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Abstract

The article considers various issues related to the peculiarities of using a package of polymers in pharmaceutics. The main types of packaging from polymers for pharmaceutical preparations are analyzed. The main requirements for materials for packaging various drugs are defined. Classification of pharmaceutical preparations by the method of their application and packaging is presented. The classification of pharmaceutical preparations according to the dosage type, the type of treatment, the method of their packaging, and general requirements has been developed. It is shown that the proposed classifications became a prerequisite for the selection of eight basic pharmaceutical preparations types and materials for them. The diagrams of the percentage materials ratio in selected pharmaceutical preparations are constructed. The analysis of the corresponding diagram showed that polypropylene (PP) and polyvinyl chloride (PVC) are most widely used. The most widespread use of materials for packaging pharmaceuticals has been analyzed the main polymers properties have been identified, the presence of which is necessary for the manufacture of packaging.
Available online: http://scholarsmepub.com/sjmps/ 166
Saudi Journal of Medical and Pharmaceutical Sciences ISSN 2413-4929 (Print)
Scholars Middle East Publishers ISSN 2413-4910 (Online)
Dubai, United Arab Emirates
Website: http://scholarsmepub.com/
Features of Packaging from Polymers in Pharmaceutics
Vyacheslav Lyashenko1*, Svitlana Sotnik2, Asaad MA Babker3
1Department of Informatics, Kharkiv National University of Radio Electronics, Kharkiv, Ukraine
2Department of Computer-Integrated Technologies, Automation and Mechatronics, Kharkiv National University of Radio
Electronics, Kharkiv, Ukraine
3Department of Medical Laboratories Science, College of Health Science, Gulf Medical University, Ajman, UAE
Original Research Article
*Corresponding author
Vyacheslav Lyashenko
Article History
Received: 22.12.2017
Accepted: 29.01.2018
Published: 15.02.2018
DOI:
10.21276/sjmps.2018.4.2.2
Abstract: The article considers various issues related to the peculiarities of using a
package of polymers in pharmaceutics. The main types of packaging from
polymers for pharmaceutical preparations are analyzed. The main requirements for
materials for packaging various drugs are defined. Classification of pharmaceutical
preparations by the method of their application and packaging is presented. The
classification of pharmaceutical preparations according to the dosage type, the type
of treatment, the method of their packaging, and general requirements has been
developed. It is shown that the proposed classifications became a prerequisite for
the selection of eight basic pharmaceutical preparations types and materials for
them. The diagrams of the percentage materials ratio in selected pharmaceutical
preparations are constructed. The analysis of the corresponding diagram showed
that polypropylene (PP) and polyvinyl chloride (PVC) are most widely used. The
most widespread use of materials for packaging pharmaceuticals has been
analyzed the main polymers properties have been identified, the presence of which
is necessary for the manufacture of packaging.
Keywords: Pharmaceuticals, packaging, preparations, polymers, requirements.
INTRODUCTION
Pharmaceutical packaging is a very complex process that is provided by a
separate industry. This is due to the fact that the issues of quality and safety are of
paramount importance. The use of advanced technology and high-quality plastic
materials for pharmaceutical packaging is one of the fundamental factors for
success in the market [1].
For the development of packaging in
pharmaceuticals, polymeric materials of various
origins are actively used. The development of new
medical materials intended for contact with
pharmaceuticals is a complex task. The polymer should
have a certain set of properties and characteristics, but
they are not always ideal for packaging. There are
several procedures. Apart from that selection of
containers and sealing materials. There are selective
ranges of materials that are found in the drug industry
and when it comes to be used in the drug industry. The
range of materials used for packing and sealing are
tested for quality control, compatibility and reliability.
Sampling for medicinal product retention, homogeneity
in quality, etc [2].
According to the "Good Manufacturing
Practice" for the drug industry, the high quality
packaging method and packaging materials must be
used in the following categories [3]:
Does not allow penetration of the product.
The packaging material should not react with the
medicinal ingredients and should not change the
formulation as well.
The packaging materials should be consistent and
strong enough even at severe external influences
such as heat, light, moisture, dampness, oxygen,
biological or mechanical contamination, etc.
For example, reduced permeability of water
vapor can lead to carburization and almost complete
loss of the tablets ability to disintegrate, increased
permeability of water vapor reduces the tablets strength.
If the strength of the packaging is low, then under
increased physical stress (impact during fall,
compression), it undergoes premature failure, leading to
a breakdown in the integrity of the packaging and
damage to tablets. Increased oxygen permeability
promotes the aerobic microorganisms development of.
