1B. Pharm, M. Pharm, K.B. Institute of Pharmaceutical Education and Research, Gandhinagar.
2M. Pharm, Department of Regulatory Affairs, K.B. Institute of Pharmaceutical Education and Research, Gandhinagar.
3Director, Saviour Pharmaceuticals, Ahmedabad.
4M. Pharm, Ph.D., Professor & Head of Department of Regulatory Affairs, K.B. Institute of Pharmaceutical Education and Research, Gandhinagar.
To ensure the safety and effectiveness of oral solid medications, pharmaceutical packaging is crucial for shielding them from mechanical, chemical, and environmental risks. The function of various packaging technologies, in particular ALU-ALU and ALU-PVC blister packs, in preserving product stability is examined in this article. While ALU-PVC adds a plastic layer for flexibility, ALU-ALU offers better protection without plastic. The primary, secondary, and tertiary systems of packaging each have specific functions in distributing and protecting the product. The study emphasizes how crucial it is to select suitable packaging to satisfy legal requirements and encourage patient adherence.
Especially when referred to as ALU-ALU Packaging, typically does not contain plastic within the layers of aluminium used. However, in other types of Blister Packaging, Such as Alu-PVC a layer of Plastic (Polyvinyl Chloride or PVC) is used along with aluminium. Understanding the composition of different blister packaging types is crucial for discerning their protective capabilities and appropriate application in the pharmaceutical industry.
Introduction of Oral Solids
In the pharmaceutical sector, packaging plays a critical role in preserving the quality of drug goods during distribution as well as ensuring their safety and effectiveness. The packaging serves as an essential barrier, shielding the medication from external influences and guaranteeing its stability from manufacturing to the final consumer, even though the drug itself has a set shelf life. In addition to providing protection, packaging is essential for increasing customer attractiveness. A well-designed packaging with eye-catching artwork and useful design can have a big impact on customer loyalty and perception. For example, medications packaged in premium, laminated blisters or cartons protect the substance and encourage proper dose, both of which contribute to improved health results. To ensure the quality of pharmaceutical items during storage, transportation, delivery, sale, and usage, pharmaceutical packaging is essential. To guarantee that the medications reach the patient safely, the packaging is designed to encapsulate or protect the pharmaceutical items. The process of properly positioning pharmaceuticals to maintain their therapeutic efficacy from the moment of packaging till consumption is known as packaging.
“Packaging Is the Art and Science Which Involves Preparing the Articles for Transport, Storage, Display and Use.”
There are 3 types of packaging systems available for pharmaceutical industries which are
The ideal requirements for the container or package should be such as:
Aluminium As a Packaging Material in Medicinal Industry:
The medical field is an important but sometimes dangerous one. The type of goods and services it offers patients is the cause. Aluminium is an incredibly flexible material that is used extensively in many different industries, but it is most commonly used in the healthcare sector. Its distinct combination of chemical and physical qualities has made it an appealing choice for pill, capsule and medicine packaging. Its outstanding durability and lightweight nature stand out among its many benefits for pharmaceutical packaging, making it convenient to handle and deal with.
Figure 1. ALU-ALU Blister Packaging
Superior protection against environmental elements that can jeopardize the stability or potency of medications is offered by aluminum foil. Additionally, these barrier qualities contribute to the product's longer shelf life, which is important for pharmaceutical organizations that need to handle their sensitive medications with precision. Nevertheless, there are worries about the possible health hazards connected to the use of aluminium in pharmaceutical packaging, despite its many benefits. It is commonly known that certain drugs and aluminium might interact chemically, compromising the treatment's safety and effectiveness. In severe cases, aluminium may even gradually infiltrate into the medication, causing an accumulation of aluminium in the body. The aluminium foil is used to create a push-through closure with lid film or blister film where tablets and capsules are protected perfectly and hygienically. These blister packs are compact and easy to port and handle. The integration of aluminum foil has made aluminum blister foil manufacturers keep every tablet well protected from the effects of the external environment and hence keep the effectiveness of all the tablets intact.
Types of Aluminium Foil Packaging:
PVC/PVDC As a Packaging Material in Medicinal Industry:
Two blister packaging materials that are frequently used in the pharmaceutical business are PVC (polyvinyl chloride) and PVDC (polyvinylidene chloride), although they can be hazardous to people and the environment. Pharmaceutical firms are therefore searching for fresh substitutes. Although polypropylene is a good option, processing it can be challenging. This article offers several coping mechanisms and performs a quick examination in this area.
