In the dynamic landscape of the pharmaceutical industry, packaging solutions play a pivotal role in enhancing drug administration and improving patient outcomes. Among the cutting-edge packaging innovations, dual-chamber systems have emerged as a valuable solution with the potential to transform the pharmaceutical supply chain. This article delves into the concept of dual-chamber solutions, highlighting some of the multifaceted possible benefits they could offer in terms of streamlining the supply chain, optimising logistics, extending drug shelf life and championing sustainability.
Unveiling the Dual-Chamber Concept
Dual-chamber systems are ingeniously designed to facilitate the reconstitution of oral medications within a single device. Comprising a bottle and a capsule, these systems feature an internal reservoir. The reservoir holds the APIs, typically in powdered form, while the bottle contains the solvent, usually water, required for reconstitution. Activating the reconstitution process involves a simple action by the patient, who rotates the capsule, thereby opening the reservoir and allowing the powder to descend into the bottle. A gentle shake of the bottle ensures the complete mixing of the powder and liquid, resulting in a fully reconstituted medication. This versatile packaging solution finds applicability in both multidose and single-dose medicines. At the moment dual-chamber packaged drugs are usually administered orally, but potentially this concept could be expanded to other administration routes, such as for example parenteral, ophthalmic and topical.
This versatile packaging solution finds applicability in both multidose and single-dose medicines
Unlocking Supply Chain Advantages
Dual-chamber solutions are present in the pharma packaging since decades, with Bormioli Pharma being one of the innovators in this niche proposing them to pharmaceutical and nutraceutical clients since the 70s. In about 50 years of experience, Bormioli Pharma can suggest some potential benefits that pharma manufacturers could leverage on in respect to conventional solutions. These advantages include:
- Flexible Drug Manufacturing: The inherent design of the dual-chamber system empowers pharmaceutical manufacturers with the ability to split the filling process between different facilities. By filling the reservoir at one location and subsequently shipping it to a final production site closer to the target distribution network, manufacturers could be able to strategically optimize their operations. For instance, a pharmaceutical company producing in Europe can dispatch compact and lightweight reservoirs to the US, or vice versa, enabling on-site assembly and filling. This approach reduces shipping costs and lead times, ensuring a more agile and efficient supply chain.
- Enhanced Storage Conditions: The segregation of the powder and liquid components within dual-chamber solutions could bestow superior stability upon pharmaceutical products. This heightened stability allows for more flexible storage conditions, alleviating the burden of stringent temperature control. Consequently, inventory management becomes more manageable, particularly in environments where maintaining precise temperature conditions proves challenging.
- Streamlined Transport: The delicate nature of pharmaceutical formulations often necessitates meticulous temperature-controlled shipping. However, the advent of dual-chamber solutions simplifies the transportation process by offering increased stability to the products. This augmented stability empowers pharmaceutical companies to navigate more demanding transportation conditions and traverse longer distances, reducing the complexity and costs associated with logistics. The result is a potentially more secure and reliable delivery of medications, regardless of the challenges faced en route.
- Simplified Supplier Base and Raw Material Procurement: The separation of the APIs from the liquid component within dual-chamber systems holds the potential to enhance drug preservation and reduce the need for preservatives. This reduction in preservatives translates into a decrease in the quantity of raw materials required for formulation. Additionally, the incorporation of barrier materials within the reservoir ensures optimal protection against moisture, enabling a further reduction in the required amount of APIs. This streamlined approach simplifies the supplier base and enhances the efficiency of raw material procurement processes, contributing to a more sustainable and cost-effective supply chain.
- Prolonged Shelf Life and Reduced Deliveries: One of the notable advantages offered by dual-chamber solutions is the extension of shelf life for pharmaceutical products. With the improved stability and separate storage of components, the need for frequent replenishment is minimized. This translates into fewer deliveries required to maintain adequate stock levels at retail locations, resulting in reduced transportation costs and environmental impact.
The separation of the APIs from the liquid component within dual-chamber systems holds the potential to enhance drug preservation and reduce the need for preservatives.
Advanced solutions to enhance protection against atmospheric agent
Reconstitution also needs enhanced drug protection. Powder, indeed, by its very nature, is highly sensitive to moisture and a failure to protect the powder can result in a loss of drug efficacy, particularly when it comes to particularly sensitive APIs. In particular, moisture can interact with the stability of the drug causing changes in the chemical structure of the formulation (e.g. oxidation, hydrolysis) or in the physical structure (e.g. polymorphism), or causing microbial growth.
That’s why pharma packaging manufacturers are developing dedicated solutions to understand, address and tackle the challenges presented by reconstitution – namely complexity, dosage errors, poor safety features and APIs protection – by the design of brand new, innovative packaging solutions.
These solutions can feature an active barrier technology, able to maximize moisture performances on a multiple scale compared to standard dual-chamber solutions available on the market.
Enhanced moisture solutions are identical to standard dual-chamber systems, featuring also an active material layer in the chamber containing the APIs, regulating the level of moisture in the container below safety levels, enhancing performances and the product shelf life. These products are not just concepts, being already available for industrial production in different formats featuring different moisture absorption performances.
Development margins and innovation
Moreover, these solutions present high margins of further development towards new applications as well as customization. That’s what happened for example to a specific concept developed by Bormioli Pharma, Plug, a dual-chamber system – composed by a specific device containing the solvent and by a bottle containing the API. The system is able to defend the integrity of the formulation throughout the supply chain in any condition, allowing drug reconstitution and the extraction with a syringe in the safest way, avoiding the use of needles that could hurt end consumers or professional users.
This concept has been first presented in international trade fairs, and then to customers and prospects in private meetings, gathering growing interest by the audience. That’s why a specific product development strategy has been implemented, also relying on external subjects. A primary pharma manufacturer has then expressed the will to further customise the container, meaning with it the transformation of the original concept to address the specific needs of the drug.
The container has been then reengineered to address the actual needs in terms of materials, liquid to be hosted, measures, simplification – reducing the number of components - and identification of a brand new user experience. Finally, further analysis has been undertaken to verify the feasibility of industrialisation of the process, that is currently ongoing.
The system is able to defend the integrity of the formulation throughout the supply chain in any condition, allowing drug reconstitution and the extraction with a syringe in the safest way
A solution addressing sustainability growing demand
In line with the growing global emphasis on sustainability, pharmaceutical manufacturers are actively embracing eco-friendly practices in packaging. The dual-chamber systems are no exception.
Bormioli Pharma relies on over 15 years of research into more responsible packaging solutions for the pharma industry, and has introduced – as industrial products – EcoPositive, a new range including environmentally conscious solutions, manufactured with recycled glass and plastics, bio-based polymers and glass and advanced polymer products made from reusable materials. Dual-chamber bottles are already available, for example, in rPET, decreasing the impact on the environment.
Moreover, the use of sustainable materials mitigates the fact that some formulations necessitate single-dose packaging, which cannot be eliminated entirely.
Conclusion
As the pharmaceutical industry continues to evolve, the role of packaging in simplifying the supply chain and fostering collaboration among stakeholders becomes increasingly crucial. Dual-chamber solutions offer remarkable potential to streamline manufacturing processes, optimise logistics, prolong shelf life, and champion sustainability. By embracing these innovative packaging solutions, pharmaceutical manufacturers can unlock numerous benefits, ranging from increased flexibility and reduced transportation complexities to enhanced patient safety and improved environmental stewardship. Through collaborative efforts and ongoing research, the industry can pave the way for a more efficient, sustainable, and patient-centric future. With each advancement in dual-chamber systems, we embark on a transformative journey toward a more streamlined and resilient pharmaceutical supply chain.