All this can ensure a rational distribution of the walls
thickness along their contour. Increased oxygen
permeability promotes the development of aerobic
microorganisms.
Vyacheslav Lyashenko et al., Saudi J. Med. Pharm. Sci., Vol-4, Iss-2 (Feb, 2018): 166-174
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Proper testing should be done to ensure the
compatibility of the packaging ingredients and the
pharmaceutical products present inside the container.
This, ultimately, determines the need to consider the
possibility of using a polymers package in
pharmaceutics as the main objective of this study.
MATERIALS AND METHODS
Related work
In [4] the aim at explaining basics of polymers
based materials from different resources and their
chemistry along with practical applications which
present a future direction in the pharmaceutical
industry. The work focuses on polymeric materials in
ocular drug delivery systems [4]. describes the
historical development of polymers and the basis of
their classification. Based on their origin and mode of
synthesis, biodegradable polymers are categorized into
various classes. The structure, chemistry,
biocompatibility, and biodegradability of these
biodegradable polymers are discussed and their
applications in pharmaceutical and medical fields are
summarized.
In [5] presented review of the various
packaging elements for pharmaceutical product is
aimed at ensuring that medicines arrive safely in the
hands of the patients for whom they are prescribed. The
paper presents: requirements in the international
pharmacopoeia; requirements for dosage form
containers; quality assurance aspects of packaging;
packaging materials and closures; repacking, relabelling
and dispensing.
In [6] reviewing the various aspects of
packaging like materials used for packaging, types of
packaging as well as recent trends of pharmaceutical
packaging in pharmaceutical market. In work, the
packaging of pharmaceutical preparations is divided
according to dosage forms: solid dosage forms,
semisolid, pressurized product and liquid. Types of
container used as primary packaging for liquid orals
are: single dose containers, multi-dose containers, well
closed containers, airtight containers, light resistant
container. For solid dosage forms: tamper evident
containers, strip packages, blister packages, child
resistant containers. An author also provides the most
complete accounting of nano-enabled packaging of
pharmaceutical products in various markets around the
globe. The main objective of this review is to
understand the current state of nano-enabled packaging
in the pharmaceutical industry, market opportunities,
the companies involved, technologies being pursued
and intellectual property (IP) trends.
The materials in manufacturing and packaging
systems as sources of elemental impurities in packaged
drug products are considered in [7]. This review article
contains the information compiled from the available
body of literature and considers two questions:
What elemental entities are present in the relevant
polymers and materials and at what levels are they
present?
To what extent are these elemental entities leached
from these materials under conditions relevant to
the manufacturing and storage/distribution of
solution drug products?
In [8] study was a screening study limited to
the investigation of the physical stability of a selection
of moisture-sensitive repackaged tablets. However,
although the physical stability is acceptable, the
chemical stability and dissolution rate may be altered.
The physical tests outlined are simple but could be
suitable for selecting candidates for further chemical
stability testing.
In [9] review of packaging of non-injectable
liquid pharmaceuticals. In the present review, we focus
on the packaging aspects of non-injectable liquid
formulations. Different packaging materials, which can
be used for packaging of non-injectable liquid
formulation, are discussed. Regulatory aspects of
Unlisted State Food and Drug Administration (USFDA)
and European Medicines Agency (EMA) are also
highlighted.
Traditional packaging for pharmaceuticals
The general classification of packaging
requirements for polymers is shown in Figure-1 [10].
Fig-1: General classification of packaging requirements for polymers
There are two main types of packaging: strip
packaging and bottle packaging. Packaging is usually
used for packing tablets and capsules. A strip package is
formed by feeding two webs of a heat sealable flexible
film through a heated crimping roller .The product is
dropped into the pocket formed before forming the final
set of seals. A continuous strip of packets is formed
which is cut to the desired number of packets in length.
Vyacheslav Lyashenko et al., Saudi J. Med. Pharm. Sci., Vol-4, Iss-2 (Feb, 2018): 166-174
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The materials used for strip package are cellophane,
polyester, polyethylene, polypropylene,
polyvinylchloride (Figure-2(a) [11].
Bottle packaging made of glass or plastic are
used for storing both liquid medications and dry syrup.
The shape of bottles which will be applied for
pharmaceutical industry should remain with less
marked neck and flat bottom in order to protect
medication from external influences. Bottles stay
compatible for filling machines as well as capping
machines (Figure-2(b) [12, 13].
