Ensuring Pharmaceutical Product Stability and Efficacy with Intelligent Sorbents
A sound packaging strategy requires the integration of all operations responsible for a product’s life cycle, from formulation to packaging and transportation and ultimately to consumer use. Factors critical to extending shelf life and protecting a drug product’s physical and chemical stability include the drug product’s chemical properties; the ingress rate of moisture, oxygen, and/or hydrocarbons through and contained within a package; the design of a package; and the choice of active packaging components. The end result is a solution that can quickly bridge the expertise gap that too often exists between formulation chemists and packaging engineers.
This approach, called Calculations through Operations, builds upon Quality by Design (QbD) principles. QbD aims to ensure a predetermined level of quality in manufacturing so that consumer risk is minimized while overall production efficiency is enhanced. For manufacturers, integrating verifiable QbD standards can not only lower costs and streamline production, but also provide potential regulatory flexibility. If quality control systems can be verified early in the production cycle, the timeline for bringing new pharmaceutical products to market could be reduced significantly.
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Incorporating Intelligent Sorbents
The Calculations through Operations approach incorporates sophisticated packaging simulation modeling that can help formulation chemists and packaging engineers identify the right conditions to ensure the stability and potency of a drug product. This tool, referred to as pseudo-empirical modeling, can be performed early in the drug development process, guiding production decisions and helping to avoid costly errors that could prove to be roadblocks to production.
The data derived from the use of pseudo-empirical modeling ensure the development of the right active packaging solution, which takes into account the drug product, its chemistry, delivery system, and required shelf life. Referred to as the “operations” component of the Calculations through Operations concept, the process of integrating a sorbent solution into a drug product’s packaging presentation is critical to maintaining drug formulation efficacy and stability.
In most cases, the goal of a sorbent is to prevent chemical and/or physical drug product degradation from taking place within a pharmaceutical package. However, with new pharmaceutical formulations and packaging configurations coming onto the market, sorbents are required to become intelligent. Rather than simply serving as a moisture absorber, sorbents must fit the role of environmental managers, providing a specific range or steady-state level of protection to pharmaceutical packaging that is increasingly taking different and more innovative shapes.
An intelligent sorbent is designed to provide a precise management outcome, which could be controlling the level of moisture, oxygen, and/or hydrocarbons in a pharmaceutical packaging system. A sorbent might be used to maintain a specific humidity range to maintain a drug’s stability or reduce or eliminate volatilized hydrocarbons. It’s sometimes necessary for a sorbent to carry out multiple protective functions.
There are several factors which are contributing to the use of intelligent sorbents including:
New Formulation Technologies
In the case of some solid-oral dose products, for example, proprietary sustained-release, targeted-release, rapid release, and tamper-resistant formulation technologies are being employed for both new and existing drug substances. Many of these products have very specific chemical and physical stability challenges. As a result, manufacturers may need to incorporate intelligent sorbents to manage oxygen or hydrocarbons as well as moisture.
Drug-Device Combination Products
For certain drug-delivery combination products such as dry-powder inhalers and active transdermal drug-delivery systems, intelligent sorbents are essential to ensuring physical and chemical stability of the products’ throughout primary shelf life as well as consumer use.
Combination Drug Products
In regards to combination drug products, where two drug substances are combined in a single dosage form, formulations can be quite complex and often require very specific sorbent functions. Multifunctional intelligent sorbents can be employed to meet the needs of such formulations.
Ensuring Quality Early in the Development Process
To help pharmaceutical manufacturers navigate through the production process and make intelligent packaging choices, a packaging vendor should be consulted early in the manufacturing process. An enormous amount of R&D resources are spent on drug discovery and development, yet too often active packaging decisions are considered much later in the product development process.
A packaging vendor that uses pseudo-empirical modeling can predict drug stability outcomes well in advance and help pharmaceutical companies identify and integrate solutions for challenging physical and chemical stability issues.
This article was written by Adrian Possumato, Global Director, Healthcare Packaging, Multisorb Technologies. Multisorb will be exhibiting in Booth A11 at Pharmapack 2010. In the Pharmapack session on Packaging and Delivery: Pulmonary, Nasal, and Ophthalmic Forms, Possumato will be presenting “Advanced Pharmaceutical Products Call for Intelligent Sorbents.”
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