PRACTICE SCHOOL REPORT

ON
VIRTUAL INDUSTRIAL TOUR
Submitted by

VARSHI
T. MAHESH YADAV

GLOBAL COLLEGE OF
PHARMACY

INDUSTRIAL TRAINING
INTRODUCTION TO PHARMACEUTICAL INDUSTRY

PHARMACEUTICAL INDUSTRY

The pharmaceutical industry discovers, develops, produces, and markets drugs or pharmaceutical
drugs for use as medications to be administered (or self-administered) to patients, with the aim to
cure them, vaccinate them, or alleviate the symptoms. Pharmaceutical companies may deal in
generic or brand medications and medical devices. They are subject to a variety of laws and
regulations that govern the patenting, testing, safety, efficacy and marketing of drugs.

TYPES OFPHARMACEUTICAL INDUSTRY

Mainline: These are the larger drug companies that have several different drugs to their name.
Moreover, these established companies, like Pfizer, have thousands of researchers working for
them, and several manufacturing plants.

Research and Development: These are smaller research organisations and pharma businesses that
focus on R&D. Additionally, while they do not have drugs on the market, they help bigger firms
with clinical trial observation as subcontractors on larger projects.

Generic: Since the expiry of drug patents help in lowering the cost of manufacture, generic drug
companies help mass-produce drugs. Moreover, these pharmaceutical companies do not work
much on R&D but help bring patent-expired medicines to the market at lower costs.

AI Manufacturers: These corporations produce bulk compounds, biomolecules and other AIs for
drug manufacturers. Further, they also help to create vaccines, serums, and other produt.

VARIOUS DEPARTMENTS OF PHARMACUTICAL

INDUSTRIES
The 4 Main Departments of Pharmaceutical Industries

1. Good Manufacturing Practice (GMP):

Good Manufacturing Practice (also called ‘current Good Manufacturing Practice’, cGMP’) is a
part of Quality Assurance this ensures that products are consistently produced and controlled to
the quality standards appropriate to their intended use as required by the marketing authorization
or product specification.

2. Good Laboratory Practice (GLP):

The laboratory premises and equipment should meet the general and specific requirements for
Quality Control (QC) areas. The personnel, premises, and equipment in the laboratories should
be appropriate to the tasks imposed by the nature and the scale of the manufacturing operations.

3. Quality Control (QC):

Quality Control (QC) is concerned with sampling, specifications and testing as well as the
organization, documentation and release of the product procedures (Fig. 19.3). This ensures the
necessary and relevant tests carried out for the release of products. The product to be released for
sale or supply should be carried out only after checking their quality.

4. Quality Assurance (QA):

Quality Assurance is a wide ranging concept which covers all matters individually or collectively
that influence the quality of a product. It is the sum or total of the organized arrangements made
with the object of ensuring the medicinal products are of the quality required for their intended
use.

Therefore, Quality Assurance includes GMP. In a pharmaceutical production process, quality

assurance is involved in several activities such as: purchasing, dispatching, warehousing,
operational protocols, manufacturing, training, quality control, validation and packaging.

ROLE OF PHARMACEUTICAL INDUSTRY

The Role of Pharmaceutical Industry in India GDP is immense. For the past few years the Indian
Pharmaceutical Industry is performing very well. The varied functions such as contract research
and manufacturing, clinical research, research and development pertaining to vaccines are the
strengths of the Pharma Industry in India.

TYPES OF DOSAGE FORMS MANUFACTURED AT

PHARMACEUTICAL INDUSTRY
1. Oral dosage forms
A. Tablet

A tablet is a hard, compressed medication in round, oval or square shape.

B. Buccal and sublingual tablet

Sublingual and buccal medications are administered by placing them in the mouth, either under
the tongue (sublingual) or between the gum and the cheek.

C. Capsule
 A capsule is a medication in a gelatin container.

Advantage: mask the unpleasant taste of its contents.

The two main types of capsules are:

I. hard-shelled capsules, which are normally used for dry, powdered ingredients,

II.soft-shelled capsules, primarily used for oils and for active ingredients that are dissolved or
suspended in oil.