Fig-2: Main types of packaging (strip and bottle packaging)
Plastics are the most important class of
packaging materials [14]. As a result of today multitude
of plastic applications there is a corresponding
enormous variety of plastic materials. The polymer
matrix as well as the incorporated plastic additives can
be made to differ in such a variety of ways with respect
to their chemical composition and structure that one
nds or can develop a tailor made product for every
application.
Plastic packaging of pharmaceuticals is
becoming quite promising and the latest trends continue
to form research and development in this field. As a
consequence, the range of plastics applications for these
purposes continues to expand with each passing year.
RESULTS AND DISCUSSION
Investigation of the types and characteristics of
polymeric packaging in pharmaceuticals
In order to choose the material for packaging,
for example, tablets, it is necessary to analyze the
interaction of pharmaceutical preparations and
packaging. We propose a classification of
pharmaceutical preparations by the method of their
application and packaging for them Figure-3.
Fig-3: Classification of pharmaceuticals by their use and packaging
Blister packing component. The four basic
components of pharmaceutical blister packages are: 1.
The forming film (forming films account for
approximately 8085% of the blister package). 2. The
lidding material (lidding materials make up 1520% of
the total weight of the package.). 3. Heat seal coating.
Blister packing [15, 16]: 1. Blister packaging is
a type of pre-formed plastic packaging used for small
consumer goods. 2. The two primary components of a
blister pack are the cavity made from either plastic or
aluminium - and the lidding, made from, paper, plastic
Vyacheslav Lyashenko et al., Saudi J. Med. Pharm. Sci., Vol-4, Iss-2 (Feb, 2018): 166-174
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or aluminium. 3. The cavity contains the product and
the lidding seals the product in the package.
Parenteral it is application: intramuscular,
intravenous, intradermally, subcutaneously, intra-
arterial, in the cavity, intraosseous, in the subarachnoid
space. Parenteral preparations. These are usually
supplied in glass ampoules, bottles or vials, plastic
bottles or bags, and prefilled syringes, which are
coloured in the case of light-sensitive substances [5].
Packaging types: 1. Primary packaging is the
materials that first envelops the product and hold it. 2.
Secondary packaging is outside the primary packaging
used to group primary packages together (corrugated
fibers, box and etc.). 3. Tertiary packaging used for
bulk handling, warehouse storage and transport
shipping. The most common form is a palletized unit
load that packs tightly into containers. Example: barrel,
container, edge protector.
It is determined that polymers are more often
used for primary packaging and in some cases for
secondary packaging. Types of packaging: strip
packaging and bottle packaging (ampoule, bottles, vial).
We propose a classification of pharmaceutical
preparations according to the dosage type, the type of
treatment, the packaging method and the general
requirements for them (Figure-4).
Fig-4: Classification of pharmaceuticals by dosage type, type of treatment, packaging method, and general
requirements
Let’s special packaging includes: unit-dose
packaging and “Device” packaging. Unit-dose
packaging. This packaging guarantees safer medication
by reducing medication errors; it is also more practical
for the patient. It may be very useful in improving
compliance with treatment and may also be useful for
less stable products [17].
“Device” packaging. Packaging with the aid of
an administration device is user-friendly and also
improves compliance. This type of packaging permits
easier administration by means of devices such as
prefilled syringes, droppers, transdermal delivery
systems, pumps and aerosol sprays. Such devices
ensure that the medicinal product is administered
correctly and in the right amount. Semi solid dosage
forms like ointments, creams etc. are packed in metallic
collapsible tubes [17].
Let’s conventional dosage includes: tablets,
capsules, liquid, topical products. In topical
formulations, including the following:
A cream formulation combined with tablets for a
semi-synthetic pleuromutilin derivative, where we
also developed, manufactured and packed both
products for clinical trials.
A thermally-reversible gel for a psoriatic condition,
currently in field trials.
Permeation studies and formulation development
for the delivery of poorly-soluble matrix
metalloproteinase inhibitors through horse shins.
A buccal liquid gel formulation to treat xerostomia,
currently in Phase II clinical trials.
A thermally-reversible gel to promote wound
healing, currently in pharmacokinetic (PK) studies
to investigate the mechanisms of its absorption.
A vaginal tablet or pessary for HIV treatment that
transforms rapidly into to gel after administration.
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Selection of materials for polymers packaging in
pharmaceuticals
When creating a package for pharmaceuticals,
its material must fully meet the specified conditions.
Selection of packaging material is product specific and
one material cannot be suitable for packaging of all the
products.
