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Faculty of Engineering
Department of Chemical Engineering
Espana, Manila
PHARMACEUTICAL INDUSTRY
Section: 3ChE-C
Course: CHEM 311 (Industrial Chemistry)
Professor: Mrs. Cristina Tiangco
Group No.: 9
Members: Cabangal, Erwin Cayl P
Cabungcal, Cesarah Justine
Kagaoan, Coleen
Mirador, Maria Clara
Pre, Trisha Mae
Romero, Ashley
Definition
A drug is any substance (with the exception of food and water) which, when taken into the body,
alters the body's function either physically and/or psychologically. They may be single compounds
or a mixture of different compounds. Their effects are intended to be beneficial but can cause
harmful side effects in some people.
Forms of Drugs
a. Tablets – are drug from which contains dried powdered active drug. It contains binders and
fillers to provide bulk and proper size.
i. Soft gelatin capsule – is manufactured in one piece in which the drug is in a liquid from
inside the soft shell
ii. Hard shell capsule- is manufactured in two pieces that fit together and hold the drug
which is in a powder or granular form
d. Cream- is a semisolid emulsion of oil and water , water being the main ingredient. Emulsifying
agent is added to keep mixed
e. Ointment- is a semisolid emulsion of oil and water, oil being the main ingredient. It is normally
applied to skin without precise measurement.
h. Liquids- come in one of two forms, solution or suspension. In a solution, drug is fully dissolved.
An example of this is syrup. On the other hand, suspensions contain fine, undissolved particles of
a drug suspended in a liquid base. It is important to always shake before use.
Branded Drugs
Branded Drugs are initially marketed as new chemical entities. These are medicines that
discovered, developed and marketed by pharmaceutical companies. The “look” of branded
drugs—size,shape, color, marking, packaging are familiar to consumers. The pharmaceutical
company ensures that the drug is safe and effective by conducting a series of laboratory studies
that take years to perform. The proper dosage and form are determined by another series of lab
studies. Then studies are performed at approved clinical research facilities across the country
where the drug is administered to real pets belonging to real people according to strict protocols.
Genetic Drugs
Generic Drugs are copies of brand name drugs. They are produced after the original patent expires.
Patent periods may last up to 20 years on some drugs. The generic drug has the same “active
ingredient” as the brand-name drug. This ingredient is the one that cures the patient; and other,
“inert ingredients”, which give the drug its colour, shape or taste, vary from the brand-name drug
to the generics. Generic manufacturer is not required to perform extensive animal and human
studies. This considerably reduces costs in comparison with relevant branded drugs.
Kinds of Drugs
Drugs can be classified into 6 types according to their area of function. These are cardiovascular,
gastrointestinal, respiratory, central nervous system, hormonal, and anti-infective drugs. The
following are some classification of drugs with its subparts and examples:
1. Cardiovascular
a. Antihypertensives
These are drugs that reduce blood pressure, block nerve impulses that cause arteries to constrict,
others slow the heart rate and decrease its force of contraction; still others reduce the amount of
certain hormones in the blood that cause blood pressure to rise. Nifedipine, Felodipine, Capropril
and perindopril are some example of drugs that treat hypertension.
2. Gastrointestinal
a. Antiulcer
These are a class of drugs, exclusive of the antibacterial agents, used to treat ulcers in the stomach
and the upper part of the small intestine. The drug works through a formation of a chemical barrier
over an exposed ulcer, thereby protecticing it from stomach acid like sucrafate. In other words, it
suppresses the secretion of stomach acid. Examples of this drug are Axid, Carafate, Cytotec and
Pepcid.
b. Antidiarrheals
These are medicines used to treat diarrhea. It works by slowing down intestinal contractions,
increasing the time it takes for the contents of the bowel to be excreted. Antidiarrheals only relieve
the symptoms of diarrhea, such as an increased frequency and urgency when passing stools, they
do not eliminate the cause of it. Examples of this drug are Derrom, Lonox, and Mofofen.