D. Liquid preparations (Cont.)

1. Linctuses

1. Linctuses are viscous, liquid oral preparations that are usually prescribed for the relief of
cough.

2. They usually contain a high proportion of syrup and glycerol which have a demulcent effect
on the membranes of the throat.
3. The dose volume is small (5ml) and, to prolong the demulcent action, they should be taken
undiluted.

2. Oral drops

Oral drops are Liquid preparations for oral use that are intended to be administered in small
volumes with the aid of a suitable measuring device. They may be solutions, suspensions or
emulsions.

2. Topical dosage forms

A. Ointments

1.Ointments are semi-solid, greasy preparations for application to the skin, rectum or nasal
mucosa.

2.The base is usually anhydrous and immiscible with skin secretions.

3.Ointments may be used as emollients or to apply suspended or dissolved medicaments to the

skin.
3. Rectal dosage forms
A. Suppository

It is a small solid medicated mass, usually cone-shaped ,that is inserted either into the rectum
(rectal suppository), vagina (vaginal suppository or pessaries) where it melts at body
temperature.

Vaginal dosage forms

Pessaries

1. Pessaries are solid medicated preparations designed for insertion into the vagina
where they melt or dissolve.
There are three types

A. Moulded pessaries: they are cone shaped and prepared in a similar way to moulded
suppositories.

B. Compressed pessaries: made in a variety of shapes and are prepared by compression in a

similar manner to oral tablets.

C. Vaginal capsules: are similar to soft gelatin oral

Parenteral dosage forms

An injection is an infusion method of putting liquid into the body, usually with a hollow needle
and a syringe which is pierced through the skin to a sufficient depth for the material to be forced
into the body.

There are several methods of injection, including:

An intravenous injection

1. It is a liquid administered directly into the bloodstream via a vein.

2. It is advantageous when a rapid onset of action is needed Capsules differing only in size.

Ophthalmic dosage forms

 Eye drops: Eye drops are saline-containing drops used as a vehicle to administer medication in
the eye. Depending on the condition being treated, they may contain steroids, antihistamines or
topical anesthetics.

Eye drops sometimes do not have medications in them and are only lubricating and tear-
replacing solutions

Otic dosage forms:

Ear drops: 1.Ear drops are solutions, suspensions or emulsions of drugs that are instilled into
the ear with a dropper.

2.It is used to treat or prevent ear infections, especially infections of the outer ear
and ear canal.

PELLETS AND PELLETIZATION TECHNIQUES

INTRODUCTION

Pellets are spherical or nearly spherical, freeflowing granules with a narrow size distribution,
typically varying between 500 and 1500 µm for pharmaceutical applications. They are generally
produced via a pelletization process whereby a powder blend consisting of an Active
pharmaceutical ingredient (API)and excipient particles is agglomerated into spherical granules.
After being processed, pellets are usually filled into hard gelatin capsules or compressed into
tablets.

1. Furthermore, they can be formulated as immediate release dosage form or in sustained drug
release over a long duration time or can be coated also to deliver a drug to a specific site of
action in the gastrointestinal tract.

2. Pellets provide the scientist with a high degree of flexibility during the design and
development of oral dosage forms.

3. They can be divided into desired dose strengths without formulation or process changes.

4. Also be blended to deliver incompatible bioactive agents simultaneously or particles with

different release profiles at the same site or at different sites within gastrointestinal tract.
5. Pellets provide development of formulation with high degree of flexibility due to freeflowing
characteristic. So they are packed easily without any difficulties.

6. The spherical shape and a low surface area to volume ratio of pellets made uniform film
coating.

7. Pellets eliminate the dose dumping effect, which gives smoother plasma concentration profile
and gradual absorption of drug than tablet, which further decrease the adverse effect of drugs.

Advantages

1. Uniformity of dose - Layering techniques and extrusionsperonization offers great accuracy

with drug delivery the pellets.

2. Spheres have excellent flow properties This becomes very useful in automated processes or in
processes where exact dosing is required, e.g. tableting, moulding operations, capsule filling, and
packaging.