However, metal containers are used for the
packaging of topical aerosols while glass and plastic
containers are used for the packaging of oral and
ophthalmic liquid formulations. Choice of packaging
material depends upon the number of factors including
product stability during processing and storage
conditions, type of dosage form, route of
administration, chemical nature of the drug [9].
Thus, when selecting the material of
pharmaceutical preparations, their purpose should be
taken into account. And it is important to determine the
materials properties in order to perform their functions.
When solving the problem of the polymers
choice for pharmaceutical preparations, it is important
to analyze the basic properties of various polymers,
their advantages and limitations in their application, as
well as the classification of polymers for operational
purposes, with recommendations for their rational use.
Also, when selecting polymers, recommendations for
processing methods, preparation conditions for
processing and molding are taken into account.
The basic requirements to the materials are
defined:
1. Protection from environmental conditions.
2. Non-reactive with the pharmaceutical product.
3. Non-toxic.
4. Adoptable to commonly employed high speed
packaging equipments.
5. Properties of plastic materials:
the packaging itself does not have an adverse effect
on the product (e.g. through chemical reactions,
leaching of packaging materials or absorption);
the product does not have an adverse effect on the
packaging, changing its properties or affecting its
protective function.
The suitability of packaging or packaging
material for any particular requirements and conditions
can only be ascertained through detailed packaging and
stability studies on the product concerned.
The results of the pharmaceutical preparations
types analysis and on the basis of the proposed
classifications of Figure 3 and Figure 4 are summarized
in Table 1.
Table-1: Types of pharmaceutical preparations and their materials
Materials
Type of pharmaceutical preparations
Bottles
Jars
Ampoules
Vials
Tubes
Strip
Cartridges
Polyethylene terephthalate (PET)
+
-
-
-
-
-
-
High Density Polyethylene (HDPE)
+
-
-
+
+
-
-
Low-density polyethylene (LDPE)
+
-
-
+
-
-
-
Linear Low Density Polyethylene (LLDPE)
-
-
-
-
+
-
-
Polyvinylidene chloride
(PVDC)
-
-
-
-
-
-
-
Polypropylene (PP)
+
+
+
+
+
+
Polyvinyl chloride (PVC)
+
-
+
+
-
+
-
Polycarbonate (PC)
+
-
-
-
-
-
-
Polystyrene (PS)
-
+
-
+
+
-
-
Polyethylene (PE)
-
-
+
+
-
-
+
Polyethersulphone (PES)
-
-
-
-
-
-
+
Polychlorotrifluoroethylene (PCTFE)/PVC
laminates
-
-
-
-
-
-
-
Styrene
-
-
-
+
-
-
-
Poly(ethylene-vinyl acetate) (PEVA)
-
-
-
-
+
-
-
Orientated polyamide (OPA)
-
-
-
-
-
-
-
The diagram of the percentage materials ratio in selected pharmaceutical preparations is shown in Figure-5
Vyacheslav Lyashenko et al., Saudi J. Med. Pharm. Sci., Vol-4, Iss-2 (Feb, 2018): 166-174
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Fig-5: Diagram of the percentage materials ratio in selected pharmaceutical preparations
Packaging recommends presented in Table-2
Table-2: Packaging recommends
Materials
Clarity
MVTR*
O2**
CO2**
Impact
Strength
Recycle
Code
PET (Oriented or Stretch Blown
Polyethylene Terephthalate)
Excellent
2.0
75
540
Good
1
HDPE (High Density Polyethylene)
Poor
0.5
4,000
18,000
Good
2
PVC (Polyvinyl Chloride)
Good
3.0
150
380
Fair
3
PP (Polypropylene)
Poor
0.5
3,500
7,000
Fair
5
PS (Polystyrene)
Excellent
10.0
6,000
18,700
Poor
6
*MVTR stands for Moisture Vapor Transmission Rate in g-mil/100in. 2/24hr. MVTR is a measure of the passage of
gaseous H2O through a barrier. The lower the rate, the longer the package protects its contents from moisture and ensures
the moisture content of the product remains the same.
**O2 and CO2 stand for Oxygen Transmission Rate (OTR) and Carbon Dioxide Transmission Rate (COTR) in cm3-
mil/m2/24hr. OTR and COTR are measures of the amount of gas that passes through a substance over a given period.
The lower the readings, the more resistant the plastic is to letting gasses through.
Consider the polymers properties from the
view point of the above requirements. Properties of selected plastic materials for pharmaceutical product in
Table-3.
