The Gastrointestinal Transit and Systemic Absorption of Diltiazem HCL from a Modified Release Dosage Form

Abstract

The primary means of administration for the vast majority of therapeutic agents is via the oral route. Many of these oral dosage forms are designed to provide a rapid disintegration in the stomach, however, over the last 5–6 years there has been a growing trend within the pharmaceutical industry to develop complex pharmaceutical dosage forms designed to deliver drug in a controlled or timed released manner after oral administration. The design of these modified release (MR) drug products is intended to optimize the therapeutic regimen by providing slow continuous delivery of drug over the entire dosing interval while also providing greater patient compliance and convenience. The development of these MR dosage forms has also placed demands on the pharmaceutical industry to design and utilize new methodologies to assess the performance of these products in vivo. Likewise, regulatory agencies are faced with the arduous task of reviewing the performance of these new drug products to assure that the dosage forms perform as expected. The task of demonstrating the performance of the dosage form is the responsibility of the sponsoring pharmaceutical company.