Compostable multi-layer primary packaging for wrapping individual solid dosage units of a medicinal product

Abstract

The present invention relates to a compostable multi-layer primary packaging suitable for wrapping individual solid dosage units of a medicinal product, comprising: 5 a multi-layer primary packaging film or laminate comprising a biodegradable and compostable polymer, the multi-layer film or laminate being configured to be processed in a film wrapping machine to encase an individual solid dosage unit of a medicinal product; 10 the multi-layer primary packaging film or laminate having sufficient mechanical strength, flexibility, and sealability to maintain an airtight and moisture-resistant barrier around the solid dosage unit after a film wrapping process; the multi-layer primary packaging film or laminate being characterized by its 15 ability to fully decompose into non-toxic organic components within an industrial composting environment within a typical composting cycle of 90 days, and / or within a home composting environment, depending on the material composition.

Description

[0001] COMPOSTABLE MULTI-LAYER PRIMARY PACKAGING FOR WRAPPING INDIVIDUAL SOLID DOSAGE UNITS OF A MEDICINAL PRODUCT

[0002] Technical field

[0003] The present invention relates to the field of medicinal product packaging, specifically to compostable primary packaging materials designed for the wrapping of individual solid dosage units of medicinal products.

[0004] Background

[0005] In the pharmaceutical industry, solid dosage unit packaging plays a critical role in ensuring the accurate delivery of medication, maintaining drug stability, and improving patient compliance. Solid dosage unit packaging is important for, for example:

[0006] - Maintaining drug stability so lifesaving levels of active component are bioavailable to the patient at the moment of taking the drug so the patient can realise the full potency of the drug and consequently the full clinical effects in for example a disease area like stroke prevention.

[0007] - Maintaining the safety profile of the regulated drug to avoid for example increases or decreases in potency of the active ingredients that might be either toxic to the patient if the drug becomes unnecessarily exposed to UV, oxidaton, water, aroma, all of which can alter the chemical properties of the regulated medicinal dose form.

[0008] - The primary packaging also is important for hazard managing harm to vulnerable groups such as children and as such should require reasonable dexterity to unwrap. Conversely the packages should be easy enough to open for use by the elderly so as not to impede medicinal compliance and concordance.

[0009] A solid dosage unit of a medicinal product refers to a single, pre-measured quantity of medication intended for one administration or use. Examples of solid dosage units include, but are not limited to, tablets, capsules, pills, powders and granules, pessaries, and suppositories. Each solid dosage unit is typically packaged separately to maintain the stability of the drug and to provide convenience for both patients and healthcare providers.

[0010] Traditionally, such packaging has been made from non-biodegradable materials, including various plastics, such as PVC, and aluminium foils, which are effective at protecting medicinal products but contribute significantly to environmental pollution. The widespread use of these materials has led to growing concerns about their environmental impact, particularly due to their persistence in the environment and the challenges associated with their disposal. Recycling, when available, contributes to carbon emissions due to the energy-intensive nature of the process itself. Blister packs, commonly used for pharmaceutical products, are particularly challenging to recycle because of their multi-component design, combining plastic and aluminium, which complicates separation and reprocessing. The regulatory landscape for drug packaging is highly complex, with stringent requirements enforced by agencies such as the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK and the European Medicines Agency (EMA) in the EU. For example, the European Medicines Agency provides a “Guideline on Plastic Immediate Packaging Materials”, adopted by the committee for medicinal products for human use (CHMP) and the committee for medicinal products for veterinary use (CVMP), which concerns the application of Part 1 , Module 3, sections 3.2.1.6, 3.2.2.2 and 3.2.2.7 of Annex I to Directive 2003 / 63 / EC, amending Directive 2001 / 83 / EC for human medicinal products, and Part 2, sections A, C and G of Annex 1 to Directive 2001 / 82 / EC for veterinary medicinal products, respectively, to plastic immediate packaging materials. The guideline covers the specific requirements for plastic immediate packaging materials. The data to be provided for plastic packaging materials depend, e.g., on the physical state of the active substance and the pharmaceutical dosage form.

[0011] Current manufacturers face limited incentives to adopt alternative packaging solutions due to the high costs, potential profit loss, and the need for extensive and costly trials to meet regulatory standards. The packaging of each individual drug requires costly and extensive research for every regulatory submission of new medicines. If an existing medicine undergoes a packaging change, it must be resubmitted to the regulatory authorities along with updated packaging data in order to be granted a new marketing authorisation for the revised packaging format.

[0012] With increasing global awareness of environmental sustainability, there is a pressing need for alternative packaging solutions that can reduce the ecological footprint of medicinal products. Compostable packaging materials have emerged as a promising solution, offering the potential to break down naturally into nontoxic organic components after use, thus mitigating the long-term environmental impact associated with traditional packaging materials.

[0013] However, developing compostable packaging for medicinal products presents unique challenges. The packaging must provide sufficient mechanical strength, flexibility, and sealability to protect the medicinal product from environmental factors such as moisture, oxygen, and light. Additionally, it must ensure the stability and efficacy of the medicinal product throughout its shelf life, which is usually 3 years. Furthermore, the packaging material should preferably be capable of being processed using conventional packaging machinery, and must comply with stringent compostability standards, such as those outlined in European Standard EN 13432, American Standard ASTM D6400, and International Standard ISO 17088, and / or the criteria set forth in TUV Austria’s OK Compost HOME certification.

[0014] Description of the invention

[0015] An object of the present disclosure is to provide a compostable primary packaging suitable for wrapping individual solid dosage units of a medicinal product, which can replace traditional primary packaging, such as blister packs, strip packs, sachets and pouches, made from non-biodegradable materials.

[0016] The medicinal product to be packaged using the compostable multi-layer primary packaging described herein is preferably a regulated medicinal product. Regulated medicinal products are subject to formal approval and oversight by competent drug regulatory authorities, such as the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), or equivalent national bodies. These products require comprehensive documentation, including validated packaging- related data, to ensure safety, efficacy, and stability throughout their shelf life. Packaging configurations for regulated medicinal products are typically specified in the approved product documentation and must be supported by validated data, including stability studies, barrier performance, and compatibility assessments. The use of compostable packaging for such products offers a sustainable alternative while maintaining compliance with stringent pharmaceutical standards.

[0017] Another object of the present disclosure is to provide a compostable primary packaging suitable for wrapping individual solid dosage units of a medicinal product, which is tamper proof.

[0018] The present disclosure addresses these objects by providing a multi-layer primary packaging film or laminate specifically designed for wrapping individual solid dosage units of medicinal products. The multi-layer film or laminate is preferably configured to be processed in a flow wrapping machine. The multi-layer primary packaging film or laminate comprises a biodegradable and compostable polymer, for example polylactic acid (PLA), polybutylene succinate (PBS), polyhydroxyalkanoates (PHA), polycaprolactone (PCL), thermoplastic starch (TPS), cellulose-based polymers, chitosan, alginates, or combinations thereof. These materials are engineered to offer the necessary barrier properties and mechanical strength to protect the medicinal product while being fully compostable under industrial composting conditions within a typical cycle of 90 days.

[0019] In the context of regulated medicinal products, the selection of primary packaging materials is subject to elevated regulatory scrutiny due to the critical role packaging plays in maintaining the safety, efficacy, and stability of the pharmaceutical dosage form throughout its shelf life. Unlike packaging for food products or nutraceuticals, which may tolerate minor deviations in quality, the packaging of regulated medicinal products must meet stringent standards to prevent adverse outcomes, including therapeutic failure or patient harm.

[0020] For example, a solid dosage unit formulated to reduce the risk of thromboembolic events may exhibit a significant therapeutic benefit. However, if the packaging fails to maintain the integrity of the dosage unit, due to inadequate barrier properties or chemical incompatibility, the medicinal product may degrade, resulting in diminished efficacy or safety. Accordingly, packaging materials for medicinal products should be selected and engineered with consideration of the specific physicochemical characteristics of the active pharmaceutical ingredient (API) and the formulation.

[0021] When designing primary packaging for solid dosage units of medicinal products, particularly those intended to be wrapped individually, it is essential to evaluate the potential for content / container interactions and ensure that the packaging material provides adequate protection against environmental factors. The following categories of reactivity are typically considered during packaging material selection and design:

[0022] Chemical Reactivity: The potential for chemical interaction between the API and the packaging material, which may be influenced by pH, temperature, and light exposure. Such interactions may result in degradation, transformation, or reduced potency of the medicinal product.

[0023] Physical Stability: Certain APIs may undergo polymorphic transitions or other physical changes that affect solubility and bioavailability. Packaging should preserve the physical form of the dosage unit throughout its shelf life.

[0024] Moisture Sensitivity: Hygroscopic APIs may absorb ambient moisture, leading to hydrolysis or potency loss. Packaging should provide an effective moisture barrier.

[0025] Light Sensitivity: Photolabile APIs may degrade upon exposure to light, particularly ultraviolet radiation. Packaging materials should incorporate light-blocking features, such as opaque or tinted films.

[0026] Temperature Sensitivity: Some medicinal products require controlled temperature conditions to maintain stability. Packaging may include insulative or thermally regulated components to ensure compliance with storage requirements. Oxidation Sensitivity: APIs susceptible to oxidation should be protected from atmospheric oxygen. Packaging solutions may include oxygen-impermeable barriers or inert gas flushing.

[0027] Interactions with Excipients and Additives: Excipients present in the formulation may interact with packaging materials, potentially affecting drug stability. These interactions should be assessed during packaging design and regulatory submission.

[0028] Leachables and Extractables: Packaging materials may release substances that migrate into the medicinal product. Comprehensive testing for leachables and extractables is required to ensure patient safety and regulatory compliance.

[0029] The compostable multi-layer primary packaging described in the present disclosure is particularly suitable for solid dosage units, where the risk of content / container interaction is generally lower than that of liquid and gel medicinal doses. Nevertheless, the packaging materials are selected and engineered to provide sufficient barrier properties and mechanical integrity to ensure the medicinal product remains stable and effective throughout its intended shelf life. The invention thereby addresses both environmental sustainability and pharmaceutical quality requirements, offering a viable alternative to conventional non-biodegradable packaging materials.

[0030] In accordance with established regulatory frameworks, including the European Medicines Agency (EMA) “Guideline on Plastic Immediate Packaging Materials,” packaging intended for direct contact with medicinal products must undergo a series of rigorous evaluations prior to submission for marketing authorisation. These evaluations are designed to ensure that the packaging maintains the safety, efficacy, and quality of the medicinal product throughout its shelf life and under anticipated storage and handling conditions. Furthermore, any change in packaging for an existing medication must go through a marketing authorisation re-evaluation (180 day process) including the formal packing research data with the specific drug. This process is necessary to legally recognise and utilise a new packaging material for any regulated drug. When preparing packaging materials for use with medicinal products, particularly solid dosage units, the following categories of testing are typically required:

[0031] Stability Testing: Stability studies are conducted to assess the ability of the packaging to preserve the medicinal product under defined environmental conditions over time, typically up to 36 months. These studies evaluate the impact of temperature, humidity, and light exposure on the integrity of both the packaging and the medicinal product.

