FORMULATION

AND PACKAGING
STAGES OF THE DRUG DISCOVERY AND
DEVELOPMENT PROCESS
• The development of a new medicinal product from a
novel synthesized chemical compound, a chemical
extracted from a natural source or a compound
produced by biotechnological processes, is a long
and complex process and involves many different
disciplines working together.
• The drug discovery and development process for a
typical research-based pharmaceutical company
can be broken down into five distinct stages.
• At each stage, there will be several activities running
in parallel, with the overall objective of discovering a
candidate drug and developing it to market as
efficiently as possible.
STAGES OF THE DRUG DISCOVERY AND
DEVELOPMENT PROCESS
1. Strategic Research
• Feasibility studies are conducted to demonstrate whether
interfering in a particular biological mechanism has an effect
that might be of therapeutic value.
• The strategic research of a particular company is usually
guided by factors such as its inherent research competence and
expertise, therapeutic areas of unmet medical need and market
potential/commercial viability.
• Companies often wish to develop a portfolio of products
within a specific therapeutic area to capture a segment of the
market.
• By focusing on a particular therapeutic area, a company can
build on its existing expertise and competence in all of its
functions with the aim of becoming a leading company in that
field.
STAGES OF THE DRUG DISCOVERY AND
DEVELOPMENT PROCESS
2. Exploratory Research
• Investigation of the biological mechanism and identification of a “chemical lead” that
interferes with it.
• During the exploratory research stage, diverse compounds are screened for the desired
biological activity. The aim is to find a chemical or molecular entity that interferes
with the process and to provide a valuable probe of the underlying therapeutic
problem.
• Traditionally, this has been achieved by the organic chemist synthesizing compounds
one at a time for the biologist to test in a linear fashion. Over the last decade, there has
been a rapid development in the technologies for creating very large and diverse
quantities of synthetic and biosynthetic molecules and for testing large numbers for
activity in less time.
• These technologies have been labeled “combinatorial chemistry” and automated
“high-throughput screening” (HTS), respectively.
• The key impact has been to accelerate the synthesis of new compounds from, say, 50
compounds per chemist year to many tens of thousands and to be able to test these
against many biological targets (e.g., biological receptors or biochemical pathways)
very quickly
STAGES OF THE DRUG DISCOVERY AND
DEVELOPMENT PROCESS
2. Exploratory Research
• The rate of technology development specifically associated with HTS for
pharmaceutical drug discovery has increased markedly over recent years with
automated techniques involving miniaturization, to allow assays on very small
samples (e.g., 1L volume), and the ability to analyze thousands of samples a day using
well microplates.
• In addition to the use of HTS for pharmacological activity, HTS tests have been
developed for assessing metabolism and pharmacokinetic and toxicity factors to speed
up the drug discovery process.
• In simple terms, a biologically active compound can be considered to consist of a
supportive framework with biofunctional groups attached that bind to a target to
induce a biological response.
• Each compound is, in effect, a unique combination of numerous possible groups.
Combinatorial techniques have replaced traditional synthetic approaches to generate
many possible combinations rapidly for biological testing.
STAGES OF THE DRUG DISCOVERY AND
DEVELOPMENT PROCESS
2. Exploratory Research
• Approaches to lead generation during exploratory research often depend on how much
is already known about the therapeutic target under consideration. For example, if the
threedimensional structure of the target (such as an enzyme-inhibitor complex) is
known, chemical leads could be found and optimized through combinatorial chemistry
and HTS.
• Alternatively, in some cases, the only available biochemical knowledge might be the
structure of a ligand for the enzyme. If there were no information at all, then the only
approach might be limited to HTS of batches of compounds from combinatorial
libraries.
• Even with combinatorial chemistry and HTS, lead generation can be extremely
laborious because of the vast number of different molecules possible (framework and
biofunctional group combinations). To ease this burden, some rational drug design and
quantitative structure activity relationships (QSARs) are often introduced to direct the
programme and utilize a company’s finite screening resource as efficiently as possible.
