Introduction
The stability of finished pharmaceutical products is influenced by a variety of environmental and product-related factors, including the chemical and physical properties of the active ingredient and pharmaceutical excipients, the dosage form and its composition, the manufacturing process, the design of the container-closure system, and the characteristics of the packaging materials.
What Is the Importance of Packaging the Drugs Properly?
The stability and safety of medications may be significantly impacted by packaging, making it a crucial component in the creation of many treatments. The effectiveness and other qualities of the packaging material are considered to ensure that the pharmaceutical items are kept in the highest possible quality, potency, and safety. Packaging is becoming increasingly critical as the market develops, both for the health and safety of patients as well as for the effective marketing of products. Given this, there are now more reasons than ever to take packaging into account while developing new medications.
What Are Some Crucial Factors to Take Into Account When Designing Packaging to Successfully Extend the Shelf Lives of the Drugs?
1. Barrier Coating - The type of material used, its thickness, and its structure (such as a coating or many layers) can all improve the barrier qualities. The Flexapharm SBC240 polyvinyl chloride/polyethylene lamination is a substitute for high-barrier materials like polychlorotrifluoroethylene (PCTFE) and cold-formed foil. It uses a polyvinylidene chloride version with a coating weight of 240 g/m2 (gram per meter square) to effectively block water vapor and oxygen. The fact that oxygen barrier performance does not alter with variations in relative humidity is an additional advantage of all SBC constructions. It is ideally suited to safeguard medications for companies looking to maximize their drugs' shelf life in a thermoformed blister rather than packing in blister packs because of the combination of moisture and oxygen barrier qualities.
2. Active Packaging - Active packaging with desiccants is becoming increasingly popular to increase the shelf life of the drug. Desiccants, oxygen absorbers, and other scavenging technologies have an increasing amount of options due to advancements in technology. Although sachets, canisters, and capsules are getting smaller and more potent, the scavenger is increasingly being included in packaging materials. Standard desiccants preserve dry conditions inside the box, but there is a chance that the environment might get too dry, which could be harmful. A few of the desiccants are activated carbon and a mixture of silica gel and activated carbon. Activated carbon guarantees the best odor absorption. A mixture of silica gel and activated carbon helps in both odor absorption and moisture protection.
3. Seal Integrity - Induction sealing, another method for extending the shelf life of bottles, keeps air and moisture out of the mouth of the container. Seal integrity depends on the cap, induction foil, and container quality. Seal integrity is also impacted by the selection of a head selection. Quality management is crucial in maintaining seal integrity since seal flaws can let oxygen, water vapor, and other undesired factors through. Modern vacuum-based leak testers may find leaks on induction-sealed bottles or blisters as small as one or two microns.
What Is the Clinical Significance of Packaging?
Drug packaging influences and affects the shelf life of the medicine. Physical and chemical properties and stabilities of the drug, in turn, determine the drug’s stability.
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Physical Stability - The visual appearance and action dissolution of the medicine are related to its physical stability. Drugs are significantly destabilized by moisture; hence packaging must be carefully designed to limit moisture exposure to increase the shelf life of the pharmaceutical product.
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Chemical Stability - Chemical stability of a drug is important to regulate as its stability governs the expiration date of the drug. The variables affecting chemical stability are decided by the time duration for which the drug can maintain its claimed potency as well as the quantity of the waste products after degradation.
The effectiveness of the medication may be impacted without suitable packing and thus preserve the drug's physical and chemical qualities, subjecting the patient to a lesser dose than planned or unintentional toxicity.
What Are the Various Packaging Materials for Drug Packaging?
The various packaging materials used for drug packaging are:
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Glass - Used for packing vials and ampoules.
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Aluminum Foil - It is used for blister packing. It provides drug stability by providing protection against moisture, oxygen, and light.
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Films - Films such as polyvinyl chloride and polychlorotrifluoroethylene are used for the blister packing of the drugs. It provides protection against moisture, light, and various other gasses.
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Plastic - Plastic has qualities of durability, flexibility, and lightness. Pharmaceuticals are packaged in a variety of plastic materials, including low-density polyethylene (LDPE), high-density polyethylene (HDPE), polyethylene terephthalate (PET), and polypropylene (PP).
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Rubber and Elastomers - Used in the manufacturing of stoppers and caps. It is used to make sure that liquid or injectable medicine containers are properly sealed and secured.
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Paper and Cardboard - Used as a secondary packaging material for boxes and cartons.
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The physical and chemical stability of the medication, which may be impacted by external elements, including light, temperature, and humidity, is maximized through optimal drug packaging. Based on its barrier qualities, blister packaging materials can be selected. Polyvinyl chloride, polyvinyl dichloride, polychlorotrifluoroethylene (Aclar), aluminum foil, and cyclic olefin copolymer are examples of common materials.
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While polyvinyl chloride is frequently chosen as the blister material because of its inexpensive cost and simplicity of manufacturing, aluminum foil still offers the best protection from moisture as it has the least moisture penetrance. Minimal moisture barriers made of polyvinyl chloride have been connected to environmental problems such as disposal. Aclar offers more effective moisture protection than polyvinyl chloride but less protection than aluminum foil.
Conclusion
Protective packaging will be impacted in the future due to the expansion of innovative drug delivery technologies, which include quick-dissolve tablets or strips and sublingual dose forms. Drug items exposed to various storage conditions and climates will require active packaging methods. To sum up, packaging factors are very important for increasing the shelf life of medicines. Pharmaceutical companies can improve the stability and integrity of drugs by choosing appropriate materials, designing effective barriers, ensuring proper sealing and closure, protecting against light exposure, controlling temperature, and providing clear labeling. This benefits patients by ensuring the availability of safe and effective medications for a prolonged period of time.
