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Tablet
Tablets are solid dosage form containing unit dose of one or more active ingredients
along with the necessary excipients and prepared by compression of the powder
particles.
Characteristics:
1. It is solid dosage form.
2. It is usually orally taken.
3. It is a unit dosage form.
4. It is prepared by compression.
Potential advantages:
1. Better chemically, physically and biologically stable.
2. Accurate dose of the drug.
3. It can be mass produced under strictly quality control.
4. It contains low price.
5. It is safe to administrate.
Disadvantages:
1. Initial investment is expensive for buying machineries.
2. It is responsible for local irritation and damage stomach.
3. Improper formulation may cause bioavailability problem.
4. It is tough for children/older to take.
5. It is not suitable for immediate administration.
Ideal Characteristics:
1. The dose should be accurate.
2. Appearance should be good.
3. Drug should be released from the tablet.
4. Should be biocompatible.
5. Packaging should be effective and safe.
6. Should be physically, chemically, microbiologically stable. | 1
7. Color and Size should be attractive.
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achieve rapid effect. |
To reduce gastric irritation.
Formulation aspect:
a) Gaseous disintegrated CO2 is generated by reaction of an acid (tartaric acid/citric
acid) and a Na carbonate/bicarbonate.
b) Water soluble friction reducing agents are used. (HPMC) Hydroxyl Propyl Methyl
Cellulose Polymer.
c) Binder may not be used.
d) Flavoring and coloring agent is used.
e) CO2 covers the taste bards of the term and helps in taste masking.
f) Packages must be completely water proof.
4) Compressed Lozenges: Example benzocaine, analgesics.
Objective:
To dissolve slowly in the mouth.
Used for localized effect in the mouth.
Characteristics:
Slowly disintegrate in the mouth.
Slow release tablets for local drug treatment.
Use for both the systemic and local effects.
Harder than ordinary tablets.
Formulation aspect:
1) No disintegrating agents are used.
2) Coloring and flavoring agent.
3) Particular filler and binders are used. Gelatin is commonly usable binder.
4) Have high mechanical strength and low porosity. Which is responsible for slow
release.
5) Sublingual tablets and buccal tablets: Example - prochlorperazine maleate for nausea
Objective:
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To release drug in the mouth followed by systemic uptake of the drug. |
Used for localized effect in the mouth.
Characteristics:
1) Drug effect can obtained without first-pass liver metabolism.
2) Sublingual tablets are placed under the tongue and
3) Buccal tablets are placed in the side of the cheek.
4) Tablets are often small and porous.
5) The latter facilitating fast disintegration and drug release.
6) They remain in position, releasing drug, for 12 hours.
Formulation aspect:
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POLYVENYLPYRROLIDONE
Concentration: 2 to 8%
Characteristics: 1) Soluble in water and ethanol.
2) Has different viscosity grade.
C. Disintegrant/Disintegrating agent: The agent which helps to break down the tablet is
called disintegrating agent.
Types: On the basis of adding position it can be divided into two types:
1) Intra granular: Required to convert primary particles from granules. 66
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2) Extra granular: Required to covert granules from tablet e.g. Starch (conc. is 5-10%)
Md. Asif Hasan Niloy
5th Semester 24 BATCH
Industrial Pharmacy
Tablet
Course Instructor: MD.SELIM HOSSAIN
D. Lubricating agent: The agents which reduces friction is called lubricating agents. On
the basis of friction these agents are classified into
1) Glidant: Remove particle-particle friction in the hopper and improve flow
property of tableting materials. e.g., Silicon dioxide/Colloidal silica (1-5% mostly
used in pharmaceuticals), Talc (1-5%), calcium scilicet (0.5 to 2%)
2) Lubricant: They reduce friction between the side surface of the tablet and the die
wall. On the basis of mechanism these are subdivided into
i. Boundary Lubricants: These produce a solid particular film between the surface
and the wall. e.g., Mg-stearate (o.2-2% mostly used in pharmaceuticals.
hydrophobic in nature), Ca-stearate (o.5-4%; hydrophobic in nature),
Polyethylene glycol (2-10%, hydrophilic in nature).
ii. Fluid Lubricants: These produce a liquid particular film between the surface and
the wall. e.g., Live mineral oil (1-3% mostly used in pharmaceuticals.
hydrophobic in nature).
3) Anti-adherent: It reduces the friction between the punch phases and surface of the
tablet. e.g., Mg-stearate (0.5-2%), Talc (1-5%)
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99
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4) Deformation of the solid body: Development of the Vander walls force and
hydrogen bonds between particles which is smaller than 50nm.
5) Elastic recovery or Decompression & Recovery: With increasing pressure the
density of the particles increases. At a moment when excess amount of pressure
applied forms deformation.
Tablet Press/Machine:
Basic Parts: 1. Die: It requires to filling tablet materials.
2. Punches: It helps in compression.
These are two types:
a. Upper punch.
b. Lower punch.