[0032] Compatibility Testing: Compatibility assessments are performed to determine whether any chemical or physical interactions occur between the packaging material and the medicinal product. Such interactions may compromise the product’s safety, efficacy, or stability and should be ruled out through validated testing protocols.

[0033] Barrier Property Evaluation: The packaging material should demonstrate adequate barrier performance against environmental factors such as moisture, oxygen, and light. These properties are important for maintaining the physical and chemical stability of the medicinal product.

[0034] Leachables and Extractables Studies: Analytical studies are conducted to identify and quantify any substances that may migrate from the packaging material into the medicinal product. These studies ensure that no harmful or reactive compounds are introduced into the formulation during storage.

[0035] Mechanical and Physical Integrity Testing: The packaging should exhibit sufficient mechanical strength and durability to withstand handling, transportation, and storage. Tests may include tensile strength, seal integrity, puncture resistance, and drop testing.

[0036] Tamper Evidence and Child Resistance Testing: Where applicable, the packaging should comply with regulatory requirements for tamper-evident features and child- resistant design. These features are essential for ensuring patient safety and preventing unauthorized access.

[0037] Human Factors and Usability Assessment: Packaging should be designed to facilitate safe and effective use by patients and healthcare professionals. Usability studies may be conducted to evaluate ease of opening, readability of instructions, and overall user interaction.

[0038] Labelling Compliance Review: The packaging should accommodate labeling that complies with applicable regulatory standards. This includes the legibility, accuracy, and completeness of information such as product name, strength, batch number, expiry date, and storage conditions.

[0039] These testing categories collectively support the regulatory submission process and ensure that the packaging material is suitable for its intended use with medicinal products. The compostable multi-layer primary packaging described in the present disclosure is designed to meet these requirements, thereby offering a sustainable alternative to conventional packaging materials without compromising pharmaceutical quality or regulatory compliance.

[0040] This innovative packaging solution offers a significant advancement in the field of medicinal product packaging, providing an environmentally friendly alternative to traditional materials without compromising the safety or effectiveness of the medicinal product. By using compostable materials that meet established standards for biodegradability and compostability, this invention contributes to the reduction of environmental pollution and supports the pharmaceutical industry's efforts to adopt more sustainable practices.

[0041] According to a first aspect illustrated herein, there is provided a compostable multilayer primary packaging suitable for wrapping individual solid dosage units of a medicinal product, comprising: a multi-layer primary packaging film or laminate comprising a biodegradable and compostable polymer, the multi-layer film or laminate being configured to be processed in a film wrapping machine to encase an individual solid dosage unit of a medicinal product; the multi-layer primary packaging film or laminate having sufficient mechanical strength, flexibility, and sealability to maintain an airtight and moisture-resistant barrier around the solid dosage unit after a film wrapping process; the multi-layer primary packaging film or laminate being characterized by its ability to fully decompose into non-toxic organic components within an industrial composting environment within a typical composting cycle of 90 days, and / or within a home composting environment, depending on the material composition.

[0042] Currently available compostable materials, when used individually as single layer packaging films, are unable to meet the comprehensive performance requirements established by pharmaceutical regulatory authorities for primary packaging of medicinal products. In particular, such materials do not provide sufficient protection to ensure the long-term stability of solid dosage units, nor do they meet the barrier and compatibility standards required to replace conventional materials such as polyvinyl chloride (PVC) used in blister packaging.

[0043] The limitations of single layer compostable materials are primarily attributable to their susceptibility to environmental degradation mechanisms, including photodegradation (UV exposure), oxidative aging, aroma permeation, and moisture uptake. These factors can compromise the mechanical integrity, barrier performance, and chemical inertness of the packaging over time, thereby rendering the material unsuitable for pharmaceutical applications where shelf life and product protection are critical.

[0044] To address these deficiencies, the present invention preferably provides a multilayer compostable packaging film or laminate (also referred to herein for example as multi-layer film or laminate, or simply film or laminate), wherein each layer is engineered to perform a distinct functional role in preserving the integrity of the medicinal product. In some embodiments, the multi-layer film or laminate comprises at least three layers, each layer contributing distinct functional properties selected from mechanical strength, barrier performance, and sealability.

[0045] The multi-layer film or laminate structure may for example comprise:

[0046] An inner layer designed for direct contact with the medicinal product, selected to minimize leachables and extractables and to ensure chemical compatibility with the formulation.

[0047] An intermediate layer providing mechanical strength, flexibility, and resistance to environmental stressors such as oxygen, moisture, and ultraviolet radiation.

[0048] An outer layer configured to enhance sealing performance and provide tamper- evident properties.

[0049] In some embodiments, the multi-layer film or laminate also comprises a biodegradable adhesive layer bonding the layers of the laminate.

[0050] The multi-layer configuration enables the packaging to meet the stringent requirements for pharmaceutical use, including barrier properties, stability over the product’s shelf life, and regulatory compliance with leachables and extractables testing. The inventive laminate thus offers a compostable alternative to PVC / aluminium blister packs, achieving comparable performance while supporting environmental sustainability.

[0051] The term primary packaging as used herein refers to the packaging intended to be in direct contact with the medicinal product. Primary packaging may also sometimes be referred to as “immediate packaging”. The primary packaging is designed to protect the solid dosage units from environmental factors such as moisture, oxygen, light, and physical damage while ensuring ease of use and patient compliance. Common primary packaging types used for wrapping individual solid dosage units such as tablets, capsules, pills, and similar forms, include blister packs, strip packs, sachets and pouches, and stick packs. The choice of packaging depends on the specific requirements of the dosage form, including stability, shelf life, and administration method.

[0052] The multi-layer primary packaging of the present disclosure is suitable for wrapping individual solid dosage units of a medicinal product. The term solid dosage unit is used herein as a common name to refer to various solid forms of medication that are intended to be taken individually, such as tablets, pills, capsules, and similar products.

[0053] Preferably, the multi-layer primary packaging of the present disclosure complies with existing regulatory frameworks for medicinal product packaging. Specifically, the multi-layer primary packaging of the present disclosure preferably complies with the European Medicines Agency “Guideline on Plastic Immediate Packaging Materials”, adopted by the committee for medicinal products for human use (CHMP) and the committee for medicinal products for veterinary use (CVMP) effective as of 1 December 2005. The data to be provided for plastic packaging materials depend, e.g., on the physical state of the active substance and the pharmaceutical dosage form.

[0054] Common types of solid dosage units of medicinal products include:

[0055] - Tablets, including compressed tablets, coated tablets, effervescent tablets, chewable tablets, buccal tablets, sublingual tablets, orally disintegrating tablets (ODTs), and extended-release tablets.

[0056] - Capsules, including hard gelatin capsules, soft gelatin capsules, modified- release capsules, and enteric-coated capsules.

[0057] - Pills, including traditional pills, which refer to small, round, solid dosage units made by rolling powdered ingredients with a binding agent.

[0058] - Lozenges and troches, including lozenges, which are solid dosage forms that dissolve slowly in the mouth to deliver medication locally or systemically, and troches, which are similar to lozenges but typically softer and designed for slow dissolution in the mouth.

[0059] - Powders and granules, including powders, which are finely divided solid dosage forms that can be taken directly or dissolved in water before consumption, and granules, which are agglomerated powders that can be swallowed whole, chewed, or dissolved in liquid.

[0060] - Pellets, including small, spherical solid dosage units often used in controlled- release formulations or for implantation.

[0061] - Suppositories, including rectal suppositories, which are solid dosage units designed for rectal administration where they dissolve or melt to deliver medication, and vaginal suppositories (pessaries), which are solid dosage units designed for vaginal administration used for local or systemic effects.

[0062] - Implants, including small, solid dosage units that are surgically placed under the skin to deliver medication over an extended period.

[0063] - Pastilles, including chewable, gummy-like solid dosage units similar to lozenges, designed for slow dissolution in the mouth.

[0064] - Caplets, including tablets shaped like capsules, designed to be easier to swallow than traditional round tablets.

[0065] In some embodiments, and for the avoidance of doubt, the “medicinal product” as used herein is a regulated medicinal product that is subject to regulatory approval and subsequent marketing authorisation by international, national, or regional drug regulatory authorities. Such medicinal products are required to submit specific packaging-related stability data as part of their regulatory submissions. This includes, but is not limited to, information concerning barrier properties and data demonstrating the potential for interaction or transfer between the packaging material and the medicinal product. The present invention is preferably used for medicinal products for which the packaging configuration is explicitly referenced in the documentation submitted for marketing authorisation, and where the packaging is listed in the approved drug information materials issued by the relevant regulatory authority.

[0066] Examples of such regulatory authorities and the corresponding documentation sections that reference packaging requirements include, but are not limited to:

[0067] European Union (EU) - European Medicines Agency (EMA), Summary of Product Characteristics (SmPC), Section 6.5: Nature and contents of container.

[0068] United States (US) - Food and Drug Administration (FDA), Prescribing Information (PI), Section 16: How Supplied I Storage and Handling.

[0069] Japan - Ministry of Health, Labour and Welfare (MHLW), Package Insert, Sections 4 and 5: Dosage & Administration; Storage & Handling.

[0070] China - National Medical Products Administration (NMPA), Instructions for Use I Package Insert, Section 7: Storage; Section 8: Packaging.

[0071] United Kingdom (UK) - Medicines and Healthcare products Regulatory Agency (MHRA), Summary of Product Characteristics (SmPC), Section 3.

[0072] Australia - Therapeutic Goods Administration (TGA), Product Information (PI), Sections 7 and 9: Dosage and Administration; Storage.

[0073] Canada - Health Canada (TPD), Therapeutic Product Monograph, Section 16: How Supplied.

[0074] The present invention may further be applicable to any equivalent national drug regulation body and equivalent registration document with medicinal packaging section number required for granting of a drug in other jurisdictions, including but not limited to Russia, Brazil, Argentina, India, Chile, Mexico, Colombia, Venezuela, countries of the African continent, New Zealand, Sri Lanka, Pakistan, Arab nations, Norway, Switzerland, Thailand, Singapore, Malaysia, South Korea, and Taiwan.

[0075] In some embodiments, the multi-layer primary packaging film or laminate is characterized by its ability to fully decompose into non-toxic organic components within an industrial composting environment within a typical composting cycle of 90 days, and / or within a home composting environment, depending on the material composition. The composting environment and cycle are based on standardized conditions, typically governed by international and national standards for compostable materials. These standards define specific criteria that materials must meet to be considered compostable under industrial or home composting conditions.

[0076] In some embodiments, the multi-layer primary packaging film or laminate is characterized by its ability to fully decompose into non-toxic organic components within an industrial composting environment within a typical composting cycle of 90 days.

[0077] Examples of such industrially compostable materials include:

[0078] Polylactic acid (PLA): A widely used biopolymer derived from renewable resources such as com starch or sugarcane. PLA degrades effectively at elevated temperatures but composts slowly under ambient conditions.

[0079] Polybutylene adipate terephthalate (PBAT): A flexible, biodegradable polyester that performs well in industrial composting.