STAGES OF THE DRUG DISCOVERY AND
DEVELOPMENT PROCESS
2. Exploratory Research
• “Representative” libraries of compounds, where each member is
selected to give information about a larger cluster of compounds, are
designed and used to reduce the amount of compounds that have to
be made and tested.
• Together with combinatorial chemistry and rational drug design,
genomics is rapidly emerging as a useful technique to enable
companies to significantly increase the number of drug targets and
improve on candidate selection success.
• A number of companies have seen the potential in defining patient
groups based on their genotypes and are now investing lots of money
to gain a clearer understanding of the genes that are important to drug
action.
STAGES OF THE DRUG DISCOVERY AND
DEVELOPMENT PROCESS
3. Candidate Drug Selection
• The chemical lead is used to generate specific chemical compounds with the optimal
desired characteristics, for example, potency, specificity, duration, safety and
pharmaceutical aspects.
• One or more candidate drugs are nominated for development.
• During the candidate drug selection stage, the chemical lead is optimized by testing a
range of selected compounds in in vitro and in vivo (animal) studies. The objective is
to select one or more candidate drugs for development with the most desired
characteristics.
• Pharmacological characteristics might include acceptable absorption, potency,
duration of action and selectivity for the receptor or enzyme. Safety characteristics
will normally include noncarcinogenicity, non-teratogenicity, non-mutagenicity, and
general non-toxicity.
• The potential for these characteristics can be predicted from relatively short-term
preclinical toxipharmacological animal studies and in vitro tests.
STAGES OF THE DRUG DISCOVERY AND
DEVELOPMENT PROCESS
3. Candidate Drug Selection
• Higher priority in the selection process will, in most cases, be given to a compound’s
optimal pharmacological and safety characteristics. However, in the event of having a
choice from a range of compounds all possessing similar pharmacological and safety
properties, there may be a significant advantage for formulation development in
selecting a compound with the most preferred pharmaceutical properties. It is useful to
conduct preformulation studies and biopharmaceutics studies at the candidate drug
selection stage to determine the most relevant physicochemical and biopharmaceutical
properties of potential candidate drugs to aid candidate selection.
• Biopharmaceutics is the study of how the physicochemical properties of the candidate
drugs, the formulation/delivery system and the route of administration affect the rate
and extent of drug absorption. Appropriate biopharmaceutical information generated at
this stage can also be very important in directing the candidate selection process and
for future dosage form design during development
STAGES OF THE DRUG DISCOVERY AND
DEVELOPMENT PROCESS
3. Candidate Drug Selection
• Generally, any pharmaceutical issues can be discovered earlier, before the candidate
drug reaches development, and any implications for product design and development
considered in advance.
• Pharmaceutical development’s involvement in the selection process and “buy-in” to
the nomination decision can often enhance the team’s working relationship with their
research colleagues.
• The objective is to achieve a seamless transition from research to development, as
opposed to the traditional “over-the-wall” approach that many pharmaceutical
companies experience to their costs.
• Earlier involvement by the Pharmaceutical Development group at the preclinical stage
should also result in better planning for full development.
STAGES OF THE DRUG DISCOVERY AND
DEVELOPMENT PROCESS
3. Candidate Drug Selection
• In spite of all these potential advantages of early pharmaceutical involvement to
candidate drug selection, there may be several barriers within a company which can
hinder this way of working. Distance between the Research group and the
Development group should not really be considered a barrier, although this can be the
case for groups on different continents with different cultures and languages.
• The important factor for success seems to be the development of a formal mechanism
for interaction, supported by senior management in the company.
• This often takes the form of a joint project team with regular meetings to review
progress. However, there may still be a lack of appreciation of what input or expertise
pharmaceutical development can offer at the candidate drug selection stage.
Opportunities to demonstrate what can be done and to educate Research colleagues
should be sought to try and overcome this attitude.
