A novel oral dosage form with drug independent formulation and variable controlled release

Abstract

A unique dosage form which uses a hydrophilic polymer was developed to provide for a predicable release of several drugs. This drug release could be optimized for controlled release using erosion. It can also be designed to release drug utilizing electrochemical processes. The accuracy of drug delivery in terms of dose and timing is of utmost importance for the patient’s health status and compliance. A well-designed drug delivery technology offers many advantages to the patient. These advantages include: reduction in dose frequency, reduction of drug side effects, reduced unwanted fluctuations in circulating drug levels, and a more uniform effect of the drug over time. The practice of drug delivery has been dramatically developed in the last decade including electronic controlled release innovative dosage forms. In this study the iontophoretic flux of ibuprofen was investigated using side- by-side diffusion cells. Iontophoresis is the process where electric current is applied to enhance transportation of drugs across the skin. The pH change was found to be an important factor in increasing the diffusion of the drug. The principle of using electric current as a driving force to control the drug release was initially demonstrated on an initial setup. Subsequently, a calcium binding polymer was the hydrogel used as a matrix to develop a new electric oral dosage form. The calcium binding polymer is produced in different forms. The production process of these forms suffers several limitations. In order to apply electric current in a practical way to the calcium binding polymer matrix a novel method was developed. The novel method also allowed for addressing the limitations related to the production process of the conventional dosage form made with this polymer. More uniform gel tablets in shape and size were produced. Different formulations were developed. Ibuprofen was the model drug initially used to investigate the factors that affected the release profiles of these tablets. A two-level, three-factor statistical design of experiments (DOE) was performed to evaluate the effect of those factors on certain responses. These responses included the release rate, time needed to release 80% of the model drug, and lag-time. A new formulation with certain adjuvants was developed. This formulation had the ability to release different kinds of drugs in a uniform release rate. A fail-safe tablet that can only release less than 20% of the drug in 24 hours was developed. The drug release was initiated only when the electric current was applied. This new electric dosage form was aimed to overcome the disadvantages related to conventional dosage forms such as the inability to supply drugs on demand.