Drug product release

FIGURE 3 Drug product release method. USP apparatus II (paddle) at 75 RPM, pH 6.8 phosphate buffer + 0.75% SDS. 

Our formulation development activities we developed both a biorelevant dissolution method, and a drug product release method. At this point in development, all of our formulation development activities are complete, making the biorelevant method less important. The formulation(s) is fixed, and we are now concerned with demonstrating that we can consistently manufacture batches of drug product. We will also want to show that the release characteristics of the dosage unit do not change on stability. Oiu" drug product release method will fulfill this role and will be the primary dissolution method, until the method conditions need to be revisited when in vivo data become available from om first clinical studies. At that time, the method should be revisited to evaluate how biorelevant our in vitro data are. 

This system assures overall compliance with cGMPs and internal procedures and specifications. The system includes the quality control unit and all of its review and approval duties (e.g. change control, reprocessing, batch release, annual record review, validation protocols, and reports, etc.). It includes all product defect evaluations and evaluation of returned and salvaged drug products. 

Non-fiber-releasing filter means any filter, which after any appropriate pretreatment such as washing or flushing, will not release fibers into the component or drug product that is being filtered. All filters composed of asbestos are deemed to be fiber-releasing filters. 

Storage of released components, drug product containers, ciosures, and iabeiing ... 

Quarantine storage before release of drug products ... 

Control of the release rate of the drug from the drug product... 

The optimized drug product may be viewed as a drug-delivery system for the one or more drugs that it contains. The goal of this drug-delivery system is to release the drug(s) to produce the maximum simultaneous safety, effectiveness, and reliability, as depicted in Fig. 9. Various physicochemical product properties that influence the quality features of safety, effectiveness, and reliability are shown in Table 6. Some physicochemical properties can affect two or all three quality features of Fig. 9. For example, consider chemical stability. As a drug decomposes, if the... 

Before treating the various classes of sustained- and controlled-release drug-delivery systems in this chapter, it is appropriate to note that drug delivery may be incorporated in other chapters where the various classes of drug products and routes of administration are discussed. In addition, the reader is referred to Chapter 14 on target-oriented drug-delivery systems. 

The section on components deals with all materials that may be used in the manufacture, processing, and packaging of drug products, plus materials used for maintenance of the building and equipment. They must be stored and handled in a safe, sanitary, and orderly manner. These precautions are needed to prevent mix-ups and cross-contamination of drugs and drug products. All items should be held until they have been sampled and tested according to the company s specifications and not released until the tests have been completed. In this section it is required that ... 

K. K. Midha, M. J. Rawson, and J. W. Huhban, Pre-scribability and switchability of highly variable drugs and drug products, J. Controlled Release, 62, 33 (1999). 

V. P. Shah, J. S. Elkins, and R. L. Williams, Evaluation of the test system used for in vitro release of drugs for topical dermatological drug products, Pharm. Dev. Tech., 4, 377 (1999). 

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