SAINIK PHARMACY COLLEGE

Mai, Devkali, Hanumanganj, Prayagraj, Uttar Pradesh- 221505

PROJECT REPORT
On

INDUSTRIAL TRAINING

AT

Scott Edil Pharmacia Ltd ,56 E.P.I.P Phase 1 Jharmajri, Baddi, District.Solan
Himachal Pradesh, India

Submitted in partial fulfillment of the requirement of the

BACHELOR OF PHARMACY

(SESSION 2022-2023)

Submitted To: Submitted By:

Mr. ABHAY KUMAR DUBEY (Name) MOHAMMAD MEHTAB SHAIKH

Asst. Professor (Roll No.) 2011170500023
(Training In-charge) (B.Pharm. 3rd Year)
 SAINIK PHARMACY COLLEGE
Mai, Devkali, Hanumanganj, Prayagraj, Uttar Pradesh- 221505

CERTIFICATE

Name: Mohammad Mehtab Shaikh

Class: B pharm 3rd Year

Enrolment No: 201117050075974

Subject: Industrial Training Report

Name & full address of the organization visited: -Scott Edil Pharmacia Ltd ,56 E.P.I.P
Phase 1 Jharmajri, Baddi, District.Solan Himachal Pradesh, India

This is certified that this report represents bona-fide training of the student in the industry
during the academic session 2022-23.

Industrial training done on SCOTT EDIL PHARMACIA LTD The report is complete /
incomplete in all respect.

Date: . 27th January 2023 to 27th February 2023

………………………….. ..……………………………

Signature Signature
(Training In-charge) ( External Examiner )

DIRECTOR

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 DECLARATION

This is to declare that I am MOHAMMAD MEHTAB SHAIKH B. PHARM,

3rd year (2022-23) student bearing (ROLL NO. 2011170500023) had
successfully completed my INDUSTRIAL TRAINING from SCOTT EDIL
PHARMACIA LTD

All the information provides by me in this report are true as per my best
knowledge about Scott Edil Pharmacia Ltd.

Date: 27/01/23 To 27/02/23

Name: Mohammad Mehtab Shaikh

Class: B Pharm 3rd Year

Subject: Industrial Training Report

Signature

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 ACKNOWLEDGEMENT

I feel extremely exhilarated to have completed this industrial training under

the valuable guidance of Mr. ABHAY KUMAR DUBEY sir I wish him for
discussing the problems and providing constant supervision.

I would like to thank DR. VIRENDRA SINGH ( Director of Sainik Pharmacy

College) for his visual knowledge.

I would like to thank MR. RAVINDRA KUMAR YADAV for his guidance.

I acknowledge my sincere thanks to for their timely support for this study.

I also thankful to those people who are working in organization for their
kindly support to provide me information regarding the process of various
sections of the organization from which they are working.

Date: 27/01/23 To 27/02/23

Name: Mohammad Mehtab Shaikh

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List of contents
Sr no. Contents Pg no.

1 Introduction

2 Tablet

3 Advantages and disadvantages

4 Method of preparation

5 Evolution of tablet

6 Albendazole

7 Injection

8 Pantoprazole

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Introduction

Scott Edil Pharmacia Ltd.

Pharmaceutical Manufacturing
one of the leading pharmaceutical manufacturers in India with a portfolio
of over 700 drug formulations for various therapeutic segments including
antibiotics, analgesics, anti-hypertensives, anti-diabetics, and vitamin
supplements.

Our company, WHO-GMP ISO 9001:2008 certified, has three world-class

units in Baddi, Himachal Pradesh, and one in Chandigarh, with
manufacturing facilities for injections (dry/liquid), ophthalmic solutions,
oral liquids, dry syrups, tablets, capsules, gels, hand sanitizer , dietary
protein and food supplements under stringent quality-control measures.`

The company owes its success to one man’s far-sightedness—Mr Balram

Krishan Aggrawal, the chairman and the main promoter of Scott-Edil. The
modest beginning of the company can be traced back to the year 1988. It
was under Mr Aggarwal’s able leadership that the business idea born out
of a small chemist shop in Kurali flourished into the present-day four
world-class manufacturing facilities.

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 1500
Qualified and dedicated Professionals

700
Quality-approved Medicines

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Countries Served

3
State-of-the-art Manufacturing Plants

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 Scott-Edil was established in 1996 and was incorporated in 2003 as a
limited company. The company has registered various trademark
certificates and has International dossiers and market authorizations with
a presence in more than 40 countries. With valuable grassroots
experience in the field of pharmaceuticals, the company has been able to
capitalise on its expertise by expanding into multiple products under its
brand—Searle Interphar.

