Experiment Findings Formulation and Evaluation of PCM Tablet.pdf

The formulation of a Paracetamol (PCM) tablet involves blending the active pharmaceutical ingredient (Paracetamol) with excipients to achieve the desired tablet properties. Typically, the process includes mixing Paracetamol with fillers like microcrystalline cellulose to provide bulk, binders such as polyvinylpyrrolidone (PVP) to ensure tablet cohesion, and disintegrants like starch to facilitate dissolution. Lubricants such as magnesium stearate are added to prevent sticking during compression, and colorants or flavors might be included for aesthetic appeal. The mixture is then compressed into tablets using a tablet press, ensuring uniformity and stability in the final product.

1. OBJECT
To prepare and characterize (evaluate) tablets of given Paracetamol (PCM) drug sample.
REFERENCE
1. Leon Lachmann, Herbert. A Liebermann, “The theory and Practice of Industrial Pharmacy”, 4
th
Edition,
2013, CBS Publishers and Distributors Pvt. Ltd., New Delhi, Page no. 470-482.
2. Ofori-Kwakye K, Osei-Yeboah F, Kipo SL. Formulation and quality evaluation of two conventional release
tablet formulations. International Journal of Pharmaceutical Sciences Review and Research. 2010
Sep;4(1):94-9.
3. Srinath KR, Chowdary CP, Palanisamy P, Krishna A, Aparna S, Ali SS, Swetha K. Formulation and
evaluation of effervescent tablets of paracetamol. Int J Pharm Res Dev. 2011 May 12;3(3):76-104.
REQUIREMENTS
 Chemical Requirements: Paracetamol (PCM), Lactose, PVP, Magnesium Stearate, Tal powder and distilled
water.
 Apparatus/Glassware’s Requirements: Hot plate, Mortar & Pestle, Hot air oven, butter paper, weighing
machine, sieve no.22, Tablet punching machine, beaker, glass rod and spatula etc.
THEORY
Wet granulation is the method of granulation by which the powder is mixed with binder solution such as
granulating liquid. This method is generally the process or unit operation involving size enlargement in which the
fine powder particle are agglomerated or brought together into larger, strong on relatively permanent structure
into granules., this process id generally used for the powder which have the alternation in flow and it does not
have any problem with solvent so it in granulating solvent used for the formulation of granules. The wet
granulation method is a widely used process in the formulation of Paracetamol (PCM) tablets. This method
involves the use of a liquid binder to agglomerate the powder particles, forming granules that improve the flow
Experiment Findings: Tablets
*Rahul Pal
1
& Prachi Pandey
2

*
1
Assistant Professor, Department of Pharmaceutics, ISF College of Pharmacy (ISFCP), Moga, GT
Road, 142001, Punjab, India.
2
Assistant Professor, Faculty of Pharmaceutical Sciences, Rama University, Kanpur, UP, India.

2. and compaction properties of the powder mix. Step-by-step overview of the wet granulation process for PCM
tablet formulation:
 Weighing involves weighting of all the ingredients and poured in the mortar pastel.
 Binder addition and mixing for formation of granules 10% PVP is used as binder solution and then mixed
properly to obtain good flow property.
 Sieving when granules are prepared then poured to different sieves and granules are formed which are being
ready to dry.
 Drying using hot air oven at 60
0
C for 20 minutes.
 Sizing: The dried granules are passed through a sieve to break down any lumps and achieve the desired
particle size distribution. This step ensures uniformity in the final tablet weight and drug content.
 Addition of Lubricants: Lubricants (e.g., magnesium stearate) and glidants (e.g., colloidal silicon dioxide)
are added to the granules to enhance the flow properties and prevent sticking to the tablet punches during
compression. This step is carried out by mixing the granules with the lubricants in a blender.
 Tablet Compression: The lubricated granules are compressed into tablets using a tablet press. The
compression force is adjusted to ensure that the tablets have the appropriate hardness, friability, and
disintegration time.
 Tablet Coating: If required, the tablets can be coated with a film or sugar coating to enhance their
appearance, mask the taste, or control the release of the drug.
Wet granulation is favored for PCM tablets because it enhances the flowability and compressibility of the powder,
leading to uniform tablet weight and consistent drug release profiles. The choice of binder, drying method, and
granule size can significantly impact the quality of the final product.
METHOD OF WET GRANULATION
Weight  Mixing  Addition of Binder (Q.S.)  Granular Sieving  Drying  Sieving of drug
granules  punching of tablet
PROCEDURE
1. Weight the ingredients at required (Table 1) concentration accurately.
2. Mix the ingredients properly in mortar and pestle.

3. 3. The PVP binder is added at specific rate to improve the binding efficiency of powder ingredients.
4. After mixing, then pass through different sieves and weigh the total amount of powdered granule which are
being using hot air oven.
5. Analyses the flow property of granules.
6. The granules are then, punched using punching machine.
7. The final tablets prepared are than evaluated as per standard of monograph.
Table 1: The list of ingredients for formulation of PCM tablet
INGREDIENTS CONCENTRATION APPLICTIONS
Paracetamol (PCM) 500 mg Drug/API salt
Lactose 135 mg Fillers/Diluent; increases tablet
volume and ensures consistency
Magnesium stearate 10mg Lubricant; prevents sticking and
improves tablet manufacturing
Talc 5mg Glidant or Anti-adherent;
enhances powder flow and
prevents sticking
Polyvinylpyrrolidone (PVP) 10% w/v in IPA Binder; ensures tablet cohesion
and structural integrity
EVALUATIONS
Flow Property
For achieving better manufacturing efficiency and product quality in powder/granules processing industries a
predictable powder flow is very crucial and for the evaluations of flowability of powder, following tests are
performed.
Table 2: Standard Limits for Flow Property
ANGLE OF REPOSE CARR’S INDEX HAUSNER RATIO FLOW PROPERTY
25-30 ≤ 10 1-1.11 Excellent
31-35 11-15 1.12-1.18 Good
36-40 16-20 1.19-.1.25 Fair
41-45 21-25 1.26-1.34 Passable
46-55 26-31 1.35-1.45 Poor

