Pharmaceutical packaging innovations: enhancing drug safety, efficacy, and patient compliance: A brief review

 Corresponding author: Abdul Wadood Ansari. Copyright © 2025 Author(s) retain the copyright of this article. This article is published under the terms of the Creative Commons Attribution Liscense 4.0. Pharmaceutical packaging innovations: enhancing drug safety, efficacy, and patient compliance: A brief review Abdul Wadood Ansari *, Arti, Ashish Kumar Yadav, Abhisek Yadav, Mohd Mushaid and Tanya Singh Pharmacy College Itaura, Chandeshwar, Azamgarh, Uttar Pradesh, 276128, India. World Journal of Biology Pharmacy and Health Sciences, 2025, 22(03), 072–087 Publication history: Received on 14 March 2025; revised on 08 May 2025; accepted on 10 May 2025 Article DOI: https://doi.org/10.30574/wjbphs.2025.22.3.0466 Abstract In the pharmaceutical sector, packaging plays a significant role in the development of different drug formulations. An essential component that protects the pharmaceutical substance is the packaging. Maintaining the quality of pharmaceuticals during storage, delivery, transit, and sale is dependent on the product's quality. Product containment, ease of use, and compliance during storage, transportation, display, and consumption. the stability of medicine solid, liquid, gel or paste form depend on packing material to prevent drug from chemical degradation. There are three levels of classification for pharmaceutical packaging: primary, secondary, and tertiary. The product is closely protected by the primary packaging. The pharmaceutical formulation has direct control over the primary package. secondary packaging that is used for product display and branding. The tertiary package, which is utilized for transportation, is the outermost package of the secondary packaging. Materials like glass, plastic, rubber metal, etc. are used for packing. By offering display, protection, identification, and information against physical damage, content loss, and undesired environmental elements including oxygen, water vapor, and light, packaging preserves the integrity of the product. The purpose of packaging is to keep a product contained so that it cannot interact with the environment. In order to turn the formulation into a product that is both aesthetically pleasing and commercially viable, pharmaceutical packaging plays a crucial role. The review article focused on type of packaging, packaging material and function of packaging. Keywords: Pharmaceutical Packaging; Materials; Pharmaceutical Dosage Form; Biodegradable Polymer; Glass; Plastics; Product 1. Introduction The science, art, and technology of enclosing or safeguarding products for use, sale, storage, and distribution is known as packaging. For the consumer to get the items safely and securely, packaging is crucial. A well-coordinated system called packaging is used to get products ready for handling, distribution, confinement, protection, and sale. Pharmaceutical packaging examines issues such as patient compliance, child safety, product diversion, and manipulation. Packaging offers defence against environmental factors such as chemical, biological, and physical hazards. Pharmaceutical packaging offers medical devices, life-saving medications, blood and blood products, and novel products like nutraceuticals. Packaging is a key component in conveying a company's identity and image. It is completely incorporated into business, government, institutions, industry, and private use in many nations. Clear details about the product, including the manufacturer's name, address, license number, batch number, expiration date, storage conditions, and route of administration, are provided by the packages outside image. Innovative concepts in dynamic packaging, intelligent packaging, and nanotechnology provide arrangements that are essential for enhancing or monitoring food quality (Mohd Sohail Ali). World Journal of Biology Pharmacy and Health Sciences, 2025, 22(03), 072–087 73 1.1. Characteristics of packaging material • It must not be harmful. • It must be FDA authorized. • It must not react with the product. • The material must shield the preparation from the environment. • It must not give the product an unpleasant taste or odour. 1.2. Types of packaging 1.2.1. Primary packaging Direct contact between the package and the product occurs in the primary packing (Praveen Nasa Department of Pharmaceutical Education & Research). It serves as the smallest distribution and use unit. Its primary goals are to inform, contain, and safeguard consumer. Syringe, container, ampoules, vials, closure, strip packaging, and blister packaging are a few examples. Figure 1 Primary packaging 1.2.2. Secondary packaging The outer packaging of the primary packaging that groups products together is known as secondary packaging. Examples: Cartoon, Boxes, Cases, Pallets, Shrink wrap. Figure 2 Secondary packaging 1.2.3. Tertiary packaging In addition to the product, primary and secondary packaging are additionally protected by tertiary packaging. It is employed for product delivery, warehouse storage, and bulk handling. Examples: Containers, Stretch wrap, Shipping Labels. World Journal of Biology Pharmacy and Health Sciences, 2025, 22(03), 072–087 74 Figure 3 Tertiary packaging 2. Packaging materials with respect to different dosage forms 2.1. Solid Dosage Forms 2.1.1. Tamper Resistant Packaging: Strip Packages One popular type of unit dose packaging for tablets and capsules is the strip package. Two webs of a heat-sealable flexible film are fed through a heated reciprocating plate or crimping roller to create a strip package. Before creating the last set of seals, the product is deposited into the pocket that has been created. Depending on the restrictions of the packing machine, a continuous strip of packets is created, typically several packets wide. The desired number