asia
 India has the 2nd largest number of USFDA-approved manufacturing plants outside the US
 India has 2,633 FDA-approved drug products. India has over 546 USFDA-approved
company sites, the highest number outside the US
 Economic prosperity would improve affordability for generic drugs in the market &
improve per capita sales of pharmaceuticals in India

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Processing of tablets

  • 1. By : Dr. K.B.Gabhane Assistant Professor Department of Pharmaceutical Chemistry, Vidyabharti College of Pharmacy, Amravati PROCESSING OF TABLETS
  • 2.
  • 3. DEFINATION  According to the Indian Pharmacopoeia : Pharmaceutical tablets are solid, flat or biconvex dishes, unit dosage form, prepared by compressing a drugs or a mixture of drugs, with or without diluents. They vary in shape and differ greatly in size and weight, depending on amount of medicinal substances and the intended mode of administration.
  • 4. Advantages  They are unit dosage form and offer the greatest capabilities of all oral dosage form for the greatest dose precision and the least content variability.  Cost is lowest of all oral dosage form.  Lighter and compact  Easiest and cheapest to package and strip.  Easy to swallowing with least tendency for hang‐up.  Sustained release product is possible by enteric coating  Objectionable odour and bitter taste can be masked by coating technique.  Suitable for large scale production.  Greatest chemical and microbial stability over all oral dosage form.  Product identification is easy and rapid requiring no additional steps when employing an embossed and/or monogrammed punch face.
  • 5. Disadvantages of Tablet dosage form are 1. Difficult to swallow in case of children and unconscious patients. 2. Some drugs resist compression into dense compacts, owing to amorphous nature, low density character. 3. Drugs with poor wetting, slow dissolution properties, optimum absorption high in GIT may be difficult to formulate or manufacture as a tablet that will still provide adequate or full drug bioavailability. 4. Bitter testing drugs, drugs with an objectionable odor or drugs that are sensitive to oxygen may require encapsulation or coating. In such cases, capsule may offer the best and lowest cost.
  • 6. General properties of Tablet dosage forms: 1. A tablet should have elegant product identity while free of defects like chips, cracks, discoloration, and contamination. 2. Should have sufficient strength to withstand mechanical shock during its production packaging, shipping and dispensing. 3. Should have the chemical and physical stability to maintain its physical attributes over time 4. The tablet must be able to release the medicinal agents in a predictable and reproducible manner. 5. Must have a chemical stability over time so as not to follow alteration of the medicinal agents.
  • 7. (A) Tablets ingested orally: Compressed tablet, e.g. Paracetamol tablet Multiple compressed tablet Repeat action tablet Delayed release tablet, e.g. Enteric coated Bisacodyl tablet Sugar coated tablet, e.g. Multivitamin tablet Film coated tablet, e.g. Metronidazole tablet Chewable tablet, e.g. Antacid tablet (B) Tablets used in oral cavity: Buccal tablet, e.g. Vitamin‐c tablet Sublingual tablet, e.g. Vicks Menthol tablet Troches or lozenges Dental cone
  • 8. (c) Tablets administered by other route: 1. Implantation tablet 2. Vaginal tablet, e.g. Clotrimazole tablet (D) Tablets used to prepare solution: 1. Effervescent tablet, e.g. Dispirin tablet (Aspirin) 2. Dispensing tablet, e.g. Enzyme tablet (Digiplex) 3. Hypodermic tablet 4. Tablet triturates e.g. Enzyme tablet (Digiplex)
  • 9. Tablet Ingredients In addition to active ingredients, tablet contains a number of inert materials known as additives or excipients. Different excipients are: Sr.no. Excipients 1 Diluent 2 Binder and adhesive 3 Disintegrents 4 Lubricants and glidants 5 Colouring agents 6 Flavoring agents 7 Sweetening agents
  • 10. Granulation technology on large scale by various techniques
  • 13. Tablet Compression Machine Tablets are made by compressing a formulation containing a drug or drugs with excipients on stamping machine called presses. Tablet presses are designed with following basic components: 1) Hopper for holding and feeding granulation 2) Dies that define the size and shape of the tablet 3) Punches for compressing the granulation within the dies 4) Cam tracks for guiding the movement of the punches. 5) A feeding mechanism for moving granulation from hopper into the dies
  • 15. Die Filling and tablet ejection process