STAGES OF THE DRUG DISCOVERY AND
DEVELOPMENT PROCESS
3. Candidate Drug Selection
• Another potential barrier is any overlapping expertise there may be in
Research and Development groups. For example, overlap may occur between
Preformulation in Pharmaceutical Development and Physical Chemistry in
Research, or between Biopharmaceutics in Development and Drug
Metabolism in Research. In these cases, it is important to clarify and agree
which group does what activity.
• A common perceived barrier to providing early preformulation and
biopharmaceutics input can be the quantity of compound required for
evaluation at this stage. The Research group may believe that significantly
more compound is required; with modern instrumental techniques, however,
this is often not the case.
STAGES OF THE DRUG DISCOVERY AND
DEVELOPMENT PROCESS
3. Candidate Drug Selection
• Other potential barriers which can influence the success of the relationship with
Research at the candidate drug selection stage are the Pharmaceutical Development
response time not being fast enough to support Research and the lack of resources that
Pharmaceutical Development can give to support the candidate drug selection
programme.
• Several compounds may have to be evaluated simultaneously to generate comparative
data to aid the selection process. Preformulation and Biopharmaceutics have to keep
pace with the pharmacologica and safety testing, otherwise there is no point in
generating the data.
• One way of achieving this is to allocate dedicated resources to these projects using
people trained to rapidly respond to the preformulation and biopharmaceutics
requirements.
• Simple formulations can be used at this stage, and rank order information is often
acceptable, rather than definitive quantitative information.
• Analytical methods should not require rigorous validation at this stage to provide these
data. Excessive documentation and rigid standard operating procedures that can slow
down the work are not usually necessary and should be avoided.
STAGES OF THE DRUG DISCOVERY AND
DEVELOPMENT PROCESS
4. Exploratory Development
• The aim of exploratory development is to gauge how the candidate drug is absorbed
and metabolized in healthy human volunteers before studying its effect on those
actually suffering from the disease for which it is intended. Occasionally, it is
necessary to conduct further smallscale studies in patients in order to make a decision
whether to progress the candidate drug into full development.
• This stage is often referred to as Phase I clinical studies or Concept Testing (Proof of
Concept). Usually a small number of healthy volunteers (who do not have the
condition under investigation or any other illness) receives the drug candidate
provided as a simple formulation, which can be different from the intended
commercial formulation.
• For example, a simple aqueous oral solution or suspension may be used, rather than a
capsule or tablet, to minimize the formulation development work at this early stage
• If the candidate drug does not produce the expected effects in human studies, or
produces unexpected and unwanted effects, the development programme is likely to be
stopped at this stage.
STAGES OF THE DRUG DISCOVERY AND
DEVELOPMENT PROCESS
5. Full Development
• Completion of longer-term safety and clinical studies (Phase II and Phase III)
in patients suffering from the disease are accomplished at this stage. Phase II
studies are dose ranging studies in a reasonable patient population (several
hundred) to evaluate the effectiveness of the drug and common side-effects.
• During Phase II, the intended commercial formulation should be developed,
and the product/process optimized and eventually scaled up to commercial
production scale.
• The candidate drug should ideally be in the intended commercial formulation
for the Phase III trials. After the satisfactory completion of Phase II trials,
large patient populations (several hundred to thousands) are involved to
statistically confirm efficacy and safety.
STAGES OF THE DRUG DISCOVERY AND
DEVELOPMENT PROCESS
5. Full Development
• Some patients will be given the drug, some a placebo product (required to be identical
in appearance) and some may be given a known market leader (with all products
appearing identical).
• The doctors and patients in the study will not know whether the patients are getting the
test drug, placebo or market leader; by switching the medication in a controlled way
(doubleblind trials), objectivity and statistical assessment of the treatment under
investigation are assured.
• Most regulatory authorities, including the U.S. Food and Drugs Administration (FDA),
the Medicines Control Agency (MCA) in the United Kingdom and the European
Agency for the Evaluation of Medicinal Products (EMEA), require three phases of
clinical trials and sufficient data to demonstrate that the new product can be licensed
as safe, effective and of acceptable quality.