[0080] Polycaprolactone (PCL): A synthetic aliphatic polyester with good biodegradability in industrial settings.

[0081] Polybutylene succinate (PBS): A biodegradable polymer that decomposes efficiently under industrial composting conditions, offering good mechanical and barrier properties.

[0082] Thermoplastic starch (TPS): A starch-based material that biodegrades rapidly in industrial composting environments but may require blending or plasticization to achieve suitable performance.

[0083] PLA-based co-extrusions and laminates: Multi-layer structures incorporating PLA and other compostable polymers may be optimized for industrial composting, even if individual layers are not compostable.

[0084] In some embodiments, the multi-layer primary packaging film or laminate is characterized by its ability to fully decompose into non-toxic organic components within an industrial composting environment within a typical composting cycle of 90 days, preferably in accordance with European Standard EN 13432, American Standard ASTM D6400, or International Standard ISO 17088.

[0085] EN 13432 specifies the requirements for packaging recoverable through composting and biodegradation. It includes criteria for biodegradability, disintegration, and eco-toxicity. According to EN 13432, compostable materials should degrade within 90 days under industrial composting conditions, which typically involve temperatures between 55 °C and 60 °C, along with controlled humidity and oxygen levels.

[0086] ASTM D6400 specifies the criteria for compostable plastics, requiring them to break down into carbon dioxide, water, inorganic compounds, and biomass at a rate consistent with other known compostable materials under aerobic composting conditions. Like EN 13432, ASTM D6400 requires that the material should degrade within 90 days under industrial composting conditions.

[0087] ISO 17088 provides the requirements and procedures for determining the compostability of plastics, similar to EN 13432 and ASTM D6400, emphasizing the decomposition of the material within a defined timeframe under specific composting conditions.

[0088] Industrial composting conditions typically involve a temperature between 55 °C and 60 °C, controlled humidity to optimize microbial activity, sufficient aeration or oxygen levels to support aerobic decomposition, and the material should fully disintegrate within 90 days, with the biodegradation process completing within six months, leaving no toxic residues.

[0089] In addition to being industrially compostable under standardized conditions, the multi-layer primary packaging film or laminate of the present disclosure may also be configured to be home compostable. Home compostability refers to the ability of the packaging material to biodegrade under ambient environmental conditions, such as those found in domestic composting systems, where temperatures generally range between 20 °C and 30 °C. In some embodiments, the multi-layer primary packaging film or laminate is characterized by its ability to fully decompose into non-toxic organic components within a home composting environment.

[0090] Home composting environments present more stringent biodegradation challenges due to lower microbial activity and reduced thermal acceleration. Accordingly, materials suitable for home compostable packaging must exhibit inherent biodegradability without reliance on elevated temperatures or industrial composting infrastructure.

[0091] To meet these requirements, the multi-layer primary packaging film or laminate may incorporate one or more of the following biodegradable and compostable polymers known for their performance in ambient composting conditions:

[0092] Polyhydroxyalkanoates (PHA): A family of microbial polyesters that degrade efficiently in soil, marine, and home compost environments.

[0093] Polybutylene succinate (PBS) and polybutylene adipate terephthalate (PBAT): Aliphatic polyesters with favorable biodegradation profiles under low-temperature conditions.

[0094] Starch-based and cellulose-based polymers: Naturally derived materials that readily disintegrate and mineralize in home compost settings.

[0095] Bio-resins such as alginate, agar, and carrageenan: Algae-derived polymers that offer rapid biodegradation and are suitable for use in compostable coatings and films.

[0096] In some embodiments, the multi-layer film or laminate comprises at least one layer composed of a home compostable polymer selected from polyhydroxyalkanoates (PHA), starch-based polymers, or cellulose-based polymers.

[0097] In some embodiments, the multi-layer primary packaging film or laminate is designed to meet the criteria set forth in TUV Austria’s OK Compost HOME certification, which defines the standards for biodegradation, disintegration, and eco-toxicity under home composting conditions. All layers and coatings of the multi-layer primary packaging film or laminate, including adhesives and surface treatments, are selected to ensure that the entire structure decomposes into nontoxic organic components without leaving persistent residues.

[0098] By incorporating materials with home compostability, the invention extends its environmental benefits beyond industrial composting infrastructure, enabling endusers to dispose of the packaging in domestic composting systems. This supports broader sustainability goals and aligns with emerging regulatory and consumer expectations for low-impact pharmaceutical packaging.

[0099] Thus, in some embodiments the multi-layer primary packaging film or laminate is industrially compostable, in some embodiments the multi-layer primary packaging film or laminate is home compostable, and in some embodiments, the multi-layer primary packaging film or laminate is industrially compostable and home compostable.

[0100] To ensure the long-term stability of medicinal products, the multi-layer primary packaging film or laminate should provide effective protection against environmental factors, particularly moisture and oxygen ingress. These barrier properties are essential for maintaining the chemical and physical integrity of solid dosage units throughout their shelf life.

[0101] Conventional pharmaceutical blister packaging, such as PVC / aluminium foil structures, typically exhibits near-zero moisture vapor transmission rate (MVTR) and oxygen transmission rate (OTR). Compostable biopolymers, by contrast, generally possess higher permeability. However, through the use of multi-layer film or laminate designs and the incorporation of specialized barrier coatings, the present invention achieves barrier performance levels that are suitable for pharmaceutical applications.

[0102] In some embodiments, the compostable multi-layer film or laminate is configured to achieve a water vapor transmission rate (WVTR) of less than 2 g / m2 / day (measured in accordance with ASTM F1249) and / or an oxygen transmission rate (OTR) of less than 2 cc / m2 / day (measured in accordance with ASTM D3985). These values are consistent with high-barrier conventional films and align with the moisture-permeation limits defined in the European Pharmacopoeia for blister packaging.

[0103] To achieve these performance levels, the laminate may incorporate biodegradable barrier layers such as glassy silicon oxide (SiOx) coatings, bio-based resins, or other compostable materials with low permeability. These layers are selected and configured to maintain compostability while providing the necessary protection against moisture and oxygen ingress.

[0104] The compostable multi-layer primary packaging film or laminate is preferably capable of forming hermetically sealed enclosures around individual solid dosage units. This requirement is important for compliance with pharmaceutical packaging standards, including ISO 11607 and Good Manufacturing Practice (GMP) guidelines.

[0105] In some embodiments, the laminate includes at least one layer configured for heat sealing, such as a PLA, PBS, or PBAT-based sealant layer. These materials enable the formation of airtight seals through the application of heat and / or pressure, ensuring that the packaging maintains its protective barrier throughout handling, transport, and storage.

[0106] Where adhesives or tie layers are used to bond multiple layers of the laminate, such components are selected to be both biodegradable and compliant with pharmaceutical safety standards. For example, compostable polyesters or biobased hot-melt adhesives may be employed to ensure that the laminate remains fully compostable and non-toxic.

[0107] The sealed packaging is preferably designed to meet the mechanical strength and seal integrity requirements defined in United States Pharmacopeia (USP) <11607>, while also complying with extraction limits specified in USP <661 >. This ensures that the packaging does not introduce harmful substances into the medicinal product and maintains its structural integrity under typical use conditions. To protect solid dosage units from physical damage, the compostable multi-layer primary packaging film or laminate should exhibit sufficient mechanical strength, including resistance to puncture, flex-cracking, and compression. These properties are essential for maintaining the integrity of the medicinal product during manufacturing, distribution, and patient use.

[0108] In some embodiments, the laminate comprises a multi-layer structure in which each layer contributes specific mechanical properties. For example:

[0109] An outer layer composed of oriented PLA or cellulose may provide stiffness and tensile strength.

[0110] An inner layer composed of PBAT, PBS, or PHA may offer ductility and impact resistance.

[0111] This combination of materials enables the laminate to achieve a balance of rigidity and toughness comparable to conventional blister packaging films. Polymer blending and orientation techniques may further enhance mechanical performance.

[0112] All components of the laminate are selected to be chemically inert and compliant with pharmacopoeia! standards, including limits on heavy metal content and leachables (e.g., USP <661 ,2>). Natural polymers such as cellulose and shellac, which have established use in pharmaceutical applications, may also be incorporated to meet safety and performance requirements.

[0113] The compostable multi-layer primary packaging of the present disclosure comprises a multi-layer primary packaging film or laminate comprising a biodegradable and compostable polymer, the multi-layer film or laminate being configured to be processed in a film wrapping machine, such as a flow wrapping machine, to encase an individual solid dosage unit of a medicinal product. In some embodiments, the multi-layer film or laminate is configured to be processed in a flow wrapping machine. The multi-layer primary packaging film or laminate is the main component of the compostable primary packaging, and in some embodiments, the compostable primary packaging is made entirely of the multi-layer primary packaging film or laminate.

[0114] The multi-layer primary packaging film or laminate is configured to be processed in a film wrapping machine to encase an individual solid dosage unit of a medicinal product. The multi-layer primary packaging film or laminate is engineered to possess properties that allow it to be effectively processed through standard or specialized film wrapping machines. These machines are typically employed in the packaging of individual solid dosage forms, such as tablets, capsules, or similar medicinal products. The multi-layer film or laminate material must exhibit sufficient flexibility, durability, and barrier properties to ensure the integrity and protection of the medicinal product throughout its shelf life, while also being fully compostable after use.

[0115] These requirements are fulfilled by the use in the multi-layer primary packaging film or laminate comprising a biodegradable and compostable polymer. The biodegradable and compostable polymer is preferably a thermoplastic polymer, allowing for the multi-layer primary packaging film to be processed, formed, shaped, and / or sealed using a film wrapping machine. Examples of biodegradable and compostable thermoplastic polymers that may be used in the multi-layer primary packaging film or laminate include, but are not limited to polylactic acid (PLA), polyhydroxyalkanoates (PHA), polybutylene succinate (PBS), polybutylene adipate terephthalate (PBAT), polycaprolactone (PCL), thermoplastic starch (TPS), cellulose acetate, poly(lactic-co-glycolic acid) (PLGA), polybutylene fumarate (PBF), and polyvinyl alcohol (PVA / PVOH). Other examples include but are not limited to algae-based polymers and mycelium-based polymers.

[0116] In some embodiments, the biodegradable and compostable polymer comprises at least one of the following:

[0117] Polylactic Acid (PLA): A bio-based polyester derived from renewable resources such as com starch or sugarcane. PLA offers high stiffness and transparency and is industrially compostable under EN 13432. Oriented PLA (uniaxially or biaxially stretched) improves mechanical strength. PLA is pharmaceutically acceptable and degrades into lactic acid.

[0118] Polyhydroxyalkanoates (PHA), including Polyhydroxybutyrate (PHB) and Polyhydroxybutyrate-co-valerate (PHBV): Microbially synthesized polyesters that are biodegradable in soil, marine, and home composting environments. PHAs exhibit good barrier properties and hydrophobicity, making them suitable for moisture-sensitive applications.

