Drug package process

This chapter will review some of the important methods for carrying out in vivo absorption and bioavailability studies, as well as attempt to provide an overview of how the information may be used in the drug discovery process. The chapter is aimed at medicinal chemists and thus will focus on the use of animals in discovery phase absorption, distribution, metabolism, and excretion/pharmacokinetic (ADME/PK) studies, rather than the design of studies that are for regulatory submission, or part of a development safety package. 

To gain FDA approval or license for marketing, a pharmaceutical product must be shown to be safe and effective for its proposed or intended use. The drug company or sponsor must also provide evidence to show that the processes and control procedures used for synthesis, manufacture, and packaging are independently validated to ensure that the pharmaceutical product meets established standards of quality. The overall effort from the inception of a new molecular entity and the establishment of analytical, scale-up, and quality control procedures, to the collection of safety and efficacy data for consideration by the FDA as part of an NDA or BLA, is called the drug development process. 

HDPE by itself is a safe plastic material on account of its chemical inertness and lack of toxicity . Film and containers made from HDPE are used on a large scale in food and drug packaging and HDPE has been used in prosthetic devices including hip and knee joint replacements. All these applications underscore polymer safety. If articles made of HDPE contain fillers, processing aids, and colorants, their toxic effects must be estimated separately. 

The system is used to monitor, control, or supervise a drug manufacturing or packaging process... 

The most logical way to ensure adequate light stability during the manufacturing and packaging process is to control the levels of iron present in the excipients in the formulation. Currently, iron content is controlled only in the sodium chloride that is used in the formulation (as <2ppm). Iron is not controlled in citric acid, sodium citrate, and the bulk drug substance, nor in water. The addition of iron specification controls for the solid components in the formulation are analyzed in Table 9. 

Manufacture. State the name and address of the manufacturer of the drug product. If more than one entity is involved in any part of the process, describe the responsibilities of each. Describe the manufacturing and packaging process for the finished dosage form. 

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