• Once these clinical studies are complete, the company can decide whether it wishes to
submit a marketing authorization application to a regulatory authority for a medicinal
drug product. Approval is usually followed by product launch to market.
PACKAGING OF
PHARMACEUTICALS
• Packaging means a collection of different packaging materials which
encase the pharmaceutical product from the time of manufacturing to
the end of the user .encasing of drugs is important for life-saving
drugs, medical devices, medical treatments, and new products like
medical nutritionals.
• Poultice, liquid, solid, powder, suspension it should be transparent to
the user about its whole information on the drug different types of
pharmaceutical packaging materials are present but it depends upon
its function and type of the material used.
• Finally packaging materials are evaluated for sterilization, storage
and certain stability studies. Packaging protects the harmful drugs
from children direct contact because different types of packaging are
produced in to market, they can’t easily open the packaging.
Packaging is an multiple user means provide presentation, protection,
identification information, about a product during storage, carriage,
display and until the product is consumed.
PACKAGING OF
PHARMACEUTICALS
The quality of the packaging of pharmaceutical products
plays a very important role in the quality of such products.
It must:
protect against all adverse external influences that can
alter the properties of the product, e.g. moisture, light,
oxygen and temperature variations;
protect against biological contamination;
protect against physical damage;
Carry the correct information and identification of the
product.
PACKAGING OF
PHARMACEUTICALS
• A distinction must be made between primary and secondary
packaging components. The primary packaging components (e.g.
bottles, vials, closures, blisters) are in direct physical contact with the
product, whereas the secondary components are not (e.g. aluminium
caps, cardboard boxes).
• The choice of primary and/or secondary packaging materials will
depend on the degree of protection required, compatibility with the
contents, the filling method and cost, but also the presentation for
over-the-counter (OTC) drugs and the convenience of the packaging
for the user (e.g. size, weight, method of opening/reclosing (if
appropriate), legibility of printing).
• Containers may be referred to as primary or secondary, depending on
whether they are for immediate use after production of the finished
product or not. Both single-dose and multi-dose containers exist.
• Containers may be well-closed, tightly closed, hermetically closed or
light-resistant, airtight.
[
PACKAGING OF
PHARMACEUTICALS
Functions of packaging:
Containment:
• The containment of the product is the most fundamental
function of packaging for medicinal products. The design of
high-quality packaging must take into account both the needs
of the product and of the manufacturing and distribution
system.
This requires the packaging:
•  Not to leak, nor allow diffusion and permeation of the
product;
•  To be strong enough to hold the contents when subjected to
normal handling.
•  Not to be altered by the ingredients of the formulation in its
final dosage form.
•  Protection
PACKAGING OF
PHARMACEUTICALS
Functions of packaging:
Containment:
• The packaging must protect the product against all
adverse external influences that may affect its quality or
potency, such as:
• light
• moisture
• oxygen
• biological contamination
• Mechanical damage
PACKAGING OF
PHARMACEUTICALS
Functions of packaging:
Stability:
• Information on stability is given in the guidelines for
stability testing of pharmaceutical products containing
well established drug substances in conventional dosage
forms.
• For primary packaging, it is necessary to know the
possible interactions between the container and the
contents.
• Normally, product/component stability and compatibility
are confirmed during the primary research and
development stage.
PACKAGING OF
PHARMACEUTICALS
Functions of packaging:
Stability:
• There are numerous possibilities of interactions between (primary)
packaging materials and pharmaceutical products, such as:
- The release of chemicals from components of the packaging materials;
- The release of visible and/or sub visible particles;
- The absorption or adsorption of pharmaceutical components by the
packaging materials;
- Chemical reactions between the pharmaceutical product and the packaging
materials;
- The degradation of packaging components in contact with the
pharmaceutical products;
- The influence of the manufacturing process (e.g. sterilization) on the
container.
PACKAGING OF
PHARMACEUTICALS
Functions of packaging:
Labels:
Throughout manufacturing, a succession of specific outer labels is applied to the
container of the medicinal product.
