Healthcare Articles

 

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Excerpts from an exclusive Interview with Mr. Adrian T. Possumato, Vice President, Healthcare Packaging, Multisorb Technologies.

 

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Published in Tablets and Capsules

pharmaceutical manufacturers seek to fill dwindling pipelines, they are developing new chemistries that are sometimes difficult to stabilize over the desired shelf life. Traditional moisture management alone is often insufficient, because many new drug products exhibit multiple, different degradation pathways. This article reviews how degradation occurs and how sorbents work...

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For in vitro diagnostic manufacturers, sorbents play a critical role in maintaining the device’s integrity.

As the face of healthcare in the U.S. changes under the Patient Protection and Affordable Care Act (ACA), in vitro diagnostic (IVD) device manufacturers will likely find themselves faced with an increased demand for diagnostic, monitoring, and screening devices. This need, coupled with the pressure healthcare professionals will face to deliver efficient results, will push device...

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Intelligent sorbents can remove moisture-induced dosing inconsistencies and protect the drug stability profile of moisture sensitive drugs.

Inhalation therapy has become a commonly used method for drug delivery as it offers several advantages over conventional delivery methods, including precise dosing, speed of action and convenience. Pressurized metered dose inhalers (pMDIs) and drypowdered inhalers (DPIs) are two common devices used for targeted delivery of an active drug ingredient into the lungs...

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Pseudo-empirical modeling

Packaging Journal interviewed Adrian Possumato, VP Healthcare Packaging,  to discuss current trends in oxygen and moisture management with regards to pharmaceutical packaging. Adrian discussed not only the current trends but also challenges with determining the correct sorbent to stabilize drug products, the benefits of adopting a QBD approach, and the benefits of using pseudo-empirical modeling. 

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FDA’s Center for Drug Evaluation and Research (CDER) established Quality by Design (QbD) principles because manufacturing efficiencies in the pharmaceutical industry were not as state-of-the-art as in others. QbD seeks to increase quality and efficiency while decreasing waste and the need for intensive regulatory oversight. QbD is defined as the systematic design of product formulations and related manufacturing processes to ensure a predefined quality by understanding how the variables in formulation and manufacturing affect the quality of a finished drug product. It ensures that the risks consumers face are minimized while production efficiency is enhanced. Drug industry packaging...

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For drugs susceptible to oxidative degradation, pseudo-empirical modeling can often provide a better indication of long-term stability compared to ICH accelerated testing.

Pharmaceutical companies undoubtedly all share a common and intense focus on drug stability. Each drug candidate will be evaluated at very early stages of the development process to determine its inherent stability and susceptibility to degradation caused by exposure to temperature, humidity, oxygen, and light. Formal stability studies are required to ensure that a drug product will maintain its safety, quality, efficacy, and physical and chemical characteristics throughout...

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Moisture and volatile substances can severely impact the quality, safety, and shelf life of pharmaceutical products, and incorporating packaging protection is a critical aspect of the manufacturing cycle. There are a number of active sorbents available to help maintain pharmaceutical integrity. Using compression technology, a new coated solid sorbent offers up to twice the protection in the same dimensional space that a traditional desiccant canister provides. Because of its smooth shape, the new form offers additional processing and line advantages for manufacturers...

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Novel formulations and drug-delivery systems require optimized packaging protection.

Dropping a sorbent into pharmaceutical packaging is the traditional approach for preventing product damage from moisture and maintaining shelf life and product efficacy. However, new formulations and packaging configurations, coupled with the ever-present pressures to speed new drugs to market, are requiring that sorbents become intelligent. Rather than simply serving as a moisture absorber, sorbents need to fill the role of environmental managers. They need to provide a specific range or steady-state level of protection to pharmaceutical packaging that is increasingly taking...

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Novel formulations and drug-delivery systems require optimized packaging protection.

Dropping a sorbent into pharmaceutical packaging is the traditional approach for preventing product damage from moisture and maintaining shelf life and product efficacy. However, new formulations and packaging configurations, coupled with the ever-present pressures to speed new drugs to market, are requiring that sorbents become intelligent. Rather than simply serving as a moisture absorber, sorbents need to fill the role of environmental managers. They need to provide a specific range or steady-state level of protection to pharmaceutical packaging that is increasingly taking...

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Pharmaceutical stability and sorbent technology can be calculated in advance.

Formulation chemists put a great deal of ingenuity into today’s pharmaceutical products. Even so, drug product formulations today are often less stable than their predecessors, and longevity can be compromised by inadequate protection. Packaging conditions are an important factor in ensuring the safety and potency of a product throughout its shelf life. However, performing tests to identify the ideal packaging requirements can be complex. Without a strategic approach to drug packaging and testing, there can be delays in bringing a new product to market...

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The movement for Quality by Design (QbD) has the potential to significantly streamline the development and approval for pharmaceuticals. A pilot program from FDA (started in July 2008) has gained headlines and many drug developers are now seriously considering the concept.

Quality by Design (QbD) is a systematic approach of reaching quality standards by looking at the entire developmental system and product life cycle. It brings to the forefront some of the essential, yet often overlooked elements of quality assurance throughout the stability profile of a drug product...

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Multisorb's Adrian Possumato addresses new technologies in sorbents and desiccants and how packaging solutions are changing to meet industry needs.

We’re seeing an increased use of sorbents (i.e., desiccants, oxygen absorbers, hydrocarbon absorbers) and intelligent sorbents, which are designed to provide a specific management outcome by controlling the level of moisture, oxygen, and/or hydrocarbons in a pharmaceutical packaging system...

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The right approach to calculating your protection needs.

Pharmaceuticals are subject to a variety of degradation pathways that compromise drug safety and shelf-life. By far the greatest degradation is caused by hydrolysis and oxidation. However, other mechanisms include racemization, photodegradation, elimination, and complexation. A number of active packaging components are available to help maintain pharmaceutical integrity; however, determining the optimal solution requires a calculated analysis that joins the expertise of packaging engineers and pharmaceutical formulation chemists...

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Exubera - the first inhaled form of insulin for treatment of diabetes - made headlines when it received FDA approval earlier this year because it promises to free diabetics from the discomfort and intrusiveness of mealtime injections. It is a dry powder form of insulin that is inhaled into the lungs prior to eating, using a specially designed inhalation device. To succeed in the emerging market for inhalation therapies, pharmaceutical manufacturers need to understand the design and production challenges unique to this form of drug delivery...

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Drug development costs are rising and pharmaceutical companies cannot afford to make mistakes in late-stage development — especially when it comes to packaging.

Drug products subjected to degradation because of environmental stresses can be salvaged if proper packaging and protection is provided by sorbents. By the time the drug product is handed from the formulation chemists to the packaging engineers, mechanisms of degradation, such as hydrolysis, oxidation, dehydration, isomerization, racemization, elimination and photodegradation, are usually known. It is then up to the packaging engineers to plan...