4. 1. Angle of Repose (): It is typically measured by allowing the powder to flow through a funnel to form a
conical pile on a flat surface and then measuring the angle formed between the surface and the slope of the
pile.
The maximum angel between the surface of powder and horizontal plane.
tan  =
??????
??????
=
������ �� ��??????��� �??????�����
������ �� ����� �� �??????�����

tan  =
ℎ
??????
=
1.9
3.6
=0.527
 = tan
-1
0.527 = 27.789 [Excellent Flowability]
The lower , higher the flowability of powder and vice-versa.
2. Carr’s Index (CI): CI, also known as the Compressibility Index, is a measure of the powder's ability to
decrease in volume under pressure. It is calculated using the bulk density and tapped density of the powder.
It also because compressibility index, lower the CI, better is the flow property.
Tapper Density = 062113, Bulk Density = 0.60625
i.e. Casrr’s Index =
????????????−????????????
????????????
=2.4034 [ Excellent Flowability]
CI indicates the compressibility of the powder, which reflects its flowability. Lower values indicate better flow
properties.
3. Hausner Ration (HR): Hausner's Ratio is the ratio of tapped density to bulk density. It is another parameter
used to assess the flow properties of a powder. It is related to the interparticle friction.
Lower the Hausner ration, better is the flow property.
Hausner Ratio (HR) =
??????����� ??????�����??????
??????��� ??????�����??????
= 1.0246 [Excellent Flowability]
Hausner's Ratio is a measure of powder cohesiveness. A lower ratio indicates better flow properties, while a
higher ratio suggests poor flowability.
4. Weight variation test: The weight variation test for PCM tablets is a crucial quality control measure to
ensure dosage uniformity across a batch. In this test, a sample of typically 20 tablets is randomly selected,
and each tablet is individually weighed using an analytical balance. The average weight of the tablets is
calculated, and the weight of each tablet is compared against this average. For PCM tablets, if the average
tablet weight is 324 mg or more, each tablet's weight should not deviate by more than ±5% from the average.
If the average weight falls between 130 mg and 324 mg, the permissible deviation is ±7.5%. For tablets
weighing less than 130 mg, the deviation limit is ±10%. The test is considered successful if no more than two
tablets deviate from these specified limits and none deviates by more than twice the allowable percentage.

5. This ensures that each PCM tablet delivers a consistent dose of the active ingredient, maintaining efficacy
and safety for the patient.
SR. NO. WEIGHT (MG) SR. NO. WEIGHT (MG)
1 600 11 594
2 595 12 645
3 640 13 614
4 610 14 650
5 613 15 653
6 614 16 638
7 660 17 595
8 615 18 604
9 600 19 624
10 617 20 607
Average Weight =
??????���� ??????�����
�
=
12338
20
=619.4 mg
5 % of 619.4 mg = 31mg
Range = 588.4-650.4
Thus; 2 tablets are not in range (sr. no. 7 & 15), but remaining 18 tablets are lying in the range.
I.P. WEIGHT LIMITS
80 mg or less ± 10%
> 80 mg ± 7.5%
> 250 mg ± 5%
5. Hardness Test: The hardness test of PCM tablets is an essential QC procedure to determine the tablet's
mechanical strength, which affects its durability during packaging, transportation, and handling. This test
measures the force required to break the tablet under pressure, usually using a hardness tester like the
Monsanto or Pfizer hardness tester. The tablets are placed between two anvils, and pressure is applied until
the tablet fractures. The force applied, measured in kilograms or newtons, reflects the tablet's hardness. For
PCM tablets, the ideal hardness typically ranges between 4 to 8 kg/cm², depending on the formulation and
intended use. Proper hardness ensures that the tablet is strong enough to withstand mechanical stress while
being soft enough to disintegrate appropriately after ingestion, ensuring effective release and absorption of

6. the active ingredient. Maintaining the right hardness is crucial for the tablet's overall quality, ensuring it
performs as intended in terms of both efficacy and safety.
SR. NO. NO. OF TURNS GIVEN TO SPRING (KGF)
1. 8
2. 9
3. 8
As per IP Monograph, 4.8 KgF is the range for hardness.
6. Friability Test: The friability test for PCM tablets is a critical quality control assessment that evaluates the
tablet's resistance to abrasion and mechanical stress during handling, packaging, and transportation. This test
is conducted using a friabilator, where a pre-weighed sample of tablets (usually around 20) is subjected to a
standardized number of rotations (typically 100) in a drum that causes the tablets to tumble and fall,
simulating the wear and tear they might experience. After the rotation, the tablets are reweighed, and the
weight loss is calculated as a percentage of the initial weight. According to pharmacopoeial standards, the
acceptable limit for friability is typically less than 1%. If the weight loss exceeds this limit, the batch is
considered to have poor friability, indicating that the tablets may crumble or break during handling. Ensuring
low friability in PCM tablets is crucial for maintaining their integrity, ensuring that they reach the consumer
intact and effective.
Initial weight take = 6.62gm
Final weight after friability test performed = 6.567gm
??????��������??????=
������� ??????����� – ??????���� ??????�����
������� ??????�����
x 100
=
6.62−6.567
6.62
?????? 100
=0.8%
IP Limit: Equal or less than 1%.
RESULT
Tablet are prepared and evaluated, the results of quality control evaluations are obtained within the specified
ranges.