  • 16. Evaluation of Tablet General Appearance Weight variation test Size and shape Content Uniformity test Unique Identification marking Disintegration test Organoleptic Properties Dissolution test Hardness Friability
  • 17. Tablet Coating To mask the taste of unpalatable drugs, protect the drug from deterioration due to light, oxygen or moisture, separate in compatible ingredients, control there lease of medicament in the gastrointestinal tract, and provide an elegant or distinctive finish to the tablet. Types of Coating: 1. Pan Coating 2. Fluid bed Coating 3. Compression Coating Machine
  • 19. Spray nozzle for tablet coating
  • 21. Tablet Deffects 1. Capping 2. Lamination/Laminating 3. Chipping 4. Cracking 5. Sticking/Filming 6. Picking 7. Binding 8. Mottling 9. Double impression
  • 22. Capping : (Upper or lower segment of tablet separates horizontally) Large amount of fines in the granulation Too dry or very low moisture content (leading to loss of proper binding action). Not thoroughly dried granules Insufficient amount of binder or improper binder. Insufficient or improper lubricant. Granular mass too cold to compress firm Poorly finished dies Deep concave punches or beveled‐edge faces of punches. Lower punch remains below the face of die during ejection. High turret speed.
  • 23. LAMINATION: (Separation of tablets into two or more distinct horizontal layers ) Rapid relaxation of the peripheral regions of a tablet, on ejection from a die Rapid decompression. Use pre‐compression step. CHIPPING : (breaking of tablet edges while the tablet leaves the press) Sticking on punch faces Too dry granules Too much binding causes chipping at bottom Groove of die worn at compression point Barreled die (center of the die wider than ends) Edge of punch face turned inside/inward Concavity too deep to compress properly High degree of attrition associated with coating process
  • 24. Sticking : (Adherence of tablet material to die) Granules not dried properly Too little or improper lubrication Too much binder Too soft or weak granules Cracking (Small fine cracks observed on upper and lower surface of tablets) Large size of Granules Too dry granules Granulation condition too cold Tablet expansion during ejection due to entrapment of air Deep concavities in dies and punches Picking (Product sticking only within letters,logos,or designs on punch faces) Low melting point substances may soften due to heat of compression Too warm granules when compression Too much amount of binder Dividing lie too deep
  • 25. Pressure applied is not enough Rough punch faces Binding (Sticking of tablet to the die and does not eject properly out of die) Too moist granules Insufficient or improper lubricant Too coarse granules Too hard granules for the lubricant to be effective Poorly finished dies Rough dies due to abrasion or corrosion Undersized dies MOTTLING (unequal distribution of color on tablet) Colored drug used along with colorless or white colored excipients Dye migration to surface of granulation while drying Improper mixing of dye during “Direct Compression” Improper mixing of color binder solution
  • 26. Blistering (Detachment of film from the substrate forming a blister) Effect of temperature on the strength, elasticity and adhesion of the film Overheating during spraying coating solution Cratering (Defect of film coating:- volcanic like craters appears exposing tablet surface ) Penetration of coating solution into the surface of tablet Inefficient drying Pitting (Pits occurs on the surface of tablet) Incontinous spreading of film Temperature of core is greater than melting point of material used in tablet Blooming (Polish of tablet show dull appearance) Prolong storage Surface roughness
  • 27. ORANGE PEEL (Coating texture that resembles orange peel surface) Shows “Orange peel” effect of the coating film Rapid Drying High Coating solution viscosity
  • 28. Some important facts  India’s cost of production is nearly 33 per cent lower than that of the US  Labour costs are 50–55 per cent cheaper than in Western countries.  Cost of setting up a production plant in India is 40 per cent lower than in Western countries  India has a skilled workforce as well as high managerial & technical competence in comparison to its peers in Asia  India has the 2nd largest number of USFDA-approved manufacturing plants outside the US  India has 2,633 FDA-approved drug products. India has over 546 USFDA-approved company sites, the highest number outside the US  Economic prosperity would improve affordability for generic drugs in the market & improve per capita sales of pharmaceuticals in India