Packaging for the reconstitution of oral medicines: current solutions and future innovations
Reconstituting drugs is common practice in the pharmaceutical industry that involves mixing a powder with a liquid to create a ready-to-use oral suspension. This process is essential to ensure the stability and effectiveness of the active ingredient, which might otherwise degrade if stored in liquid form for long periods. Traditionally, reconstitution requires the patient to manually add a diluent - usually water - to the powder following specific instructions. However, there are also simpler and more straightforward of preparation and administration methods, and packaging can play a vital role in ensuring the effectiveness of the reconstitution process and the drug itself.
Traditional packaging solutions for reconstitution
In today's market, there are various packaging solutions designed to simplify the reconstitution process and ensure dosing accuracy. The most common of these are:
- Bottles with powder and measuring cup These bottles are sold with a powder containing the active ingredient. At the time of use, a diluent (usually water) is added to a level indicated on the bottle. A measuring cup is supplied to dose the correct amount of suspension.
- Single-dose sachets: sachets containing single-dose powder are a practical and very common solution. The patient simply needs to mix the powder with a specified amount of liquid at the moment of administration.
- Dosing syringes: these are mainly used for paediatric patients. Syringes allow the required suspension dose to be accurately measured after reconstitution.
Possible difficulties in traditional reconstitution
- Choice and use of solvent: in most cases, patients are responsible for choosing the drug’s solvent and dosage. This is particularly problematic in countries with little access to drinking water, where the purity and safety of water for reconstitution are crucial. Patients are often unaware that different pharmaceutical processes require specific types of water (such as purified or distilled water) and using unsuitable water can compromise drug efficacy.
- Incorrect or inaccurate dosage: another common error during reconstitution is that of dosage. Accidental errors occur when instructions for dosing water or powder are not followed correctly, often due to distractions or inaccuracies in measuring instruments. ‘Intentional' mistakes can result from mistaken beliefs, such as adding more water than necessary to increase the volume of the product, with the idea of saving money. In both cases, the use of inadequate amounts of water compromises drug efficacy, increasing the risk of toxicity or reducing the efficacy of the active ingredient.
Reconstitution errors often result from packaging design, which leaves too much room for patient interpretation. With standard modes, the powdered drug is packaged in a bottle and the solvent, usually water, has to be added manually. In some cases, the solvent is supplied separately by the pharmaceutical company; in others, it is not included, leaving the patient to choose the correct solvent and dosage.
Dual-chamber solutions: a step forward
Dual-chamber solutions is a significant innovation in the field of drug reconstitution packaging. This type of packaging allows oral medicines to be reconstituted directly inside the container, following a simple guided procedure. Thanks to the two separate chambers, the active ingredients and the solvent remain isolated, providing greater protection and extending the product's shelf life.
The dual-chamber system usually includes a plastic bottle containing the solvent and a cap that contains the powder. When the container is sealed, neither the solvent nor the powder is accessible, preventing the patient from altering the preset doses. The integrity of the product is guaranteed by a tamper-evident ring, which must be removed to allow reconstitution. After removing the ring, the patient simply screws the cap on, thus releasing the powder into the solvent. The drug is fully reconstituted safely and precisely by simply shaking the bottle.
These solutions can be designed for both single and multiple doses, adapting to different administration needs.
Quality and advantages of dual-chamber systems
- Improved drug stability: by separating the active ingredient from the diluent, stability of the drug is significantly improved. This is particularly important for drugs that are moisture- or light-sensitive, which could rapidly degrade in solution.
- User-friendly: the dual chamber solution design makes the reconstitution process simple and intuitive. One press or rotation of the container is enough to automatically mix the two components, reducing the risk of errors.
- Accurate dosing: reconstitution takes place directly inside the container, eliminating the need for transfers that could result in product loss or inaccurate dosing. Pre-dosed ingredients ensure precise reconstitution, with no margin for error.
- Contaminant reduction: by keeping powder and liquid separate until use, the risk of microbiological contamination is reduced, ensuring greater product safety.
Innovation and new packaging solutions for drug reconstitution
The evolution of drug reconstitution packaging continues to be fuelled by the need for safety, precision and convenience. Recent technological progress is paving the way for new possibilities, including:
- Smart packaging The incorporation of digital technologies can lead to the development of 'smart' packaging that provides visual or audible instructions for reconstitution, monitoring drug use and even connecting to mobile devices to track the administered doses. One example is Bormioli Pharma's 'eTune', a smart closure device that can be applied to double-chamber systems, which offers visual guidance on correct use and, when connected to an app, acts as an information tool.
- Barrier materials The use of advanced materials to improve protection against external agents such as moisture, thereby increasing product durability and stability.
- Customised solutions: close collaboration between pharmaceutical companies and drug manufacturers enables the development of tailor-made solutions, adapted to the specific needs of both the drug and the patient, through expert advice and targeted design approaches.
The packaging sector for the reconstitution of oral medicines is evolving rapidly to meet the increasing demands for safety, precision and user-friendliness. While traditional solutions have adequately served their purpose, innovations such as dual chamber packaging represent a significant step forward, improving not only drug stability but also the overall user experience.
Looking ahead, the adoption of digital technologies in packaging, the development of advanced barrier materials and the creation of customised solutions through collaboration between pharmaceutical companies and packaging manufacturers promise to further revolutionise the industry. These advances represent a major opportunity to improve patients' quality of life and optimise therapy management, paving the way for a future in which drug administration is increasingly safe, simple and precise.