3. Respiratory
a. Antitussives
These are medicines that suppress coughing., also known as cough suppressants. It control coughs
by acting on the cough center in the brain. Antitussive drugs include Zonatuss, Tessalon,
Robitosin and Codeine.
b. Expectorants
These are medicines that increase bronchial secretions and make it easier to cough up mucus from
the airways and lungs. They are used in the treatment of chesty, wet, productive or phlegmy
coughs, which typically occur with a cold. Ammonium Chloride, Potassium guiacolsulfonate are
some of the examples.
c. Decongestants
Decongestants are are medicines that relieve congestion by reducing swelling, inflammation and
mucus formation. They are typically used for conditions associated with nasal or eye congestion,
such as a cold, hay fever, rhinitis, sinusitis or allergies. They can be taken orally or as nose drops
or spray. If they are orally taken, they act slowly but does not interfere with the production of
mucus or the movement of cilia in the respiratory tract. Increase in blood pressure is a possible
side effect of this method. If taken in nose drops or spray, they provide immediate relief and it
slows down the movement of cilia. Some examples of this drug are Afrin, Dristan, Vicks Sinex,
and Sudafed.
These are drugs used in the treatment of anxiety or insomnia which selectively reduce activity in
the central nervous system. A sedative drug is a medicine that reduces excitement and calms the
patient. Sedating drugs include barbiturates, chlorodiazepoxide, clorazepate, diazepan,
meprobamate, and axazepam. A hypnotic drug , commonly known as sleeping pills, is a substance
used for initiation and/ maintenance of sleep. Hypnotic drugs inlcude flurazepam, temazepam and
triazolam.
b. Tranquilizers
These are drugs used to used to reduce anxiety, fear, tension, agitation, and related states of mental
disturbance. It calms activity in some areas of the brain but allow the rest to funciton normally. It allows
transmission of some nerve impulses and restrict others. Tranquilizers are classified as antipsychotics and
antidipressants. Antipsychotic drugs are used to treat symptoms of severe pyschiatric disorder. Drugs most
frequently used are the phenolthiazines such as chlorpromazine, thioridazine, and trifluoroperazine.
Antidepressant drugs are used to treat mental depression. An example of which are tricyclic and the monoamine
oxidase (MAO) inhibitors, such as pargyline and phenelzine.
c. Analgesic
These are medicines that are used to relieve pain. They are also known as pain killers. It falls
under two categories, narcotics and non-narcotics.Narcotic drugs are derived from opium poppy.
Narcotic drugs relieve pain by acting directly on the central nervous system. They are much
stronger and are used when pain signals are too severe to be controlled by non-narcotic analgesics
Hydrocodone, Methadone, Morphine, and Fentanyl are some examples of narcotic drugs. Non-
narcotic drugs act primarily in peripheral tissues to inhibit the formation of pain-producing
substances such as prostaglandins. They do not bind to opioid receptors and are not classified under
the Controlled Substances. They are milder forms of the painkillers. Salicylates such as Aspirin
and other drugs like Paracetamol, Ibuprofin, Diclofenac, and Ketoprofin are most commonly used
non-narcotic drugs.
5. Hormones
a. Antidiabetic
Antidiabetic drugs are medicines developed to stabilise and control blood glucose levels amongst
people with diabetes. They are commonly used to manage diabetes. This drug induces the pancreas
to secrete more insulin by acting on small groups of cells within the pancreas that make and store
insulin. Metformin, Amylin, Glucobay Amaryl and Lyxumia are examples of this.
b. Steroids
These are drugs used to treat inflammatory diseases such as arthritis or to treat poison ivy, hay
fever, or insect bites. Methylprednisolone and prednisone are examples of this.
6. Anti-infectives
a. Anti-Infectives
These are drugs used to treat wide variety of bacterial infection. They are produced synthetically
or are derived form molds. They slow the growth of bacteria or cause their death by interfering
production of necessary nutrients or by damaging their cell membrane. Aminoglycosides,
cephalosporoins,erythromycins, penicillin and tetracyclines are some antibiotics used.
b. Anti-Viral
These are drugs used to inhibit production of viruses that cause disease. Most antiviral agents are
only effective while the virus is replicating. Examples are Abacavir (for HIV), Amantadine (for
influenza) Adefovir (for Chronic Hepatitis B) and Acyclovir ( for chicken pox )
The development of a new therapeutic drug is a complex, length and expensive process. It can take
10-15 years and over £500 million to develop a drug from an initial concept, test its safety and
effectiveness in humans and then get it into the hospital market. The development of a medicine
is divided into two major stages, the discovery stage and development stage.
