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Review

Global Innovations in Sustainable Pharmaceutical Packaging in the Last 25 Years: A Scoping Review

by
Sophie Jackman
†,
Peter Mc Guinness
†,
Lia Brennan
,
Ruby Pereira
,
Anne Tyrrell
,
Anna Maria Barry
,
Cait Brennan
and
Bernard D. Naughton
*
School of Pharmacy and Pharmaceutical Sciences, Trinity College Dublin, The University of Dublin, D02 PN40 Dublin, Ireland
*
Author to whom correspondence should be addressed.
†
These authors contributed equally to this work.
Sustainability 2025, 17(23), 10716; https://doi.org/10.3390/su172310716
Submission received: 16 October 2025 / Revised: 13 November 2025 / Accepted: 17 November 2025 / Published: 29 November 2025
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Abstract

Pharmaceutical packaging is integral to the efficacy, safety, quality and regulatory compliance of medicinal products. However, traditional pharmaceutical packaging can cause harmful environmental effects due to a lack of eco-design methods, excessive use of synthetic materials, and a lack of effective recycling techniques. In response, a range of innovations in sustainable pharmaceutical packaging have emerged to mitigate these environmental effects. This scoping review aims to identify and map global innovations in sustainable pharmaceutical packaging developed within the last 25 years, examine implementation challenges, identify gaps in the literature, and suggest a framework to guide the pharmaceutical industry in adopting these eco-innovations. Following the PRISMA-ScR guidelines, this review analysed 100 studies from grey and academic literature published between the years 2000 and 2025. Data extraction and thematic analysis was performed and revealed four main areas of innovation: biodegradable materials, design, smart technology, and waste management. Key barriers to their adoption include regulatory, safety, and economic challenges. One gap identified in the literature was the lack of a framework to aid the implementation of innovations in sustainable pharmaceutical packaging. Therefore, this review also proposes a responsible packaging innovation framework.

1. Introduction

Pharmaceutical packaging for human and veterinary products fulfils multiple scientific, functional and regulatory requirements such as physical protection, preservation, identification, information provision, protection from light, spillages and leakage prevention, shelf life or sterility preservation, as well as anti-tamper controls and child safety, to guarantee the quality, safety and efficacy of pharmaceutical products [1]. The evolution of pharmaceutical packaging has a long history, but notably in the 1950s, plastic and aluminium pharmaceutical packaging became very popular, because of their advantageous properties of being lightweight, durable, and having cost-effective production [2,3].
The growth of the plastic pharmaceutical packaging industry has been profound, and is expected to reach a value of US$ 107.63 billion by 2034 [4]. However, huge amounts of fossil fuels such as natural gas and coal are burned to produce traditional petroleum-based synthetic plastics, and once produced, synthetic plastics can take between 100 and 1000 years to degrade [5,6]. This has devastating environmental impacts, including a significant carbon footprint that contributes to the climate crisis, as well as harmful effects on both marine and terrestrial wildlife [7]. Aluminium, on the other hand, is infinitely recyclable. In spite of this, the majority of aluminium used in pharmaceutical packaging is not recycled due to the complex multi-layer structure of pharmaceutical blisters, which requires energy-intensive separation before recycling [8]. These challenges highlight the urgent need for a new era of sustainable pharmaceutical packaging that aligns with World Health Organisation (WHO) guidelines, One Health principles, and global circular economy initiatives.
As defined by the United Nations (UN), the term ‘sustainability’ is coined as ‘meeting the needs of the present, without compromising the needs of the future’ [9] a term which is aligned with the concept of responsible innovation, which is ‘taking care of the future through collective stewardship of science and innovation in the present’ [10]. In recent years, there has been a growing number of global initiatives promoting sustainability and carbon neutrality, especially targeting multinational corporations, including the pharmaceutical industry. Given that the pharmaceutical industry is estimated to generate 300 million tonnes of plastic waste annually, it faces increasing pressure to adopt more sustainable practices [11]. Many pharmaceutical companies have publicly committed to achieving net-zero carbon emissions. AstraZeneca and GlaxsoSmithKline (GSK) both have publicly announced targets to reach net zero [12].
The UN 17 Sustainable Development Goals (SDGs) were established to address multiple global challenges while simultaneously promoting sustainability [13]. Among them, SDG 9 (Industry, Innovation and Infrastructure), SDG 12 (Responsible Consumption and Production), and SDG 13 (Climate Action) are particularly relevant to the pharmaceutical industry. Other relevant initiatives include the UN-backed Race to Zero emissions by 2050, and the European Green Deal, which aims to make Europe the first climate-neutral continent by 2050 [14,15]. Additionally, the WHO has encouraged pharmaceutical industries to integrate environmental sustainability into product design, packaging and lifecycle assessments, emphasising the One Health approach to reduce risks to humans, animals and ecosystems.
Although there are no EU Regulations governing the technical specifications of pharmaceutical packaging, the EMA advises that manufacturers comply with relevant material monographs provided in the European Pharmacopoeia. However, recent regulations passed will have major effects on how pharmaceutical packaging is designed, produced and disposed of. For example, Regulation (EU) 2025/40 on Packaging and Packaging Waste states that all packaging must be recyclable and plastic packaging must contain a required percentage of recycled plastic by 2030, with financial penalties in place for infringements of this regulation [16]. Primary packaging in contact with medicinal products is exempt from this regulation until 1st January 2035; however, this exemption highlights the immediate need for pharmaceutical companies to invest in sustainable packaging solutions, including biodegradable, compostable, or mono-material alternatives compatible with recycling infrastructure. Additionally, stricter waste management regulations have become increasingly prevalent. The Extended Producer Responsibility (EPR) framework, as outlined in Directive (EU) 2018/851, mandates that producers bear the financial responsibility for waste prevention and treatment operations [17]. While each individual member state has its own specific rules, contributing to greater complexity, Ireland introduced a significant amendment in 2023. Under the European (Packaging) Regulations 2014 (S.I. No. 282/2014), all ‘major producers’ who place 10 tonnes or more of packaging on the Irish market are now legally required to comply with EPR provisions, with penalties for non-compliance [18]. This underscores how pharmaceutical industries must also consider the waste management of their packaging.
The term ‘innovation’ is described as ‘the use of new ideas, products or methods where they have not been used before’. Despite evolving research, the literature surrounding innovations in sustainable pharmaceutical packaging remains fragmented and relatively few innovations have emerged.