The level of processing is indicated by the following words:
• Quarantine
• Storage
• Distribution.
• Specifications for labels for finished drug products are defined in the WHO
guidelines on GMP for pharmaceutical products .
- Written labels on the packaging:
• Permit the identification of each active ingredient by means of its INN, and
also give the dosage form and the trade name/trademark. All information
concerning the medicinal product, as required by national legislation, must be
stated on the packaging.
• Preserve the stability of the medicinal product by giving advice on its storage
PACKAGING OF
PHARMACEUTICALS
Functions of packaging:
Labels:
After the stability of the product has been evaluated, one of the following
recommendations as to storage conditions can be prominently indicated on the
label:
•  Store under normal storage conditions;
•  Store between 2 and 8 °C (under refrigeration, no
• freezing);
•  Store below 8 °C (under refrigeration);
•  Store between -5 and -20 °C (in a freezer);
•  Store below -18 °C (in a deep freezer).
PACKAGING OF
PHARMACEUTICALS
Functions of packaging:
Repacking, relabeling and dispensing:
In some countries, it is common practice not to dispense drugs in the original
packaging, but rather in a personalized manner to each patient .This applies
especially to solid oral dosage forms, and involves the “repacking” and
“relabeling” of drugs in small quantities.
Different drugs may even be included in “customized” medication packages,
also referred to as “patient med packs”. The quantities of drugs supplied in this
way are usually enough only for a short period of time, i.e. to provide drugs for
immediate use. It should be remembered, however, that data obtained in
stability studies undertaken by the manufacturer are no longer valid for drugs
removed from the original package.
PACKAGING OF
PHARMACEUTICALS
Functions of packaging:
Package inserts for patients (patient information leaflets):
• Product information must help patients and other users to understand the
medication. The patient package insert, together with the label, provides the
patient with key information concerning the proper use of the product,
potential adverse drug reactions and interactions, storage conditions and the
expiry date.
• In OTC medicinal products, the package insert, together with the label, may
constitute the only pharmaceutical advice that the patient receives.
PACKAGING OF
PHARMACEUTICALS
Functions of packaging:
• Compliance:
• Packaging and labeling may help to reinforce the instructions given by the
physician or the pharmacist, and improve compliance with drug therapy. In
this respect, packaging becomes a compliance aid.
• The design of pharmaceutical packaging should be such that the product can
easily be administered in a safe manner to the patient. If the patient feels at
ease with the packaging and route of administration, the design of the
packaging may become a key factor in increasing compliance. This is also an
important factor in clinical trials.
PACKAGING OF
PHARMACEUTICALS
Functions of packaging:
Protection of patients:
• Packaging must not only increase compliance through its
design, but must also protect the patient and indicate the
integrity of the product .
• Packaging equipped with a tamperevident device protects
against incidental and accidental poisoning. To protect
children, several child-resistant closures have been developed
PACKAGING OF
PHARMACEUTICALS
Packaging materials and closures
Glass:
• For a large number of pharmaceuticals, including medicinal products for oral
and local administration, glass containers are usually the first choice (e.g.
bottles for tablets, injection syringes for unit- or multi dose administration.
• Classifications of types of glass are given in the European and United States
pharmacopoeias, whereas no such classification exists in the Japanese
pharmacopoeia.
• Glass can be tested for light transmission and hydrolytic resistance. In the
Japanese pharmacopoeia, such tests are described only for glass containers
for injection, whereas in the European and United States pharmacopoeias
they are given for all types of glass containers.
PACKAGING OF
PHARMACEUTICALS
Packaging materials and closures
Plastics:
• Some containers are now being made of plastics;
• the main use is for bags for parenteral solutions.
• Plastic containers have several advantages compared with glass containers
unbreakable, collapsible, light resistant.
Metal:
• Metal containers are used solely for medicinal products for non parenteral
administration. They include tubes, packs made from foil or blisters, cans,
and aerosol and gas cylinders.