Discovery Stage
In this stage, diseases and conditions that lack effective treatments or have treatments with
unwanted side effects or poor patient compliance are identified. Next, is screening and search for
a chemical, protein, or gene that plays an important role in a particular disease. The chemicals that
may interact with that target, by screening thousands of existing compounds to find suitable
candidates or by studying the structure of the target to develop a hypothesis about what a medicine
for that target should look like, are gathered. Next, small molecule is synthesized to meet those
criteria. The molecule is modified and asked many questions that eventualy left with a few selected
drug candidates for preclinical trials.
Development Stage
Upon completion of the discovery stage, the next step is to evaluate its safety and efficacy. This
marks the beginning of the development phase.
Preclinical Evaluation
In this stage, a variety preclinical tests is conducted to evaluate safety before human tests begin.
The preclinical tests can be in vitro or in vivo (e.g. animals or cell lines).
Clinical Trials
If preclinical testing of a compound proves successful, it moves into clinical trials where teams of
physicians and other clinical scientists conduct studies to determine if the medicine is safe in
people and effective for the target disease. There are generally three phases of clinical trials:
Phase I
This phase involves the first human tests in a small number of healthy volunteers to assess
tolerability and potential dosing.
Phase II
In this phase, a small group of volunteer patients who have the disease being studied are monitored
in placebo-controlled trials. The goal is to establish the proof of concept or whether the medicine
has the potential to positively impact the disease. Researchers continue to evaluate the drug’s
safety and determine optimal dose strength and schedule.
Phase III
The medicine is tested in large, randomized, placebo-controlled trials with larger numbers of
patient volunteers to confirm the efficacy and safety profile by generating statistically significant
data. Researchers further evaluate safety and efficacy and identify side effects.
The clinical trials from all of the development phases provide the data required to prepare
submissions for regulatory approval to agencies around the world. The requirements for securing
regulatory approval vary across different countries and geographic regions.
Following regulatory approval, clinical studies are conducted to support additional indications or
new formulations as well as for post-marketing monitoring and research.
Tablet Processing
First of all, raw materials are stored inside the material control warehouse wherein spoilage is
avoided. These materials are then delivered to Formula Administration wherein they are weighed
and checked for their formulas. This step is called the dispensing which is crucial in determining
the dosage. Then, they are passed to solid processing line where they are processed and prepared
for mixing. They undergo wet mixing where excipients and binders are added. They are then
granulated before drying. Two ovens are used for this, the conventional oven (slow) and the Glatt
machine (fast). Other commonly used dryers include Fluidized – bed dryer, Vacuum tray dryer,
Microwave dryer, Spray dryer, Freeze dryer, Turbo - tray dryer, Pan dryer, etc. After that, they go
to the dry granulator, also called cominution machine then the dry mixer wherein they are mixed
with lubricants and then go to the tabletting colton. Plain tablets are coated in a rotating pan where
shellac-alcohol solution is added for the shell coating. Dusting powder and gelatin are next added
as subcoating to make the tablet firm then the smoothing solution followed by added coloring
solution. After coating, they are transferred to another pan for polishing with wax.
Quality control and analysis in the pharmaceutical industry are very important since human
intake drugs so any negligence could harm humans. There are two types of tests conducted,
physical and microbiological. There are four physical attributes to be tested, first is the hardness
of the tablet. Hardness is determined by placing the tablet in the sample holder of the hardness
testing machine and then applying pressure until it is crushed. The pressure exerted to crush the
tablet is recorded. Next is the dissolution and disintegration test wherein samples are placed under
simulated conditions in the stomach such as pH (1.5 - 3.5), temperature (approx. 37oC), acids and
enzyme present and the time it takes to dissolve is recorded. Another is its moisture content which
is analyzed through automated machines. Last is the friability test to determine the firmness and
compression of the tablet. All the data gathered from these tests are compared to the standard
which will indicate if the product is accepted or not. As for microbiological tests, there are three.