Vyacheslav Lyashenko et al., Saudi J. Med. Pharm. Sci., Vol-4, Iss-2 (Feb, 2018): 166-174
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Table-3: Properties of plastic materials for pharmaceutical product
Materials
Properties
Example pharmaceutical
product
PET (Oriented or Stretch Blown
Polyethylene Terephthalate)
clarity, lightness, strength, toughness, barrier to
liquid and gas
HDPE (High Density Polyethylene)
stiffness, strength, toughness, resistance to
moisture, permeability to gas, ease of
processing
PVC (Polyvinyl Chloride)
versatility, ease of blending, strength,
toughness, clarity, transparency
PP (Polypropylene)
strength, toughness, resistance to heat,
chemicals, grease and oil, barrier to moisture
PS (Polystyrene)
versatility, clarity, easily formed
DISCUSSION OF THE RESULTS
With the proposed classifications of materials
for the pharmaceuticals packaging, it is possible to
determine the packaging type, the form of the drug and
the rational material whose properties are important to
take into account, as they affect the quality,
compatibility and reliability of the drug.
The proposed classification in Figure 4 differs
from existing ones in that it contains special packaging
types, which can be unit-dose packaging or "device"
packaging, which allows to expand the range of dosage
pharmaceuticals forms.
To conduct research on the characteristics of
the polymers packaging in pharmaceuticals, the most
widely used types of pharmaceutical preparations are
selected and the materials for them are determined. The
result was a diagram of the percentage materials ratio in
selected pharmaceutical preparations.
Vyacheslav Lyashenko et al., Saudi J. Med. Pharm. Sci., Vol-4, Iss-2 (Feb, 2018): 166-174
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As a result, for the selected polymers that are
used for packaging most forms of drugs, the table
recommends packaging. Data from the table can be
used as a guideline when selecting or creating a new
material for packaging.
CONCLUSION
As a result of the polymers packaging features
studies in pharmaceuticals, the existing range of
polymers and dosage forms is disclosed for their
application.
The analysis of possible pharmaceutical
preparations from polymers is carried out. The main
requirements for materials for packaging various drugs
are defined.
As a result of the polymers analysis, the
following classifications are presented: pharmaceutical
preparations by the method of their application and
packaging; pharmaceutical preparations by type of
dosage, type of treatment, their method and packaging
and general requirements. The proposed classifications
became a prerequisite for the selection of eight basic
types of pharmaceutical preparations and materials for
them.
As an analysis consequence of the polymers
use for different dosage forms, a percentage chart of the
materials in the selected pharmaceutical preparations
was constructed. The diagram shows that polypropylene
(PP) and polyvinyl chloride (PVC) are most widely
used.
Analyzing the most widely used materials for
the pharmaceuticals packaging, the following properties
of polymers that are necessary are identified: clarity,
chemicals, stiffness, strength, toughness, resistance to
moisture, permeability to gas, ease of processing,
versatility.
ACKNOWLEDGMENT
The authors would like to acknowledge the
keen support for this work of the Medical Laboratories
Science department, College of Allied Health Science,
Gulf Medical University, Ajman, UAE and also the
Department of Informatics, Kharkov National
University of Radio Electronics, Kharkov, Ukraine [18-
23].
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... Several standards of quality for pharmaceutical packaging have been highlighted as guidelines for manufacturers for the production of packaging which maintain the integrity of the pharmaceutical products before they are prescribed to the patients. The requirements are as follows: (i) approved by the FDA, (ii) non-toxic, (iii) prevention and preparedness against environmental conditions, (iv) does not impart taste or odors to the product (v) non-reactive with the product so as to not affect the product identity, (vi) protects the dosage form against damage or breakage, (vii) tamper-resistant when necessary and (viii) adaptable to high-speed packaging machines (Das et al., 2018;Lyashenko et al., 2018). Packaging techniques as well as the selection of packaging material, machinery and labelling must be considered in order to fulfill the standards set forth by the guidelines (Zadbuke et al., 2013). ...
... Multi-layer blister films based on PVC are also commonly used for pharmaceutical blister packaging whereby PVC presents as the thermoformable backbone of the structure (Sabah et al., 2014). PVC is also used for bottles and ampoules (Lyashenko et al., 2018). However, it must be emphasized that PVC should not be used with radiation sterilization because it turns red-brown under exposure to gamma rays. ...
... PET offers many advantages for packaging applications such as high strength, lightweight, excellent strength, clarity and chemical resistance, and good barrier for liquid and gas. It can also be used to make bottles in a variety of colors and appearances (Pareek and Khunteta, 2014;Lyashenko et al., 2018). ...
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... (Lyashenko et al, 2018):• Senior friendliness.• Hermetically sealed.• ...
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