Pharmaceutical

industry: Aspirin

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Introduction:
Pharmaceutical industry produces a wide range of medications, drugs, and
pharmaceutical products for treating medical conditions and improving
human health.
We will solely be discussing the manufacturing of acetylsalicylic acid
otherwise known as Aspirin
Aspirin is one of the safest and least expensive pain relievers on the
marketplace. While other pain relievers were discovered and manufactured
before aspirin, they only gained acceptance as over-the-counter drugs in
Europe and the United States after aspirin's success at the turn of the
twentieth century.

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Historical
background
• The compound from which the active
ingredient in aspirin was first derived,
salicylic acid, was found in the bark of
a willow tree in 1763 by Reverend
Edmund Stone of Chipping-Norton,
England.
• Bayer marketed aspirin beginning in
1899 and dominated the production of
pain relievers until after World War I.

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Aspirin can be properad by reacting salicylic acid with an excess of acetic anhydride, using a strong acid
catalyst. The reaction produces acetic acid (vinegar) as a side product. Aspirin exerts its painkilling effect
by inhibiting production of molecules called prostaglandins.
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Raw Materials:
• To produce hard aspirin tablets, corn starch and water are added to the active
ingredient (acetylsalicylic acid) to serve as both a binding agent and filler, along
with a lubricant.
• Binding agents assist in holding the tablets together; fillers (diluents) give the
tablets increased bulk to produce tablets of adequate size. A portion of the
lubricant is added during mixing and the rest is added after the tablets are
compressed. Lubricant keeps the mixture from sticking to the machinery.
• Possible lubricants include: hydrogenated vegetable oil, stearic acid, talc, or
aluminum stearate. Scientists have performed considerable investigation and
research to isolate the most effective lubricant for hard aspirin tablets.

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Manufacturin
g:
The procedure for manufacturing hard aspirin tablets, known as dry-
granulation or slugging, is as follows:
1. Chemical Synthesis:
The primary step in aspirin tablet synthesis is the chemical reaction that converts salicylic
acid (the starting material) into acetylsalicylic acid (aspirin). This reaction typically
involves acetylation, where acetic anhydride or acetyl chloride is used as the acetylating
agent. Reactors are used to facilitate this reaction. The reaction is usually carried out
under controlled conditions of temperature and pressure.
2. Filtration and Purification:
After the chemical reaction, the mixture may contain impurities, unreacted starting
materials, and by-products. Filtration units, such as filter presses or vacuum filters, are
used to separate the solid aspirin product from the reaction mixture. This step helps
remove unwanted substances and purify the aspirin.
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3. Drying
The purified solid product obtained from the filtration step may still contain residual
moisture. Drying equipment, such as rotary dryers or fluidized bed dryers, is used to
remove moisture and ensure the aspirin is in a dry, stable form suitable for further
processing.
4. Mixing and Blending:
Once dried, the aspirin is mixed with other excipients and additives to create the final
tablet formulation. This step involves blending the aspirin powder with ingredients like
binders, disintegrants, lubricants, and fillers. Mixing and blending equipment, such as
ribbon blenders or cone blenders, ensure uniform distribution of these components.
5. Tablet Compression:
The blended mixture is then compressed into tablet form using tablet compression
machines. These machines use punches and dies to compress the powdered mixture
into tablets of consistent size, shape, and weight. The tablets may have a specific
design, such as bevelled edges or scoring lines, for easier handling and ingestion.
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 The first three steps in aspirin manufacture: weighing, mixing, and dry
screening. Mixing can be done in a Glen Mixer, which both blends the
ingredients and expels the air from them. In dry screening, small batches
are forced through a wire mesh screen by hand, while larger batches can
be screened in a Fitzpatrick mill. 8
4. Mixing and Blending:
Once dried, the aspirin is mixed with other excipients and additives to create the final
tablet formulation. This step involves blending the aspirin powder with ingredients like
binders, disintegrants, lubricants, and fillers. Mixing and blending equipment, such as
ribbon blenders or cone blenders, ensure uniform distribution of these components.
5. Tablet Compression:
The blended mixture is then compressed into tablet form using tablet compression
machines. These machines use punches and dies to compress the powdered mixture
into tablets of consistent size, shape, and weight. The tablets may have a specific design,
such as bevelled edges or scoring lines, for easier handling and ingestion.
6. Coating (Optional):
In some cases, aspirin tablets may undergo a coating process to improve their
appearance, taste, stability, or to control drug release. Coating can be achieved using
coating pans or fluid bed coaters. A coating solution containing polymers, pigments, and
other additives is applied to the tablets and then dried.
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 Finished aspirin tablets often have a
line "scored" down the centre so
This drawing illustrates the principle of that the tablet can be broken into
compression in a single-punch machine. First, the two parts with ease.
aspirin mixture is fed into a dye cavity. Then, a
steel punch descends into the cavity and
compresses the mixture into a tablet. As the
punch retracts, another punch below the cavity
rises to eject the tablet.
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6. Coating (Optional):
In some cases, aspirin tablets may undergo a coating process to improve their
appearance, taste, stability, or to control drug release. Coating can be achieved using
coating pans or fluid bed coaters. A coating solution containing polymers, pigments, and
other additives is applied to the tablets and then dried.

7. Quality Control:
Throughout the entire process, quality control measures are implemented to ensure that
the aspirin tablets meet required standards for potency, uniformity, dissolution, and
other critical parameters. Various analytical techniques, such as high-performance liquid
chromatography (HPLC), are used to test the tablets at different stages of production.
These industrial units and processes work in conjunction to produce aspirin tablets that
are safe, effective, and consistent in quality. The pharmaceutical industry follows strict
regulatory guidelines and good manufacturing practices (GMP) to ensure the quality and
safety of the final product.
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Thank you!

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