With a 1500-strong family of employees, the company aspires to raise the

bar further. Focused on its core values—transparency, customer-
commitment and affordable healthcare—the company remains anchored
to the idea of scientific innovation for the better health of humans.

Under its efficient leadership, Scott Edil envisions becoming a 10,000-

crore company by the year 2025

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Tablet
A tablet is a pharmaceutical oral dosage form or solid unit dosage form
and Tablet is also known as Pills .
Tablets may be defined as the solid unit dosage form of medication with
suitable excipients .
It comprises a mixture of active substances and excipients, usually
in powder form, that are pressed or compacted into a solid dose.
Tablets are prepared either by moulding or by compression. The
excipients can include Diluents, Binders or Granulating
agents, Glidants (flow aids) and Lubricants to ensure efficient tabletting .
Disintegrants to promote tablet break-up in the digestive tract.
sweeteners or flavours to enhance taste; and pigments to make the
tablets visually attractive or aid in visual identification of an unknown
tablet.
A polymer coating is often applied to make the tablet smoother and
easier to swallow, to control the release rate of the active ingredient, to
make it more resistant to the environment (extending its shelf life), or to
enhance the tablet's appearance.
Medicinal tablets were originally made in the shape of a disk of whatever
colour their components determined, but are now made in many shapes
and colours to help distinguish different medicines.

Tablets are often imprinted with symbols, letters, and numbers, which
allow them to be identified, or a groove to allow splitting by hand. Sizes of
tablets to be swallowed range from a few millimetres to about a

centimetre.

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Advantage
* Tablets are easy to administered.
* Tablets are easy to be dispensed.
* More stable dosage form.
* Maintain accuracy in dose age.
* Bitter and nauseous substances can be given easily in tablet form after giving a
suitable coating to the Tablets.
* Tablets are the lightest and the most compact of all dosage forms.
* Packaging and transportation of Tablets is easiest and cheapest as compared to all
other dosage forms.

Disadvantages
* Some drugs resist compression due to their atmospheric nature and low density character,
such drugs can't be compressed into Tablets.
* Bitter tasting drugs, drugs with objectionable odour or drugs sensitive to Oxygen or or
atmospheric moisture may require encapsulation or a special type of coating which may
increase the cost of the finished tablets.
* Drugs with poor wetting and slow dissolution properties are difficult to convert into Tablets
which provide full Drug bioavailability.

How tablet are manufactured

The most common tablet manufacturing process techniques are wet granulation, dry
granulation, and direct compression.
Your active pharmaceutical ingredients’ (APIs) physical and chemical stability
influences manufacturing.
For successful tablet manufacturing, you need granulators, mixing equipment, drying
machinery, and coating systems.
Even if you’re using the right equipment to manufacture your product, there is a wide
range of common tablet defects that can occur that affect quality.

Wet Granulation

A method commonly used for compressed tablet production, wet

granulation involves a size enlargement process and an adhesive
substance known as binder. Manufacturing tablets using the wet
granulation technique increases the chances of meeting all physical
requirements for tablet formation.

Here are the steps for a successful wet granulation tablet manufacturing process:

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  Weigh, mill, and mix your active pharmaceutical ingredients APIs with
powdered excipients.
 Prepare the binder solution.
 Mix your binder solution with powders to create a damp mass.
 Wet screen the dampened powder into pellets or granules using a mesh
screen.
 Dry the moist granules.
 Use dry screening to size granulation.
 Mix the dried granules with lubricant and disintegrants.
 Compress the granules into tablets

Advantages of wet granulation:

 The major advantage of wet granulation is that it forms granules and

is more spherical than the powder, hence has better flow properties,
and suitable for different types of dissolution rates.
 The wet granulation process improves the flowability,
compressibility, and cohesiveness of the powder, due to which the
powder is easily flowing and compressed.
 The method of wet granulation can be used for high-dose
pharmaceuticals with weak compressibility that is not affected by
moisture and heat.
 The presence of water in the form of moisture can help to improve
the dissolution rate of hydrophobic drugs.
 Wet granulation reduces the level of dust present during the
manufacturing process as compared with other methods.
 It maintains the same density of all granules since good material
uniformity is maintained due to particle segregation prevention.

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  Tablets made from a wet granulation process are ideal for tablet
coating.