Figure 2. PVC/PVDC Blisters Packaging
In medical blister packaging, PVC, either by itself or in conjunction with polyvinylidene chloride (PVDC), aluminum chlorotrifluoroethylene (CTFE), or oriented polyamide nylon (OPA), accounts for nearly all of the market. PVC is an inexpensive, transparent polymer that has a low permeability index to air humidity, good thermoforming, physical, and chemical resistance, and low permeability to oils, fats, and aromatic compounds. PVC is the most used material for blister packing, yet it provides the least amount of protection of any material. The pharmaceutical industry typically uses PVDC film, which is 0.2 mm to 0.8 mm thick and more rigid than PVC. Because the greater the thickness, the less likely it is that light will travel through the film, thickness has a profound effect on light barrier qualities. PVC and PVDC materials come in a variety of colors, including blue, red, amber, white opaque, clear translucent, and more. Since clear transparency has a lower barrier, it is mostly utilized for medications that remain stable when exposed to light and moisture. PVDC is used in PVC Laminated or coated packaging, reducing the permeability of PVC to oxygen and moisture by 5-10 times. PVDC cannot be used as a sole material due to its relatively high cost and mechanical properties. For items like multivitamin pills or capsules that have a long shelf life and are not very sensitive to external conditions, PVDC combined with a PVC base coat yields the best results. PVC has good chemical resistance and low permeability to oils, fats, and flavouring ingredients. When combined with PVDC, gas and moisture permeability is reduced significantly compared to uncoated PVC. This coating is critical for maintaining the integrity and shelf life of Pharmaceutical Products. Other Coatings like PVC/CTFE, Offer even lower water-Vapour permeability. For medications requiring the utmost protection, a combination of OPA/ Aluminium/PVC is chosen. PVC is a non-toxic, inert substance. Its formulation for pharmaceutical applications ensures the safety and effectiveness of drugs by not interacting with them. used in pharmaceutical packaging for many years. PVC satisfies several international regulatory requirements for medicine packaging and has a demonstrated safety profile. PVC is extremely versatile for a variety of drug forms due to its ease of processing into diverse shapes. PVC is made without plasticizers when it comes to blisters. The plastic is very flexible even without softening additives. To improve its barrier qualities or for other practical purposes, PVC is easily laminated or coated with various materials. For example, to strengthen the barrier against gases and moisture, a layer of PVDC can be applied. Unlike other polymers, PVC is mainly composed of table salt-derived chlorine. As a result, PVC is more economical than alternatives and uses less primary energy derived from fossil fuels. Unlike other polymers, PVC is mainly composed of table salt-derived chlorine. As a result, PVC is more economical than alternatives and uses less primary energy derived from fossil fuels.
Reasons for selecting PVC/PVDC:
Alu-Alu Blister Packaging:
Alu-Pvc Blister Packaging:
Summary
Table 1. Material Comparison between ALU-ALU and ALU-PVC
|
ALU-ALU Packaging |
ALU-PVC Packaging |
Composition |
Aluminium Foil Layer sandwiched between plastic film layers. |
Aluminum foil layer with a layer of polyvinyl chloride (PVC) |
Barrier Properties |
Exceptional shield against humidity, oxygen, and UV rays. |
Good barrier against moisture and light. |
Visibility |
No visibility for the contents inside the blister cavities. |
Transparent PVC film for excellent product visibility. |
Tamper Resistance |
Enhanced tamper resistance with features like blister perforations or tear lines. |
Can be made tamper-resistant with appropriate blister designs. |
Flexibility |
Less flexible, suitable for standard-sized blisters. |
More flexible, and suitable for various blister shapes and sizes. |
Cost |
Generally, more expensive |
Generally, more economical |
Heat Resistance |
Aluminum-based materials with good resistance to temperature changes. |
Plastic-based materials with limited heat resistance. |
Recyclability |
Less recyclable due to a combination of materials. |
More recyclable with separate PVC and aluminium recycling. |
Shelf Life |
Extended shelf life due to excellent barrier properties. |
Good protection but slightly inferior barrier properties. |
Table 2. Material Comparison between PVC and PVDC
|
PVC |
PVDC |
Composition |
Polyvinyl Chloride is created through the polymerization of the vinyl chloride monomer and is known for its strength and resistance to environmental factors. |