• Aluminum and stainless steel are the metals of choice for both primary and
secondary packaging for medicinal products. They have certain advantages
and provide excellent tamper-evident containers. Metal is strong,
impermeable to gases and shatter proof, it is the ideal packaging material for
pressurized containers.
PACKAGING OF
PHARMACEUTICALS
Packaging materials and closures
• Closures used for the purpose of covering drug containers after the filling process
should be as inert as possible. They should not give rise to undesired interactions
between the contents and the outside environment, and should provide a complete
seal.
• Besides their protective function, closures must also allow the easy and safe
administration of the drug.
• Depending on the application, closures may have to be pierced with a needle for
intravenous sets. Such closures are made from elastomeric materials (rubbers), while
those that cannot be pierced are generally made from plastics such as polyethylene or
polypropylene.
• Depending on the type of container, closures may have different shapes and sizes, e.g.
stoppers for infusion or injection bottles or plungers for prefilled syringes. A special
design of stopper may also be required for some pharmaceutical production processes
such as lyophilization.
• Closures, as primary packaging components, are of critical importance and must be
carefully selected.
PACKAGING OF
PHARMACEUTICALS
Packaging material for different formulations
Solid dosage forms:
Tamper resistant packaging:
• The requirement for tamper resistant packaging is now one of the major consideration in the
development of packaging for pharmaceutical products. Tamper evident containers are closed
containers fitted with a device that irreversibly indicates if the container has been opened.
• The following package configuration have been identified by the FDA as examples of packaging
systems that are capable of meeting the requirements of tamper resistant packaging as defined by
FDA regulation
• Film wrappers
• Blister package
• Strip package
• Bubble pack
• Shrink seal and bands
• Foil paper or plastic pouches
• Bottle seals
• Tape seals
• Breakable caps
• Sealed tubes
PACKAGING OF
PHARMACEUTICALS
Packaging material for different formulations
Solid dosage forms:
Strip packages:

• A strip package is a form of unit dose packaging that is commonly used for the packaging of tablets
and capsules. A strip package is formed by feeding two webs of a heatsealable flexible film through
either a heated crimping roller or a heated reciprocating plate. The product is dropped into the
pocket formed prior to forming the final set of seals. A continuous strip of packets is formed,
generally several packets wide depending on the packaging machine's limitations. The strip of
packets is cut to the desired number of packets in length.
• The strips formed are usually collated and packaged into a folding carton. The product sealed
between the two sheets of film usually has a seal around each tablet, with perforations usually
separating adjacent packets. The seals can be in a simple rectangular or "picture-frame" format or
can be contoured to the shape of the product .Different packaging materials are used for strip
packaging based on their properties for high-barrier applications a
paper/polyethylene/foil/polyethylene lamination is commonly used.
PACKAGING OF
PHARMACEUTICALS
Packaging material for different formulations
Solid dosage forms:
Blister packages
• When one thinks of unit dose in pharmaceutical packaging, the package that invariably comes to
mind is the blister package. This packaging mode has been used extensively for pharmaceutical
packaging for several good reasons. It is a packaging configuration capable of providing excellent
environmental protection, coupled with an esthetically pleasing and efficacious appearance. It also
provides user functionality in terms of convenience, child resistance, and no, tamperresistance.
• The blister package is formed by heat-softening a sheet of thermoplastic resin and vacuum-drawing
the softened sheet of plastic into a contoured mold. After cooling, the sheet is released from the
mold and proceeds to the filling station of the packaging machine.
PACKAGING OF
PHARMACEUTICALS
Packaging material for different formulations
Containers for liquids Parentrals
Injectable formulations are packaged in to containers made of plastic or glass. Container system
includes ampoules, syringes, vials, bottles, cartridges, bags ampoules are all glass, and plastic are all
bags.
Rubber materials for rubber stoppers for vials and bottles, rubber plungers and rubber seals for
syringes, cartridges.
Irrigation solutions are packaged in glass bottles with aluminum screwcaps.
A single-dose container is one that holds a quantity of drug intended as a single dose and when opened
cannot be resealed with assurance that sterility has been maintained.