Disadvantages of wet granulation:

 The major disadvantage of wet granulation is that the presence of moisture

can cause a reaction between the drug/drugs and the additive.
 The process is not suitable for compounds and excipients that are moisture-
sensitive.
 The dissolution rate of tablets produced by wet granulation may decrease
with aging.
 It includes several processing steps compared with other methods.
 It takes more time, energy, space hence it is a costly method as compared
with conventional methods.
 To conduct the granulation process, we need an experienced person.
 Wet granulation process requires more equipment and less space than dry
granulation.

Dry Granulation

The dry granulation tablet manufacturing process works by compacting

powder mixtures into large pieces or compacts and breaking them down
into granules. Dry granulation is typically used when tablet excipients
have sufficient, inherent binding properties. Dry granulation can also be
used to prevent drug substance exposure to elevated temperatures
during drying or moisture. The dry granulation tablet manufacturing
process eliminates several manufacturing steps but still requires
weighing, mixing, slugging, dry screening, lubrication, and granule
compression.

Here are the steps for a successful dry granulation tablet manufacturing process:

 Weigh and mill formulation ingredients like drug substances and excipients.
 Mix the milled powders.
 Compress the mixed powders into slugs.
 Mill and sieve the slugs.
 Compress them into tablets.

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Advantages of dry granulation:

 The major advantage of dry granulation is that the formulation does

not have moisture content, because granular liquid or solvent is not
used in the process. It is suitable for pharmaceuticals (drugs or
excipients) that are sensitive to moisture.
 The dry granulation process requires less equipment, less space,
more economic than wet granulation.
 The drying step is not involved in this type of method, hence it is
suitable for heat-sensitive materials.
 Dry granulation does not require any special excipients; it uses
conventional grades of material.
 Tablet manufacturing by dry granulation improves the disintegration
time.
 The rate of dissolution of tablets produced by dry granulation does
not decrease with aging

Disadvantages of dry granulation:

 The main disadvantage of dry granulation is that since it does not

form granules, it may not have better flow properties.
 The dry granulation method leads to low flowability, compressibility,
and cohesiveness of the powder, causing the powder to not easily
flowing and compressed.
 The process produces a lot of dust which can lead to cross-
contamination.

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  It requires a special heavy-duty apparatus for granulation.
 Dry granulation tablets are softer than wet granulation tablets which
make them difficult to tablet coating or film coating.
 It extensively damages the sieving screening and other tools which
are used in the process.

Direct Compression

The direct compression tablet manufacturing process directly compresses

powdered materials into tablets without modifying physical properties.
Using the direct compression tablet manufacturing process is a cost-
effective way to develop tablets, and it’s a common solution for producing
generic products in the pharmaceutical industry. Direct compression also
avoids a wide range of wet and dry granulation problems.

Here are the steps for a successful direct compression tablet

manufacturing process:

 Mill therapeutic agents and excipients.

 Mix the milled powders, disintegrants, and lubricants.
 Compress the tablets.

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EVALUATION OF TABLETS

Size & Shape:

It can be dimensionally described & controlled. The thickness of a tablet

is only variables. Tablet thickness can be measured by micrometre or by
other device. Tablet thickness should be controlled within a ± 5%

variation of standard value.

Weight Variation test (U.S.P.):

Take 20 tablet and weighed individually. Calculate average weight and compare
the individual tablet weight to the average. The tablet pass the U.S.P. test if no

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more that 2 tablets are outside the percentage limit and if no tablet differs by
more than 2 times the percentage limit.

Content Uniformity Test:

Randomly select 30 tablets. 10 of these assayed individually. The Tablet pass the
test if 9 of the 10 tablets must contain not less than 85% and not more than
115% of the labelled drug content and the 10th tablet may not contain less than
75% and more than 125% of the labelled content. If these conditions are not
met, remaining 20 tablet assayed individually and none may fall out side of the
85 to 115% range.

Dissolution Test (U.S.P.):

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Apparatus-1: A single tablet is placed in a small wire mesh basket
attached to the bottom of the shaft connected to a variable speed motor.
The basket is immersed in a dissolution medium (as specified in
monograph) contained in a 100 ml flask. The flask is cylindrical with a
hemispherical bottom. The flask is maintained at 37±0.5^C by a
constant temperature bath. The motor is adjusted to turn at the
specified speed and sample of the fluid are withdrawn at intervals to
determine the amount of drug in solutions.

Unique identification marking:

These marking utilise some form of embossing, engraving or printing. These

markings include company name or symbol, product code, product name etc

Tableting Process:
The tableting process can lead to several potential surface defects, such as:

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Capping
The separation of a tablet’s top from its main body is often the result of air
entrapment, poorly finished or shaped dies and punches, incorrect take-off blade
adjustments, or unnecessarily high turret speeds. As for formulation causes of
capping defects in tablets, multiple fines in granulation during pressing, improper
binding material, and low moisture content can lead to capping.

