PPA-Institute

PLASTIC
بعد عقود طويلة من استخدام الزجاج مع كل المستحضرات الدوائية
ظهر استخدام البلاستيك في عملية التغليف واللي حل مشاكل كتير وكان له مميزات كتير لكن كمان كان له عيوب خطيرة لازم السيطرة عليها
هانعرف مع بعض ايه العيوب والمميزات دي وكمان هانتعرف على انواع البلاستك المختلفة المناسبة للتغليف الدوائي

Plastics may be defined as any group of substances, of natural or synthetic origins, consisting chiefly of polymers of high molecular weight that can be moulded into a shape or form by heat and pressure.
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► Uses
Used for many types of pack including;
Rigid bottles for tablets and capsules, squeezable bottles for eye drops and nasal sprays, jars, flexible tubes and strip and blister packs.

► Advantages
1. Less weight than glass,
2. Flexible
3. Variety of sizes and shapes
4. Essentially chemically inert, strong, rigid Safety use, high quality, various designs
5. Extremely resistant to breakage
6. Least expensive than glasses
7. Ease of transportation

► Disadvantages
1. Absorption
2. Permeable to moisture
3. Poor printing,
4. Thermostatic charge
5. They are not as chemically inert as Type -I glass

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█ CLASSES OF PLASTICS :

◙Thermosets type :
They need heat for processing into a permanent shape. During heating such materials form permanent crosslinks between the linear chains, resulting in solidification and loss of plastic flow.
e.g. Urea formaldehyde (UF),Phenolic formaldehyde ,Melamine formaldehyde (MF), Epoxy resins (epoxides), Polyurethanes (PURs)

◙Thermoplastics type :
Capable of being shaped after initial heating and solidifying by cooling.
Resistant to breakage and cheap to produce and providing the right plastics are chosen will provide the necessary protection of the product in an attractive containers.

e.g. Polyethylene(HDPE – LDPE), Polyvinylchloride(PVC),Polystyrene Polypropylene, Nylon(PA), Polyethylene terepthalate(PET) ,Polyvinylidene chloride(PVdC), Polycarbonate Acrylonitrile butadiene styrene(ABS)
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█ TYPES OF PLASTICS

►1.POLYETHYLENE(HDPE – LDPE)
This is used as high and low density polyethylene.

Low density polyethylene (LDPE) is preferred plastic for squeeze bottles.
Properties: Ease of processing , barrier to moisture, strength /toughness, flexibility, ease
of sealing.
High density poly ethylene (HDPE) is less permeable to gases and more resistant to oils, chemicals and solvents.
Properties: Stiffness, strength / toughness, resistance to chemicals.
It is widely used in bottles for solid dosage forms.

Drawback: prone to stress cracking in the presence of surfactants or vegetable or mineral oils.
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►2.POLYPROPYLENE
It has good resistance to cracking when flexed.
Good resistance to heat sterilization.
It is colorless, odorless thermoplastic material with excellent tensile properties even at high temperature.
Excellent resistance to strong acids and alkalis.
Low permeability to water vapour.
Permeability to gases is intermediate between polyethylene HD and un-plasticized PVC
Suitable for use in closures , tablet containers and intravenous bottles.
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►3.POLYSTYRENE
Versatility, insulation, clarity, easily foamed (“Styrofoam”).
It is also used for jars for ointments and creams with low water content.

Drawback: Chemicals like isopropyl myristate produce crazing(a fine network of surface cracks) followed by weakening and eventually collapsible of the container.
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►4.POLYVINYL CHLORIDE
Versatility , ease of blending, strength / toughness, resistance to grease/oil, resistance to chemicals, clarity.
Used as rigid packaging material and main component of intravenous bags.

Drawback: Poor impact resistance which can be improved by adding elastomers to the plastics but it will increase its permeability.
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►5.POLY VINYLEDENE CHLORIDE:
PVC&PVDC
Excellent barrier properties against: moisture, water vapour, UV light, aroma, inorganic acids, alkalis, aqueous salt solutions, organic water soluble acids, aliphatic hydrocarbons , esters of long chain fatty acids, detergent base materials, emulsifying agents and wetting agents.
Good thermoform ability.

PVDC is very cost-effective, as coating weight can be customized depending on the requirements of the barrier properties.
Medical grade and non-toxic.
High levels of transparency which improves the aesthetics of the product.

Sources & References : first comment

█ What are the types of glass, used in pharmaceutical packaging?

