Product design administration routes

Intravenous aqueous injections provide an excellent means of achieving a rapid therapeutic response. Parenteral product design, e.g., vehicle and other excipient selection, as well as choice of route of administration, can prolong therapeutic activity and increase onset times, Thus, oily solutions, suspensions, or emulsions can be administered by subcutaneous or intramuscular routes to create prolonged effect, i.e., depot injection. 

The routes of administration must also be taken into account in the assessment of firstly how to package the product and secondly how to protect it from all the hazards mentioned earlier. There might be special cases in compound packs where the fragility of an administration device has to be considered, as well as the risk to the product. These administration routes affect the overall design of the package and the protection necessary in warehousing or distribution. 

Type of Study Study Location of Objective(s) Identifier Study Report of the Study Study Design and Type of Control Test Product(s) Dosage Regimen Route of Administration Number of Subjects Healthy Subjects or Diagnosis of Patients Duration of Treatment Study Status Type of Report... 

A dosage form is a medicated product specially designed for administration depending upon the routes to the patient for the diagnosis and treatment of disease. 

The following discussion will focus on how to apply the previously discussed concepts to the validation of marketed products. To provide a fuller understanding of this procedure, the manufacture of several dosage forms designed for different routes of administration will be examined. For each dosage form, critical process steps and quality control tests will be identified. Useful statistical techniques for examining the assembled data will be illustrated. It is also important to note that not all of the collected information for a product lends itself to this type of analysis. This will become more apparent as we proceed with the evaluation of the five drugs under consideration. 

Enhancement in drug delivery and absorption via a specific route of administration often becomes essential in the design of novel pharmaceutical products and new therapies. On the one hand, biotechnological therapeutic molecules usually require enhancers for their successful administration by noninjectable modes alternatively, for the more efficient delivery of conventional drugs, other routes that overcome the disadvantages of traditional administration may also require additional augmentation. 

When assessing the potential routes of administration, one must consider the physicochemical properties of the drug, its ADMET properties, the therapeutic indication, and the patient population, some of which are discussed below. Table 1 provides a list of some of those factors that must be addressed when determining the most favorable route of administration and the subsequent formulation for delivery. Ideally the route of administration and subsequent formulation will be optimized after identifying critical design parameters to satisfy the needs of patients and health care professionals alike while maintaining the safety and efficacy of the product. 

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