[0119] Polybutylene Succinate (PBS) and Polybutylene Succinate-co-Adipate (PBSA): Aliphatic polyesters with good flexibility, toughness, and heat-sealability. PBS and PBSA are industrially compostable and may degrade in home composting when formulated appropriately.

[0120] Polybutylene Adipate Terephthalate (PBAT): A flexible, biodegradable copolyester that is industrially compostable and often used in blends to enhance ductility and sealability.

[0121] Polycaprolactone (PCL): A synthetic biodegradable polyester with a low melting point and excellent flexibility. PCL is industrially compostable and often used as a softening agent in polymer blends.

[0122] Thermoplastic Starch (TPS): Derived from natural starch sources and plasticized for film formation. TPS is biodegradable and compostable, and may be blended with other polymers to improve barrier and mechanical properties.

[0123] Cellulose Acetate and Regenerated Cellulose (e.g., NatureFlex™): Renewable, compostable polymers with good oxygen barrier properties and heat resistance. These materials are suitable for outer layers or print carriers. NatureFlex™ films may support shelf lives of approximately 6 months to 2 years depending on formulation and storage. Poly(lactic-co-glycolic acid) (PLGA): A copolymer of PLA and glycolic acid, offering tunable degradation rates and biocompatibility. PLGA is used in medical applications and may be suitable for pharmaceutical packaging layers.

[0124] Polybutylene Fumarate (PBF): A lesser-known biodegradable polyester with potential for use in compostable packaging applications.

[0125] Polyvinyl Alcohol (PVA / PVOH): A water-soluble polymer that is biodegradable under specific conditions. PVA is used in pharmaceutical films and coatings and may be included in compostable packaging when formulated appropriately.

[0126] Shellac: A natural resin with pharmaceutical approval (e.g., as a tablet coating). Shellac may be used as a biodegradable coating or barrier layer in compostable packaging.

[0127] Chitosan: A biodegradable polysaccharide derived from chitin, with antimicrobial properties and potential use in pharmaceutical packaging coatings.

[0128] Lignin-Based Polymers: Derived from wood biomass, lignin offers UV resistance and may be used in biodegradable barrier coatings.

[0129] Protein-Based Polymers, such as zein (corn protein) and soy protein: Biodegradable and compostable materials with film-forming capabilities, suitable for use in coatings or blend layers.

[0130] Algae-Based Polymers, including alginate (alginic acid), agar, and carrageenan: Naturally occurring polysaccharides extracted from marine algae. These materials are bio-based, home compostable, and offer good oxygen barrier properties when dry. Seaweed films may be used as discrete layers or coatings to enhance sustainability and barrier performance.

[0131] Algal Cellulose Films: Cellulose-based films derived from algae, which may be enhanced with coatings or blended with other biodegradable materials to improve moisture and oxygen barrier properties. Algal Bioplastics (e.g., ALGAL®): Bioplastics derived from algae species, engineered for high barrier performance. Certain formulations have demonstrated shelf lives of up to 2-3 years in food packaging applications and may be adapted for pharmaceutical use.

[0132] Mycelium-Based Materials (e.g., MycoComposite™): Composites formed from fungal biomass and agricultural waste. These materials offer strong mechanical protection and moderate barrier properties, and may be used as structural or intermediate layers in multi-layer films or laminates.

[0133] BioFlex®: A biodegradable film with shelf life performance of approximately 6 months to 2 years, depending on formulation and environmental exposure.

[0134] STAGG™ Barrier Film: A compostable barrier film with shelf life potential of 1-2 years, depending on sealing method and formulation.

[0135] BPI-Certified PLA Films: PLA-based films certified for industrial composting. Shelf life typically ranges from 1-2 years under controlled conditions.

[0136] Starch-Based PLA / PS Blends: Composite films combining starch and PLA or polystyrene alternatives. Shelf life generally ranges from 1-2 years.

[0137] GreenDot® Bioplastics: Starch-based biodegradable materials with shelf life performance of 1-2 years, depending on formulation and environmental protection.

[0138] Novamont Mater-Bi®: A family of compostable polymers with shelf life potential of 1-2 years, depending on formulation, thickness, and storage conditions.

[0139] In some embodiments, combinations or blends of the above polymers may be used to tailor the mechanical, barrier, and compostability properties of the multilayer primary packaging film or laminate. Such blends may include co-extruded multi-layer film structures or multi-layer laminates wherein each layer contributes specific functional attributes, such as sealability, stiffness, moisture resistance, or oxygen barrier performance.

[0140] The multi-layer primary packaging film or laminate has sufficient mechanical strength, flexibility, and sealability to maintain an airtight and moisture-resistant barrier around the solid dosage unit after a film wrapping process.

[0141] The multi-layer primary packaging film or laminate is preferably sealable by applying heat and / or pressure. Examples of sealing techniques include, but are not limited to, heat sealing, crimping, or ultrasonic sealing. In other words, the multi-layer primary packaging film or laminate comprises a material or layer configured or arranged to allow sealing of the compostable multi-layer primary packaging around the solid dosage unit by applying heat and / or pressure. The material or layer configured or arranged to allow sealing of the compostable multilayer primary packaging around the solid dosage unit by applying heat and / or pressure may for example be the multi-layer film or laminate itself, or an outer layer of the laminate, or a coating layer.

[0142] In some embodiments, the biodegradable and compostable polymer is selected from the group consisting of polylactic acid (PLA), polybutylene succinate (PBS), polyhydroxyalkanoates (PHA), polycaprolactone (PCL), thermoplastic starch (TPS), cellulose-based polymers, chitosan, alginates, or a combination thereof.

[0143] In some embodiments, the biodegradable and compostable polymer is selected from the group consisting of polylactic acid (PLA), polybutylene succinate (PBS), polyhydroxyalkanoates (PHA), polycaprolactone (PCL), thermoplastic starch (TPS), or a combination thereof.

[0144] In some embodiments, the biodegradable and compostable polymer is polylactic acid (PLA). PLA is a biodegradable and compostable polymer derived from renewable resources like corn starch or sugarcane. It has good mechanical properties, including rigidity and clarity, which make it suitable for forming packaging films. PLA also offers moisture and oxygen barrier properties, useful for protecting solid dosage units of medicinal products. In some embodiments, the biodegradable and compostable polymer comprises polybutylene succinate (PBS). PBS is a biodegradable aliphatic polyester known for its flexibility, toughness, and heat resistance. It decomposes under composting conditions and is often used in packaging films for its durability and ease of processing. Its mechanical properties make it a good choice for applications requiring more flexibility and impact resistance.

[0145] In some embodiments, the biodegradable and compostable polymer comprises polyhydroxyalkanoate (PHA). PHAs are a family of biodegradable polyesters produced by microbial fermentation of renewable resources. They exhibit excellent biodegradability in various environments, including soil and marine settings, making them highly suitable for sustainable packaging. PHA also provides good barrier properties against moisture and oxygen, which are useful for protecting medicinal products.

[0146] In some embodiments, the biodegradable and compostable polymer comprises polycaprolactone (PCL). PCL is a biodegradable polyester with a relatively low melting point, offering excellent flexibility and good compatibility with other biopolymers. It degrades in composting environments and is often used as a softening agent in blends with other polymers. Its flexibility and toughness make it useful for packaging films for medicinal products.

[0147] In some embodiments, the biodegradable and compostable polymer comprises a thermoplastic starch (TPS). TPS is derived from natural starch and plasticized with water or glycerol to create a biodegradable and compostable material. It is a sustainable, renewable resource that provides good barrier properties when blended with other biopolymers. TPS is particularly useful in packaging applications where biodegradability and cost-effectiveness are prioritized.

[0148] A combination of these polymers, such as blending PLA with PBS or PCL, can enhance the overall performance of the multi-layer primary packaging film or laminate by balancing rigidity, flexibility, and barrier properties. Such blends can create films with improved mechanical strength and better protection for solid dosage units, while still being fully compostable and biodegradable.

[0149] In some embodiments, the multi-layer film or laminate comprises a heat-sealable layer selected from PLA, PBS, PBAT, or PCL.

[0150] In some embodiments, the biodegradable and compostable polymer comprises an algae-based polymer. Algae-based biodegradable and compostable polymers offer several advantages that make them particularly suitable for use in compostable packaging films for medicinal products. Algae are a fast-growing, renewable resource that can be cultivated with minimal environmental impact, requiring less land and water than traditional crops. This makes algae-based polymers an eco-friendly alternative to petroleum-based plastics, aligning with sustainability goals in pharmaceutical packaging. Algae-based polymers are naturally biodegradable and compostable, breaking down into non-toxic byproducts in composting environments. This is crucial for reducing the environmental footprint of medicinal packaging waste, which typically requires strict disposal due to potential contamination. Algae-based polymers are inherently non-toxic, making them safe for use in packaging medicinal products where safety and contamination risk are concerns. Their biocompatibility ensures they won't interact chemically with the medication, preserving product integrity. Algae-based materials can offer excellent barrier properties, such as moisture and oxygen resistance, which are essential for maintaining the stability and efficacy of solid dosage medicinal products. Effective barrier protection ensures that the medicine is shielded from environmental factors that could degrade its quality. Algae-based polymers can be engineered or blended with other biodegradable materials to tailor mechanical strength, flexibility, and barrier performance. This allows the packaging to meet specific requirements, such as protecting the medicinal product from moisture, oxygen, or light. Examples of algae-based biodegradable and compostable polymers include alginate (alginic acid), agar, and carrageenan.

[0151] Alginate is a natural polysaccharide extracted from brown algae. It is biodegradable, compostable, and offers good film-forming properties. Alginate has excellent moisture barrier capabilities, making it suitable for protecting medicinal products from humidity. It can also be used as a coating or combined with other biopolymers for enhanced barrier performance.

[0152] Agar is another algae-derived polysaccharide, primarily extracted from red algae. It is biodegradable, compostable, and has gel-like properties, making it useful in film-forming applications. Agar-based films are known for their excellent oxygen barrier properties, which are essential for protecting medicinal products from oxidation.

[0153] Carrageenan is a biodegradable polysaccharide extracted from red seaweed with film-forming abilities. Carrageenan-based films are compostable and can offer good moisture and oxygen barrier properties. It is often used in combination with other polymers to enhance mechanical strength and flexibility in packaging films.

[0154] In some embodiments, the multi-layer primary packaging film or laminate comprises at least one layer composed of a biodegradable and compostable polymer selected from the group consisting of polylactic acid (PLA), polybutylene succinate (PBS), polyhydroxyalkanoates (PHA), polycaprolactone (PCL), thermoplastic starch (TPS), or a combination thereof.

[0155] In some embodiments, the multi-layer film or laminate comprises at least one layer composed of a mycelium-based material or an algae-based polymer film.

[0156] In some embodiments, the multi-layer primary packaging film or laminate comprises at least one layer composed of an algae-based polymer.

[0157] In some embodiments, the multi-layer primary packaging film or laminate comprises at least one layer composed of a mycelium-based polymer.

