PHARM.

D III YEAR Pharmaceutical Formulation – I 838806

PREPARATION OF APPIRIN TABLETS

AIM: To prepare and submit Aspirin tablets by direct compression method.
REQUIREMENTS: Mortar and pestle, spatula, beaker, Sieve
PRINCIPLE: Tablet is an important solid dosage form which is usually prepared with the aid of
suitable pharmaceutical excipients. Tablets may vary with size, shape, cut, hardness, thickness. Their
disintegration and dissolution characteristics and other aspects change depending on their intended
use and method of manufacturing.
Compressed tablets are mainly prepared by 3 basic methods
• Wet granulation
• Dry granulation
• Direct compression
DIRECT COMPRESSION: In the direct compression method, directly compressible filler (also
called a filler-binder) is blended with the active(s), a lubricant and a disintegrating agent. Such free
flowing directly compressible fillers make direct compression possible and practical. These include
anhydrous lactose, unmilled dicalcium phosphate dihydrate, microcrystalline cellulose (e.g., Avicel
PH 101), and modified (spray processed) lactose (e.g., Ludipress). Modified starch,
e.g. Starch 1500 flows better and compresses better than original starch, but are not as effective as
other materials as the sole filler-binder. Generally, Starch 1500 is used as a component of a direct
compression filler system, most likely for its disintegrating property, i.e., as a more
compactible and better flowing substitute for starch. Certain materials like mannitol, sorbitol and
modified sucrose are particularly useful in formulating direct compression chewable tablets.
Direct compression method can be classified as
a) Direct Compression with direct compressible materials and
b) Direct Compression by Slugging method
Equipment’s used in direct compression method:
1. Electronic Balance
2. Sieve
3. Double cone blender
4. Rotary Press

Advantages of direct compression technology

➢ The adoption of direct compression technology is based on the following advantages or
benefits
➢ Direct compression method requires fewer processing steps (unit operations) and less
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PHARM.D III YEAR Pharmaceutical Formulation – I 838806

equipment. Therefore, the method is potentially less expensive than other methods used in
tablet manufacture.
➢ Tablet manufacture can be carried out without the involvement of moisture and heat. Hence,
product stability is almost guaranteed.
➢ Some direct compressible excipients possess inherent disintegration properties e.g.,
microcrystalline cellulose.
➢ Tablets produced by direct compression method generally show faster dissolution times than
those prepared by wet granulation. This is because tablets manufactured by direct compression
method disintegrate into primary particle state unlike those manufactured by wet granulation
method which breaks down into granules and finally into primary particle state.
➢ Changes in dissolution profile are less likely to occur in tablets manufactured by direct
compression (if stored for a long time) than in those prepared by wet granulation.
➢ Because direct compression excipients have a relatively high binding capacity, the pressure
required to manufacture the desired hardness is, in general, less with direct compression
vehicles than with conventional granulations, resulting in both higher production rates and
longer machine life.
➢ Lubrication is performed in the same vessel as powder mixing, thereby reducing both transfer
losses and contamination of equipment.
Limitations of direct compression technology
➢ There are a number of reasons why direct compression may not be suitable for a wide array of
products and they include:
➢ High-dose drugs may present problems with direct compression if it is not easily compressible
by itself.
➢ The choice of excipients used in the manufacture of tablets by direct compression technology is
highly restricted since most materials do not have inherent binding properties.
➢ Low-dose drugs may not be uniformly blended.
➢ Direct compression excipients are often more expensive than other tablet excipients used in wet
granulation or slugging.
➢ A vast majority of drug substances are rarely so easy to tablet by direct compression. Thus, in
choosing a vehicle, it is necessary to consider the dilution potential of the major filler-binder

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PHARM.D III YEAR Pharmaceutical Formulation – I 838806

Ingredients table (Formula)

Ingredients Quantity
Aspirin 75 mg
PVP 40 mg
Mg Stearate 4 mg
Talc 8 mg
Lactose 273 mg

PROCEDURE (Direct Compression with direct compressible materials)