These containers include fusion-sealed ampoules and prefilled syringes and cartridges
PACKAGING OF
PHARMACEUTICALS
Packaging material for different formulations
Closures
The closure is normally the most vulnerable and critical component of a container in so far as stability
and compatibility with the product are concerned. An effective closure must prevent the contents from
escaping and allow no substance to enter the container.
Function of a closure:
Provide a totally hermetic seal.
Provide an effective seal which is acceptable to the products.
Provide an effective microbiological seal.
Types of closures
Closures are available in five basic designs
Threaded screw cap
Lug cap
Crimp-on (crowns)
pilfer proof closure
Roll-on
Many variations of these basic types exist, including vacuum, tamperproof, safety, child resistant, and
liner less types, and dispenser applicators.
PACKAGING OF
PHARMACEUTICALS
Packaging material for different formulations
Closures
1. Threaded Screw Cap:
The screw cap when applied overcome the sealing surface irregularities and provides physical and
chemical protection to content being sealed. The screw cap is commonly made of metal or plastics.
The metal is usually tinplate or aluminum, and in plastics, both thermoplastic and thermosetting
materials are used.

1. Threaded Screw Cap 2. Lug cap

2. Lug Cap:
The lug cap is similar to the threaded screw cap and operates on the same principle. It is simply an
interrupted thread on the glass finish, instead of a continuous thread. It is used to engage a lug on the
cap sidewall and draw the cap down to the sealing surface of the container. Unlike the threaded
closure, it requires only a quarter turn. The lug cap is used for both normal atmospheric-pressure and
vacuum pressure closing.
PACKAGING OF
PHARMACEUTICALS
Packaging material for different formulations
Closures

3. Crown Caps:
This style of cap is commonly used as a crimped closure for beverage bottles and has remained
essentially unchanged for more than 50 years.

4. Roll-On Closures:
The aluminum roll-on cap can be sealed securely, opened easily, and resealed effectively. It finds wide
application in the packaging of food, beverages, chemicals, and pharmaceuticals. The roll-on closure
requires a material that is easy to form, such as aluminum or other light-gauge metal. Re sealable, non
re sealable, and pilfer proof types of the roll-on closure are available for use on glass or plastic bottles
and jars.
PACKAGING OF
PHARMACEUTICALS
Packaging material for different formulations
Closures

5. Pilfer proof Closures

The pilfer proof closure is similar to the standard roll-on closure except that it has a greater skirt
length. This additional length extends below the threaded portion to form a bank, which is fastened to
the basic cap by a series of narrow metal "bridges." When the pilfer proof closure is removed, the
bridges break, and the bank remains in place on the neck of the container. The closure can be re sealed
easily and the detached band indicates that the package has been opened. The torque is necessary to
remove the cap.
PACKAGING OF
PHARMACEUTICALS
Packaging material for different formulations
Packaging for liposomes
1. Hermetically sealed borosilicate glass ampoules
Provide a secure environment for lipids sensitive to oxidation. The ampules are shipped in cardboard
liners for protection and storage convenience. Ampules are pre-scored for easier opening. Once the
seal is broken, sample may be transferred to a Screw Cap Storage Vial.

2. Narrow-mouth borosilicate glass bottles

Convenient for shipping and storage of larger volumes of lipids. The closure system is composed of a
closed-top screw cap with a teflon liner fused to a silicone rubber backing. The liner is sonically
welded to the cap, therefore no glue can come in contact with the organic solution.
PACKAGING OF
PHARMACEUTICALS
Packaging material for different formulations
Packaging for liposomes
3. Wide-mouth borosilicate glass bottles
Convenient for shipping and storage of dry powder lipids. Larger openings provide easier access to
lipid samples. The closure system is composed of a closed-top screw cap with a teflon liner.

4. The Screw Cap Storage Vial

Designed as a storage option for materials shipped in glass ampules or bottles. The closure system
contains an open-top screw cap with a teflon liner fused to a silicone rubber septum.