Sorbents represent a class of active packaging components that can be used to guard against the effects of degradation, ensuring the integrity of packaged pharmaceuticals and other environmentally sensitive products. The author answers some common questions and discusses the benefits of active packaging to ensure product stability.
Q: What are some of the key threats to product stability?
A: Pharmaceuticals and other products are subject to a variety of degradation pathways that compromise safety and shelf-life. By far the greatest degradation is caused by hydrolysis and oxidation. There are a number of packaging components available to help maintain product integrity; however, determining the optimal solution requires a calculated analysis drawing on diverse areas of expertise.
It’s critical when determining a degradation-prevention program that manufacturers consider the whole manufacturing and packaging process, from the pharmaceutical formulation to the packaging environment and to the distribution chain. What might work in one part of the operation may not work at another end — solutions determined upstream may have unintended consequences downstream.
When developing the optimum package protection, the best approach to take is a multidisciplinary one that considers the knowledge and experience of packaging engineers, formulation chemists, analytical chemists, and the sorbent supplier.
Q: How do companies implement moisture management into their packaging?
A: Protecting a product from degradation is a critical component of manufacturing success, and packaging considerations are key. Choosing your packaging components requires careful strategy and considering the “big picture.” The bottom line is to consider the whole spectrum of factors involved in product degradation, and every aspect of upstream and downstream processing. Calculating these factors with a modeling system, supported by a knowledgeable partner, can lead to a more shelf-stable and safer product.
Q: Can a sorbent solution be customized to meet the specific demands of customers?
A: Certainly. As part of a systems approach, every aspect of moisture control can be customized to meet the needs of a customer. Packaging solutions must consider all facets of the manufacturing and development processes.
To optimize package protection for solid-dose formulations, pharmaceutical manufacturers need to employ a technique of moisture and oxygen ingress modeling to analyze the rates of degradation for a given pharmaceutical. Chemical degradation pathways can cause a loss of pharmaceutical potency after several weeks, whereas two to three years of shelf-life may be required depending on distribution channels. Modeling also determines steady-state levels of oxygen within bottles and moisture permeation across bottle walls, and material permeability.
As far as packaging is concerned, equipment can be customized to meet the needs of several markets. For instance, the pharmaceutical industry is driven by the need for positive placement verification. As such, several levels of verification can be provided to guarantee that the sorbent has been placed properly into the bottle, package, etc.
Q: What trends do you anticipate in the future for sorbent technologies?
A: Respiratory drug delivery systems that employ dry powder inhalation (DPI) devices are a significant new trend, offering clinical benefits, dosage control, and patient convenience. Integrating sorbent technologies into DPI devices will preserve the quality and safety of pharmaceutical formulations and ensure that the device functions accurately and effectively each time it is used. Because proper desiccation is an integral part of DPI device functioning, the choice of sorbent is crucial. Packaging components that respond to changes in the head-space of packaging relative to outside conditions provide an ideal solution. They regulate humidity levels within a DPI device without making contact with the dry powder and optimize conditions for drug delivery.
A new generation of desiccants — coated solid format (CSF) sorbents — is particularly well suited for DPI applications because they significantly increase the level of functional desiccation per unit volume. Through condensed density technology, CSF sorbents are able to deliver twice the moisture protection in the same dimensional space as a typical loose-fill desiccant. CSF sorbents can be made from silica gel, activated carbon, or a combination of both.
Overall, when evaluating the desiccation requirements for inhalation devices, pharmaceutical manufacturers should consider the interactions between drug formulation, device, and packaging. They must also consider all of the sources of moisture, including the plastic from which a device is manufactured and any inserts or other components of the package. It is only once these factors are taken into consideration, that manufacturers can make the best decision regarding the most appropriate sorbent technology for DPI applications.
Adrian Possumato is the global manager,pharmaceutical market with Multisorb Technologies,Inc.(Buffalo,NY).He works closely with drug innovators and generic pharmaceutical manufacturers to determine the best selection of packaged sorbents to stabilize pharmaceutical formulations.He has over 15 years of experience in the pharmaceutical and chemical industries.He can be reached at apossumato@multisorb.com,tel.908-849-3005,fax 908-849-3006.