Research Aim and Objectives

This paper aims to address the gap in the literature regarding sustainable pharmaceutical packaging by identifying existing and prospective sustainable packaging solutions.
The paper objectives are as follows
  • To identify and analyse relevant papers concerning sustainable packaging
  • To discuss sustainable ways to improve pharmaceutical packaging
  • To describe the barriers to sustainable pharmaceutical packaging and how to manage those barriers.

2. Methods

2.1. Study Design

This review was designed according to the Joanna Briggs Institute (JBI) methodology framework for scoping reviews. The Preferred Reporting Items for Systematic reviews and Meta-Analysis extension for Scoping Reviews (PRISMA-ScR) guidelines were used to report the findings of the scoping review [19]. A scoping review was selected due to the evolving nature of the evidence base, the need for a broad overview of sustainable pharmaceutical packaging innovations, and to accommodate the inclusion of diverse sources from both academic and grey literature [20]. The review also considered global regulatory frameworks and sustainability guidelines, including European Medicines Agency (EMA), Food and Drug Administration (FDA), the WHO, and One Health principles, to ensure relevance of innovations in the context of international compliance and patient safety.

2.2. Inclusion Criteria

Screening inclusion and exclusion criteria were as follows and are found in the Supplementary Materials Table S1:
(1)
Studies relating to innovations in sustainable pharmaceutical packaging, following the definitions included in the introduction.
(2)
Studies published in the English language.
(3)
Studies published between 2000 and 2025.
(4)
Studies with full text availability.

2.3. Search Strategy

A search strategy was developed, which was conducted in three databases specialising in biomedical, life, and health sciences: Embase, CINAHL, and PubMed. These databases were chosen to support the identification of literature relevant to our study aims and objectives. Combinations of keywords were used to identify papers describing global innovations in sustainable pharmaceutical packaging. A full summary of the keywords used in the search strategy can be found in the Supplementary Materials Tables S2–S4. For each search, the following filters were applied: (i) years: 2000–2025, (ii) language: English. A citation screening of references cited in the included studies was also performed.
Due to the limited number of eligible peer-reviewed academic publications, grey literature was searched to strengthen the comprehensiveness of the evidence base for this emerging topic and to identify any suitable literature not identified in the academic databases. Although grey literature may not be as reliable as peer-reviewed academic papers, it can provide a rich source of data, which is valuable for scoping reviews in emerging topic areas. A supplementary grey literature search was conducted in Google Scholar using the keywords ‘Sustainable Pharmaceutical Packaging’. The following filters were also applied to this search: (i) years: 2000–2025, (ii) language: English. The first 500 most relevant studies of the grey literature search were eligible for inclusion.
The final peer-reviewed database search was carried out on the 22nd January 2025, and the final grey literature search was conducted on the 24th February 2025. The citation screening of the peer-reviewed literature was completed on the 7th March 2025.

2.4. Evidence Source Selection

The PRISMA-ScR was used in this study, as shown in Figure 1. Studies meeting the inclusion criteria from both the peer-reviewed and grey literature searches were uploaded to Covidence 2025, an online software platform used to streamline the process of conducting scoping reviews and other reviews. A title and abstract screening of each study retrieved from the search, involving two reviewers, was carried out against the eligibility criteria to identify potentially relevant information sources. The full text of sources deemed eligible was uploaded into Covidence 2025. A full-text review was carried out by two reviewers to identify studies that met the inclusion criteria. Any disagreements between reviewers were resolved by a third independent reviewer.

2.5. Data Extraction

The data extraction was carried out using a Covidence data extraction form developed by the authors. The author extracted the following data using the extraction form in the Supplementary Materials Table S5: study title, study objectives, research question(s), population (i.e., researchers, pharmaceutical company), context, type of evidence source (i.e., peer-reviewed literature, grey literature), citation details (i.e., author, year of publication, title, journal), study settings, country of origin, study aims, types of innovation(s) (i.e., material, design, smart technology), details on innovation(s), materials and technologies used, challenges and barriers identified, outcomes and impacts, details on outcome and impacts. A second author reviewed the completed data extraction form to ensure accuracy before approval.

2.6. Data Analysis

Data was analysed using the Braun and Clarke thematic analysis approach, whereby six steps were followed: (1) familiarising yourself with the data, (2) generating initial codes, (3) searching for themes, (4) reviewing themes, (5) defining and naming themes, and (6) writing the final report [21].

3. Results

3.1. Evidence Sources Identified

The initial peer-reviewed literature search yielded 367 studies in total: Embase (n = 313), PubMed (n = 16) and CINAHL (n = 11). A total of 27 papers were included from citation screening. Duplicate papers were removed (n = 81). The titles and abstracts of 286 studies were screened. A total of 255 studies were excluded as they did not fulfil the inclusion criteria. Therefore, 31 studies underwent a full-text review, during which a further 18 sources were removed, as they failed to meet the inclusion criteria or the full text was inaccessible. Thus, a total of 13 academic publications were included for assessment.
The initial Google Scholar search identified a total of 512 evidence sources, and n = 13 duplicates were removed. A total of 499 studies were included for title and abstract screening, with 358 studies failing to meet the inclusion criteria and subsequently removed. Following this, a total of 141 studies were selected for full-text review, after which a further 54 sources were deemed ineligible due to a failure to meet the inclusion criteria or the full text was inaccessible. Thus, a total of 87 grey literature sources were included in the review.

