ACTIVITY NO.

7
ACETAMINOPHEN TABLETS 300 mg

Name: Villajuan, Kirsten Joyce Q. Date: May 4, 2021

Yr. and Section: PH 3-A Group No.: Group 2
Company Name: DICISAFE

DATA SHEET

Product Name: ACETAMINOPHEN Tablet 300 mg Batch Size: 50 tablets

Manufacturing Order No.: B7050221 Date of Manufacture: May 2021
Finishing Order No.: 407 Control/Lot no.: 3A-0207
Batch Number: 02-07050421 Expiry Date: May 2022

Formula:

Name of Product Generic Name: Acetaminophen

Brand Name: Cetylphen

Active Ingredients Use in the formulation

Acetaminophen Active ingredient (analgesic/antipyretic)

Excipients

Starch paste, 10% Binder/Diluent/Disintegrant

Lactose Filler/Binder/Diluent

Stearic Acid Lubricant

Talc Glidant/Lubricant

Dose:
Adults and Children 12 years and older:
Orally, 1 to 2 tablets every 4 to 6 hours, as needed for pain and/or fever, or, as directed by a
doctor.
Do not take more than 4 g (8 tablets) in each 24-hour period.
Do not use more than the recommended dose.

Special Instructions:
● Do not take this medicine if you are allergic to acetaminophen or any ingredient in the
product.
● Avoid long-term use of acetaminophen in patients with anemia or with heart, lung,
kidney, or liver disease.
 ● If more than the recommended dosage has been given, consult a doctor or contact a
Poison Control center right away. Quick medical attention is important for adults as well
as for children even if you do not notice any signs or symptoms because of the risk of
delayed, serious liver damage.
● Ask a doctor before use if the patient has kidney or liver problems or is taking warfarin.
● If you are pregnant or breastfeeding, consult your doctor before use.
● Stop use and ask a doctor if new symptoms occur, symptoms do not get better, redness
or swelling is present, fever gets worse or lasts more than 3 days, or if pain gets worse
or lasts more than 10 days.
● Keep the product out of sight and reach of children.
● Store at temperatures not exceeding 30°C.

Use:
For the relief of minor aches and pains such as headache, backache, menstrual cramps,
muscular aches, minor arthritis pain, toothache, and pain associated with the common cold and
flu.
For fever reduction.

Answers to Questions
1. Differentiate Wet Granulation and Dry Granulation Method.

Wet Granulation is a common method for producing compressed tablets. It is the

method of forming granules by the addition of a granulating liquid. This fluid aids in the
bonding of particles. The liquid solution is basically non-toxic and volatile. The solvent
must be volatile so it can be extracted later by drying. Wet granulation involves
combining the powder with a granulating fluid and forcing it through a sieve to form
tablets. Wet granulation is needed to prevent the powder's active components from
being destroyed. Wet granulation processes usually necessitate more machinery, plant
space, and higher investment costs than dry granulation processes.

Dry granulation is the method of creating granules without the use of a liquid solution.
The powder mixture is compacted into large chunks before being broken down or sized
into granules. The compacting force ensures that particles are bonded together. The
agent or the diluent must have coherent characteristics for this process. Dry granulation
is particularly useful for materials that degrade in moisture or at elevated temperatures
required for drying the granules in wet granulation.

Reference/s:
Allen. (2017). Ansel’s pharmaceutical dosage forms and drug delivery systems (11th
ed.). Lippincott Williams and Wilkins.
Madhusha. (2018). Difference Between Dry and Wet Granulation: Definition, Process,
Differences. Pediaa.Com.
https://pediaa.com/difference-between-dry-and-wet-granulation/.
2. What are the different steps involved in the Wet Granulation Method? Dry
Granulation Method?