of packets in length is sliced off of the packet strip. According to their qualities, several packaging materials are used for strip packaging in high-barrier applications; a paper/polyethylene/foil/polyethylene lamination is frequently employed (Lachman, 2009). Figure 4 Strip Package Blister Package Heat-softening a thermoplastic resin sheet and vacuum-drawing the melted plastic into a curved Mold creates the blister package. The sheet is taken out of the Mold and sent to the packing machine's filling station once it has cooled. A heatsealable backing material is used to cover the product-filled, semi-rigid blister that has already formed. Aluminium foil that has been heat-sealed is typically used as the peelable backing material. To provide adequate sealing for product protection and tamper resistance, the foil's coating needs to work with the blister substance. PVC, PVC/polyethylene blends, polystyrene, and polypropylene are often aluminium membrane are utilized in tropical regions to offer better defence against high humidity. World Journal of Biology Pharmacy and Health Sciences, 2025, 22(03), 072–087 75 Figure 5 Blister Package Bubble Pack Although there are various techniques to create the bubble pack, it is often created by sandwiching the product between a stiff backing material and a thermoformable, extensible, or heat-shrinkable plastic film. Heat-softening the plastic film and vacuum-drawing a pocket into it, much to how a blister forms in a blister packaging, are the usual methods used to achieve this. After the product is dropped into the pocket, it is sealed to a stiff surface, like paperboard coated with heat sealant. When using a material that shrinks when heated, The film contracts into a bubble or skin around the product when the package is passed through a heated tunnel, securely securing it to the backing card (Manukonda Keerthi, 2014). Figure 6 Bubble Pack Child Resistant Container Commonly referred to as CRCs, child-resistant containers are made to keep kids away from potentially dangerous items (Manukonda Keerthi, 2014). Legally speaking, within five minutes of receiving the package, at least 80% of the test panel's 20–42-month-old children are unable to open it. Thus far, all child-resistant compliance testing standards define such a package as immediate packaging that is difficult for young children (less than 52 months old) to open but does not present any challenges for older adults (over 65) to open and, when necessary, re-close correctly (P. D. Bairagi, 2018). Figure 7 Child Resistant Container World Journal of Biology Pharmacy and Health Sciences, 2025, 22(03), 072–087 76 Film Wrapper A translucent film featuring a unique design is firmly wrapped around a product or product container. To remove the product and open the container, the film needs to be ripped or cut. Options for substrates include voidable films that produce an image when removed and ultra-destructible films. Solvent-sensitive papers, for instance. Shrink Seals and Bands Heat or drying causes the bands or wrappers with the unique design to shrink, sealing the cap and container union. To remove the product, the seal needs to be cut or ripped. The shrink band concept uses a stretch-oriented polymer's (often PVC) heat-shrinking properties. The heat-shrinkable polymers are typically made as extruded, orientated tubes that are only a little bit bigger than the bottle's neck ring and cap (Manukonda Keerthi, 2014). Figure 8 Shrink Seals and Bands Breakable Caps When someone tries to open one of these caps, it breaks. In addition to offering exterior tamper evidence, these caps can be used in conjunction with interior seals to give double security (Manukonda Keerthi, 2014). Sealed tubes The tube's mouth is sealed, and in order to get the product, the seal must be broken. Shrink tubing A packaging design known as a flexible pouch is one that can offer a package that is both tamper-resistant and, with the right material choice, has a high level of environmental protection. During the product filling process, either vertical or horizontal forming, filling, and sealing (f/f/s) machinery is typically used to create a flexible Figure 9 Shrink Tubing World Journal of Biology Pharmacy and Health Sciences, 2025, 22(03), 072–087 77 3. Containers for semi solid and pressurized products 3.1. Collapsible Metal and Plastic Tubes • Its small opening keeps unused portions of the contents from becoming seriously contaminated. • Because the patient is less likely to remove too much, waste is decreased. • Microbial contamination and oxidative or hydrolytic degradation of the remaining contents are decreased because, unlike in conventional containers, when a portion of the preparation is expelled, it is not replaced by an equivalent volume of air. • Applicators with nozzles can be installed to make it easier to administer medication into bodily cavities like the vagina or nose. Although tin, lead, tin-coated lead, and plastics are also utilized, aluminium makes up the majority of collapsible tubes. Because aluminium tubes have an oxide film on their surface, they are resistant to corrosion. 3.1.1. Glass plastic pots Good substitutes are cylindrical, wide-mouthed, squat pots made of glass or appropriate polymers with a screw made of plastic (or infrequently metal) or, in the case of plastics, a slip-over top. Glass pots come in a variety of colours, including clear, amber, and opal white. Glass is stable, inert, and hygienic; it also permits transparency and makes the content visible. Compared to plastics, they are more costly unless the patient returns them for reuse (Manukonda Keerthi, 2014). 