[0158] In some embodiments, the multi-layer primary packaging film or laminate comprises at least one layer composed of a cellulose-based polymer. In some embodiments, the multi-layer film or laminate comprises a cellulose-based outer layer providing UV resistance and printability. Different layers of the laminate may be composed of different biodegradable and compostable polymers, wherein each layer is designed to contributes to the overall barrier properties, mechanical strength, and sealability of the laminate.

[0159] In some embodiments, the laminate comprises a first layer composed of polylactic acid (PLA) to provide strength and rigidity, and a second layer composed of polybutylene succinate (PBS) to provide flexibility and sealability.

[0160] In some embodiments, the laminate comprises an inner layer composed of polyhydroxyalkanoate (PHA) for direct contact with the medicinal product, and an outer layer composed of a thermoplastic starch (TPS) for improved barrier properties against moisture and oxygen.

[0161] In some embodiments, the laminate comprises a layer of polycaprolactone (PCL) to provide heat-sealability, and a layer of polylactic acid (PLA) to provide strength and rigidity.

[0162] In some embodiments, the laminate comprises a layer of comprising, or consisting of, an algae-based polymer.

[0163] In some embodiments, the laminate comprises a layer of a biodegradable adhesive, bonding the biodegradable and compostable polymer layers of the laminate, while ensuring that the entire laminate structure remains fully compostable.

[0164] In some embodiments, the multi-layer primary packaging film or laminate comprises a co-extruded film of polylactic acid (PLA) and polybutylene succinate (PBS), offering a balance of mechanical strength, flexibility, and compostability.

[0165] Combining cellulose-based films, starch-based films, and PLA-based films in a layered configuration can enhance the overall performance and shelf life of compostable pharmaceutical packaging. Each material contributes distinct functional properties that, when integrated into a multi-layer laminate, result in improved mechanical strength, barrier performance, and compostability. Cellulose- based films provide excellent barrier properties against gases and moisture and are inherently biodegradable. In a layered structure, cellulose can act as a stabilizing layer, contributing to mechanical durability and enhancing the structural integrity of the packaging. Starch-based films are biodegradable and offer good film-forming capabilities. When used in combination with cellulose and PLA, starch-based layers can improve flexibility and reduce brittleness, while benefiting from the mechanical and barrier properties of adjacent layers. PLA-based films are widely used for their clarity, strength, and biodegradability. Additives may be incorporated to improve its moisture and oxygen barrier properties, heat resistance, and flexibility. PLA-based films are particularly suitable as outer or inner layers in pharmaceutical packaging, providing protective and sealing functions. A biodegradable adhesive may be used to bond the layers into a cohesive laminate. The adhesive is selected for compatibility with each layer and may also contribute to the overall barrier performance. The resulting structure exhibits enhanced thermal stability, mechanical strength, and barrier integrity, supporting extended shelf life and regulatory compliance.

[0166] In some embodiments, the multi-layer primary packaging film or laminate comprises a multi-layer structure designed to be home compostable, wherein each layer is composed of a biodegradable and compostable material selected to meet pharmaceutical packaging requirements under ambient composting conditions.

[0167] In some embodiments, the multi-layer primary packaging film or laminate comprises:

[0168] An outer layer comprising a cellulose-based film, such as NatureFlex™. The cellulose-based film provides mechanical durability, UV resistance, and water repellency. NatureFlex™ is derived from regenerated cellulose and is certified as home compostable.

[0169] An intermediate layer comprising a starch-based film, e.g. a starch-based composite film such as those produced by Green Dot Bioplastics. The starch- based film contributes to oxygen barrier performance and structural integrity. An inner layer comprising a PLA-based film, optionally with additives, configured for direct contact with the medicinal product. PLA-based films may be formulated suitable for home composting and provide adequate chemical inertness. In an alternative embodiment, the inner layer comprises another biodegradable and compostable polymer such as PLA, PBS, PBAT, or PHA which can be used for heat sealing.

[0170] In some embodiments each of the outer, intermediate, and inner layers is home compostable.

[0171] The multi-layer primary packaging film or laminate may further comprise a compostable moisture barrier coating, preferably a bio-based moisture barrier coating.

[0172] In some embodiments, the PLA-based inner layer is formulated to meet leachables and extractables requirements for pharmaceutical use.

[0173] In some embodiments, the compostable multi-layer primary packaging film or laminate comprises:

[0174] An outer layer comprising a cellulose-based film, such as NatureFlex™. The cellulose-based film provides mechanical durability, UV resistance, and water repellency. NatureFlex™ is derived from regenerated cellulose and is certified as home compostable.

[0175] An intermediate layer comprising a cellulose-based film, such as NatureFlex™. The cellulose-based film provides mechanical durability, UV resistance, and water repellency. NatureFlex™ is derived from regenerated cellulose and is certified as home compostable. The dual-layer cellulose-based film configuration enhances structural integrity and printability, while maintaining compostability.

[0176] An inner layer comprising polylactic acid (PLA), or an alternative biodegradable and compostable polymer such as PBS, PBAT, or PHA which can be used for heat sealing. The inner layer is configured to enable hermetic sealing under heat and / or pressure, ensuring barrier integrity and compliance with pharmaceutical packaging standards.

[0177] The multi-layer primary packaging film or laminate may further comprise a compostable moisture barrier coating, preferably a bio-based moisture barrier coating.

[0178] This multi-layer structure is designed to meet the mechanical, barrier, and regulatory requirements for pharmaceutical primary packaging, while maintaining full industrial compostability and, in some embodiments, home compostability.

[0179] In some embodiments, the multi-layer primary packaging film or laminate comprises a multi-layer structure configured for industrial composting. Each layer of the multi-layer primary packaging film or laminate comprises a biodegradable and compostable material selected to meet pharmaceutical packaging requirements, including barrier performance, mechanical strength, and compatibility with medicinal products.

[0180] In some embodiments, the multi-layer primary packaging film or laminate comprises:

[0181] An outer layer comprising a cellulose-based film, such as NatureFlex™. The cellulose-based film provides mechanical durability, UV resistance, and water repellency. NatureFlex™ is derived from regenerated cellulose and is certified as home compostable.

[0182] An intermediate layer comprising a mycelium-based material (e.g., Mycoflex™) or an algae-based polymer film. This intermediate layer provides enhanced oxygen barrier performance, structural support, and resistance to UV and moisture ingress.

[0183] An inner layer comprising PLA-based film, optionally with additives, configured for direct contact with the medicinal product. The PLA-based film may be formulated to meet leachables and extractables requirements for pharmaceutical use. In some embodiments, the intermediate layer comprises a mycelium-based material selected from Mycoflex™ or a similar fungal composite.

[0184] In some embodiments, the intermediate layer comprises an algae-based polymer selected from alginate, agar, carrageenan, or algal cellulose.

[0185] In some embodiments, the outer layer comprises NatureFlex™.

[0186] The multi-layer primary packaging film or laminate may further comprise a compostable moisture barrier coating, preferably a bio-based moisture barrier coating.

[0187] In some embodiments, the laminate is configured for industrial composting in accordance with EN 13432.

[0188] In some embodiments, the laminates are bonded together using a bio-based adhesive or by heat sealing.

[0189] In some embodiments, the laminates are bonded using a bio-based hot melt adhesive or a bio-based aqueous polymer adhesive, selected to ensure compatibility with pharmaceutical standards and maintain the compostable nature of the laminate.

[0190] In some embodiments, the laminates are bonded using a bio-based hot melt adhesive based on compostable thermoplastic polymers, such as PBAT and / or PLA. One example of such a bio-based hot melt adhesive is Ecovio® (BASF).

[0191] In some embodiments, the bio-based hot melt adhesive, such as Ecovio® may be used as a sealant layer providing heat-sealability and mechanical cohesion in multi-layer films or laminates. The bio-based hot melt adhesive may be incorporated into the laminate structure either as a discrete film layer or as a coating or tie layer, provided that the overall packaging remains fully compostable and suitable for pharmaceutical use. Ecovio® is a compound material based on polybutylene adipate terephthalate (PBAT) and polylactic acid (PLA), designed to offer enhanced mechanical performance and barrier properties while maintaining full compostability under industrial composting conditions.

[0192] Ecovio® is industrially compostable according to EN 13432, ASTM D6400, and other international compostability standards, and certain grades are also certified for home composting. The material is approved for food contact applications and is suitable for use in pharmaceutical packaging subject to compliance with applicable pharmacopoeia! and regulatory requirements. The material’s compatibility with flow wrapping processes and its ability to maintain structural and barrier performance over extended shelf-life periods (e.g., 2-3 years) make it a suitable candidate for regulated medicinal product packaging.

[0193] Other suitable adhesives for bonding the laminate, selected to ensure compatibility with pharmaceutical safety standards and maintain the compostable nature of the laminate, may include:

[0194] Lignin-Based Adhesives: Derived from wood biomass, lignin-based adhesives offer biodegradability and moderate barrier properties. Shelf life typically ranges from 1 to 2 years, depending on formulation and storage conditions. Examples include LigniOx and BASF lignin-based solutions, which may be suitable for foodcontact and pharmaceutical packaging applications, subject to regulatory compliance.

[0195] Bio-Based Polyurethane Adhesives: These adhesives are formulated from renewable resources and may be used in flexible packaging applications. Shelf life is generally 1 to 2 years, with optimal performance maintained under controlled temperature and humidity. Examples include Bostik bio-based adhesives and H.B. Fuller’s EcoMelt™, which offer hot melt functionality and sustainability credentials.

[0196] Natural Rubber Adhesives: Derived from latex or other natural rubber sources, these adhesives are biodegradable and may be suitable for compostable packaging. Shelf life is typically around 1 to 2 years, with stability influenced by environmental conditions. Commercial examples include Adhesive Technologies natural rubber adhesives and Scotch natural rubber formulations, which may be evaluated for food and pharmaceutical use.

[0197] These adhesives may be used as tie layers, sealant layers, or coating layers within the laminate structure, provided that the overall packaging remains fully compostable and compliant with applicable pharmacopoeia! and regulatory standards. Final selection should consider the adhesive’s mechanical performance, barrier contribution, and compatibility with the selected biodegradable substrates.

[0198] In some embodiments, the multi-layer primary packaging film or laminate further comprises an outer surface treatment or coating, for example to enhance barrier properties against oxygen and moisture, or sealing properties, or both.

[0199] In some embodiments, the multi-layer primary packaging film or laminate further comprises one or more barrier coatings applied to one or more surfaces of the multi-layer film or laminate. These coatings are selected to enhance moisture resistance, oxygen impermeability, and UV protection, while maintaining the biodegradability and compostability of the overall structure. The coatings are compatible with both industrial and home composting standards, depending on the formulation and thickness. In some embodiments, the multi-layer film or laminate comprises a barrier coating selected from silicon oxide (SiOx), shellac, alginate, or nanocellulose.

[0200] To achieve pharmaceutical-grade barrier performance using compostable materials, the invention contemplates the use of ultra-thin, biodegradable or bioinert barrier coatings, including but not limited to:

[0201] Silicon Oxide (SiOx) coatings: A vacuum-deposited, glass-like inorganic layer typically applied at thicknesses of 20-80 nm. SiOx coatings significantly reduce both oxygen transmission rate (OTR) and water vapor transmission rate (WVTR) and have been found to maintain compostability when applied to biodegradable substrates such as PLA or cellulose. In some embodiments, a single SiOx layer is applied to a base film; in other embodiments, two SiOx-coated layers are laminated to form a high-barrier composite structure. The SiOx layer degrades to silica (sand), which is environmentally benign.

