Bioprocessing Production of Paracetamol Syrup Edit

Faculty of Engineering and the Built
Environment
Department of Chemical Engineering
Advance Diploma
BIOPROCESSING & ENVIRONMENTAL

SUSTAINABILITY 4
(BES470S)
GROUP 10: PRODUCTION OF PARACETAMOL SYRUP
Student surname Student name Student number

Ntsenge Olwetu 217293948
Xego Khanyisile 215207181
Mokwele Lesedi 215028511
Juwele Zukile 216131960
Nyokana Zandiswa 214246477
Table of Contents
Abstract.................................................................................................................................. 1
Introduction............................................................................................................................ 1
Background........................................................................................................................ 1
Objectives........................................................................................................................... 1
Materials and Equipment........................................................................................................2
Materials............................................................................................................................. 2
Equipment:......................................................................................................................... 2
Experimental.......................................................................................................................... 3
Conclusion............................................................................................................................. 7
Reference............................................................................................................................... 8
Abstract
This report is based on the bioprocess production of paracetamol syrup. Paracetamol is
widely used in the form of a syrup, with a percentage of acting ingredient (Abdullahu et al.,
2012). The materials that are needed to produce the product are listed in table 1.
Paracetamol can be produced using different manufacturing process. All these methods are
currently used to produce paracetamol, but the first route (from p-nitrochlorobenzene route)
is the most cost-effective and widely used.
Introduction
Background
Paracetamol is one of the most popular and most used analgesic and antipyretic drugs
throughout the world. The drug is available without a prescription, both in mono- and multi-
component preparations. Paracetamol is widely used in the form of a syrup, with a
percentage of acting ingredient (Abdullahu et al., 2012). Several solvents are used in the
preparation of the paracetamol syrup. The solvents are used in varying proportions. Ethanol
or propylene glycol or a mixture of the two are well known carriers of paracetamol in
paracetamol syrups.
Paracetamol is made by reacting 4-aminophenol with ethanoic anhydride. This reaction

forms an amide bond and ethanoic acid as a by-product. When the reaction is complete the
paracetamol is then isolated and purified. The syrup is primarily composed of a mixture of
sugars, water, and minerals. The mechanism of action is complex and entails inhibiting
enzyme function in the brain which allows it to treat pain and fever. It activates certain
receptors in the brain that inhibit pain signals.
It is proposed as a first-line treatment of pain associated with osteoarthritis. Patients that

cannot be treated with non-steroidal anti-inflammatory are often treated with paracetamol,
these include people with bronchial asthma, peptic ulcer disease (Singh, Kumar and Prasad,
2018). The paracetamol syrup is known for producing few and minor side effects, these
nausea and vomiting.
Objectives
● Highlight the production of paracetamol syrup
● Significance of paracetamol syrup
● Determine the materials and equipment utilised in the process
Materials and Equipment
Materials
Materials are the substances needed to form the product. Each material is used for a
specific function, whether it is used as a reactant, catalyst, or any other function. The
functions of the materials used in the reaction process are provided below:
Table 1: Materials and their functions
Material Function
Sodium Chloride React with P-nitrochlorobenzene to form P-
nitrophenol.
P-nitrochlorobenzene Main reactant which reacts with Sodium
Chloride.
Sulfuric acid Neutralize P-nitrophenol.
Acetic/hydrochloric acid React with p-nitrophenol to form p-
aminophenol.
Iron Catalyst in second reaction to form p-
aminophenol.
Activated charcoal Treat p-aminophenol mixture.
Sodium sulphite Used as an antioxidant agent.
Disodium edetate To help remove heavy metals, such as lead
and mercury from the blood circulatory
system.
Acetic anhydride Reacts with aminophenol to form
paracetamol.
Sodium hydrosulphite Extracts paracetamol from solution
Equipment:
The equipment used help in obtaining the desired composition and yield of product.
The most common reactor used in this process is a continuous stirred tank reactor. This
reactor is preferred over other because it contains a stirrer which ensures homogeneity of
the reactants. There are two reactors used in the process, one is used for the acetylation
process and the second is used for the purification process. The functions of each
equipment are provided below:
Equipment Function
Reactor To carry out the chemical reactions that
form paracetamol
Centrifuge To separate different size particles.
Filter To separate a solid from a liquid.
Crystallizer To extract the desired product from the
solvent.
Dryer To dry the product for preservation and
increase its purity.
Experimental
The production of paracetamol
Paracetamol can be produced through different manufacturing routes:
• From p-nitrochlorobenzene
• From phenol
• Through the electrolytic reduction of nitrobenzene
• Trom p-hydroxyacetophenone.
All these methods are currently used to produce paracetamol, but the first route (from p-
nitrochlorobenzene route) is the most cost-effective and widely used. All routes have a
common method of synthesis, except for the fourth route, which produces p-aminophenol,
from which paracetamol is finally manufactured. From p-aminophenol, it is only a one step
method, called acetylation.
Following are the steps of producing paracetamol from p-nitrochlorobenzene