3.1.2. Aerosols The product is released through a valve in pressurized packages. When choosing the packaging for any product, the pressure used to force the product out is a crucial factor. Pressurized system packaging of medicinal active substances. Aerosols rely on the force of Figure 10 Aerosol liquid or pressurized gas to force their contents out of containers. It is possible to remove a dose without contaminating the materials. Stability is improved. for these materials negatively impacted by moisture and/or oxygen. Sterility can be preserved throughout the dispensing of a dose when it is a crucial consideration (Manukonda Keerthi, 2014). 3.1.3. Container for liquid /Parenteral Glass or plastic containers are used to package injectable compositions. Ampoules, syringes, vials, bottles, cartridges, and bags are all part of the container system. All ampoules are made of glass, while all bags are made of plastic. Rubber components for syringe and cartridge seals, rubber plungers, and rubber stoppers for vials and bottles. Glass bottles World Journal of Biology Pharmacy and Health Sciences, 2025, 22(03), 072–087 78 with screw tops made of aluminium are used to package irrigation solutions. A container that contains a quantity of medication meant for a single dose and that, once opened, cannot be sealed again with guarantee that sterility has been preserved is known as a single-dose container. These containers consist of prefilled syringes and cartridges as well as fusion-sealed ampoules (Manukonda Keerthi, 2014). 3.1.4. Single dose containers A container that contains a certain amount of the preparation meant to be used all at once or in part. Figure 11 Single Dose Container 3.1.5. Multi dose containers This hermetic container allows successive sections of the contents to be withdrawn without compromising the strength, quality, or purity of the remaining pieces (vials). Typically, the tool is a spoon or a 5-milliliter cup. Figure 12 Multi Dose Container 3.1.6. Well closed containers Prevent the product from becoming contaminated by undesirable foreign substances and from losing its contents while being used. 3.1.7. Air tight containers: Are impenetrable to gases, liquids, and solids when used and stored normally the container must stay airtight after reclosing if it will be opened more than once. World Journal of Biology Pharmacy and Health Sciences, 2025, 22(03), 072–087 79 3.1.8. Light resistant containers Light-resistant containers are necessary for a lot of pharmaceutical items. Generally speaking, a container composed of high-quality amber glass or an opaque material that resists light will minimize light transmission enough to safeguard a medication that is sensitive to light. Plastic can be treated with substances known as ultraviolet (UV) absorbers to reduce the transmission of brief UV radiation. The coextruded two-layer, high-density polyethylene bottle, which consists of an outer layer of white polyethylene coextruded with an inner layer of black polyethylene, is a recent development in plastic packaging. The container offers moisture protection and light resistance that surpasses that of amber glass. It is being utilized more and more in pill and capsule packaging to shield the contents from radiation with a wavelength between 290 and 150 nm (Manukonda Keerthi, 2014). 3.2. Closures 3.2.1. Threaded Screw Cap When used, the screw cap eliminates surface imperfections and protects the enclosed material both chemically and physically. Typically, the screw cap is composed of metal or plastics. Both thermoplastic and thermosetting materials are utilized in plastics, and the metal is typically aluminium or tinplate. The screw cap's thread meshes with matching threads molded into the bottle's neck when it is put on. Figure 13 Threaded Screw Cap 3.2.2. Lug Cap The thread cap and the lug cap are comparable. Instead of a continuous thread, the glass finish merely has an interrupted thread. It pulls the cap down to the container's sealing surface by engaging the lug on the cap sidewall. It is utilized in both vacuum and ambient situations. Figure 14 Lug Cap 3.2.3. Crown Caps This type of cap has hardly altered in over 50 years and is frequently used as a crimped closure for beverage bottles (Arif sabah, 2014) World Journal of Biology Pharmacy and Health Sciences, 2025, 22(03), 072–087 80 Figure 15 Crown Caps 3.2.4. Pilfer proof Closures With the exception of its longer skirt, the pilfer-proof closure is comparable to the conventional roll-on closure. Below the threaded section, this extra length forms a bank that is secured to the basic cap by a number of thin metals "bridges." The bridges shatter when the pilfer-proof lid is removed, leaving the bank on the container's neck in place. The detachable band shows that the package has been opened, and the closure is readily resealed. In order to remove the cap, torque is required (Lachman, 2009). 3.2.5. Roll-On The aluminium roll-on cap needs to be properly resealed, opened with ease, and sealed tightly. It is widely used in the packaging of chemicals, pharmaceuticals, food, and beverages. Materials that are easy to shape, like aluminum or other light-gauge metal, are needed for the roll-on closing. For use on glass or plastic bottles and jars, roll-on closures come in three varieties: resealable, non-resealable, and theft-proof. Figure 16 Roll-on 3.3. Suppositories Package • These strips come in pouch-style packaging and are made of four layers of material: poly, aluminium, poly, and paper (with the poly inner layer and the paper outermost layer). There are three reasons why strip packs are better than blister packs. • The suppository can be readily withdrawn without breaking, unlike blister packs, which frequently do. • Unlike strip packs, blister packs frequently need to be refrigerated to prevent shape deformation. • Unlike blister packs, which are typically made of pvc, strip packs are made of four layers of material, including aluminium, which has superior moisture barrier qualities and makes the product more stable. 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