[0202] Plasma-deposited siloxane coatings: Formed by plasma polymerization of organosilicon gases, these coatings function similarly to SiOx but may include organic content. They provide a flexible, compostable barrier layer and may be used as an alternative to vacuum-deposited SiOx.

[0203] Shellac-based coatings: Shellac is a natural resin with excellent moisture barrier properties and is approved for pharmaceutical use. In some embodiments, shellac is applied as a thin coating layer, optionally plasticized or reinforced with biodegradable nanofillers such as nanocellulose. Composite coatings comprising shellac and nanocellulose may achieve barrier performance comparable to conventional plastics while remaining fully compostable.

[0204] Seaweed-derived polysaccharide coatings: Algal biopolymers such as alginate or carrageenan may be used as oxygen barrier coatings, particularly under low- humidity conditions. In some embodiments, a dual-layer barrier is formed by applying a seaweed-derived coating (e.g., calcium-crosslinked alginate) beneath a hydrophobic overcoat such as shellac or wax. These coatings are edible, biodegradable, and compatible with pharmaceutical applications.

[0205] Polyvinyl alcohol (PVOH) coatings: PVOH is a synthetic but biodegradable polymer with excellent oxygen barrier properties when dry. In some embodiments, PVOH is used as an intermediate layer, encapsulated between hydrophobic outer layers to prevent premature dissolution. Modified or blended forms of PVOH may be used to improve water resistance while maintaining compostability.

[0206] Bio-nanocomposite Coatings: In some embodiments, the barrier coating comprises a biodegradable polymer matrix (e.g., PLA, shellac, or PHA) reinforced with nano-additives such as nanoclay or nanocellulose. These nanocomposites reduce gas permeability by creating a tortuous diffusion path and may be tailored to meet specific barrier requirements. All components are selected to ensure compliance with compostability standards and pharmaceutical safety guidelines.

[0207] Each of the above coatings may be used individually or in combination. In some embodiments, a hybrid barrier system is employed, wherein an organic barrier (e.g., shellac or alginate) is overlaid with an inorganic barrier (e.g., SiOx) to achieve synergistic performance. These combinations are designed to exceed the barrier limitations of individual materials while maintaining full compostability and regulatory compliance.

[0208] The inventive use of such coatings enables the compostable multi-layer primary packaging to meet or exceed the barrier performance typically associated with conventional pharmaceutical packaging materials such as PVC / aluminium blister films, while offering a sustainable and environmentally responsible alternative.

[0209] In some embodiments, the multi-layer primary packaging film or laminate comprises an outer surface biodegradable and compostable polymer coating. Examples of biodegradable and compostable thermoplastic polymers that may be used in the polymer coating to enhance barrier properties against oxygen and moisture, or sealing properties, or both, include, but are not limited to polylactic acid (PLA), polyhydroxyalkanoates (PHA), cellulose nanocrystals (CNC), cellulose nanofibers (CNF), chitosan, starch-based coatings, polyvinyl alcohol (PVA / PVOH), carnauba wax, beeswax, alginates, silk protein (fibroin), and lignin.

[0210] In some embodiments, the multi-layer primary packaging film or laminate further comprises a thin-film coating layer to enhance barrier properties against oxygen and moisture. The term “thin-film coating” refers to a very fine layer of material, typically ranging in thickness from a few nanometers to several micrometers, which is applied to a substrate surface to modify its physical, chemical, or functional properties. Thin-film coatings are commonly used to provide barriers (e.g., against moisture, oxygen, or UV light), enhance surface durability, or add other protective or decorative functions without significantly altering the bulk properties of the substrate. These coatings can be applied using various techniques, including vacuum deposition, spraying, and dipping. Due to their low thickness, thin-film coatings typically have a low impact on the compostability of the coated film. Examples of materials that may be used in the thin-film coating to enhance barrier properties against oxygen and moisture include, but are not limited to silicon dioxide (SiO2), calcium carbonate (CaCO3), zinc oxide (ZnO), magnesium oxide (MgO), chitosan, lignin, cellulose-based coatings (e.g., regenerated cellulose). In some embodiments, although not compostable, the multi-layer primary packaging film or laminate further comprises a very thin metallization coating, e.g. an aluminium coating applied by vacuum coating methods. While traditional metallization can hinder compostability, very thin metal layers having a thickness in the range of 10 to 100 nm on compostable substrates can sometimes remain compostable under industrial conditions. These films provide excellent gas and moisture barriers.

[0211] In some embodiments, the compostable multi-layer primary packaging film or laminate comprises:

[0212] An outer layer comprising a PLA / PBAT blend film, optionally oriented to enhance mechanical strength and printability. This layer provides durability, transparency, and a printable surface suitable for pharmaceutical labeling.

[0213] An intermediate layer comprising a shellac-nanocellulose (NFC) coating applied to the inner surface of the PLA / PBAT film, overcoated with a thin silicon oxide (SiOx) layer. The shellac / NFC matrix provides enhanced moisture resistance and oxygen barrier properties, while the SiOx layer further reduces permeability to near aluminum foil-like levels.

[0214] An inner layer comprising PLA or PBS, configured for direct contact with the medicinal product and capable of forming hermetic seals under heat and pressure. This layer ensures compatibility with pharmaceutical standards for leachables and extractables and supports secure sealing during flow wrapping.

[0215] In some embodiments, the compostable multi-layer primary packaging film or laminate comprises: An outer layer comprising a seaweed-derived polysaccharide film, such as alginate or agar-based material, optionally coated with a plasma-deposited SiOx layer. This layer provides excellent oxygen barrier properties, UV resistance, and printability, while maintaining full compostability.

[0216] An intermediate layer comprising a PHA / PBAT blend film, offering mechanical strength, flexibility, and moisture resistance. This layer supports the structural integrity of the laminate and contributes to the overall barrier performance.

[0217] An inner layer comprising the same PHA / PBAT blend or a PLA-based film, configured for direct contact with the medicinal product and optimized for heat sealing. The inner layer is selected to meet pharmaceutical safety standards and ensure compatibility with flow wrapping equipment.

[0218] In some embodiments, the compostable multi-layer primary packaging film or laminate comprises:

[0219] An outer layer comprising a co-extruded PBAT / PLA blend, providing toughness, flexibility, and a printable surface. This layer serves as the exterior of the laminate and contributes to mechanical durability.

[0220] An intermediate layer comprising a biodegradable polyester such as PHBV or PLA blended with nanoclay, forming an embedded oxygen barrier. This layer reduces gas permeability and enhances the shelf-life stability of the medicinal product.

[0221] An inner layer comprising a PBAT / PBS blend, configured for direct contact with the medicinal product and optimized for heat sealing. This layer ensures airtight sealing and compliance with pharmaceutical packaging standards.

[0222] Optionally, a surface barrier coating, applied to the outer surface of the laminate, comprising a silicon oxide (SiOx) layer. This ultra-thin coating enhances moisture and oxygen barrier performance without compromising compostability. Each of the above laminate structures is designed to meet the mechanical, barrier, and regulatory requirements for pharmaceutical primary packaging, while maintaining full industrial compostability and, in some embodiments, home compostability.

[0223] In some embodiments, the multi-layer primary packaging film or laminate is manufactured using one or more of the following methods:

[0224] Co-extrusion: Co-extrusion is a widely adopted technique for producing multi-layer compostable films. It enables the simultaneous extrusion of multiple biodegradable polymers, forming a composite structure with tailored mechanical and barrier properties. Co-extrusion is particularly suitable for applications requiring high throughput and consistent layer integration, and is compatible with compostable materials such as PLA, PBAT, PBS, and PHBV.

[0225] Adhesive Bonding: In some embodiments, the laminate layers are bonded using bio-based adhesives specifically formulated for compostable packaging. These adhesives allow for flexible layer combinations and customization of functional properties, including sealability, barrier performance, and mechanical strength. Suitable adhesives include compostable hot-melt adhesives based on PLA or PBAT, or aqueous bio-polymer adhesives derived from starch, lignin, or natural rubber.

[0226] Heat Sealing: For thermoplastic compostable materials such as PLA, PBS, or PBAT, heat sealing may be employed to join layers or form sealed enclosures. Heat sealing provides strong, hermetic seals and is compatible with flow wrapping and form-fill-seal processes. The sealing temperature and pressure are selected based on the thermal properties of the compostable polymers used.

[0227] Each of these manufacturing methods may be selected based on the specific material composition, desired laminate structure, and performance requirements of the final packaging. Co-extrusion and adhesive bonding are particularly advantageous for achieving multi-functional laminates with compostable integrity, while heat sealing is preferred for forming sealed packages during wrapping operations.

[0228] In some embodiments, the multi-layer primary packaging film or laminate comprises at least 50 wt%, at least 60 wt%, at least 70 wt%, at least 80 wt%, or at least 90 wt% of the biodegradable and compostable polymer, based on the total weight of the multi-layer primary packaging film or laminate. In some embodiments the multi-layer film or laminate comprises at least 80 wt% of biodegradable and compostable polymers based on the total weight of the laminate.

[0229] In some embodiments, the multi-layer primary packaging film or laminate further comprises up to 30 wt% based on the total weight of the multi-layer primary packaging film or laminate, of a biodegradable and compostable material that can be used in combination with the thermoplastic biodegradable and compostable polymer to enhance the functional properties of the multi-layer primary packaging film or laminate, such as strength, flexibility, and barrier performance, while ensuring environmental sustainability. Examples of such biodegradable and compostable materials include, but are not limited to cellulose, starch, chitosan, alginates, lignin, proteins, (e.g., soy protein, zein), wax (e.g., beeswax, carnauba wax), polyvinyl alcohol (PVA / PVOH), natural fibers (e.g., hemp, flax, bamboo).

[0230] In some embodiments, the multi-layer primary packaging film or laminate further comprises up to 20 % by weight of compostable additives, for example selected from the group consisting of plasticizers, compatibilizers, nucleating agents, antioxidants, antimicrobial agents, fillers, barrier enhancers, colorants, UV stabilizers, or biodegradable adhesives.

[0231] In some embodiments, the multi-layer primary packaging film or laminate is free from non-compostable additives.

[0232] The suitable thickness or grammage of the multi-layer primary packaging film or laminate for hermetically sealing and protecting a solid dosage unit of a medicinal product would depend on the specific material properties and the required barrier performance against moisture, oxygen, and physical damage. Higher thickness or grammage is often necessary to achieve excellent barrier properties, especially for products that are sensitive to moisture or oxygen. A thicker film or laminate provides greater resistance to tearing and puncturing during handling and transportation. The multi-layer film or laminate should have sufficient thickness to form a reliable, hermetic seal during the heat-sealing process.