3. Prevention of dust formation Resulting in an improvement of the process safety, as fine

powders can cause dust explosions and the respiration of fines can cause health problems.

4. Controlled release application of pellets due to the ideal low surface area-to-volume ratio that
provides an ideal shape for the application of film coatings.

5. They can be blended to deliver incompatible bioactive agents simultaneously and/or to

provide different release profiles at the same or different sites in the gastrointestinal (GI) tract.

Therapeutic Advantages

1. Pellets can disperse freely throughout the GIT after administration and consequently the drug
absorption is maximized.

2. The wide distribution of spherical particles in the gastrointestinal tract limits localized build-
up of the drug, avoiding the irritant effect of some drugs on the gastric mucosa;

3. Reduce inter- and intra-patient variability

4. Modified-release multiparticulate delivery systems are less susceptible to dose dumping than
single-unit dosage forms.

Disadvantages

1. Pellets filling involve capsule filling which can increase the costs

2. Tableting of pellets destroy film coating on the pellets.

3. The size of the pellets may vary from formulation to formulation but usually is in range of
0.05 mm and 2 mm.

4. The control of manufacturing process is complicated with too many process variables as well
as formulation variables.

A SHORT HISTORY OF PELLETS

Although various industries have routinely utilized pelletization processes since the turn of the
20th century in order to manufacture particles with defi ned sizes and shapes, it was only in the
early 1950’s, in response to a desire to sustain the release of drugs over an extended period of
time, that the pharmaceutical industry developed a keen interest in the technology. In 1949,
pharmaceutical scientists at Smith Kline & French (SKF) realised the potential of candy seeds in
developing sustained-release preparations and began the development of tiny drug pellets that
could be loaded into capsules. In time, extensive research was conducted to develop pelletization
techniques and major ressources were allocated towards exploring methods that were faster,
cheaper and more efficient, both in terms of formulation and processing equipment . The trend is
expected to continue in the forseeable future. Also, the role of pellets, especially of spheroids, in
oral dosage form design and development has increased substantially during recent decades.
Currently, pellets containing the active ingredients are administered in the form of suspensions,
capsules or tablets, a great number of this kinds of pharmaceutical products being available on
the market. Also, pelletization is used in various industries, such as agriculture (fertilizers and
herbicides), mineral processing, food and detergent industry.
Desirable Properties of Pellets

1. For Uncoated pellets

a. Uniform spherical size

b. Narrow particle size distribution

c. Good flow property

d. Low friability

e. Even surface

f. Low dust formation

g. Reproducible packing

h. Ease of coating

2. For Coated pellets

a. Maintain all above properties

b. Desirable drug release characteristics

FORMULATION OF PELLETS

Commonly used formulation in the manufacturing of pellets are as follows:

1.Excipients

2. Disintegrants

3. Surfactants

4. PH adjusters

5. Seporating agents
6. Glidents

7. Release modifiers
PELLETIZATION TECHNIQUES

PELLETIZATION PROCESS
1. AGITATION

Pelletization is a form of tumble-growth (agitation) agglomeration, whereby material fines are

“grown” through a tumbling motion and the addition of water or a binding agent.

A. Balling

It is pelletization process in which pellets are formed by a continuous rolling and thumbing
motion in pans, discs, drums or mixtures. The process consists of conversion of finely divided
particles in to spherical particles upon the addition of appropriate amounts of liquid.

2. COMPACTION

While the pelletizing process is a form of tumble growth agglomeration, the compaction process
is a form of pressure agglomeration. ... Additionally, these two processes produce very
different end products, with the pelletization process resulting in rounded pellets, and the
compaction process resulting in jagged granules

A. Compression

It is one type of compaction technique for preparing pellets. Pellets of definite sizes and shapes
are prepared by compacting mixtures or blends of active ingredients and excipients under
pressure. The formulation and process variables controlling the quality of pellets prepared are
similar to those used in tablets manufacturing.

