Highly stable, cost-effective, eco-friendly packaging for Standard Solution and Parenteral Nutrition drugs manufacturing.

Standard Solutions and Parenteral Nutrition (PN) are vital elements of effective healthcare for many patients. Delivered intravenously, they form part of a set of medical nutrition strategies that includes oral nutritional supplements and enteral feeding and are typically adopted when enteral strategies are either insufficient or unsuitable (due to, for example, coma or dysphagia). PN becomes essential when digestive function is severely compromised and its use is growing significantly, in line with increasing levels of cancer and the rising prevalence of malnutrition.

Standard Solutions, of sterilized water and salt or Water for Injection and glucose, are delivered for rehydration and to meet basic energy requirements, respectively. Parenteral admixtures, the large volume sterile infusions delivered to patients requiring PN, are substantially more complex and specified to completely fulfil nutritional requirements. They may incorporate a wide range of amino acids; carbohydrates e.g glucose, and lipids; electrolytes; trace elements and vitamins. Admixtures are industrially manufactured or prepared locally within the hospital under aseptic conditions. In hospital preparation is typically for direct administration; industrial products may require a substantially longer shelf life.*

Packaging associated with drug manufacturing of Standard Solutions and PN ranges from ampoules for individual substrate components, to large volume containers for ready-to-use aqueous solutions, through to options for all-in-one formulations that also incorporate lipids. The sterility, purity and stability of solutions and admixtures is a critical issue, since these parameters directly impact patient health. As with any infusion, particulate contamination is a major concern since the introduction of particulates can trigger severe health effects.

Glass packaging offers many important benefits for Standard Solutions and PN applications. These include:

• A high level of chemical stability to a wide range of components and solutions, including high concentration calcium and magnesium salt electrolyte solutions
• Excellent resistance to variability in temperature and humidity
• Ease of inspection during entire drug life cycle (from production to administration by a nurse).

SGD Pharma delivers a wide range of products for Standard Solutions and PN, primarily manufactured in Type II or Type I glass.

* M Barnett et al. ‘Basics in clinical nutrition: Parenteral nutrition admixtures, how to prepare parenteral nutrition (PN) admixtures’ e-SPEN, the European Journal of Clinical Nutrition and Metabolism (4) 2009