FIGURE -1 DIRECT COMPRESSION FLOW CHART

FIGURE -2 DIRECT COMPRESSION FLOW CHART

SHARDA SCHOOL SCHOOL OF PHARMACY

PHARM.D III YEAR Pharmaceutical Formulation – I 838806

OBSERVATION TABLE

OBSERVATION RESULT
Bulk density:
Tapped density:
Carr’s Compressibility Index:
Hausner’s ratio:
Angle of repose:

ASPIRIN TABLETS
Category Analgesic
Direction
Storage STORE IN A COOL PLACE
“FOR INTERNAL USE ONLY”
Mfg Date
Exp Date
Batch No
Lic No
Department Of Pharmaceutics
Sharda School Of Pharmacy
Gandhinagar,Pethapur.

SHARDA SCHOOL SCHOOL OF PHARMACY

 PHARM.D III YEAR Pharmaceutical Formulation – I 838806

EVALUATION OF ASPIRIN TABLETS

AIM: To evaluate prepared Aspirin tablets by using direct compression method.
REQUIREMENTS: Beaker, Test tubes, Test apparatuses Evaluation parameters of tablets:
APPEARANCE:
Tablet from each formulation were randomly selected and organoleptic properties such as color,
taste, and shape were evaluated.
HARDNESS TEST:
The tablet hardness is defined as the force required to break a tablet in a diametric direction. A
tablet was placed between two anvils. Force was applied to anvils and crushing strength that
causes the tablet to break was recorded. The hardness was measured using Monsanto hardness
tester.
THICKNESS:
The thickness of tablets was determined using a Vernier caliper. Three tablets from each batch
were used, and average values were calculated.
FRIABILITY TEST:
The friability of tablets was determined using Roche Friabilator. It is express in percentage (%).
Ten or twenty tablets were initially weighed and revolved at 25 rpm for 4 min. The tablets were
then reweighed after removal of fines and the percentage of weight loss was calculated. The %
friability was then calculated by,
F = (Winitial – Wfiinal) x 100 / Winitial
Acceptance criteria for % friability % weight loss should be less than 1%.
WEIGHT VARIATION TEST:
Twenty tablets were selected randomly from each batch and weighed individually on electronic
balance. The individual weighed is then compared with average weight for the weight variations.
The following percentage deviation in weight variation is allowed (U.S.P).
Average weight % difference
130 mg or less 10
130 – 324 mg 7.5
More than 324 mg 5

DISINTEGRATION TIME TESTING:

It was determine using USP tablet disintegration test apparatus, using 900 ml of distilled water
without disk at room temperature. Test was performed on 6 tablets. One tablet each is kept in all

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 PHARM.D III YEAR Pharmaceutical Formulation – I 838806

six tubes. The tubes travel upward and downward in water at 37⁰C±2⁰C. The time taken for all the
six tablets to break down and pass through the mesh at the bottom of the tube is noted. The tablets
pass the test if all the six tablets disintegrate within the prescribed time ( Less than 30 mins for
uncoated tablets as per U.S.P).
REPORT: The evaluation tests are performed and all the tablets are found to be in the acceptable
limits.

OBSERVATION RESULT
Shape
Hardness
Friability
Weight variation
Disintegration test

VIVA QUESTIONS:
How can we calculate friability of uncoated tablet?
Which test apparatus is used for invitro drug release study?
What are the different organoleptic properties are tested for tablet?

ASPIRIN TABLETS
Category Analgesic
Direction
Storage STORE IN A COOL PLACE
“FOR INTERNAL USE ONLY”
Mfg Date
Exp Date
Batch No
Lic No
Department Of Pharmaceutics
Sharda School Of Pharmacy
Gandhinagar,Pethapur.

SHARDA SCHOOL SCHOOL OF PHARMACY

 PHARM.D III YEAR Pharmaceutical Formulation – I 838806

PREPARATION OF PARACETAMOL TABLETS

AIM: To prepare and submit paracetamol tablets by wet granulation method.
REQUIREMENTS: Mortar and pestle, spatula, beaker, Sieve
PRINCIPLE: Tablet is an important solid dosage form which is usually prepared with the aid of
suitable pharmaceutical excipients. Tablets may vary with size, shape, cut, hardness, thickness. Their
disintegration and dissolution characteristics and other aspects change depending on their intended
use and method of manufacturing.
Compressed tablets are mainly prepared by 3 basic methods
• Wet granulation
• Dry granulation
• Direct compression
Wet granulation is the widely used method for the production of compressed tablets.

