Product Line Extensions

Solid oral dosage forms containing new chemical entities (NCEs) are commonly formulated into tablets or capsules as their first market image formulation. Subsequent drug product line extension development on these NCEs may evaluate more specialized drug delivery systems. Dissolution testing of standard oral tablets or capsules will commonly utilize the paddle or basket apparatus. In this chapter we focus primarily on the development and subsequent validation of dissolution testing methods that use these two devices. 

Until only a few years ago, a company intending to market a new drug product in the EU would submit a national NDA in each country in which authorization was sought. While national procedures may still be used in limited situations, such as for approval of product line extensions, a firm must choose the mutual recognition or centralized system. (We will not discuss the approval process for generic products.)... 

Other applications for chewing gum formulations include delivery of antacids such as calcium carbonate, antiemetics for travel sickness, and vitamins and minerals. However, the potential for a buccal delivery, a fast onset of action, and the opportunity for product line extension makes it an attractive alternative delivery form for other applications. 

Once the first NCE product has been approved by the government regulatory agency, additional products (Product Line Extensions, or PLEs) are often developed. Requests for PLEs usually come from Marketing and Sales, but ideas can come from any employee/department, particularly from Product R D. Regulatory approval of most PLEs is less demanding than for NCEs, e.g., there are fewer safety and clinical experiments. 

Table 6 Example of potential confusion due to product line extensions...

Data on the history of revenues and unit sales volume for drugs coming off patent in each of the study years are presented in figures F-3 and F-4. Substantial differences were recorded in the pattern of revenue and unit volume loss across these subsamples, although originator sales and unit volume declined in all but one cohort of drugs. The sales volume for the 1986 cohort actually increased after patent loss. This was primarily due to verapamil s product line extension. 

Because patent expiry for a racemate tends to proliferate the drug as generics, product line extension for an existing racemate technology can be obtained by switching to a single stereoisomeric form (the racemic switch). This is an incentive to produce the drugs in their pure enantiomeric forms. 

Marketed product Line extensions, new package, new manufacturing site, new vendors Phase IV... 

---