3.2. Study Descriptions

3.2.1. Studies by Year of Publication

No studies were identified for the years 2000–2005, 2007 and 2010 (Figure 2). The highest number of included studies was identified in the year 2024 (n = 24). Studies were unevenly distributed throughout the twenty-five years, with the majority being identified for the years 2020–2024. * Note: the search included sources up to March 2025. Thus, data from 2025 may not represent the full year.

3.2.2. Geographical Distribution of Studies

Studies were identified from 32 countries. The highest number of evidence sources was identified from India (n = 25), followed by the US (n = 8) and Finland (n = 8), the United Kingdom (n = 5), China (n = 5) and Portugal (n = 5).

3.3. Global Innovations

Four primary themes relating to innovations in global sustainable pharmaceutical packaging were identified from the analysis of included studies. These were sustainable packaging material innovations, e.g., plant-based, microbial-based and algae-based packaging materials (n = 33) [12,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53], design innovations, e.g., packaging volume/weight reduction and use of life-cycle assessments (n = 19) [12,47,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70], smart technology innovations, e.g., the use of e-PIL/QR codes and computer-based tools for eco-design (n = 10) [55,63,71,72,73,74,75,76,77,78] and waste management innovations, e.g., novel processes for the separation of aluminium and plastic in waste pharmaceutical blister packs (n = 8) [8,79,80,81,82,83,84,85]. (Figure 3) Many papers discussed more than one theme.

3.4. Material Innovations

For the purposes of this review, sustainable packaging materials were defined as biodegradable or compostable materials intended to replace petroleum-based plastics in pharmaceutical packaging. Sustainable packaging materials were explored by the greatest number of studies compared to other themes. The sustainable material innovations were categorised into subthemes by material source: plant-based, microbial-based, and algae-based packaging materials. The majority of evidence sources described sustainable packaging materials from multiple sources (n = 22). One study described the use of microorganism-based materials only for pharmaceutical packaging [43].

3.4.1. Plant-Based Packaging Materials

Materials from plant sources emerged as the most explored sustainable materials. A study by Ge et al. reported the development of an active rosmarinic acid-gelatin biodegradable film with antioxidant and antibacterial functions proposed for food and pharmaceutical packaging [29]. The remaining studies highlighted various forms of cellulose as a potential bioplastic for packaging pharmaceuticals [31,37,46,49,51] while three of these studies highlighted cellulose-chitin films as bioplastic materials for potential application in pharmaceutical packaging. A study by Ji et al. described a method to improve the oxygen barrier, mechanical, and optical properties of nanocellulose and nanochitin films to a level that satisfies the requirements for certain food packaging applications, evidencing a step closer to making these plant-based, sustainable materials suitable for pharmaceutical packaging [31].

3.4.2. Algae-Based Packaging Materials

Lomartire et al. highlighted the advantageous characteristics of seaweed-derived polysaccharides for the development of potential sustainable pharmaceutical packaging materials, such as biocompatibility, non-cytotoxicity and antimicrobial properties, highlighting that sustainable algae-based food packaging has already been tested by consumers [36]. In a separate study, Lomartire et al. reported that a start-up company based in London, “Nopla”, has developed a natural, edible, fully biodegradable plastic-such as a substance from seaweed [35]. Similarly, Rane et al. developed a biocomposite film by blending k-carageenan from red seaweed with nanosilica. This biopolymer showed improved barrier properties, enhanced flexibility and mechanical strength compared to the carageenan biofilm alone, increasing its suitability for the packaging of pharmaceuticals [42].

3.5. Design Innovations

In the context of this review, design innovations were defined as design strategies to reduce the environmental impact of pharmaceutical packaging throughout its lifecycle. Two subthemes were identified: packaging volume-weight reduction and the use of life cycle assessment (LCA) tools.

3.5.1. Packaging Volume/Weight Reduction

Evidence from the included studies suggests that simple changes to packaging design can significantly reduce the amount of material used, thereby decreasing packaging weight and/or volume and enhancing overall sustainability [47,54,55,58,59,61,65,66,70]. For example, a study by Falconnier–Williams et al. estimated that by reducing the sealing area around each alveolus in a pharmaceutical blister to 2 mm and arranging the dosage form in two rows, a reduction of 37% of the primary packaging material could be achieved [63]. Similarly, another study described a method to replace traditional syringes with pre-filled syringes to remove the requirement for secondary packaging, reducing the weight and volume of the packing by 30% and 50%, and halving carbon emissions from storage and transport [12].

3.5.2. Use of Lifecycle Assessment Tools for Eco Design

Evidence from the studies described LCA as a key tool to allow pharmaceutical companies to make well-informed and impactful decisions surrounding the eco-design of sustainable pharmaceutical packaging [61,65,66,67,68]. Across the studies, LCA tools were used to evaluate the environmental impacts of pharmaceutical packaging design throughout its lifecycle, helping pharmaceutical companies to decide what sustainability interventions, such as material reduction strategies, are required in the product lifecycle and to validate the environmental effects of these choices throughout the product lifecycle. For example, a study by Bassani et al. proposed a five-phase ecodesign approach using LCA to improve the environmental performance of pharmaceutical packaging [61].

3.6. Smart Technology Innovations

In this review, smart technology innovations were defined as an innovation that uses digital technology to improve the sustainability of pharmaceutical packaging. Subthemes identified included the use of the electronic patient information leaflet (e-PIL) (n = 2) and the use of computer-based tools for sustainable packaging design (n = 2).

3.6.1. The Use of the e-PIL/QR Codes

A study by Safrai et al. explored the environmental benefits of the introduction of an e-PIL that can be accessed via QR codes to increase the sustainability of pharmaceutical packaging, reporting that this strategy has already been mandated in Brazil [55]. The study estimated that the inclusion of the PIL in oral contraceptive products alone leads to 6110 tons of paper waste and generates over 5760 tons of CO2 eq per annum in the US and Europe alone [55]. In addition to the materials required to manufacture PILs, their production also contributes to major greenhouse gas emissions through tree harvesting, pulping and printing. Recycling PILs can also be challenging due to the use of glossy, thick paper, which may also contain metal clips [78]. Moreover, many patients do not benefit from the PIL due to the small font (minimum font size of 9), use of jargon, and, in some cases, multiple languages printed on the PIL. Additional benefits of the e-PIL reported included enhanced patient education, increased ease of updating the information and reduced environmental impact of pharmaceutical packaging [55]. Another study by Sirkas et al. reported that this approach has been trialled within the European Union (EU), whereby the European Commission gave temporary permission to certain countries in 2022 to market hospital-use medicines without the printed leaflet in the box [78].

