System components dosage control

In addition to providing data to show that a proposed container closure system is suitable for its intended use, an application should also describe the quality control measures that will be used to ensure consistency in the packaging components. These controls are intended to limit unintended postapproval variations in the manufacturing procedures or the materials of construction for a packaging component and to prevent adverse elfects on the quality of a dosage form. 

All chemical feed systems (gas, liquid, dry) have several components in common (Figure 2-1). All chemicals must be conveyed (delivered) to the process water flow, dispersed into the water, and their dosage controlled consistently and accurately. 

Pressurized metered dose inhalers are still the most frequently used systems and they have proven their value in therapy. However, their application in early phases of biopharmaceuti-cal research and further development of dosage forms seems less convenient, since they require special components including propellants, special containers, metering valves, and controlled filling conditions (pressure-filling or cold-filling). 

Another example of an excipient-excipient interaction that can be used to our advantage is the one between xanthan gum and locust bean gum (carob gum or cer-atonia) in the presence of water. This interaction forms the basis of the identification test for Xanthan Gum NF. The interaction creates a much more viscous gel system than can be created using either component alone. This has been used in the formulation of controlled release oral solid dosage forms in the TimeRx drug delivery system (11). 

An accurate statement of the weight or measure of each component, using the same weight system (metric, avoirdupois, or apothecary) for each component Reasonable variations may be permitted, however, in the amount of components necessary for the preparation in the dosage form, provided they are justified in the master production and control records ... 

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