[0233] The multi-layer primary packaging film or laminate should preferably have a thickness in the range of 80 to 150 microns (pm), depending on the number of layers and the desired barrier properties. Each layer can contribute specific properties such as heat-sealability, mechanical strength, or barrier performance.

[0234] The grammage of the multi-layer primary packaging film or laminate may preferably be in the range of from 40 to 120 grams per square meter (g / m2). For more sensitive medicinal products requiring higher protection, grammages closer to 100-120 g / m2are preferred. Laminates typically have a higher grammage due to the additional layers providing extra protection.

[0235] The compostable multi-layer primary packaging should preferably remain structurally and functionally stable for a period of time which exceeds the shelf life of the solid dosage unit of the medicinal product. This stability ensures that the packaging maintains its protective properties, such as moisture and oxygen barriers, mechanical integrity, and chemical inertness, throughout the intended storage period of the medicinal product. Stability is important to protect the medicinal product from environmental factors that could degrade its potency or safety. The packaging resists degradation, permeability, and breakdown caused by factors such as humidity, temperature, or light exposure during storage and transportation. Only after the product is consumed or expired should the packaging begin its biodegradation or composting process, ensuring both product safety and environmental sustainability. In order to achieve this, the compostable packaging materials are formulated to meet the stability requirements of pharmaceutical packaging, balancing biodegradability with extended durability during the lifecycle of the product. In some embodiments the compostable multi-layer primary packaging remains structurally and functionally stable for a period of at least 2 years. In some embodiments, the compostable multi-layer primary packaging remains structurally and functionally stable for a period of at least 3 years. In some embodiments, the compostable multi-layer primary packaging remains structurally and functionally stable for a period of at least 4 years. Stability is preferably evaluated under ambient storage conditions. Stability may for example be evaluated at a temperature in the range of 10-40 °C, such as in the range of 15-25 °C, and a relative humidity in the range of 30-50%.

[0236] In some embodiments, the sealed multi-layer primary packaging is tamper-proof by virtue of a high sealing strength that causes visible damage upon attempted opening.

[0237] In some embodiments, the multi-layer film or laminate comprises a printed surface including product identification, batch number, expiry date, and dosage strength.

[0238] The compostable multi-layer primary packaging for wrapping individual solid dosage units of a medicinal product can conveniently be realized by using a using a compostable multi-layer primary packaging film or laminate in an automated film wrapping process. The film wrapping process may preferably be a wrapping process of the form-fill-seal (FFS) type. FFS packaging is a general term for a packaging process where the packaging material is formed into a specific shape (such as a bag, pouch, or wrapper), filled with the product, and then sealed. FFS can be carried out in either a horizontal (HFFS) or vertical (VFFS) orientation, depending on the product and packaging requirements.

[0239] Horizontal Form-Fill-Seal (HFFS): In HFFS packaging, the packaging material is formed into a horizontal tube, the product is filled into the tube, and then the package is sealed.

[0240] Flow wrapping is a common type of HFFS where the packaging material (often a flexible film) wraps around the product in a continuous horizontal motion, and the film is sealed around the product as it moves through the machine, creating a hermetically sealed package.

[0241] According to a second aspect illustrated herein, there is provided a method for wrapping individual solid dosage units of a medicinal product using a compostable multi-layer primary packaging film or laminate, comprising the steps of: a) providing a compostable multi-layer primary packaging comprising a multilayer primary packaging film or laminate according to any one of the preceding claims as described above with reference to the first aspect; b) feeding the multi-layer primary packaging film or laminate into a film wrapping machine, wherein the multi-layer film or laminate is configured to be formed around the individual solid dosage units of the medicinal product; c) placing individual solid dosage units of the medicinal product onto the multilayer primary packaging film or laminate as it moves through the film wrapping machine; and d) sealing the multi-layer film or laminate around each individual solid dosage unit by applying heat and / or pressure to create a hermetic seal, thereby ensuring an airtight and moisture-resistant barrier.

[0242] In some embodiments of the second aspect illustrated herein, there is provided a method for wrapping individual solid dosage units of a medicinal product using a compostable multi-layer primary packaging film or laminate, comprising the steps of: a) providing a compostable multi-layer primary packaging comprising a multilayer primary packaging film or laminate according to any one of the preceding claims as described above with reference to the first aspect; b) feeding the multi-layer primary packaging film or laminate into a flow wrapping machine, wherein the multi-layer film or laminate is configured to be formed into a continuous tubular shape around the individual solid dosage units of the medicinal product; c) placing individual solid dosage units of the medicinal product onto the multilayer primary packaging film or laminate as it moves through the flow wrapping machine; d) sealing the multi-layer film or laminate around each individual solid dosage unit by applying heat and / or pressure to create a hermetic seal, thereby ensuring an airtight and moisture-resistant barrier; and optionally e) cutting the continuous tubular film into individual packages, each containing an individual solid dosage unit of the medicinal product; and f) collecting the individually wrapped solid dosage units for further handling, storage, or distribution.

[0243] An embodiment of a flow wrapping method for wrapping individual solid dosage units of a medicinal product will now be described in more detail.

[0244] In step a) a compostable multi-layer primary packaging comprising a multi-layer primary packaging film or laminate according to any one of the preceding claims as described above with reference to the first aspect is provided. The multi-layer primary packaging film or laminate is selected for its barrier properties, providing protection against moisture, oxygen, and light, while also being compatible with the wrapping process. The multi-layer primary packaging film or laminate is a multi-layer structure, wherein each layer contributes to the barrier properties, mechanical strength, and sealability. One layer may serve as a heat-sealing layer, while others contribute to the overall integrity and protection of the medicinal product.

[0245] In step b) the multi-layer primary packaging film or laminate is fed into a flow wrapping machine, specifically designed for processing compostable films. The multi-layer film or laminate is configured to be transformed into a continuous tubular shape as it passes through the machine. This is achieved by guiding the multi-layer film or laminate around a forming collar, which shapes the flat material into a cylindrical form. The speed and tension of the film are carefully controlled to ensure smooth feeding and to prevent material tearing or wrinkling, which is particularly important when dealing with compostable materials that may have different mechanical properties compared to conventional plastics. The flow wrapping machine is equipped with rollers, guide tracks, and tension control systems to ensure the multi-layer film or laminate is accurately aligned and consistently processed throughout the wrapping cycle.

[0246] In step c), the individual solid dosage units (such as tablets, capsules, or other medicinal forms) of the medicinal product are placed onto the multi-layer primary packaging film or laminate as the multi-layer primary packaging film or laminate moves through the flow wrapping machine. The dosage units are introduced into the packaging line by a precise dosing or feeding mechanism, which deposits one unit at a time onto the moving film.

[0247] The feeding system is synchronized with the movement of the film to ensure that each solid dosage unit is positioned correctly on the centerline of the tubular packaging material, enabling uniform sealing and minimal material waste. The dosage units are spaced at regular intervals to match the desired final package size.

[0248] In step d) the multi-layer primary packaging film or laminate, now formed into a tubular shape with individual solid dosage units, is sealed around each unit to create a hermetic seal. This seal is achieved through the application of heat and / or pressure to the multi-layer film or laminate. The sealing process typically involves two stages:

[0249] - Longitudinal Sealing: The overlapping edges of the tubular film are sealed together along the length of the package. This is done by passing the film through a set of heated sealing rollers or a heat bar that applies controlled pressure and temperature to fuse the edges of the compostable film or laminate without damaging its structure or integrity.

[0250] - Transverse Sealing: After the longitudinal seal is completed, the tubular film is sealed transversely between each solid dosage unit. This creates individual sealed compartments around each dosage unit. Heat-sealing jaws apply heat and pressure at the points between the dosage units, ensuring an airtight and moisture-resistant barrier around each unit. This prevents contamination, degradation, and exposure to environmental factors.

[0251] The temperature and pressure applied during the sealing process are carefully controlled to match the characteristics of the multi-layer primary packaging film or laminate, ensuring a strong seal without compromising the compostable nature of the packaging.

[0252] In an optional step e) the continuous tubular film is cut into individual packages. A cutting mechanism, typically a rotary knife or blade, is positioned downstream of the transverse sealing station to sever the tubular film at the sealed areas, creating individual packages. Each package contains a single solid dosage unit hermetically sealed within the compostable multi-layer primary packaging. The cutting is synchronized with the sealing process to ensure that the film is cut precisely at the sealed areas, avoiding damage to the sealed compartments or the contents inside.

[0253] In an optional step f) the individually wrapped solid dosage units are collected for further handling. The flow wrapping machine may be equipped with a conveyor system or collection tray to receive the finished packages. The individually wrapped units are then ready for storage, distribution, or further packaging (e.g., secondary packaging like cartons or boxes).

[0254] The method may accommodate different sizes and shapes of solid dosage units, allowing flexibility in packaging various medicinal products using the same compostable film or laminate.

[0255] The process may further include quality control checks such as automated weight checks, visual inspections, or other non-destructive testing methods to ensure that each package is correctly sealed and contains the intended solid dosage unit.

[0256] In some embodiments the method further comprises the providing the wrapped individual solid dosage units with information concerning the medicinal product. Labeling or coding can be integrated into the process to add batch numbers, expiration dates, or barcodes to the film before or after the sealing process. This can be done via thermal printing or inkjet systems. The primary packaging must typically include specific information to ensure proper identification, safe use, and traceability of the product. This is regulated by health authorities such as the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and other national regulatory bodies. The exact requirements can vary slightly by jurisdiction, but generally, the information should include the name of the medicinal product, which can include both the brand name and the generic (International Non-proprietary Name, INN) or scientific name, the name of the active ingredient, if necessary, the strength of the product (e.g., 500 mg), the pharmaceutical form (e.g., tablet), batch number (lot number), expiry date (typically in the format of month / year, e.g., Exp: 04 / 2028), route of administration, storage conditions, special warnings or precautions, marketing authorization holder, name and address of the company or entity responsible for the product’s marketing authorization, regulatory approval number, and barcodes or serialization. However, for very small packaging regulatory agencies may allow some of the above information to be omitted, provided it is available on the outer packaging. Thus, on the wrapped individual solid dosage units of the present disclosure it may be sufficient to provide the name of the medicinal product, the name of the active ingredient, if necessary, the strength of the product (e.g., 500 mg), the pharmaceutical form (e.g., tablet), batch number (lot number), expiry date (typically in the format of month / year, e.g., Exp: 08 / 2024), and the name of the company or entity responsible for the product’s marketing authorization.

[0257] According to a third aspect illustrated herein, there is provided an individual solid dosage unit of a medicinal product wrapped and hermetically sealed in a compostable multi-layer primary packaging as described above with reference to the first aspect. The compostable multi-layer primary packaging and the wrapped solid dosage unit of a medicinal product may be further defined as described above with reference to the first aspect.

[0258] The wrapped solid dosage unit of a medicinal product of the present disclosure may preferably be designed in a way that prevents unauthorized access to the medicinal product. In some embodiments, the wrapped solid dosage unit of a medicinal product of the present disclosure is configured to be tamper proof. In the context of medical packaging, tamper-proof refers to packaging that is designed to prevent unauthorized access or tampering with the contents, providing a visible indication if any attempt has been made to interfere with the product. This type of packaging ensures the safety, integrity, and authenticity of the medicinal product, protecting it from contamination, alteration, or theft. Tamper-proof packaging is essential in maintaining patient safety and public trust in pharmaceuticals.