3.6.2. The Use of Computer-Based Tools for Packaging Eco-Design

De Couvreur et al. introduced a user-centred design support framework, a digital tool developed to support packaging designers in creating sustainable and consumer-friendly over-the-counter pharmaceutical packaging [63]. The other study by Mcglinchey et al. described a Green Lean Six Sigma approach by the application of a computer-based design and decision-support tool to improve sustainability in pharmaceutical companies [75]. The study proposes a tool that integrates sustainability principles into the Lean Six Sigma process, helping pharmaceutical companies to identify inefficiencies, reduce pharmaceutical packaging waste, and reduce their carbon emissions associated with packaging.

3.7. Waste Management Innovations

For the purposes of this review, waste management innovations were defined as any innovative process aimed at reducing the negative environmental impact associated with the disposal of pharmaceutical packaging. Novel processes for the separation of aluminium from plastic in waste pharmaceutical blister packaging were identified as a subtheme [8,79,80,82,83].
A study by Wang et al. describes an economically feasible, hydrometallurgical method for the separation of aluminium and plastic for recycling waste pharmaceutical blisters, whereby aluminium recovery can be up to 100% [83]. In a related study by Agarwal et al. the recovery of aluminium by up to 88% was achieved by an electrohydraulic fragmentation method [79]. Additionally, the use of environmentally friendly biobased solvents for the separation of aluminium and polymers was explored in a study by Nieminen et al., and revealed that lactic acid and deep eutectic solvent (DES) could be used to effectively separate aluminium and plastic without the use of environmentally harmful solvents [82].

3.8. Challenges and Implications

This study identified several challenges which impeded the advancement of sustainable pharmaceutical packaging innovations. These included regulatory challenges, safety challenges, economic challenges and other challenges (Table 1).

4. Discussion

4.1. Sustainable Material Innovations

Polymers derived from natural sources are known as biopolymers [86]. Biopolymers have the advantage of being biodegradable in nature, ultimately degrading to non-hazardous byproducts such as carbon dioxide, water and biomass, which reduces the reliance on fossil fuels and ecological footprints, and promotes SDGs 9 and 13 [44]. The evidence demonstrates that while there is a wide variety of plant-, microbial and algae-based sustainable materials in development, further research and development are required to generate sustainable alternatives for pharmaceutical packaging [84,87].
The first step in the production of bioplastics for the use of pharmaceutical packaging is the sourcing and extraction of biopolymers from natural sources, which can pose as the first challenge for pharmaceutical industries and lead to unintended consequences such as habitat loss, biodiversity impacts, pollution or increases in greenhouse gas emissions, impacting SDG 12. Algal-based biopolymers that can be cultivated on non-terrestrial lands may hold an advantage over plant-based biopolymers, which may contribute to deforestation, if not extracted from renewable sources [88]. However, standard hydrocolloid extraction techniques for algae-based biopolymers such as alginate and carrageenan require high amounts of energy, water and chemical solvents [36]. This jeopardises the overall sustainability as well as increasing the cost of algae-based biopolymers compared to synthetic plastics. Emerging regulatory guidance on life cycle assessments (LCAs) and ISO-compliant environmental impact reporting could incentivise the adoption of greener extraction technologies, such as microwave-assisted, ultrasound-assisted, and supercritical fluid extraction, to improve sustainability [19]. However, Khalil et al. reported innovative ‘green’ extraction techniques, including microwave-assisted extraction, ultrasound-assisted extraction, and supercritical fluid extraction, among others, which aim to reduce chemical solvent use and improve sustainability [22].
Secondly, pharmaceutical companies may find it challenging to source novel biopolymers for pharmaceutical packaging compared to traditional plastics, wherein packaging manufacturers may have extensive manufacturing experience. One manufacturing challenge they may face is that cellulose-based films can often undergo excessive shrinkage during their formation, reducing effectiveness [45]. Zamruddin et al. exhibited how various techniques, such as the addition of plasticisers or cationic surfactants, can modify film surface tension and reduce shrinkage during production [51]. Regulatory alignment with EMA and FDA packaging guidelines, including mechanical stability, barrier properties and GMP compliance, is essential when scaling these innovations. The cost and scalability of the manufacture of innovative biopolymers to meet the ever-increasing demands of pharmaceuticals is also a concern for the pharmaceutical industry [33]. Further research into the improvement of biopolymer production is recommended.
The barrier, thermal, optical, mechanical and chemical resistance properties of biodegradable or compostable materials are often unsuitable compared to the petroleum-based plastics currently used in pharmaceutical packaging [48]. These characteristics are essential to the protection of medication safety, quality and efficacy. Compliance with ISO 15378:2017 and EU GMP Annex 13 for primary packaging materials should be considered during material development. As many of the sustainable materials identified in this review are only in early-stage development, further validation based on regulatory guidance will be necessary for the future introduction of these materials. Public–private partnerships and multi-stakeholder consortia, including regulators, may help develop regulatory frameworks specific to sustainable pharmaceutical materials.
The high cost of the transition towards bioplastics may also hinder the implementation of sustainable pharmaceutical packaging materials. Financing research, costly trial and error periods and the industrial switch to bioplastic production will be expensive [39]. The raw materials required to produce biopolymers are also often more expensive than conventional plastics, representing a further economic barrier to their use in the pharmaceutical industry, but global incentives, grants and tax credits under climate action and green innovation policies may accelerate adoption. Furthermore, upcoming EU and WHO guidance on sustainable pharmaceutical packaging may provide regulatory incentives or recognition for the use of validated biopolymers.
Current use of biodegradable or compostable packaging materials by the pharmaceutical industry was not identified in this review. The Association of the British Pharmaceutical Industry (ABPI) confirm that as of now, there are no operational, sustainable, or biodegradable alternatives for primary medicine packaging, confirming the significant gap in the implementation of sustainable packaging materials across the pharmaceutical sector [89]. Therefore, future progress will necessitate intense R and D efforts to afford sustainable packaging material which fulfils regulatory expectations while reducing environmental impacts. Future research should integrate regulatory compliance, environmental impact, and patient safety in design, while including stakeholder feedback from healthcare professionals and patients.