Tablet Press/Machine: Tablet machines are basically two types
a. Single punch machine
b. Multi punch machine.
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Tablet Machine Brand Name 1. Cudmach 2. Kikusui 3. Sviac
4. Killian 5. Hatta 6. Fette 10
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7. Monusty 8. Courtoy 9. Stokes.
Md. Asif Hasan Niloy
5th Semester 24 BATCH
Industrial Pharmacy
Tablet
Course Instructor: MD.SELIM HOSSAIN
Weight variation: This is associated with under or over filling of the dye cavity during
tablet production. Over weight is responsible for toxicity.
Reason:
1) Formulation: Improper amount of gradient.
Solution: Use adequate gradient/sufficient gradient.
2) Tableting process: Poor mixing of gradient/lubricant.
Solution: Ensure optimum mixing of gradient or lubricant.
3) Tableting machine:
Length variation of lower punches.
Solution: Replace damaged punch.
Instrument parts are not properly cleaned.
Solution: Clean all parts properly.
Improper setting of instrument.
Solution: Instrument should be set up properly.
Double impression: It is the occurrence of too impression or too imprint on the upper
or lower surface of the tablet.
Reason:
1) Tableting machine: Free rotation and uncontrolled traveling of the lower punch
between compression and ejection.
Solution: Proper controlling of punches. Especially lower punch.
Tests
1) Concentration variation test.
2) Content uniformity test.
3) Hardness test.
4) Friability test.
5) Disintegration test.
6) Dissolution test.
7) Appearance
8) Size and Shape (diameter/thickness).
9) Organoleptic properties (color, odor)
10) Assay or potency.
11) Presence of impurity.
Content uniformly
Used to check the weight of the tablet.
If API amount is less than 40mg apply correct dose test. It is applicable for low dose
tablets.
At first take 30 tablets and assayed for result.
85 to 115% is the acceptable range.
Hardness Test
Used to check
Hardness test machines:
Monsanto Hardness taster.
Pfizer Hardness taster.
Exceptable limit: In industry pressure is measured in kg.
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Oral tablets: 1 to 10kg
Chewable tablets: 3kg 15
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Sustain release tablets: 10 to 20kg.
Md. Asif Hasan Niloy
5th Semester 24 BATCH
Industrial Pharmacy
Tablet
Course Instructor: MD.SELIM HOSSAIN
Friability Test
Used to ensure that tablets do not break up during production and subsequent process
packaging like-packaging, transportation.
Friability test machines: Friabilator (Roche Company)
At first take 10 tablets and then weighted out.
Then take place in the machine to rotate the tablets for 100 times.
This machine rotate 25 times per minute.
Again weighted out the tablets. And finally
% of weight loss = (Initial weight -Final weight)/(Initial weight) 100
Normal range: Loss amount is not more than 1%
Disintegration Test
Used to measure the time requires to break down into granules.
Take 6 tablets and allow to pass through the machine. And calculate the time
requires to break down of the tablets.
Temperature: Requires 37
29 to 32 movements per minute.
Sieve size is 2 tp 2 0.2 mm
Required medium like water, phosphate buffer.
For uncoated tablets: - For film-coated tablets: -
Time: 15 minutes Time: 30 minutes
Media: H2O Media: H2O or 0.1M HCl
For sugar-coated tablets: -
Time: 60 minutes
Media: H2O or 0.1M HCl
For effervescing tablets: -
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5minutes in beaker contains 200ml of water at room temp.
For enteric coated tablets: - 16
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First 2hours in 0.1M HCl and then 3 hours in phosphate buffers (pH 6.8)
Md. Asif Hasan Niloy
5th Semester 24 BATCH
Industrial Pharmacy
Tablet
Course Instructor: MD.SELIM HOSSAIN
Dissolution Test
Used to check the rate at which granules goes to solution form.
Machines:
USP dissolution apparatus I called Basket method.
Used for capsules.
USP dissolution apparatus II called Paddle method.
Used for tablets.
Reasons: Manufacturing process.
Type of dosage form.
Nature and amount of excipients.
Medium of dissolution: It varies with the drug types.
Water: 6.5/7.2 phosphate
Buffer: 0.1M HCl
Temperature: 37
Rotation Speed: It varies with the drug types. The normal range is 25rpm, 50rpm, 75rpm,
100rpm. And 75% should be dissolved in 45 minutes.
After going to solution form (10minutes) 5ml of the sample solution was separated and
then 5ml medium was added to the solution to maintaining balance.
The 5ml was taken to the UV spectroscopy or other spectroscopy to find out the
absorbance and calculate the dissolution rate.
After 1 hour the solution which was achieved may consider as 100% and then the
dissolution rate of the solution which is taken after 10 minutes is calculated.
Potency 96%
Overage 3%
Label claim 500mg
Batch size 100000
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Amount of drug = kg
1000 1000
500 100000 (100+3)
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96 1000 1000
kg
Md. Asif Hasan Niloy
5th Semester 24 BATCH
Industrial Pharmacy