Q: What are some of the key threats to product stability?
A: Pharmaceuticals and other products are subject to a variety of degradation pathways that compromise safety and shelf-life. By far the greatest degradation is caused by hydrolysis and oxidation. There are a number of packaging components available to help maintain product integrity; however, determining the optimal solution requires a calculated analysis drawing on diverse areas of expertise.
It’s critical when determining a degradation-prevention program that manufacturers consider the whole manufacturing and packaging process, from the pharmaceutical formulation to the packaging environment and to the distribution chain. What might work in one part of the operation may not work at another end — solutions determined upstream may have unintended consequences downstream.
When developing the optimum package protection, the best approach to take is a multidisciplinary one that considers the knowledge and experience of packaging engineers, formulation chemists, analytical chemists, and the sorbent supplier.
Q: How do companies implement moisture management into their packaging?
A: Protecting a product from degradation is a critical component of manufacturing success, and packaging considerations are key. Choosing your packaging components requires careful strategy and considering the “big picture.” The bottom line is to consider the whole spectrum of factors involved in product degradation, and every aspect of upstream and downstream processing. Calculating these factors with a modeling system, supported by a knowledgeable partner, can lead to a more shelf-stable and safer product.
Q: Can a sorbent solution be customized to meet the specific demands of customers?
A: Certainly. As part of a systems approach, every aspect of moisture control can be customized to meet the needs of a customer. Packaging solutions must consider all facets of the manufacturing and development processes.
To optimize package protection for solid-dose formulations, pharmaceutical manufacturers need to employ a technique of moisture and oxygen ingress modeling to analyze the rates of degradation for a given pharmaceutical. Chemical degradation pathways can cause a loss of pharmaceutical potency after several weeks, whereas two to three years of shelf-life may be required depending on distribution channels. Modeling also determines steady-state levels of oxygen within bottles and moisture permeation across bottle walls, and material permeability.
As far as packaging is concerned, equipment can be customized to meet the needs of several markets. For instance, the pharmaceutical industry is driven by the need for positive placement verification. As such, several levels of verification can be provided to guarantee that the sorbent has been placed properly into the bottle, package, etc.
Q: What trends do you anticipate in the future for sorbent technologies?
A: Respiratory drug delivery systems that employ dry powder inhalation (DPI) devices are a significant new trend, offering clinical benefits, dosage control, and patient convenience. Integrating sorbent technologies into DPI devices will preserve the quality and safety of pharmaceutical formulations and ensure that the device functions accurately and effectively each time it is used. Because proper desiccation is an integral part of DPI device functioning, the choice of sorbent is crucial. Packaging components that respond to changes in the head-space of packaging relative to outside conditions provide an ideal solution. They regulate humidity levels within a DPI device without making contact with the dry powder and optimize conditions for drug delivery.
A new generation of desiccants — coated solid format (CSF) sorbents — is particularly well suited for DPI applications because they significantly increase the level of functional desiccation per unit volume. Through condensed density technology, CSF sorbents are able to deliver twice the moisture protection in the same dimensional space as a typical loose-fill desiccant. CSF sorbents can be made from silica gel, activated carbon, or a combination of both.
Overall, when evaluating the desiccation requirements for inhalation devices, pharmaceutical manufacturers should consider the interactions between drug formulation, device, and packaging. They must also consider all of the sources of moisture, including the plastic from which a device is manufactured and any inserts or other components of the package. It is only once these factors are taken into consideration, that manufacturers can make the best decision regarding the most appropriate sorbent technology for DPI applications.
Adrian Possumato is the global manager,pharmaceutical market with Multisorb Technologies,Inc.(Buffalo,NY).He works closely with drug innovators and generic pharmaceutical manufacturers to determine the best selection of packaged sorbents to stabilize pharmaceutical formulations.He has over 15 years of experience in the pharmaceutical and chemical industries.He can be reached at apossumato@multisorb.com,tel.908-849-3005,fax 908-849-3006.