4.2. Design Innovations

Design can play an important role in packaging sustainability [90]. The pharmaceutical blister packaging market value is expected to reach US$149.3 billion by 2026, driven by its advantageous properties, including enhanced environmental protection, tamper-evident features, and support for patient adherence [80]. Blister packaging can generate a significant amount of waste, with estimates that up to 8533 tonnes of blister waste is generated annually in Germany alone [59]. The volume and weight reduction strategies identified in this review demonstrate that small changes to the design of pharmaceutical packaging hold the potential to contribute to sustainable packaging. Design innovations should incorporate LCA principles, regulatory compliance with EMA/FDA, and One Health considerations to avoid unintended consequences.
However, the implementation of eco-design changes can present challenges. As pharmaceutical packaging is required to protect the product during transport and from environmental factors such as light, temperature, oxidation and moisture, there are concerns that the reduction in thickness of blister components such as the sealing film could compromise protection, potentially diminishing the product’s stability and shelf-life. Evidence shows that reducing aluminium from 25 µm to 20 µm does not affect barrier properties while saving 20% raw materials [91]. As the labelling requirements for immediate packaging of pharmaceutical products laid down in Article 55 of Directive 2001/83/EC are not extensive, the reduction in space between tablets in the blister should not pose a major challenge, and also reduce the raw materials required [92].
Nonetheless, from a patient perspective, smaller blisters suggested in the evidence may make it difficult for patients with dexterity issues to use their medications. Additionally, smaller tertiary packaging may also present challenges, such as difficulty interpreting the braille on the packaging exterior. Patient safety and accessibility must be evaluated in regulatory submissions, maintaining or improving the risk/benefit balance. Future research into patient impacts of structurally optimised pharmaceutical packaging is recommended.
Depending on the country, modification of packaging design requires regulatory approval to ensure the continued compliance of the packaging with quality, safety and efficacy standards. This lengthy process may deter pharmaceutical companies from pursuing eco-design changes, as it could result in medicine shortages or delayed product availability.
Although there is clear value in LCA tools in designing sustainable pharmaceutical packaging, challenges need to be overcome to make LCA more accessible for pharmaceutical companies. For instance, it is estimated that performing a comprehensive LCA can cost between US$50,000 and US$100,000, representing a major financial burden, especially for small-sized pharmaceutical companies [93]. Currently, there are no incentives or rewards, either monetary or non-monetary, for conducting LCAs as part of a marketing authorisation application (MAA) to the European Medicines Agency (EMA). In fact, the only environmental component that has to be included in the MAA is the Environmental Risk Assessment (ERA), which focuses solely on the active pharmaceutical ingredient (API) and excludes any details on pharmaceutical packaging [94]. If the EMA and other such regulatory agencies regulated that pharmaceutical sustainability, including packaging, must be included in the MAA, or provided incentives or rewards such as tax breaks for pharmaceutical industries to perform LCAs, their adoption may become more widespread.
In their study of blister packaging sustainability, Pedrosa de Oliveira et al. highlighted the significant lack of published LCAs specific to pharmaceutical packaging [28]. The limited availability of data poses another barrier to the adoption of LCAs, as it introduces uncertainties in calculation and modelling structuring [66]. The establishment of accessible and centralised databases for published LCAs by pharmaceutical industries and researchers is recommended. This would help to promote data accessibility, LCA methodology strategies, and increase the development of more sustainable pharmaceutical packaging solutions.

4.3. Smart Technology Innovations

Amongst the range of innovations discussed in this review, the e-PIL appears to be the eco-packaging innovation closest to widespread implementation, evident from its current use in certain countries such as Brazil and Japan, as well as ongoing trials in the EU [63,78].
For global realisation of the advantages of the e-PIL, such as reduced costs and carbon emissions, the associated challenges, such as accessibility, digital illiteracy, and regulatory barriers, must be addressed first [95]. Europe is committed to the digital transition, with the e-PIL pilot project having been completed in 2024 [96]. However, under Articles 58–59 of Directive 2001/83/EC of the EU, to obtain an (MA), all medicinal products are required to contain a physical PIL [92]. This limits the implementation of the e-PIL innovation in Europe, as deviating from MA practices can lead to major administrative and financial penalties for the pharmaceutical industry. By contrast, in Japan, an amendment to the Pharmaceutical and Medical Devices Act introduced the elimination of physical PILs in August 2021. Japan’s successful e-PIL implementation may serve as a model for other regulatory agencies such as the EMA. Moreover, as per Regulation (EU) 2025/40 on Packaging and Packaging Waste, QR codes on reusable packaging will be mandatory in order to provide instructions on reusability and recyclability by January 2028 [16]. Additionally, packaging must be scaled down to its minimum size with no more than 40% of the total volume being empty space, which presents a challenge for the labelling requirements of outer pharmaceutical packaging, which must comply with Article 54 of Directive 2001/83/EC. QR codes provide a logical solution for not only physical PIL wastage, but also for incoming sustainability regulations.
Nevertheless, there are barriers to QR code and e-PIL adoption. The paper-based leaflet currently performs a protective function in some packaging medicines, such as glass vials, during transportation, so the pharmaceutical industry will be required to reconfigure packaging processes [95]. However, this may present an opportunity for the pharmaceutical industry to implement other sustainable design-related improvements, such as volume/weight reduction, concurrently. Moreover, in a survey conducted by Camilleri et al., it was revealed that consumers prefer graphical elements displayed on physical packaging rather than QR codes [63]. Therefore, patient education campaigns may be beneficial to promote the use of and patient acceptance of QR codes and e-PILs. Another barrier to QR code and e-PIL adoption is a lack of internet access. One practical solution to this could be to offer printed PIL copies to patients upon request, provided by pharmacists or other healthcare professionals. Alternatively, while these challenges are being investigated, more sustainable paper-based approaches could include standardising PIL weight, using QR codes to reduce the size of the PIL or including clear packaging disposal instructions to reduce environmental impact, which may represent a temporary compromise to improve sustainability while balancing concerns around discontinuation of traditional paper PILs.
Despite these challenges, the introduction of e-PIL represents a significant step toward more sustainable pharmaceutical packaging and sets the stage for future collaboration between stakeholders such as the pharmaceutical industry and regulatory authorities.