[0259] In some embodiments, the wrapped solid dosage unit of a medicinal product of the present disclosure is rendered tamper proof by a high sealing strength, such that the sealed portions of the packaging cannot be opened, without causing significant and visible damage to the multi-layer primary packaging film or laminate.

[0260] According to a fourth aspect illustrated herein, there is provided the use of a compostable multi-layer primary packaging as described above with reference to the first aspect for wrapping and hermetically sealing an individual solid dosage unit of a medicinal product. The compostable multi-layer primary packaging and the wrapped solid dosage unit of a medicinal product may be further defined as described above with reference to the first aspect.

[0261] The medicinal product of the present disclosure may be any medicinal product provided in solid form. However, it has been found that the multi-layer primary packaging and methods for wrapping of the present disclosure may be especially advantageous for ethical prescription medicinal products. Ethical prescription medicinal products refer to medicinal products that can only be dispensed to patients with a valid prescription from a licensed healthcare provider, such as a doctor, dentist, or nurse practitioner. The term “ethical” in this context relates to the ethical responsibility of healthcare professionals to determine when a drug should be prescribed, rather than the drug being available for direct consumer purchase.

[0262] In some embodiments, as explained in detail herein with reference to the first aspect, the term “medicinal product” as used herein refers to any pharmaceutical formulation that is subject to regulatory approval and subsequent marketing authorisation by international, national, or regional drug regulatory authorities.

[0263] Such medicinal products are required to submit specific packaging-related stability data as part of their regulatory submissions. This includes, but is not limited to, information concerning barrier properties and data demonstrating the potential for interaction or transfer between the packaging material and the medicinal product.

[0264] The present invention thus provides a compostable pharmaceutical packaging solution that meets regulatory standards for safety, stability, and barrier performance, while offering environmental benefits through industrial and home compostability. The use of multi-layer films or laminates, novel barrier coatings, and flow wrapping techniques enables the packaging of individual solid dosage units in a manner that is both pharmaceutically robust and ecologically responsible.

[0265] As used herein, the term “compostable” refers to the ability of a material to biologically degrade under composting conditions into non-toxic, organic components such as carbon dioxide, water, biomass, and inorganic compounds, without leaving visible, distinguishable, or toxic residues. Compostability is assessed according to internationally recognized standards and may be classified into two categories: industrial compostability and home compostability.

[0266] In the context of the present disclosure, materials that are industrially compostable should preferably meet the criteria set forth in European Standard EN 13432, American Standard ASTM D6400, and / or International Standard ISO 17088.

[0267] These standards require that the material disintegrates during composting, biodegrades at a rate comparable to natural compostable materials, and does not produce harmful residues or adversely affect the quality of the resulting compost.

[0268] In the context of the present disclosure, materials that are home compostable should preferably meet the criteria set forth in the TUV Austria OK Compost HOME certification.

[0269] To be considered home compostable, all components of the packaging, including films, coatings, adhesives, and inks, must biodegrade completely and safely in a home composting environment, leaving no persistent residues. In some embodiments, the multi-layer primary packaging film or laminate described herein is both industrially compostable and home compostable, depending on the specific material composition and laminate configuration.

[0270] Generally, while the products, polymers, materials, layers and processes are described in terms of “comprising” various components or steps, the products, polymers, materials, layers and processes can also “consist essentially of” or “consist of” the various components and steps.

[0271] It will be understood that the various features and embodiments described in the present disclosure may be combined, rearranged, or substituted in any technically feasible manner, unless otherwise explicitly stated. References to specific materials, layer configurations, manufacturing methods, or packaging processes are not intended to be limiting, and any such features may be used in combination with one another to achieve the desired functional and regulatory outcomes.

[0272] For example, any of the described biodegradable and compostable polymers may be used interchangeably or in combination across different layers of the multi-layer film or laminate. Similarly, the barrier coatings, adhesive systems, and sealing techniques disclosed herein may be applied to any suitable laminate structure, provided that the overall packaging remains compliant with compostability and pharmaceutical safety standards.

[0273] While the invention has been described with reference to various exemplary embodiments, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted for elements thereof without departing from the scope of the invention. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the invention without departing from the essential scope thereof. Therefore, it is intended that the invention not be limited to the particular embodiment disclosed as the best mode contemplated for carrying out this invention, but that the invention will include all embodiments falling within the scope of the appended claims.

Claims

CLAIMS1 . A compostable multi-layer primary packaging suitable for wrapping individual solid dosage units of a medicinal product, comprising: a multi-layer primary packaging film or laminate comprising a biodegradable and compostable polymer, the multi-layer film or laminate being configured to be processed in a film wrapping machine to encase an individual solid dosage unit of a medicinal product; the multi-layer primary packaging film or laminate having sufficient mechanical strength, flexibility, and sealability to maintain an airtight and moisture-resistant barrier around the solid dosage unit after a film wrapping process; the multi-layer primary packaging film or laminate being characterized by its ability to fully decompose into non-toxic organic components within an industrial composting environment within a typical composting cycle of 90 days, and / or within a home composting environment, depending on the material composition.

2. The compostable multi-layer primary packaging of claim 1 , wherein the medicinal product is a regulated medicinal product.

3. The compostable multi-layer primary packaging of any one of the preceding claims, wherein the multi-layer film or laminate comprises at least three layers, each layer contributing distinct functional properties selected from mechanical strength, barrier performance, and sealability.

4. The compostable multi-layer primary packaging of any one of the preceding claims, wherein the multi-layer film or laminate comprises a biodegradable adhesive layer bonding the layers of the laminate.

5. The compostable multi-layer primary packaging of any one of the preceding claims, wherein the multi-layer film or laminate comprises a heat-sealable layer selected from PLA, PBS, PBAT, or PCL.

6. The compostable multi-layer primary packaging of any one of the preceding claims, wherein the multi-layer film or laminate comprises a barrier coating selected from silicon oxide (SiOx), shellac, alginate, or nanocellulose.

7. The compostable multi-layer primary packaging of any one of the preceding claims, wherein the multi-layer film or laminate comprises a cellulose-based outer layer providing UV resistance and printability.

8. The compostable multi-layer primary packaging of any one of the preceding claims, wherein the multi-layer film or laminate is configured to achieve a water vapor transmission rate (WVTR) of less than 2 g / m2 / day and / or an oxygen transmission rate (OTR) of less than 2 cc / m2 / day.

9. The compostable multi-layer primary packaging of any one of the preceding claims, wherein the multi-layer film or laminate comprises at least one layer composed of a home compostable polymer selected from polyhydroxyalkanoates (PHA), starch-based polymers, or cellulose-based polymers.

10. The compostable multi-layer primary packaging of any one of the preceding claims, wherein the multi-layer film or laminate comprises at least one layer composed of a mycelium-based material or an algae-based polymer film.11 . The compostable multi-layer primary packaging of any one of the preceding claims, wherein the multi-layer film or laminate comprises at least 80 wt% of biodegradable and compostable polymers based on the total weight of the laminate.

12. The compostable multi-layer primary packaging of any one of the preceding claims, wherein the multi-layer film or laminate remains structurally and functionally stable for at least 3 years under ambient storage conditions.

13. The compostable multi-layer primary packaging of any one of the preceding claims, wherein the multi-layer film or laminate is configured to be processed in a flow wrapping machine.

14. The compostable multi-layer primary packaging of any one of the preceding claims, wherein the sealed packaging is tamper-proof by virtue of a high sealing strength that causes visible damage upon attempted opening.

15. The compostable multi-layer primary packaging of any one of the preceding claims, wherein the multi-layer film or laminate comprises a printed surface including product identification, batch number, expiry date, and dosage strength.

16. The compostable multi-layer primary packaging of claim 1 , wherein the multilayer film or laminate comprises: an outer layer comprising a cellulose-based film; an intermediate layer comprising a starch-based film or a cellulose-based film; and an inner layer comprising a PLA-based film, configured for direct contact with the medicinal product.

17. The compostable multi-layer primary packaging of claim 16, wherein each of the outer, intermediate, and inner layers is home compostable.

18. The compostable multi-layer primary packaging of claim 16 or 17, wherein the PLA-based inner layer is formulated to meet leachables and extractables requirements for pharmaceutical use.

19. The compostable multi-layer primary packaging of claim 1 , wherein the multilayer film or laminate comprises: an outer layer comprising a cellulose-based film; an intermediate layer comprising a mycelium-based material or an algae-based polymer film; andan inner layer comprising a PLA-based film, configured for direct contact with the medicinal product.

20. The compostable multi-layer primary packaging of claim 19, wherein the intermediate layer comprises a mycelium-based material selected from Mycoflex™ or a similar fungal composite.21 . The compostable multi-layer primary packaging of claim 19 or 20, wherein the intermediate layer comprises an algae-based polymer selected from alginate, agar, carrageenan, or algal cellulose.

22. The compostable multi-layer primary packaging of any one of claims 19 to21 , wherein the outer layer comprises NatureFlex™.

23. The compostable multi-layer primary packaging of any one of claims 19 to22, wherein the laminate is configured for industrial composting in accordance with EN 13432.

24. A method for wrapping individual solid dosage units of a medicinal product using a compostable multi-layer primary packaging film or laminate, comprising the steps of: a) providing a compostable multi-layer primary packaging comprising a multilayer primary packaging film or laminate according to any one of the preceding claims; b) feeding the multi-layer primary packaging film or laminate into a film wrapping machine, wherein the multi-layer film or laminate is configured to be formed around the individual solid dosage units of the medicinal product; c) placing individual solid dosage units of the medicinal product onto the multilayer primary packaging film or laminate as it moves through the film wrapping machine; and d) sealing the multi-layer film or laminate around each individual solid dosage unit by applying heat and / or pressure to create a hermetic seal, thereby ensuring an airtight and moisture-resistant barrier.

25. The method of claim 24, comprising the steps of: a) providing a compostable multi-layer primary packaging comprising a multilayer primary packaging film or laminate according to any one of claims 1-23; b) feeding the multi-layer primary packaging film or laminate into a flow wrapping machine, wherein the multi-layer film or laminate is configured to be formed into a continuous tubular shape around the individual solid dosage units of the medicinal product; c) placing individual solid dosage units of the medicinal product onto the multilayer primary packaging film or laminate as it moves through the flow wrapping machine; d) sealing the multi-layer film or laminate around each individual solid dosage unit by applying heat and / or pressure to create a hermetic seal, thereby ensuring an airtight and moisture-resistant barrier; and optionally e) cutting the continuous tubular film into individual packages, each containing an individual solid dosage unit of the medicinal product; and f) collecting the individually wrapped solid dosage units for further handling, storage, or distribution.

26. An individual solid dosage unit of a medicinal product wrapped and hermetically sealed in a compostable multi-layer primary packaging according to any one of the preceding claims.