Stepsinvolved in wet granulation method are

h) Weighing and blending of ingredients
i) Preparing a damp mass by adding wet binder
j) Converting the damp mass into wet granules
k) Drying of granules
l) Sizing the granules by dry screening
m) Addition of lubricants
n) Formation of tablets by compression
During the preparation process each step may influence the quality of tablet produced. In this
preparation Aspirin used as API (Aspirin, also known as acetylsalicylic acid, is a medicationused
to treat pain, fever, or inflammation), lactose as adjuvant, acacia as binding agent, starch
monohydrate as disintegrant, magnesium stearate as lubricant and talc as Glidant.

ADVANTAGES :

Advantages of wet granulation

1. Wet granulation modifies the properties of formulation ingredients to overcome their tableting
deficiencies. Granules formed are relatively more spherical than the powders and have better flow
properties.

2. Improved compressibility of powders resulting from wet granulation process allows the use of low
pressure during compression. This reduces machine wear and thus improves the life of the machine.

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 PHARM.D III YEAR Pharmaceutical Formulation – I 838806

3. The process makes use of conventional excipients and therefore is not dependent on the inclusion of
special grades of excipients.

4. It ensures better content uniformity, especially for soluble low-dose drugs.

5. The process may improve the dissolution rate of poorly soluble drugs by imparting hydrophilic
properties to the surface of the granules.

6. Wet granulation prevents segregation of components of a homogenous powder mix during

processing, transferring, handling and/or storage, leading to reduced intra- and inter-batch variability.

Tablets manufactured by wet granulation are amenable to post-processing unit operations such as tablet
coating.

8. Wet granulation reduces the level of dust present during manufacturing process thereby reducing the
incidence of cross-contamination and risk to workers.

9. Wet granulation reduces the amount of air entrapment thereby increasing powder compressibility.

Ingredients table (Formula):

Ingredients Quantity
Paracetamol 200 mg
Starch 85 mg
Mcc 200 mg
Mg Stearate 10 mg
Talc 5 mg
Aerosil 1 mg

PROCEDURE:
a) Divide disintegrating agent (starch monohydrate) into 2 portions to incorporate during wet
granulation and after drying of granules to act as an intragranular and extra granular
disintegrant.
b) Wet Granulation: Accurately weigh and mix the specified amount of Aspirin and other
excipients (except half of the disintegrating agent and lubricant) until uniform powder is
formed by geometric mixing.
c) A damp mass of the mixture is prepared by adding appropriate amount of the acacia and drop
wise addition of water.

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 PHARM.D III YEAR Pharmaceutical Formulation – I 838806

d) Wet mass is subsequently passes through a 6/10 mesh sieve/screen to form wet granules.
Resulted granules are spread evenly on a large piece of paper in a tray and dried at 40⁰C-
60⁰C for 30min in an oven.
e) Dried granules are passed through a sieve 16 or 20 # and mixed with remaining half of the
disintegrating agent and lubricant.
f) Resulting granules mixture is compressed in a tablet compression machine to obtain tablets.
g) Prepared tablets are stored properly for further evaluation.

REPORT: Paracetamol tablets were prepared by wet granulation method and submitted

VIVA QUESTIONS:
➢ What is the use of paracetamol tablet?
➢ What is the use of diluent and Glidant in tablet formulation?
➢ Give examples.Give some examples of binders used in tablet formulation.
➢ Why disintegrating agents are used in 2 portions in tablet preparation?

PARACETAMOL TABLETS
Category Antipyretic
Direction
Storage STORE IN A COOL PLACE
“FOR INTERNAL USE ONLY”
Mfg Date
Exp Date
Batch No
Lic No
Department Of Pharmaceutics
Sharda School Of Pharmacy
Gandhinagar,Pethapur.

SHARDA SCHOOL SCHOOL OF PHARMACY