4.4. Waste Management Innovations

The review indicates that novel methods to increase the recyclability of pharmaceutical blisters through the separation of aluminium and plastic components should be further explored to reduce associated waste. Separation of these components and subsequent recycling contributes to a circular economy, the zero-waste strategy, and also SDG 12. Considering that approximately 85% of solid pharmaceuticals in Europe are packed in blisters, addressing the recyclability of this packaging format is critical to reducing pharmaceutical packaging waste on a large scale [97]. Furthermore, the research into effective recycling strategies should also be complemented by further investigation into the fate of active pharmaceutical ingredient (API) residues in plastic recycling processes to ensure that no harmful contaminants remain in recycled blister material [97]. This could be addressed by using validated cleaning procedures and analytical test methods currently used for pharmaceutical manufacturing equipment, where swabs are taken from the equipment surface and tested for likely contaminants.
However, the scale-up of these innovative lab-based processes to a commercial scale may present both technical and economic challenges. For example, Nieminen et al. highlight difficulties related to solvent recovery and the management of dissolved aluminium, which may hinder the feasibility of widespread application [82]. Considering this, the transition to mono-material blisters that do not require such complex recycling processes may represent an alternative solution. However, novel monolayer blister packaging designs, while potentially more recyclable, may result in a lower lifespan of the blister, and consequently, the medicinal product [28]. This could lead to increased rates of drug and packaging production, thereby reducing overall sustainability. Future research to optimise the functional properties of monolayer blister, while balancing increased blister material thickness and overall product weight with recyclability to extend their lifespan, is recommended.
Furthermore, both petroleum-based plastics and aluminium are derived from non-renewable resources, highlighting that although increasing the recyclability of pharmaceutical blisters might represent a valuable short-term improvement, bioplastics for pharmaceutical blister packaging may replace traditional plastic-aluminium blister packaging in the long term.
This review did not find any waste management innovations relating to the disposal of biodegradable/compostable pharmaceutical packaging materials. To prepare for the anticipated transition to sustainable packaging materials, new waste management methods will be required to effectively separate bioplastics from common plastics to prevent cross-contamination in current recycling processes [28]. Globally, alternative recycling infrastructure is required to ensure that bioplastic packaging can be segregated from conventional plastic for disposal in the form of biodegradation and/or compost [48]. Avoidance of landfill and incineration sites, which can result in the release of high volumes of harmful gases such as methane into the atmosphere, contributing to global warming [49] also presents a challenge. This can potentially be overcome by introducing the correct segregation of waste and biodegradation and/or compost strategies in the community, such as packaging disposal, biodegradable or not, at specific collection points as part of a take-back scheme [65].
Take back schemes are promoted in the EPR as outlined in Directive (EU) 2018/851, and although it has been adopted at the EU level, its application to the pharmaceutical industries remains limited in many member states [17]. For example, in Ireland, there is no take-back scheme in place for waste pharmaceutical blister packaging. Changes in legislation to extend producer responsibility to the pharmaceutical sector across all member states are necessary to support the advancement and adoption of sustainable separation techniques and effective recycling of both traditional and novel biodegradable pharmaceutical blister packaging. Further research into the scale-up and implementation of these methods is recommended.

4.5. Responsible Packaging Framework

The 2020 European Federation of Pharmaceutical Industries and Associations (EFPIA) White Paper on Climate Change highlights a diverse range of climate action initiatives being taken by global pharmaceutical companies across Europe, but there is little mention of sustainable pharmaceutical packaging, despite the evidence of important innovations in this area [98]. This highlights the need for a clear, structured framework for pharmaceutical companies to follow in adopting sustainable pharmaceutical packaging practices.
Applying a responsible innovation framework for sustainable pharmaceutical packaging represents a potential solution to the challenges hindering its application and can help to promote industry uptake. Responsible Innovation is defined as “taking care of the future through collective stewardship of science and innovation in the present” [10]. A responsible innovation approach can help the pharmaceutical industry ensure that sustainable pharmaceutical packaging innovations adopted have a positive impact on society and the environment.
The four key elements of responsible innovation include anticipatory governance, inclusivity, reflexivity and responsiveness [99]. Anticipation involves the prediction of the potential environmental, economic and regulatory impacts of sustainable pharmaceutical packaging innovations by packaging manufacturers and pharmaceutical companies; for example, the use of an LCA tool to foresee the environmental risks of an innovation. Inclusivity aims to involve the relevant stakeholders, such as patients, healthcare professionals, pharmaceutical companies and regulatory authorities, as well as global sustainability frameworks such as One Health, in the innovation process to understand their perspectives and overcome challenges they help to identify. Reflexivity is where the pharmaceutical company critically reflects on the packaging innovation, for example, whether it aligns with the company’s sustainability goals, the regulatory and safety challenges. Responsiveness ensures the pharmaceutical industry can adapt the sustainable packaging innovations in response to feedback from key stakeholders, for example, adopting a change in an innovation due to early stakeholder feedback, such as a regulatory requirement. Aligning with the Naughton et al. framework, the responsible impact element could be the LCA coupled with a well-designed impact assessment to understand the responsible impact of the innovation across different levels and dimensions.
The ENKORE project offers another promising example of inclusivity work in this regard, aiming to meet this gap in policy through the development of a framework incorporating innovative materials, eco-design principles and digital product passports to support the development and delivery of sustainable pharmaceutical packaging [100]. Importantly, ENKORE is also focused on cross-sector collaboration, a key element of responsible innovation, to overcome the barriers to the implementation of sustainable pharmaceutical packaging. Going one step further, this responsible packaging innovation framework outlined below (Figure 4) could supplement the emerging sustainability by design framework (SbD)to guide sustainability through packaging [101].

