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New approaches to packaging protection for solid-dose drug formulations.

It is an industry axiom that the number one threat to solid dosage stability is moisture and its effect on increasing molecular mobility. As such, incorporating desiccants into packaging for moisture control has been a long-established practice. An array of new solid dose drug formulations, however, can reasonably be described as unstable ... and therefore require special protection beyond the "traditional" moisture-controlling desiccant or oxygen scavenger. Drug manufacturers have shelved a number of molecules that are particularly moisture-sensitive or highly oxidative during the past 10-20 years because they could not be stabilized through reformulation and/or traditional packaging protection options. Thus, many promising drugs have been stopped in the pipeline for years!

Fortunately, manufacturers now have a number of new active packaging options to protect increasingly unstable pharmaceutical/ nutraceutical formulations. Desiccants, themselves, are undergoing expanded usage and new applications. Technologies in moisture and oxygen control are helping to extend product shelf-life, improve brand quality and, most importantly, enable the marketing of health and drug products that had previously been considered too unstable. This includes the use of desiccants to reduce the rate of moisture-mediated oxidation.

As the science of packaging protection evolves to meet new market demands, this article examines some new options and how they reflect changes and new challenges in the nutraceutical and pharmaceutical industry.

New Desiccant Formats

Traditional desiccant formats for solid dosage forms are sachets and canisters. Although there is no question that these will continue to dominate the market worldwide, some new formats are, quite literally, taking shape. The canister format, although widely popular, has disadvantages that warrant consideration. Take the mould, for example; any imperfections--such as a hanging lip--can get caught up in desiccant insertion equipment and cause a jam. Also, canisters formed from two parts that are snapped together can break open under the extreme pressures experienced during production runs. Similar equipment jams are frequently associated with delaminated canister labels. If machinery jams, or if a canister breaks open and contaminates a product line, this results in downtime and lost productivity.

One new desiccant that offers an alternative is the coated solid format (CSF). Using compression technology, coated solids replace loose-fill formats by concentrating silica gel, activated carbon or a combination of both to protect against degradation and adsorb volatilized hydrocarbons. A compressed solid, while having equivalent performance to traditional canisters, has no lid, eliminating any potential contamination from loose-fill desiccants spilling onto packaging lines. Because it can be shaped exactly like a canister, it can be substituted using existing dispensing equipment.

As the name implies, these formats are coated, and coatings are formulated to be smooth. This means there are no edges to get caught in machinery ... and the coatings prevent any chalking or residue.

Concentrating Protection for Drug Formulations

A coated solid format is attracting attention from pharmaceutical manufacturers for reasons beyond production line efficiency, however. New drug formulations that are unstable may require high levels of protection. The standard operating procedure has been to increase the number of canister or packet drops per bottle, but this can become an impractical and expensive strategy. Because coated solids are compressed, the format offers twice the protection in the same dimensional space that a traditional desiccant canister provides. For products that require especially high levels of desiccant, this format thus provides a cost-effective and efficient packaging solution.

Handling Highly Oxidative Compounds

Manufacturing companies have risked losing a growing number of promising drug candidates before they go into clinical trials because of severe oxidation. A good example of an oxidative formulation includes new, reduced dosage hormone replacement drugs. For drugs such as these, traditional oxygen absorbers will not work in an HDPE package because they do not absorb moisture ingress through the bottle. Moisture ingress leads to excessive hydration, negatively affecting tablet dissolution.

To meet this challenge, new intelligent oxygen scavengers have been developed for products that strictly oxidize, enabling manufacturers to achieve drug stability without necessitating formulation changes. These new oxygen scavengers are unique because they are preloaded with a certain level of moisture. That may seem counterintuitive, as the goal is to reduce moisture, but for these scavengers some moisture is required to act as a catalyst for the oxygen removal process. Typically, there is not much moisture in a pharmaceutical product, so by preloading oxygen scavengers with moisture, they act as effective oxygen absorbers in solid-dose HDPE bottle presentations. The moisture that comes in through the bottle continues the reaction, so a desired humidity level can be maintained in packaging.

[ILLUSTRATION OMITTED]

This represents a more advanced technology than traditional oxygen scavengers because it removes oxygen while maintaining a specific, equilibrium-relative humidity within the package environment. The result: a product once considered too unstable can now be marketed.

Getting the Right Packaging Solution

Many of the new chemical entities being investigated today are very unstable and may suffer from chemical attrition via multiple pathways of degradation. It stands to reason that as a result of this degradation, packaging protection needs to become more specific as well. The fact that new and better protection options are on the market clearly benefits drug manufacturers; however, it is more important than ever to rely on the scientific and engineering resources of packaging professionals. Desiccant and oxygen absorption options have been reformulated to keep pace with the new drug formulations entering the market. The trick is to make sure your packaging protection formulation is the right one.

About the Author

Adrian Possumato is the Pharmaceutical Market Business Development Leader with Multisorb Technologies, Inc. (Buffalo, New York, USA). He works closely with drug innovators and generic pharmaceutical manufacturers in their R&D, quality, regulatory, engineering and manufacturing departments to determine the best selection of packaged sorbents to stabilize pharmaceutical formulations. He has more than 15 years of experience in the pharmaceutical and chemical industries.

Tel. +1 908 849 3005

apossumato@multisorb.com

www.multisorb.com
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Title Annotation:technology
Author:Possumato, Adrian
Publication:Nutraceutical Business & Technology
Geographic Code:1USA
Date:May 1, 2008
Words:978
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