Figure 1: p-nitrochlorobenzene to p-nitrophenol
Step 1: Starting from p-nitrochlorobenzene, p-nitrophenol is made. The reaction is done

using about 15% NaOH under high temperature (160 °C) and pressure as a result sodium
salt of p-nitrophenol is formed. On neutralization with aqueous sulfuric acid, p-nitrophenol is
produced, which is then crystallized and centrifuged. This p-nitrophenol is then converted to
p-aminophenol from which paracetamol is manufactured.
Figure 2: Conversion of p-nitrophenol to p-amonophenol
Step 2: p-Nitrophenol (PNP) is converted to p-aminophenol (PAP) by reducing with iron and
acetic acid or hydrochloric acid. The reaction mixture containing PAP is treated with
activated charcoal. In addition, sodium sulfite (anti-oxidant) & disodium edetate (chelating
agent) are used to get a better quality of PAP. During crystallization, pH is adjusted &
sodium hydrosulfite (Na2S2O4) is added. The solution is then filtered, crystallized,
centrifuged, and dried.
Figure 3: Conversion of p-aminophenol to paracetamol
Step 3: p-Aminophenol is converted to paracetamol or acetaminophen (APAP) by

acetylation of p-aminophenol (PAP). The reaction is carried out with acetic anhydride at an
elevated temperature of 80−90 °C. The byproduct, acetic acid, is recycled in the acetylation
reaction.
Abbreviations
PNCB – p-nitrochlorobenzene
PNP – p-nitrophenol
PAP – p-aminophenol
APAP – Acetaminophen
Conclusion
Paracetamol is one of the mostly used analgesic and antipyretic drugs throughout the world.
Paracetamol is used in the form of a syrup and it is available without prescription. Among the
vast ways of producing paracetamol syrup, the first route is the most cost-effective and
widely used. This syrup entails few and minor side effects such as nausea and vomiting. To
achieve the production of the syrup, material and equipment is used. The most commonly
used equipment in this production is the Continuous stirred tank reactor. Paracetamol can
also be produced from different routes which have common method except for the fourth
route.
Reference
Abdullahu, B. et al. (2012) ‘Study of formulation of pharmaceutical solution form of

paracetamol in the pediatric clinical practice.’, Medicinski arhiv, 66(1), pp. 5–8. doi:
10.5455/medarh.2012.66.5-8.
Singh, P., Kumar, P. and Prasad, N. (2018) ‘Formulation and evaluation of an Anti-pyretic
(Paracetamol) syrup for Paediatric’, International Journal of Research and Development in
Pharmacy & Life Sciences, 7(1), pp. 2924–2930. doi: 10.21276/ijrdpl.2278-
0238.2018.7(1).2924-2930.
Roy, J., 2012. An Introduction To Pharmaceutical Sciences. Cambridge: Woodhead Pub.

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Faculty of Engineering and the Built

BIOPROCESSING & ENVIRONMENTAL

GROUP 10: PRODUCTION OF PARACETAMOL SYRUP

Student surname Student name Student number

Paracetamol is made by reacting 4-aminophenol with ethanoic anhydride. This reaction

It is proposed as a first-line treatment of pain associated with osteoarthritis. Patients that

Materials and Equipment

Table 1: Materials and their functions

Paracetamol can be produced through different manufacturing routes:

• Through the electrolytic reduction of nitrobenzene

Following are the steps of producing paracetamol from p-nitrochlorobenzene

Step 1: Starting from p-nitrochlorobenzene, p-nitrophenol is made. The reaction is done

Figure 3: Conversion of p-aminophenol to paracetamol

Step 3: p-Aminophenol is converted to paracetamol or acetaminophen (APAP) by

Abdullahu, B. et al. (2012) ‘Study of formulation of pharmaceutical solution form of

Roy, J., 2012. An Introduction To Pharmaceutical Sciences. Cambridge: Woodhead Pub.

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