Firstly, the parenteral products (those administered or occurring elsewhere in the body than the
mouth and alimentary canal) are injected in the ears of the rabbits. If the rabbit’s body temperature
deviates from normal, this indicates fibril formation. The microbiologists then reject the product.
This is called the pyrogen test. Pyrogen is a substance typically released by a bacterium. Next is
the sterility test wherein microbiologists test for presence of microorganisms. If there are any, the
product is rejected. The last one is the LAL (Limulus Amebocyte Lysate) test. LAL is an aqueous
extract of blood cells (amoebocytes) from the Atlantic horseshoe crab that reacts with the bacterial
endotoxin lipopolysaccharide (LPS), which is a membrane component of gram-negative bacteria.
Parenteral products are used again as samples then the microbiologist detects and quantifies the
presence of endotoxin by observing if there is gel clotting in the sample. If there is, the sample is
rejected.
VII. Industry Updates
Process engineers – are responsible for developing new industrial processes and
designing new process plants and equipment or modifying existing ones. The
processes that they come up with are also used for delivering regular
recommendations on how to maintain staff levels and lower costs, while meeting
all of the quality standards set forth by the company and government regulations.
In the pharmaceutical industry, they design and strategize processes in the
production of drugs, select suitable equipment for any unit operation with proper
material of construction, and optimize the cost production and profit of the
company.
Product development managers – are the ones who investigate, design, and assess
products they brainstorm for a company. These professionals coordinate all stages
of product development, from initial concept art, to finalization and distribution.
Quality control analysts – performs various analyses to evaluate the quality of raw
materials, in-process materials, and finished goods and ensure compliance with
established standards. They are also responsible for conducting and validating
various biological and chemical quality control (QC) assays. Quality control
analysts in the pharmaceutical industry assure that every product manufactured by
the company passes the prescribed standards for the safety of all consumers
concerned.
B. Major companies and the Department of Science and Technology (DoST) in the Philippine
Pharmaceutical Industry
Figure 7.1: Department of Science produced in the plantation such as Lagundi (anti-cough/anti-
and Technology Logo asthma), Sambong (diuretic/anti-urolithiasis), Yerba Buena
(analgesic), and Tsaang Gubat (antimobility/antispasmodic).
Only Pascual Laboratories and the Cotabato plantation are operating medicinal tablets
because other companies have terminated production due to machinery complications and
insufficient funds. Chinese businessmen are primary distributors of herbal medicines having seven
(7) Chinese herbal medicines registered with the Bureau of Food and Drugs (BFAD). Currently,
the Department of Health (DOH) suggested for the implementation for an institution or program
to upgrade and to expedite the research and development (R&D) sector of the pharmaceutical
industry. R&D is vital to the framework of providing new drugs, and innovating past medicinal
products.
1) Superantibiotics
One of the serious problems encountered and still experienced by the people living in the
21st century is antimicrobial resistance (AMR) because the microbes have developed resistance
against the medications we have developed to counter them. Intake of incorrect or non-prescribed
drugs will result to grave effects and consequences in the system of our bodies. Antimicrobial
resistance happens when microorganisms (such as bacteria, fungi, viruses, and parasites) change
when they are exposed to antimicrobial drugs (such as antibiotics, antifungals, antivirals,
antimalarials, and anthelmintics). Microorganisms that develop antimicrobial resistance are
sometimes referred to as “superbugs”. As a result, the medicines become ineffective and infections
persist in the body, increasing the risk of spread to others. Intake of incorrect or non-prescribed
drugs will result to grave effects and consequences in the system of our bodies.