Lamination
This defect involves the breakage of a tablet into multiple layers. Excessive turret
speeds, rapid decompression, and elevated pressure force can cause it. Lamination
can result from the same formulation issues as capping, in addition to the rapid
relaxation of a tablet’s peripheral regions due to the lack of a material’s
compactness.

Chipping
Chipping, or the breakage of small bits of tablet edges, can occur when there are
substandard die shapes or conditions. Wet material, insufficient lubricant, and
improper binders that lead to sticking are potential issues in formulations.

Binding
This defect is the presence of scored or rough tablet edges resulting from improperly
finished or sized dies with incorrect clearance or extreme pressure in the tablet
press. Formulation-related challenges include excessive moisture and other granular
factors, as well as insufficient lubrication.

Picking
When a portion of a tablet sticks to a punch face, the leading process-related cause
is the free rotation of lower and upper punches during the tablet’s ejection or
abraded punch faces. Picking’s formulation-related causes include high moisture in
the granules, an excessive binder amount, and improper lubrication.

Thickness
Improper or inconsistent tablet thickness may result from poorly cleaned or
maintained tablet presses and varying lengths in punch tooling. The primary
formulation-related cause is inconsistent die filling.

Black Spots
Contaminated material, scorched material from within the die bore, and improper
feeder setup or adjustment are process-related sources of visible spots or
contaminants in tablet material. The leading formulation-related cause is

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contamination during any process preceding tableting. Black spots can also be
caused by unique combinations of certain products, machine component materials
and lubricants.

Shape
The primary process-related causes for variations in tablet shape are extreme press
speeds or short pre-compressions. In formulation, the most likely origin of shape
inconsistencies is highly soft or damp tablets.

Albendazole
Albendazole is an antihelminthic drug prescribed for treating a variety of parasitic
worm infestations such as ascariasis, filariasis or roundworm disease, giardiasis,
trichuriasis, pinworm disease, neurocysticercosis, and hydatid disease.

It is also used to treat strongyloidiasis, trichinosis, trichostrongyliasis, capillariasis,

cutaneous larva migrans, and microsporidiosis including Septata intestinalis
infection.

Albendazole works by killing sensitive parasites in the body.

Trade Names/Brand Names of Albendazole

India :
Albeder (400mg) | Womgo (400mg) | Albins (400mg) | Albezole
(10ml) | Lupibend (400mg) | Endy (400mg) | Biz (400mg) | Aldosh
(10ml)

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When should Albendazole not be taken? (Contraindications)
Contraindicated in pregnant and breastfeeding women, neonates, patients with
known hypersensitivity, and liver impairment.

How should Albendazole be taken?

It comes in a tablet form to take by mouth (orally). Should be taken with food .

What are the warnings and precautions for Albendazole?

• Monitor blood counts and liver function.

• Patients being treated for neurocysticercosis should receive appropriate steroid and
anticonvulsant therapy as required.

• It is important to take iron every day while you are being treated for hookworm
infection because it causes anemia.

• Administer within 7 days of start of normal menstruation in women of childbearing

age.

• Adequate non-hormonal contraceptive measures must be taken during and for 1

month after therapy.

• Perform liver function tests and blood counts before and every 2 wk during high
dose therapy of hydatid disease.

• It may cause bone marrow depression.

• It may cause dizziness. Do not drive or perform other possibly unsafe tasks until
you know how you react to it.

• In young children, the tablets should be crushed or chewed and swallowed with
glass of water.

What are the side effects of Albendazole?

• Central Nervous System: Headache, seizures, confusion, raised intracranial
pressure, dizziness/vertigo, signs that meningeal sings.
• Skin: Reversible hair loss, infection, hypersensitivity including rash and hives,
allergic reactions.
• Gastrointestinal: Abdominal pain, nausea/vomiting.
• Genitourinary: Acute kidney failure, dark urine.
• Liver: Abnormal Liver Function Tests, inflammation of liver
• Blood: Decrease in the number of white blood cells, thrombocytes, hemoglobin.
• Miscellaneous: Fever

