Introduction to industrial pharmacy

Ahmed Hassan
Asst. Prof. PhD. Biochemistry
2025‫م‬
Email: ahmedhassan@[Link]
Introduction to Industrial Pharmacy
Industrial Pharmacy is a specialized branch of pharmaceutical
sciences that focuses on the manufacture, development, quality
control, packaging, and regulation of pharmaceutical products on a
large or commercial scale.
industrial pharmacy is concerned with transforming active
pharmaceutical ingredients into safe, effective, and high-quality
finished dosage forms like tablets, capsules, injections, creams, and
more.
Key Areas in Industrial Pharmacy:
1-Formulation Development – Designing and optimizing drug
manufacturing systems (e.g., tablets, capsules, injections).
2-Pharmaceutical Manufacturing – Scaling up production processes
while maintaining product quality
3-Quality Assurance (QA) & Quality Control (QC) – Ensuring
products meet regulatory standards (e.g., GMP - Good Manufacturing
Drug industry includes:
A-Regulatory Affairs – Preparing documentation and ensuring
compliance with national and international drug organizations
and regulations (e.g., FDA, EMA: European Medicines Agency).
B-Packaging and Labeling – Ensuring proper packaging to
maintain drug stability, patient safety, and drug bioavialbility
C-Research and Development (R&D) – discovery new drug
formulations and improving existing ones.
Importance of Industrial Pharmacy:
1-Ensures mass production of medicines that are safe, effective,
and affordable.
Plays a vital role in the drug development, from lab to market.
Supports public health by ensuring the availability and
reliability of medications.
Types of Dosage Forms (with properties): Dosage forms are broadly
classified into many categories::
I-Solid Dosage Forms These are the most common and widly used dueto
their stability, convenience, and ease of manufacturing.

Type Properties

Compressed powder form. Stable, easy to handle. Can be coated

Tablets
(film/sugar/enteric) for taste masking or controlled release.

Drug enclosed in gelatin shells. Masks taste, easier to swallow. Can hold
Capsules
powder, granules.

Powders Fine or coarse particles. Quick dissolution, but less convenient for dosing.

Larger, irregular particles. Better flow and stability than powders. Often used
Granules
for reconstitution.

Intended for slow dissolution in mouth. Used for local action in the throat or
Lozenges
mouth.
Liquid Dosage Forms
These are useful for patients who have difficulty
swallowing solids, such as children and elderly.
Type Properties
Clear, homogenous liquid with dissolved
Solutions
drug. Rapid absorption, but lower stability.

Suspension Insoluble drug particles dispersed in a

s liquid. Must be shaken before use.

Mixture of oil and water phases stabilized

Emulsions
by emulsifiers. Used for oral or topical use.

Sweet, viscous liquids with high sugar

Syrups
content. Mask unpleasant taste.

Clear, sweetened hydro-alcoholic solutions.

Elixirs
More stable than syrups.
Semi-Solid Dosage Forms: Mainly used for topical application on skin
or mucous membranes.
Type Properties

Emulsions with oil/water base. Non-greasy

Creams
and easily washable.

Greasy, oil-based. Provide occlusive effect

Ointments
and longer action.

Transparent or translucent, water-based.

Gels
Good for quick absorption.

High proportion of solids. Thick and

Pastes
provide a protective barrier.
Sterile Dosage Forms
Used when drug must be free from microbes ( e.g., injected
directly into body
Type Properties
Solutions or suspensions for
Injections parenteral use (IV, IM, SC). Must be
sterile and pyrogenic-free.
Large-volume sterile solutions,
Infusions
usually given IV.
Ophthalmic Sterile solutions or ointments for
preparation the eyes. Must be isotonic and free
s from irritants.
Novel Drug Delivery Systems (NDDS): Advanced systems for
controlled or targeted drug release
Type Properties
Delivers drugs through the skin over time.
Transdermal patches
Avoids first-pass metabolism??
Microspheres/ For controlled or targeted drug delivery.
Nanoparticles Enhances bioavailability.
Vesicles used for targeted delivery,
Liposomes
especially for anticancer drugs.

Key Properties of Ideal Dosage Forms:

A-Stability: Chemical and physical stability over shelf life.
B-Uniformity: Accurate and consistent dosing.
C-Bioavailability: Efficient absorption and therapeutic action.
D-Patient compliance: Pleasant taste, easy to use, convenient.
E-Safety: Free from contaminants, non-toxic excipients.
 Packaging :
it it a process of preparing the pharmaceutical
preparations for preserve, shipment and transport
 It involves all of the operations from production
through distribution channels to the end consumer.
The wide range of pharmaceutical products are
transferred to market by packaging , such as
A-solid powders ( granules, tablets, capsules)
 B-semisolids (e.g. creams, ointments, gels)
 C-liquids (such as solutions, suspensions, emulsions)
The packaging include paper, glass, plastics, rubber,
metal or combination materials such as laminates.
Examples of primary packs include blister packs,
strip packs, sachets, bottles, ampoules, vials, bags,
tubes and syringes.
The properties of primary pack must be
1-compatible with the product, and take nothing out
of the product and add nothing in.
Drug absorption into the pack would reduce product
potency, while chemicals leaching out of the pack and
into the product could induce drug degradation.
2- protect the product against atmospheric actors, such
as extremes of temperature, light, moisture, oxygen,
carbon dioxide, particulates (e.g. dust, dirt), as well
as biological hazards, such as microorganisms, insects
and rodents, and enable product stability.
Drug molecules can undergo chemical reactions caused by
light, heat, moisture, or atmospheric gases, such as
oxygen:
A-light can provide the energy necessary for the formation a
drug isomer to change its configuration. Protection from light
is usually achieved by using an opaque or amber-coloured
container.
B-Oxygen can cause drug degradation via oxidation.
C-Carbon dioxide can dissolve in the water in un buffered
aqueous products, and lower their pH by forming carbonic
acid.
D-Water can cause drug degradation via hydrolysis.
E-Moisture gain into a product can also cause dilution of
liquid products, wetting of solid products and an aqueous
Secondary packs also contribute to protection
against atmospheric actors to some extent,
although their major role is to provide protection
against mechanical hazards, such as shock (e.g.
when dropped), compression, vibration, abrasion,
puncture, etc., during handling, storage and
transport.
A closure :
It is a device – e.g. stopper, lid, top or cap – which
is used to close a container, and is an integral part of
the pack, the closure must be inert, compatible
with the contents, and protect the contents against
environmental hazards (oxygen, light, moisture, etc.)
 Certain closures must maintain sterility, e.g. in
multi-use parenteral vials.
The closure has to be user- friendly, allow easy
opening to patient and be easy to reclose , as well
as child-resistant.
Metal tubes (ointments and creams) have two
closures – a cap at one end while the other end of the
tube is sealed by folding and crimping.
Flexible packaging, such as pouches, sachets and
blister packs do not contain a closure as defined
above.
They are instead sealed by heat and/ or pressure, or
with adhesives, and are non-re closable packs
Containers for packaging:
1-glass containers 2- Plastics containers 3-rubber containers
4- Metal containers 5-paper containers:


1-glass containers
Pharmaceutical types of glass containers:
Four types of glass : as types I, II, III and NP glass – are used to
package pharmaceuticals.
Type I glass:
This is the best pharmaceutical grade and is produced by adding
boron oxide to glass, so glass is also called borosilicate glass.
 It shows the least amount of leaching of glass components, and is
used in ampoules and vials or liquid parenteral products.
Type II glass:
This is the next (lower) grade and is made from the same materials as
standard glass (soda lime glass). type II glass is also referred to as treated
soda lime glass or de-alkalized soda lime glass. Type II glass is suitable for
solutions that can be buffered to remain below pH 7.

Type III glass:

This is the third (lower) grade. This glass used in food packaging. It is
used to package large volumes (normally >100 mL)

Type IV Non parenteral (NP) glass:

This is the lowest grade and is called Non parenteral glass, and, as the
name suggests, is not used for packaging parenteral products, as small
volumes of the parenteral products would be easily contaminated by
sodium and other materials leaching out of the glass.
NP glass is suitable for packaging large volumes (normally >100 mL) of
topical products like creams and of oral products, such as mouthwashes.
2- Plastics containers : They are widely used as containers
such as:
• bottles for solid and liquid products
• tubes or creams, ointments and gels
• pouches to contain individual suppositories, blister packs
• bags to contain intravenous solutions and parenteral
nutritional products
• bottle closures.

3- Rubbers containers:

they are used as a closure they allow a needle to enter the
container, and reseal when the needle is removed. They are
soft enough to mould and conform to the opening of the
4- Metal containers:
It is widely used to package food.
Aluminum and tinplate are the metals used in the packaging of
pharmaceuticals. They are used in the form of cans, tubes ( for creams,
ointments, gels), pouches ( for powders, granules, liquids, suppositories).
 Metal has many advantages as a packaging material, it is mechanically
strong and can withstand the high internal pressure in containers, it is
resist the crash , low weight , impermeable to gases and light.
Both soft and hard forms of aluminum and tinplate are used in
pharmaceutical packaging;
A-hard material is used for in aerosol cans
B-while soft metal is used as the collar on parenteral vials with
rubber stoppers.
 soft forms allows that when metal tubes are squeezed to expel the
product, e.g. a cream, the tube does not return back into its original
shape and so air will not sucked back into the container, which could
protect the drug product from contamination
5-paper containers:
It is one of the oldest pharmaceutical packaging
materials. It has applications including labels and
leaflets, cartons, bags and sacks, and sachets.
paper is not usually used in the manufacture of the
primary pack.
An exception is the sachet, which is the primary pack,
where the paper is separated from the product by a
layer of another material( eg. Nylons).
Paper has many advantages as a packaging material: low
cost and readily available, generally non-toxic ,easily
recycled, readily torn or cut open, rigidity and strength
allow its use in cartons, easily printed and coated
Paper does have certain disadvantages:
 no protection properties against moisture, gases and odors,
sensitive to the moisture, no protection against heat or cold
condition
To overcome such disadvantages, paper can be combined
with other materials. For example, paper can be further
coated by polymers or laminated to plastic or to aluminum
oil to improve its barrier properties to gases and moisture, and
to create heat sealing ability when used in the primary pack.
laminate :
A laminate is made by bonding together two or more layers
of different materials, such as paper, plastic and metal.
The aim is to combine the desirable properties of the different
plies into a single packaging structure.
 Questions :
 The properties of primary pack must be?
 Drug molecules can undergo chemical reactions caused by light, heat, moisture, or
atmospheric gases, such as oxygen, discuss that
 NP glass is not used for packaging parenteral products, discuss that
 the closure must be :1-…..,2-…….,3-……..,
 Metal tubes have two closures – a cap at one end while the other end of the tube is
sealed by heating ( true or false)
 pouches, sachets and blister packs contain a closure. sealed by folding and
crimping( true or false)
 borosilicate glass shows the least amount of leaching of glass components( true or
false)
 define : de-alkalized soda lime glass, borosilicate glass, NP glass
 Metal has many advantages as a packaging material, what are they?
 Soft metals is used for in aerosol cans, while hard metal is used as the collar on
parenteral vials with rubber stoppers. ( true or false)
 soft metal can protect the drug product from contamination. Commen
 paper is not usually used in the manufacture of the primary pack(true or false)
 Paper has many advantages and disadvantage. What are they?