طبعا الزجاج المستخدم في صناعة الدواء لازم يكون له مواصفات وتركيبة خاصة لان الانواع العادية من الزجاج ممكن تتفاعل مع المادة الدوائية نتيجة لكونها مواد عالية التفاعل

والخطورة مش بس في المواد الدوائية .. المياة المستخدمة في تصنيع الادوية بيكون لها نشاط تفاعلي قوي مع الزجاج.

هانعرف في موضوع النهردا تركيب الزجاج
انواعه المختلفة واستخدامات كل نوع
العوامل اللي بتأثر على اختيارنا لنوع الزجاج
الطرق المختلفة لتشكيل الزجاج
واخيرا مميزات وعيوب الزجاج كوعاء للتغليف

Glass containers are usually the first choice of packaging materials for pharmaceutical products.
Glass is an inorganic material mostly silicates or mixture of materials which when heated up and then cooled, it solidifies without crystallization.

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█ Composition of glass
Glass is principally made up of silica (59-80%) with varying degree of calcium oxide (5-12 %) sodium oxide (12-17 %) aluminium oxide (0.5-3.0 %), barium oxide, boric oxide, potassium oxide, and magnesium oxide.
The high melting point of glass is due to the presence of silica.
The melting point and melt viscosity of the glass is modified by the addition of oxides.

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█ Classification of Glass

Glass containers are classified into four types ; Type I, II, III glass & IV glass based on their degree of chemical/hydrolytic resistance to water attack.
The degree of attack is dependent on the degree of alkaline release under the influence of the attacking media.
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►i. Type I (Borosilicate glass / Neutral glass)
It contains 80% silica, 10% boric oxide, small amount of sodium oxide and aluminium oxide. It is chemically inert and possess high hydrolytic resistant due to the presence of boric oxide. It has the lowest coefficient of expansion and so has high thermal shock properties.
◙ Uses :
• suitable for most preparations whether parenteral or non-parenteral.
• also be used to contain strong acids and alkalis
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►ii. Type II (soda-lime-silica glass/ treated soda-lime glass/ De alkalized soda lime glass)
This is a modified type of Type III with a high hydrolytic resistance resulting from suitable treatment of the inner surface of a type III glass with sulfur.
This is done to remove leachable oxides and thus prevents blooming/weathering from bottles. Type II glass has lower melting point when compared to Type I glass and so easier to mould.
◙ Uses :
• suitable for most acidic and neutral aqueous preparations whether parenteral or non-parenteral.
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►iii. Type III (Regular soda lime glass)
This is an untreated soda lime glass with average chemical resistance.
It contains 75% silica, 15% sodium oxide, 10% calcium oxide, small amounts of aluminium oxide, magnesium oxide, and potassium oxide.
Aluminium oxide impacts chemical durability while magnesium oxide reduces the temperature required during moulding.
◙ Uses :
• used for parenteral products or for powders for parenteral use ONLY WHERE there is suitable stability test data indicating that Type III glass is satisfactory.
• used in non-aqueous preparations and powders for parenteral use with the exception of freeze-dried preparations.
• It is also used in packaging of non-parenteral preparations.
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►Type IV (Type NP glass/General-purpose soda lime glass)
This type of glass container has low hydrolytic resistance.
This type of glass containers are not used for products that need to be autoclaved as it will increase erosion reaction rate of the glass container.
◙ Uses :
• It is used to store topical products and oral dosage forms

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█ Process of Forming Glass Containers
Glass containers are formed through the following methods
1. Blowing – this involves the use of compressed air to form the molten glass in the cavity of a mold.
2. Drawing – this involves the pulling of molten glass through dies that shape the soft glass into ampoules, vials etc.
3. Pressing – The glass is formed by the use of mechanical force which presses or forces the molten glass against the ride of a mold.
4. Casting –the force of gravity or centrifugal force is used to initiate the formation of molten glass in the cavity.

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█ Factors that influence the choice of a glass container
These factors include:
• Limit of alkalinity and hydrolytic resistance of the glass container
• Thermal expansion properties of the glass container (freeze drying)
• Sensitivity of the glass container to barium or calcium ions

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█ Advantages glass containers:
• Glass containers are mainly used in packaging liquid preparations due to their rigidity and their superior protective qualities.
• Its high transparency allows easy inspection of its contents.
• It offers better protection because of it is relatively impermeable to air and moisture.
• It is chemically resistance to most medicinal products.
• Colored glass (amber glass and red coloured glass) can protect its content from ultraviolet rays and certain wavelengths.
• Glass containers can be easily sterilized using heat.

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█ Disadvantages glass containers:
• Glass containers are expensive to manufacture.
• They are fragile and relatively heavy.
• During heat sterilization, some types of glass containers have the tendency of shedding some part of the silica into the formulation.

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