4.6. Strengths, Limitations and Future Research

The inclusion of both peer-reviewed and grey literature studies is a notable strength of this review, as it allowed for a broad range of innovations to be explored and helped to identify gaps in the literature. Moreover, it is understood that this is the first review of its kind to map a range of innovations in sustainable pharmaceutical packaging and to investigate challenges associated with their implementation. Additionally, to the best of the authors’ knowledge, this is the first research paper which proposes a preliminary implementation framework for sustainable pharmaceutical packaging. However, the large volume of evidence identified, particularly from the grey literature sources, made it difficult to complete a detailed extraction and analysis of all included studies. Furthermore, relevant studies may have been omitted from the review due to the exclusion of studies in non-English languages, as well as the lack of a citation screening of the grey literature sources due to time constraints. Considering the interdisciplinary nature of sustainable pharmaceutical packaging, we recommend that future collaboration between material science, pharmacology and environmental policy stakeholders takes place to further develop solutions to increase adoption of innovations which may affect multiple industries [102]. As there is also little published literature with quantitative measurable impacts of sustainable pharmaceutical packaging, it is suggested that future research in this area be conducted to generate multi-stakeholder feedback and data that can support informed decision-making and guide the development of effective sustainability strategies.

4.7. Comparative Analysis

The four categories of sustainable pharmaceutical packaging innovations identified in this review: sustainable materials, design, smart technology and waste management, differ in maturity, feasibility and stakeholder relevance. Overall, sustainable material innovations offer the greatest long-term sustainability potential but face challenges relating to barrier performance, regulatory authorisation, and scalability. On the other hand, design innovations that reduce packaging volume or weight, and the use of life-cycle assessment tools, represent an immediately implementable approach which are particularly valuable as they may enable environmental improvements without altering medicinal product quality, safety or efficacy. Smart technology innovations, encapsulating e-PILs and the use of computer-based tools for eco-design, offer notable reductions in paper use and improved patient-friendliness. With regulatory reform, the EU could also achieve these benefits, as demonstrated in other regions where these innovations are already implemented. Finally, waste management innovations, particularly those enabling the separation and recycling of multi-material blister packaging, provide a transitional approach while material alternatives continue to develop. In conclusion, design and smart technology innovations offer more immediate opportunities to improve sustainability, whereas sustainable materials and waste management innovations are likely to have a greater contribution in the medium to long-term, due to their more complex challenges and barriers.

5. Conclusions

This review identified a range of emerging sustainable pharmaceutical packaging innovations during the last 25 years, encompassing four main themes: material innovation, design innovation, smart technology innovation and waste management innovation. These advancements support the pharmaceutical industry in meeting the multiple sustainability targets and goals set by numerous non-governmental organisations (NGOs) and governments across the globe. However, several barriers hindering the adoption of sustainable packaging innovations exist. Challenges include meeting required regulatory specifications (e.g., EMA, FDA, ISO 15378:2017), maintaining physical attributes necessary for equivalent protection to current packaging, high costs, patient acceptability, and limited industry experience. There is a challenge to meet the required regulatory specifications and physical attributes necessary to provide an equal level of protection that current packaging solutions can offer. In addition, there are high costs, patient acceptability, and a lack of industry experience, to name but a few. Additionally, the absence of a framework for the implementation of sustainable packaging innovations in the pharmaceutical industry was identified as a gap in the literature reviewed. To address this gap, this study proposes a responsible implementation framework which considers regulatory compliance, life cycle assessment, and stakeholder engagement, to help guide sustainable packaging innovation management In the future, the establishment of centralised information databases, further optimisation of existing sustainable packaging, increased patient education, potential regulatory changes, and publication of additional implementation frameworks, will accelerate adoption, improve environmental outcomes, and ensure regulatory alignment for sustainable pharmaceutical packaging innovations globally.

Supplementary Materials

The following supporting information can be downloaded at: https://www.mdpi.com/article/10.3390/su172310716/s1, Table S1: Study inclusion and exclusion criteria; Table S2: Detailed 3 step search strategy; Table S3: Concepts and Keywords; Table S4: Search strategy for CINAHL, Embase and Pubmed; Table S5: Data extraction form. Table S6: List of references included in research paper.

Author Contributions

Conceptualisation, B.D.N., P.M.G., S.J., R.P., A.T., L.B., C.B. and A.M.B.; methodology, B.D.N., P.M.G., S.J., R.P., A.T., C.B. and L.B.; investigation, P.M.G., S.J., R.P., A.T. and L.B.; data curation, P.M.G., S.J., R.P., A.T. and L.B.; writing—original draft preparation, S.J., P.M.G. and B.D.N.; writing—review and editing, S.J., P.M.G., R.P., A.T., L.B., C.B., A.M.B. and B.D.N.; supervision, B.D.N.; project administration, S.J. and P.M.G. All authors have read and agreed to the published version of the manuscript.

Funding

This research received no external funding.

Institutional Review Board Statement

Not applicable.

Informed Consent Statement

Not applicable.

Data Availability Statement

Data are contained within the article/Supplementary Materials.

Acknowledgments

The authors would like to thank Andrew Jones, Subject Librarian for the School of Pharmacy and Pharmaceutical Sciences Trinity College Dublin, for his guidance in developing the search strategy.

Conflicts of Interest

The authors declare no conflicts of interest.

