Not only for medicines, but the packaging design should be properly designed to best meet the requirements of product safety, marketing, and sterility especially for pharmaceutical preparations. Before studying pharmaceutical packaging designs, have you studied about packaging materials used in pharmaceutical packaging? If not, must read by clicking here.
All manufacturing, processing, and storage parameters are carefully considered while manufacturing the pharmaceutical and biological products. After being made with such sensitivity, the packaging and shipping of these medicines from the facilitator to the consumer needs to be controlled. The packaging and shipping of these medicines is done after proper designing of the packaging container. The properties of the medicines such as nature and type of formulation, stability characteristics, shelf life, and usage are taken into consideration while selecting packaging design.
The different types of packaging designs are discussed below.
Table of Contents
Pharmaceutical Packaging design: Collapsible tubes
The collapsible tube is an appealing, lightweight, unbreakable pharmaceutical packaging design container that makes it simple to administer controlled amounts. It also has a good seal, which adequately protects the substance. Due to the tube’s lack of “suck back,” there is very little chance that the section that is still in the tube will become contaminated. These tubes are the ideal packaging for viscous materials including dentifrices, ointments and creams used in medicine, and cosmetic creams and gels. These tubes could be laminated, made of metal, or composed of plastic. Below is a discussion of these sorts.
Metal collapsible tubes
Tin, lead, and aluminium are the three most often used metals with ductile properties and are used in the production of tubes. Tin is the most expensive of these metals, while lead is the least expensive. Tin and lead are laminated to give it a pleasing look and oxidation resistance. Prior to usage, the tin is often alloyed with 0.5% copper to give the alloy rigidity. On the other hand, 3% antimony is utilized, if necessary, to give rigidity to the lead tubes.
Plastic tubes
LDPE and HDPE are currently the most frequently used materials in plastic tubes. The former is more prevalent and less expensive. Compared to low density HDPE, which is uncoated, it provides additional protection. Because the coatings act as the primary barrier in both cases, coated high density polyethylene is just marginally more protective than coated low density polyethylene.
Under pressure and heat, a plastic tube’s sidewall is formed into a length of continuous, hose-like tubing that is then cut. In a separate mechanised procedure, the neck and shoulder are formed and connected to the tube. After that, the tube is decorated, primarily with offset printing. The tubes’ tops are covered, leaving the bottoms free for filling, and then they are heat-sealed to make them as strong as the rest of the tube.
Compared to other containers or dispensers, plastic tubes have a number of intrinsic practical advantages. They are (1) inexpensive, (2) lightweight, (3) strong, (4) comfortable to the touch, (5) flexible, facilitating product dispensing, (6) odourless and inert to most chemicals, (7) unbreakable, (8) leak proof, (8) capable of maintaining their shape throughout their use, and (10) high machinability. They also (11) with a special “suck-back” mechanism that stops product ooze. Relaxing hand pressure allows the product to be sucked back into the tube if too much is delivered with one squeeze.
Laminations
The creation of a third form of collapsible tube, the laminated tube, as a result of permeation issues with plastic tubes and corrosion and breakage issues with metal tubes. This tube is made from flat, printed stock and is laminated with various layers of plastic, paper, and foil. In a device known as a “sideseamer,” the edges of the lamination, which are specifically matched to the product needs, are heated and sealed together to form a continuous tube. The head is then injection-molded onto the tube after it has been trimmed to length. LDPE is frequently used to mould the head.
Since there is a chance that some product will bleed through this moulded head, a head insert made of urea formaldehyde can be moulded into the head to minimize product leaking. In addition to medications, depilatories, hand creams, hair care products, and denture adhesives, laminated tubes are now used in other markets than the dentifrice sector.
Pharmaceutical Packaging Design: Closures
When it comes to stability and compatibility with the product, the closure is typically the most delicate and important part of a pharmaceutical packaging design container. An effective closure must stop the contents from spilling out and keep nothing from getting into the container. The seal’s effectiveness is influenced by a variety of factors, including the liner’s resilience, the container’s sealing surface’s flatness, and most importantly the tightness or torque with which the seal is applied. Below is a discussion of the five fundamental closure designs.
Threaded screw cap
Common materials for screw caps are metal and plastic. Typically, tinplate or aluminium is used as the metal, while both thermoplastic and thermosetting materials are employed in plastics. For corrosion protection, metal caps are typically lacquered or enamelled on the inside.
The threads of the screw cap connect with the corresponding threads moulded into the bottle neck when it is applied. By overcoming imperfections in the sealing surface and providing resistance to chemical and physical reactions with the product being sealed, a liner (often a plastisol inner gasket) in the cap seals the product in the container. It is an important and widely used pharmaceutical packaging design.
Lung cap
The threaded screw cap and the lug cap both work on the same principles. Instead of a continuous thread, it is simply an interrupted thread on the glass finish. It is utilized to pull the cap down to the sealing surface of the container by engaging a lug on the sidewall of the cap. It simply requires a quarter turn, as opposed to the threaded closure.
Both normal atmospheric pressure and vacuum pressure are sealed with the lug cap. Because it provides a hermetic seal and works well in sterilization equipment and on production lines, the cap is frequently used in the food sector.