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Injection

Pantoprazole
Pantoprazole, sold under the brand name Protonix, among others, is
a proton pump inhibitor used for the treatment of stomach ulcers, short-
term treatment of erosive esophagitis due to gastroesophageal reflux
disease (GERD), maintenance of healing of erosive esophagitis, and
pathological hypersecretory conditions including Zollinger–Ellison
syndrome. It may also be used along with other medications to

eliminate Helicobacter pylori. Effectiveness is similar to other proton

pump inhibitors (PPIs. It is available by mouth and by injection into a vein.
Common side effects include headaches, diarrhea, vomiting, abdominal
pain, and joint pain. More serious side effects may include severe
allergic reactions, a type of chronic inflammation known as atrophic
gastritis, Clostridium difficile colitis, low magnesium, and vitamin B12
deficiency. Use in pregnancy appears to be safe. Pantoprazole is a proton
pump inhibitor that decreases gastric acid secretion. It works by
inactivating (H+/K+)-ATPase function in the stomach

MEDICINAL USES
 Pantoprazole is used for short-term treatment of erosion and
ulceration of the esophagus for adults and children five years of age
and older caused by gastroesophageal reflux disease.
 It can be used as a maintenance therapy for long-term use after
initial response is obtained, but there have not been any controlled
studies about the use of pantoprazole past a duration of 12 months.

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  Pantoprazole may also be used in combination with antibiotics to
treat ulcers caused by Helicobacter pylori. It can also be used for
long-term treatment of Zollinger-Ellison syndrome.
 It may be used to prevent gastric ulcers in those taking NSAIDs.
 In the hospital, intravenous administration is indicated when
patients are unable to take the medication by mouth.

Children
Pantoprazole is only indicated for the short-term treatment of erosive
esophagitis in children ages seven and older; and the safety and
effectiveness of pantoprazole have only been established in the treatment
of erosive esophagitis in children.
Elderly
The incidence of adverse effects occurring in people aged 65 years and
older was similar to that in people aged 65 years and less.
Pregnancy
In reproductive studies using doses largely greater than the
recommended doses performed on rats and rabbits, there was no evident
harm on the development of the baby.
Breast feeding
Pantoprazole has been found to pass through the breast milk. Additionally,
in rodent cancer studies, pantoprazole has been shown to potentially
cause tumor growth. The clinical relevance of the finding is unknown, but
risks and benefits are recommended for consideration in determining the
use of therapy for the mother and child.

Adverse effects
 Infection: Stomach acid plays a role in killing ingested bacteria. Use
of pantoprazole may increase the chance of developing infections
such as pneumonia, particularly in hospitalized patients.

Common
 Gastrointestinal: abdominal pain (6%), diarrhea
(9%), flatulence (4%), nausea (7%), vomiting (4%)
 Neurologic: headache (12%), dizziness (3%)
 Neuromuscular and skeletal: arthralgia (3%)

Rare
 Gastrointestinal: constipation, dry mouth, hepatitis
 Blood problems: low white blood cell count, thrombocytopenia
 Immunologic: Stevens–Johnson syndrome, toxic epidermal
necrolysis.

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Interactions
Due to its effect of reducing stomach acidity, use of pantoprazole can
affect absorption of drugs that are pH-sensitive, such
as ampicillin esters, ketoconazole, atazanavir, iron
salts, amphetamine and mycophenolate mofetil. Additional medications
that are affected include bisphosphonate derivatives, fluconazole,
clopidogrel, and methotrexate.

Method of preparation of pantoprazole

A process for converting pantoprazole sodium to pantoprazole sodium
sesquihydrate, comprising the steps of:

1.forming pantoprazole sodium by a process in accordance with any

preceding claim.

(ii) dissolving pantoprazole sodium in acetone;

(iii) co-distilling with ethyl acetate till precipitation occurs;

(iv) cooling the suspension to room temp;

(v) adding water in a quantity sufficient enough to form the

sesquihydrate;

(vi) stirring at room temp;

(vii) chilling the reaction mixture; and

(viii) isolating pantoprazole sodium sesquihydrate by filtration and drying.

Conclusion

During one semester training period, a lot of experience, knowledge and exposure that I
have handy . All disclosures were awaken myself in a boost of self-confidence to face life
more challenging now.

During my industrial training, there are many changes from the point of learning
environments and discussion among colleagues. It can directly increase the dedication and
rational attitude toward myself.

However, there are still some weaknesses that can be improved in the future. Therefore I
conclude that the industrial training program has provided many benefits to students even if
there are minor flaws that are somewhat disfiguring condition , so that this weakness can be
rectified in the future.

xxiii
I can conclude that this industry is through training I received a lot of exposure in the
computing world. I would like to thank also the mr Fahim khaleed giving students -
students find their own experience with having Industrial Training like this.

xxiv
THANK YOU

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