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Figure 1. The PRISMA flow chart for articles identified in this review.
Figure 1. The PRISMA flow chart for articles identified in this review.
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Figure 2. Number of included studies per year. * 2025 does not contain a full years data.
Figure 2. Number of included studies per year. * 2025 does not contain a full years data.
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Figure 3. The themes and subthemes of global innovations in sustainable pharmaceutical packaging.
Figure 3. The themes and subthemes of global innovations in sustainable pharmaceutical packaging.
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Figure 4. Responsible Packaging Innovation Framework.
Figure 4. Responsible Packaging Innovation Framework.
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Table 1. Challenges and Implications for Sustainable Pharmaceutical Packaging.
Table 1. Challenges and Implications for Sustainable Pharmaceutical Packaging.
Regulatory Challenges:Implications:Solutions:
Current guidelines for the authorisation of medicinal products, such as Directive 2001/83/EC, are outdated regarding sustainability.Lack of clear guidance or incorporation of sustainable packaging alternatives for the pharmaceutical industry.Revision of Directive 2001/83/EC to incorporate environmental performance criteria in packaging approval.
Regulatory frameworks for the incorporation of biopolymers are lacking.Deters pharmaceutical industries from developing sustainable biopolymers for use in pharmaceutical packaging.Creation of harmonised guidelines for biopolymer-based packaging through collaboration between researchers, regulators and industry.
Regulatory gaps exist in the definition of compostability and biocompostability for pharmaceutical packaging.Hinders the development of innovative compost facilities to cater for sustainable pharmaceutical packaging.Establishment of an EU-wide definition of compostability and biocompostability, and investment into industrial composting infrastructure.
Regulations surrounding printing PILs hinder the transition to e-PILs and QR code-based systems.A product will not achieve EMA (MA)without the product containing a printed PIL.Amendment to the EU Regulations to implement QR codes and e-PILs on pharmaceutical packaging.
There is a lack of standardised medication take-back programmes throughout Europe.Due to the difficult recycling techniques required for pharmaceutical blisters, without take-back programmes, pharmaceutical blisters are most likely incinerated or landfilled.Implementation of EU-coordinated take-back schemes funded through EPR contributions from pharmaceutical companies.
Safety Challenges:Implications:Solutions:
Packaging materials must ensure the quality, safety and efficacy of medicinal products throughout their shelf-life.Sustainable innovations cannot compromise their protective function.Development of multi-layer sustainable packaging systems that maintain barrier protection and reduce plastic content, while accelerating real-time stability testing for new sustainable materials.
Biopolymers often underperform when compared to traditionally used plastics in terms of mechanical strength, thermal resistance and barrier properties.There is an increased risk of microbial contamination and a reduction in the shelf-life of pharmaceuticals, which is undesirable.Continued research and development into next-generation biopolymers, which improved mechanical and thermal resistance.
The lifespan of sustainable monolayer blisters is less than that of traditional multi-layer blisters.This may question the overall sustainability of monolayer blisters.Improvement of moisture-resistant and oxygen-barrier coatings specifically designed for monolayer blister films.
Digital innovations such as the e-PIL may exclude elderly users, partially sighted or the blind or those in areas with limited internet access.This limits the effectiveness of e-PILs if patients cannot access critical product information.Implementation of dual access information systems, where a patient can obtain a printed PIL upon request.
Economic Challenges:Implications:Solutions:
High production and infrastructure costs are associated with sustainable materials and advanced processing techniquesPharmaceutical companies are less likely to adopt more sustainable approaches if it comes with high costs, in the absence of regulation.Government subsidies and tax incentives to reduce initial costs.
Recycling of mixed material packaging can result in complex and costly separation procedures.High costs deter the widespread adoption of recycling of pharmaceutical blisters.Implementation of Extended Producer Responsibility schemes to support the cost of collection and recycling.
Transitioning to biodegradable packaging requires substantial initial investments.High investments also require long-term cost reduction, impacting other areas of the pharmaceutical industry.Adoption of a phased transition strategy, allowing gradual integration of biodegradable packaging alongside conventional materials.
Other Challenges:Implications:Solutions:
Lack of public awareness and stakeholder cooperation.This hinders sustainable packaging implementation and waste management solutions.Public education led by health authorities and pharmacies to increase awareness of sustainable packaging and proper disposal.
Poor waste systems and limited take-back programmes.Eliminates a circular economy for pharmaceutical packaging.Establishment and accessibility of take-back programme points in pharmacies, clinics, and health centres.
Lack of infrastructure for sustainable alternatives and limited suppliers.Results in slow change and long lead times.Government and EU funding grants to accelerate the scaling of green manufacturing technologies.
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MDPI and ACS Style

Jackman, S.; Mc Guinness, P.; Brennan, L.; Pereira, R.; Tyrrell, A.; Barry, A.M.; Brennan, C.; Naughton, B.D. Global Innovations in Sustainable Pharmaceutical Packaging in the Last 25 Years: A Scoping Review. Sustainability 2025, 17, 10716. https://doi.org/10.3390/su172310716

AMA Style

Jackman S, Mc Guinness P, Brennan L, Pereira R, Tyrrell A, Barry AM, Brennan C, Naughton BD. Global Innovations in Sustainable Pharmaceutical Packaging in the Last 25 Years: A Scoping Review. Sustainability. 2025; 17(23):10716. https://doi.org/10.3390/su172310716

Chicago/Turabian Style

Jackman, Sophie, Peter Mc Guinness, Lia Brennan, Ruby Pereira, Anne Tyrrell, Anna Maria Barry, Cait Brennan, and Bernard D. Naughton. 2025. "Global Innovations in Sustainable Pharmaceutical Packaging in the Last 25 Years: A Scoping Review" Sustainability 17, no. 23: 10716. https://doi.org/10.3390/su172310716

APA Style

Jackman, S., Mc Guinness, P., Brennan, L., Pereira, R., Tyrrell, A., Barry, A. M., Brennan, C., & Naughton, B. D. (2025). Global Innovations in Sustainable Pharmaceutical Packaging in the Last 25 Years: A Scoping Review. Sustainability, 17(23), 10716. https://doi.org/10.3390/su172310716

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