Polyvinylidene Chloride is a synthetic thermoplastic produced by the polymerization of vinylidene chloride, |
Barrier Properties |
Offers moderate barrier protection against moisture and gases. This makes it suitable for general consumer goods and non-sensitive pharmaceutical products |
Provides superior barrier properties compared to PVC. It is highly effective in protecting products from moisture, oxygen, and other gases, making it ideal for moisture-sensitive and perishable products. |
Mechanical Properties |
Has good mechanical strength and is resistant to abrasion and impact. This makes it a durable choice for a wide range of products. |
While also strong, the primary focus of PVDC is on barrier properties rather than mechanical strength. |
Cost consideration |
Generally, less expensive than PVDC, making it a cost-effective option for many applications. |
More expensive due to its enhanced barrier properties. The cost is justified for products that require extended shelf life or are highly sensitive to moisture and gases. |
Flexibility and Formability |
High Flexible and easy to form into different shapes. |
While it can be formed into blisters, it is typically less flexible than PVC and is often used as a coating over PVC to enhance barrier properties. |
Applications |
Used in non-sensitive pharmaceutical packaging and preferred for products that do not require high barrier protection against moisture and gases . |
Ideal for packaging moisture-sensitive pharmaceuticals, food products and perishable items. Often used in combination with PVC, where PVDC acts as a coating to enhance barrier properties. |
Regulatory and Health Aspects |
Concerned about the release of harmful substances from PVC, especially when it contains certain plasticizers. |
Generally considered safe for food and pharmaceutical packaging, but its use is regulated to ensure that no harmful substances leach into the packaged products. |
CONCLUSION:
The comparison between ALU-ALU and ALU-PVC blister packaging reveals distinct advantages and limitations for each material. ALU-ALU offers superior protection against environmental factors like moisture, light, and oxygen, making it ideal for sensitive drugs, though it is costlier and less flexible in design. ALU-PVC, while providing slightly lower barrier protection, is more cost-effective and versatile, with the added benefit of transparency for visual inspection. The choice of packaging should be based on the drug's stability needs, environmental conditions, and cost considerations. As environmental concerns rise, there is a growing need for sustainable packaging alternatives that balance protection with ecological impact.
ACKNOWLEDGMENT
I would like to take this opportunity to extend my heartfelt thanks to everyone who has supported and guided me throughout my research project, “ALU-ALU Packaging Vs ALU-PVC Blister Packaging: Waste to Value - A Comparative Analysis.” First and foremost, I would like to express my sincere appreciation to my academic mentor, Mrs. Zuki Patel, Assistant Professor of Regulatory Affairs, for her invaluable guidance, unwavering support, and insightful recommendations during this project. Her expertise and constant assistance have been instrumental in shaping the direction of my work. I am also deeply grateful to my industrial mentors, Mr. Hitesh Dani, Director of Saviour Pharmaceuticals, their professional insights and guidance on the regulatory landscape have significantly enhanced my understanding of the subject. I would also like to thank my colleagues and the entire faculty of the Department of Regulatory Affairs at K.B.I.P.E.R. for their continuous support and constructive feedback. Their encouragement has been essential in the successful completion of this work. I am especially thankful to my family for their unwavering support, patience, and belief in me, which has been my greatest strength throughout this journey. Lastly, I wish to express my deep gratitude to everyone who has contributed to the completion of my thesis, whether directly or indirectly.
Conflict of Interest Statement
The authors declare no conflicts of interest related to this study, “ALU-ALU Packaging Vs ALU-PVC Blister Packaging: Waste to Value - A Comparative Analysis.” The research was conducted independently, and there are no financial, personal, or professional relationships that could have influenced the study's outcomes.
REFERENCES
Charmi Patel, Hitesh Dani, Maitreyi N. Zaveri, Zuki Patel*, ALU-ALU Packaging Vs ALU-PVC Blister Packaging: Waste to Value - A Comparative Analysis, Int. J. of Pharm. Sci., 2025, Vol 3, Issue 3, 2810-2818 https://doi.org/10.5281/zenodo.15100484