B. Extrusion

It produces rod shaped particles of uniform diameter from wet mass. The wet mass is forced
through dies and shaped into small cylindrical particles with uniform diameter. Such shaping of
wet mass into long rods, commonly termed ‘extrudate’.

3. LAYERING

It includes deposition of successive layers of drug entities from solution, suspension or dry
powder on nuclei which may be crystals or granules of the same material or inert starter seeds. In
solution/suspension layering, drug particles are dissolved or suspended in the binding liquid. In
powder drug layering, a binder solution is first sprayed onto previously prepared inert seeds,
followed by the addition of powder.

a)Powder Layering :

In powder layering liquid saturation is low and irrespective of the solubility of the drug in the
binding liquid, complete dissolution does not occur. Typically, a binder solution is first sprayed
onto the nuclei, followed by the addition of powder. The most nuclei tumble in the rotating pan
of disc, pick up powder particles, and form layers of small particles that adhere to each other and
the nuclei by means of capillary forces developed in the liquid phase. As additional bonding,
liquid is sprayed, layering of more powder on the nuclei continues until the desired pellet sizes
are obtained. On drying, the binder and other dissolved substance crystallize out and the liquid
bridges are partially replaced by solid bridges. On spraying with binder, fines may pick up
moisture and enter a nucleate on phase.
b)Solution and Suspension Layering :

Principle of the suspension and solution layering process: Solution and suspension layering
involve the deposition of successive layers of solutions and suspensions of drug substances,
respectively, on starter seeds that may be inert materials or crystals or granules of the same drug.
In principle, the factors that control coating processes apply directly to solution or suspension
layering. During solution or suspension layering, all the components of the formulation are
dissolved or suspended in the application medium and hence determine the solids contents and
the viscosity of the liquid sprayed. As the solution or suspension is sprayed onto the product bed,
the droplets impinge on the starter seeds or cores and spread evenly on the surface, provided that
the drying conditions and fluid dynamics are favorable. This is followed by the drying phase
which allows dissolved materials to crystallize and form solid bridges between the core and
initial layer of the drug substance as well as among the successive layers of drug substance. The
process continues until the desired layers of drug and hence the target potency of the pellets are
achieved. The rate of particle growth is rather slow due to the incremental addition of the
dissolved or suspended drug .In this process, though the particle population remains the same,
the size of the pellets increases as a function of time and, as a result, the total mass of the system
increases. Figure 3 shows the principal of solution or suspension layering.

4. GLOBULATION

Globulation is a process where liquid materials like melt, solution, or suspension are atomized
to generate spherical particles or pellets. During spray drying, the atomized droplets are
contacted by a hot gas stream and evaporation of the liquid is initiated.
A. Spray Drying

During spray drying, a drug solution or suspension is sprayed, with or without excipients, into a
hot-air stream generating dry and highly spherical particles. Though this technique is suitable for
development of controlled release pellets, it is generally employed to improve the dissolution
rates and hence improve the bioavailability of poorly soluble drugs. The spray dried powder
particles are homogenous, approximately spherical and nearly uniform in size. The design and
operation of spray drier can influence a great number of the characteristics of the final product,
such as particle size and size distribution, bulk density, porosity, moisture content, flowability
and friability.

B. Spray congealing

It is a technique similar to spray-drying. Spray congealing is a process in which a drug is

allowed to melt, disperse or dissolve in hot melts of gums, waxes, fattyacids or other melting
solids. The dispersion is then sprayed into stream of air and other gases with a temperature below
the melting point of formulation components. Under appropriate processing conditions, spherical
congealed pellets are obtained.

Factors affecting pelletization technique

1. Moisture content

Moisture in the wet mass brings cohesiveness to powder so that the wet mass can be extracted
and spheronizer to give spherical shape. High moisture contents lead to agglomeration of pellets
during the process of spheronization.

2. Rheological characteristics

The optimum rheological condition leads to good flow ability in order to extrudate the wet mass.
The rheological variations make improper and nonuniform extrudate.

3. Solubility of excipients and drug in granulating fluid

Soluble drug get dissolve in a granulating liquid. Thus increasing the volume of liquid phase
leads to over wetting of pellets. But increase in wetting liquid increases plasticity but includes
sticky mass.