Crown caps
These are friction fitting closure types. This style of cap is commonly used as a crimped closure for beverage bottles and has remained essentially unchanged for more than 50 years. Crown is made of tin free steel and tin plate. The crown has a short skirt with 21 flutes that are crimped into locking position on the bottle head. Crowns also contain compressible lining material for efficient closing.
Roll-on closures
The metal roll-on cap may be effectively sealed, opened with ease, and resealed. It has several uses in the packaging of foods, drinks, chemicals, and medicines. Aluminum or another light-gauge metal that is simple to shape is needed for the roll-on closure. For use on glass or plastic bottles and jars, roll-on closures come in resealable, non-resealable, and pilfer-proof varieties.
Pilfer-proof closures
The normal roll-on closure and the pilfer-proof closure are comparable, but the pilfer-proof closure has a longer skirt. This additional length forms a bank below the threaded portion and is connected to the primary cap by a number of thin metal “bridges.” The bridges collapse when the tamper-evident closure is removed, but the bank on the container’s neck stays in place. Although the user can reseal the closure, the band’s separation shows that the package has already been opened. The bridges must be broken and the cap removed with nominal torque.
Non-reusable Roll-on closures
A reusable cap is not desirable in all packing situations. Unthreaded glass finishes are required for non-reusable caps. These closures’ skirts are rolled under the glass container’s retaining rings to preserve liner compression. These types of closures contain tear-off tabs that make them impervious to tampering and theft.
Plastic closures
The thermosetting and thermoplastic materials are the two fundamental categories of plastic that are typically utilized for closures. They have vastly distinct physical and chemical characteristics, and each variety is made using fundamentally different manufacturing processes.
Thermosetting resins
Threaded closures frequently employ thermosetting plastic resins made of phenolic and urea. Heat causes the thermosetting plastic to soften initially before curing and hardening it to its final condition. Because there is no more mobility after curing, even with the application of more heat and pressure, shaping must take place during the first stage of softening. Contrary to thermoplastic materials, which can be reprocessed, thermosetting materials go through a permanent chemical change throughout the moulding process.
Phenolics
Phenolic moulding compounds come in a variety of grades and dark hues, most frequently black or brown. When a strong, durable item is required and dark colours are acceptable, phenolics are employed. The phenolics’ best qualities include strength, heat resistance, rigidity, and chemical resistance. Despite coatings being expensive, the biggest disadvantage is a colour restriction. Phenolic is a strong closure that can withstand the torquing forces of capping machines and sustain a secure seal for an extended period of time.
Urea
This thermosetting resin is a tough, transparent substance that accepts colouring well. Despite being more expensive than phenolics, urea is a good choice for high-end products due to its heat resistance and other characteristics. With urea, elegant hues are possible because the translucency adds brightness and depth to the colours. Urea plastic is a rigid, brittle material that is tasteless and odourless, and it comes in an infinite variety of colours. In moist situations, it absorbs water, although this water absorption has no lasting negative effects on the plastic.
Thermoplastic resins
90% or more of all thermoplastic closures are made of polystyrene, polyethylene, and polypropylene. Every material has a unique set of performance benefits, and the specific resin used is determined by the physical and chemical qualities required for the application as well as the specific product being packaged.
Pharmaceutical Packaging Design: Closure liners
Any material used inside a cap to provide a seal between the closure and the container is referred to as a liner. Liners typically consist of a face material and a tough backing. The backing material must be flexible enough to regain some of its original shape when removed and returned and soft enough to absorb any flaws in the sealing surface. In order for the liner to snap into place and be free to rotate, it is typically cemented into the cap with an adhesive or the cap might be designed with an undercut. Factors affecting selection of a closure liner include Compatibility (chemical resistance). Appearance, Gas- and vapor-transmission rates-WVTR, oxygen, CO2, Removal torque, Heat resistance, Shelf-life, and Economics.
Homogenous liners
These single-piece liners can be purchased as a rubber or plastic disc or ring. They are frequently employed for pharmaceuticals due to their homogenous characteristics and ability can survive high-temperature sterilization, despite being more costly and difficult to apply.
Heterogenous or composite liners
These are made up of layers of various materials picked out for particular needs. The composite liner typically comes in two pieces: a face and a rear. The face of the product is typically in touch with it, and the rear offers the necessary sealing and cushioning.
Pharmaceutical Packaging Design: Stoppers
In the pharmaceutical packaging designs, rubber is utilized to create stoppers, cap liners, and bulbs for dropper assemblies. The rubber stopper is mostly utilized with single-use syringes and multiple-dose vials. Neoprene, butyl, and natural rubber are the three most often used rubber polymers. Rubber, vulcanizing agent, accelerator/activator, extended filler, reinforced filler, softener/plasticizer, antioxidant, pigment, specific components, and waxes are the typical elements of a rubber closure.
One or more rubber ingredients may be extracted into the parenteral solution when the rubber stopper comes into touch with an active agent, an antibacterial preservative, or other substances. These extractives may: (1) obstruct the chemical analysis of the active ingredient; (2) alter the parenteral preparation’s toxicity or pyrogenicity; (3) interact with the drug preservative to result in inactivation; and (4) alter the preparation’s chemical and physical stability, causing particulate matter to appear in the solution.
However, the users can read an article by Pharmatutor for additional considerations.
Quality control of Packaging Materials
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