2) Memory-enhancing drug
The goal of developing a memory-enhancing drug is to help patients diagnosed and
struggling with Alzheimer's disease, dementia, and various memory loss-related diseases. Memory
is a faculty of the mind filled with stored information, recollection of our past, and one of the
things that makes us human, things that mold us the way we are, or things that make you; you.
thereby improving brain energy production. The image on the left (Figure 7.2) shows the multi-
modal Magnetic Resonance Imaging (MRI) study of methylene blue in human subjects.
3) 3D Printed drug
In this ever-changing world, technology continues to evolve and so does the level of
enhancement on how we produce things in accordance to our convenience and welfare. Now, some
things can be created instantly in a minute or less. One of the processes that can construct such is
3D printing. 3D printing, also called as additive manufacturing, is a process of making three-
dimensional solid objects from a digital file. The creation of a 3D printed object is achieved using
additive processes. In an additive process, an object can be created by laying down successive
layers of material until construction is complete. Each of these layers can be seen as a thinly sliced
horizontal cross-section of the eventual object.
This type of production mechanism is usually seen in electronics and mechanics but today
it is also paving its way through pharmaceutical industry. Food and Drugs Administration (FDA)
has approved the world’s first ever 3D printed drug called Spritam (see figure 7.3). Spritam was
created by Aprecia Pharmaceuticals wherein they used 3D Printing technology to create a more
porous pill that is easier to swallow.Dr. Stephen Hilton (2015) of the University College London
(UCL) School of Pharmacy said that the vision behind 3D Printing is that medication will be
customized to individuals in ways that make it safer and more effective. The size, dose, appearance
and rate of delivery of a drug can be designed to suit an individual.
Chem Bits
Herbal medicines or Medicinal Plant Products (MPP) are finished, labeled, medicinal
products that contain plant or other plant material as active ingredient(s). Plant materials include
juices, gums, fatty oils, essential oils, and any other substance of this nature. These medicines may
contain excipients in addition to the active ingredients. Plant-based medicines now come in various
forms such as tablets, syrups, capsules, and powders. However, medicines for common ailments
are expensive. Mostly curative, relief drugs and medicines for common ailments such as
headaches, muscle pains, stomach aches can now be easily cured with medicine made from plants
and herbs found in many Filipino backyards and gardens which are cheaper yet no less effective
than the commercially available drugs. Some Herbal Medicines that can be used are the ff:
Alugbati or leaves and roots for skin cuts Boil leaves or roots and use it for
Vine Spinach washing.
Bawang or fresh leaves or dried for Crush and apply on affected joints
Garlic or fresh garlic rheumatism, with rheumatism before bedtime.
headaches,
For headaches, apply crushed
high blood
garlics on both sides.
pressures
For high blood pressures, eat
together with meals.
Bayabas or young leaves for diarrhea Boil 5-6 leaves in water for 15 mins.
Guavas Drink ½ glass for every 3-4 hours.
Camantigui or whole plant for hematoma Crush whole plant and apply.
Touch Me Not
Dalandan or peel of the fruit For stomach Boil the peel in a cup of water for 15
Sweet Orange ache, mins. Drink for stomach aches.
or Kehel headaches
For headaches, squeeze the peel on
the nose.
Luya or Ginger flesh for skin cuts, For skin cuts and diseases, apply on
skin diseases, affected area.
gas pains, sore
For gas pains and sore throats, drink
throat,
boiled ginger.
rheumatism
For rheumatism, add few drops of
cooking oil on crushed broiled
ginger and apply on affected area.
Mais or Corn hair or “busal” for inducing Boil and drink the mixture.
urination
Malunggay or seeds, bark, leaves, for skin cuts Apply crushed leaves on skin cuts.
Horse Radish and fruit
good laxative
Papaya or ripe fruit and sap of for skin cuts Apply sap on skin cuts.
Melon Tree the tree
good laxative
Sabila or Aloe leaves for scalds, Apply juice on affected area once a
burns, skin day.
ulcers
Sampalok or fruit and young for For fever, crush the flesh portion 1-
Tamarind leaves constipation 2 ripe fruits in a glass of water then
add sugar to taste and drink every 4
good as
hours.
aromatic bath
For constipation, eat ripe fruit and
follow it up with few glasses of
water.