4. Composition of granulating fluid

Besides water, alcohol, water/alcohol mixture, ethyl ether, dilute acetic acid, isopropyl alcohol is
used as a granulating liquid. Aqueous polymer dispersion containing HPMC, PVP, etc can also
be used as granulating fluid.

5. Physical properties of starting material

Quality of pellets depend not only composition but also on different grades of the same product.
The swelling property of material used in pelletization technique decides the release rate of drug
in pellets.

5. Speed of Spheronizer

It affects the size, hardness, sphericity and density of pellets. The high speed gives high
sphericity, lower friability, smooth surface and higher crushing strength.

6. Extrusion screen

The quality of pellets is greatly influenced by the characteristics of orifice of the screen. And
increase in orifice dimension resulted in increased mean pellet size. The increase in orifice depth
decreased with the presence of water at the extrudate surface.

EQUIPMENTS USED FOR THE MANUFACTURING PELLETS:

1. Extruder Machine

An extruder is simply the machine used to complete the extrusion process. Using a system of
barrels and cylinders, the machine heats up the product and propels it through the die to create
the desired shape.
3. Basket Extruder Machine

Basket Extruder is the low pressure extruder for mass output used widely in Agro Chemical,
Pesticide & Chemical Industries. Basket Extruder is a simple designed equipment to provide
higher output at less cost. ... The output from Basket Extruder is in the range of 500 microns (0.5
mm) to 2000 microns (2.00 mm).
4. Axial Powder Extruder

The Axial Xtruder is a twin screw extruder used to make large extrudates from 2.0- 8.0mm.
The extruder converts wetted powders into pellets of a controlled size and shape.
5. Double Screw Extruder:

the twin-screw extruder is a machine consisting of two co-penetrating and self-cleaning

identical screws which are mounted on shafts and rotate in the same direction in a fixed closed
housing called “barrel” . The twin-screw extruders operate continuously with very short
residence times.
REFERENCE:

1. www.biologydiscussion.com/microbiology-2/pharmaceutical-microbiology/4-main-d…
many-. vakilsearch.com/advice/how types-of-pharmaceutical-companies-exist/.

2. Gothi GD. Pelletization, Journal of Global Pharma Technology. 2010;2(1):45-57.

3. Mircea H and Cecilia A. Pelletization techniques used in pharmaceutical fields, Practica
farmaceutica. 2011;4:206-211.

4. Ghebre-Sellassie. Pharmaceutical Pelletization Technology, Marcel Dekker, Inc., New York,

1989.

5. Punia Supriya, Bala Rajni and Rana AC. Pelletization Technique: A literature Review,
International Research Journal of Pharmacy. 2012;3(3):43-47

6. Hiren P Patel, Patel JK, Ravi R Patel and Manish P Patel. Pellets: A General Overview,
International Journal of pharma world Research. 2010.

7. Shyamala Bhaskaran and Lakshmi PK. Extrusion Spheronization –A Review, International

Journal of PharmTech Research. 2010;4(2):2429-2433.

8. Jawahar N and Patel Hardik Anilbhai. Multi Unit Particulates Systems (MUPS): A Novel
Pellets for Oral Dosage Forms. Journal of Pharmaceutical Sciences and Research. 2012;
4(9):1915-23.

9. Anshuli Sharma and Sandhya Chaurasia. Multiparticulate drug delivery system: Pelletization
through Extrusion and Spheronization. 2013;4(2):6-9.

10.10. Afifa Bathool, Gowda D Vishwakanthe, Mohmmed S Khan and Vikas K Gupta.
Pelletization as a key tool for oral drug delivery: A review, Journal of Pharmacy Research.
2011,4(11):3282-86. 11. Ramu S, Ramakrishna G, Balaji M, Kondala rao K, Haranadh reddy S
and Pavan kumar D. Multiple Unit Drug Delivery System: Pelletization Techniques, American
Journal of Advanced Drug Delivery. 2013;1(1):011-021.