Wet Granulation
The steps required are:
A. Weighing and blending the ingredients
A mechanical powder blender or mixer is used to mix specified amounts of active
ingredient, diluent or filler, and disintegrating agent until uniform.
B. Preparing a dampened powder or a damp mass
To aid in the adhesion of the powder particles, a liquid binder is added to the
powder mixture. To prepare the granulation, either a dampened powder molded
into granules or a damp mass resembling dough is formed and used. A good
binder produces an appropriate tablet hardness while not interfering with the
drug's release from the tablet.
C. Screening the dampened powder or damp mass into pellets or granules
To prepare the granules, the dampened powder granules are screened, or the
wet mass is pressed through a screen (usually 6 or 8 meshes). This can be
achieved by hand or with special equipment that extrudes the granules through
the apparatus's perforations. The resulting granules are uniformly distributed
through large, lined trays and dried up to a constant weight or moisture content.
D. Drying the granulation
Granules can be dried in temperature-controlled ovens that keep track of time,
temperature, and humidity.
E. Sizing the granulation by dry screening
Following drying, the granules are passed through a smaller mesh filter than that
used to prepare the initial granulation. The size of the punches to be used
determines the degree to which the granules are reduced. In general, the smaller
the granules, the smaller the tablet to be made. Screens with a mesh size of 12
to 20 mesh are commonly used for this purpose. Sizing the granules is needed
so that the free-flowing granulation can fully and quickly fill the die cavity for
tablet compression. Uneven tablets are produced as a result of voids or air
spaces left by excessive granulation.
F. Adding lubricant and blending
After dry screening, a dry lubricant is dusted over the spread-out granulation
through a fine-mesh screen.
G. Forming tablets by compression

Dry Granulation
The steps required are:
A. Weighing formulation ingredients
The right amount of formulation ingredients is dispensed. The excipients and
active ingredient(s) must be finely divided; otherwise, particle size reduction must
be performed.
B. Mixing of formulation ingredients
 The ingredients of the dispensed formulation are combined in a powder mixer
until the powder mix is uniform. It's worth noting that at this point, half of the
lubricant in the formula is added to improve powder flow during slugging and
prevent compressed powder from sticking to the die during precompression..
C. Compression of mixed powders into slugs
The mixture is compressed into large, flat tablets or pellets. This is known as
“precompression (slugging),” and the compacts formed in the process (typically
25 mm diameter by 10 - 15 mm thick) are known as “slugs.” The slugging
technique or roller compaction may be used to compress mixed powders into
slugs. The pressure used to create the slugs is usually lower than the pressure
used in the final compression.
D. Milling and sieving of slugs
Following slugging, the next step in the dry granulation process normally entails
breaking slugs into smaller pieces with a hammer mill or other traditional milling
equipment. To produce uniform granules, the milled slugs are screened.
E. Mixing with disintegrant and lubricant
After screening, the rest of the lubricant and other excipients, such as the
disintegrant, glidant, etc, are incorporated and gently combined for a uniform
blend.
F. Compression of granules into tablets
A single or rotary tablet press equipped with appropriate punches and dies
compresses the mixed granules into tablets.

Two Techniques:
● Slugging - The powder mixture is slugged, or compressed, into flat tablets or
pellets about 1 inch in diameter after the ingredients have been weighed and
mixed. The slugs are broken up by hand or with a mill and sized by passing them
through a screen with the desired mesh. The lubricant is applied as normal, and
the tablets are formed by compression.
● Roller compaction - Powder compactors may be used instead of slugging to
improve the powder density by pressing it at 1 to 6 tons of pressure between the
rollers. The compacted material is broken up, sized, and lubricated before being
compressed into tablets as usual. Roller compaction is frequently preferred over
slugging.
 Reference/s:
Allen. (2017). Ansel’s pharmaceutical dosage forms and drug delivery systems (11th
ed.). Lippincott Williams and Wilkins.
Manufacture of Tablets by Dry granulation method. Pharmapproach.com. (2020).
https://www.pharmapproach.com/manufacture-of-tablets-by-dry-granulation-method/.

3. Why do you need to lubricate the powders before compression of the tablet is
done?

Lubricants contribute to the preparation of compressed tablets in several ways:

● They improve the flow of the granulation in the hopper to the die cavity.
● They prevent adhesion of the tablet formulation to the punches and dies during
compression.
● They reduce friction between the tablet and the die wall during the ejection of the
tablet from the machine.
● They give a sheen to the finished tablet.

Reference/s:
Allen. (2017). Ansel’s pharmaceutical dosage forms and drug delivery systems (11th
ed.). Lippincott Williams and Wilkins.
.
4. What are the indications of a poorly lubricated granulation?

Tablet defects such as picking, sticking, and capping are caused by inadequate
lubrication. Tablets with low moisture may be achieved when drying granules is not
properly performed. The presence of small quantities of film fragments flaking from the
tablet surface is referred to as picking. Sticking occurs when formulation granules or
particles attach and adhere to the face of a punch cap, resulting in defective tablets. Too
much moisture and lubricants may lead to sticking of granules and poor compatibility as
it reduces the hardness of the table. Capping occurs when the top of the tablet
separates from the rest of the tablet due to insufficient time for the fill material to bond
after compression.
Reference/s:
Allen. (2017). Ansel’s pharmaceutical dosage forms and drug delivery systems (11th
ed.). Lippincott Williams and Wilkins.