Siling Labuyo ripe fruit for rheumatism Crush the fruit, add oil, and apply on
or Red Pepper affected area.
Tangan leaves and seeds for Powder the roasted seeds, add oil
Tangan or hemorrhoids and apply on affected area.
Castor Oil
Plant
Gumamela or flower buds, roots for boils, Pound 2-4 fresh flower buds into a
Showflower abscesses, paste and apply on boils, abscesses,
mumps, and mumps.
bronchitis,
For bronchitis, take infusion of
cough
flowers in hot water as expectorant.
Kintsay or whole plant for high blood Eat raw leaves and stem every day.
Celery pressure
Mangga or bark or flesh of seed for cough, For cough, soak the leaves on boiled
Mango diarrhea water then drink.
https://medical-dictionary.thefreedictionary.com/Antiulcer+Drugs
https://www.drugs.com/drug-class/antidiarrheals.html
https://www.drugs.com/drug-class/antitussives.html
https://www.drugs.com/drug-class/decongestants.html
https://www.drugs.com/drug-class/expectorants.html
http://www.emedexpert.com/compare/opioids-non-opioids.shtml
Branded Drugs are initially marketed as new chemical intities. These are medicin
The drug is discovered, researched, tested, developed, produced and marketed. The
pharmaceutical company ensures that the drug is safe and effective by conducting a series of
laboratory studies that take years to perform. The proper dosage and form are determined by
another series of lab studies. Then studies are performed at approved clinical research facilities
across the country where the drug is administered to real pets belonging to real people
according to strict protocols. These facilities may be veterinary school hospitals or private
veterinary clinics.
generic drugs may cost 30-80% less than the original versions
Sources:
https://vcahospitals.com/know-your-pet/the-differences-between-brand-name-and-generic-
medications
http://www.paramountias.com/current-affairs/2017/August/14/is-generic-drug-deflation-good/
https://www.cadth.ca/generic-drugs/similarities-and-differences-between-brand-name-and-
generic-drugs
http://www.dbsalliance.org/pdfs/GenericRx.pdf
https://medical-dictionary.thefreedictionary.com/Antiulcer+Drugs
What is a drug?
A drug is any substance (with the exception of food and water) which, when taken into the body,
alters the body's function either physically and/or psychologically.
Drugs may be legal (e.g. alcohol, caffeine and tobacco) or illegal (e.g. cannabis, ecstasy, cocaine
and heroin).
Source: http://watershed.org.au/drug-information.html
Kinds of Drugs
I. Cardiovascular Drugs
AntiHypertensives
Ex. Nifedipine, Felodipine, Capropil, Perindopril
II. Gastrointestinal Drugs
-
Antiulcer
Ex. Axid (Nitzatidine), Carafate (Sucralfate) ,Pepcid (Famotidine)
Antidiarrheals
Ex
https://www.yourgenome.org/facts/how-are-drugs-designed-and-developed
http://www.aiche-metrony.org/Chem%20Eng%20in%20Pharma.pdf
http://www.emedexpert.com/compare/opioids-non-opioids.shtml
Several characteristics distinguish the pharmaceutical industry from other industries. A newly
released pharmaceutical agent is usually available only by physician prescription. Patients in effect
transfer decision-making authority on the appropriateness of medications for their ailments to the
gate-keeping physicians (or pharmacists and nurses in some countries). Generally, a prescription
may become available OTC (i.e., without physician prescription) for a non-chronic condition that
is relatively easy to self-diagnose and has low potential for harm from self-medication under
conditions of widespread availability
http://www.encyclopedia.com/medicine/drugs/pharmacology/pharmaceutical-industry
http://www.aei.org/publication/how-the-pharmaceutical-industry-works-from-research-to-drug-
to-market/
http://www.pacificbiolabs.com/drug_stages.asp
http://www.pharmaceutical-journal.com/publications/tomorrows-pharmacist/drug-development-
the-journey-of-a-medicine-from-lab-to-shelf/20068196.article zzz
http://nmtpharma.com/en/drug-development-stages/
http://scientifist.com/timeline-pharmaceutical-drug-development-idea-market/