Iontotherapeutic device and process and iontotherapeutic unit dose

A lightweight, portable transdermal periodic iontotherapeutic device for transdermal administration of a systemically-effective amount of an ionized peptide pharmaceutical, which is adapted to be worn by a subject being iontotherapeutically treated, comprising:

• 1) a DC power supply capable of providing an iontotherapeutically effective and physiologically acceptable DC current in the range up to about 10 mA;
• 2) a periodic waveform generator electrically connected to the DC power supply and having integrated circuitry capable of providing a) a periodic waveform in the square, triangular, sinusoidal, trapezoidal, or combination thereof;
• b) an on/off ratio of 1/50 to 10/1;
• and c) a repetition frequency from about 10 Hz to about 50 kHz;
• 3) an output circuit electrically connected to said waveform generator which a) can provide a periodic DC current in a pre-selected waveform of said forms;
• b) monitors current intensity delivered;
• c) adjusts and maintains the current intensity within predetermined maximum and minimum levels and d) delivers the current to a reservoir electrode for iontotherapeutic transdermal administration of said peptide pharmaceutical;
• 4) a pharmaceutical reservoir electrode which can be preselected to be either the cathode or the anode depending upon whether the ionized pharmaceutical is anionic or cationic;
• said electrode having a receptacle adapted to receive a unit dose of said peptide pharmaceutical in which a peptide is in aqueous solution at a pH at least 1.0 pH unit below or above the isoelectric point of said peptide;
• said electrode with said received unit dose adapted to be placed in electrical contact with the intact skin to be treated iontotherapeutically;
• said electrode having a terminal to receive and to transmit through said unit dose the said DC periodic current and said unit dose adapted to be in electrical contact with said terminal;
• 5) receptor electrode adapted to be in electrical contact with the intact skin to be treated and forming with said pharmaceutical reservoir electrode a combination of anode and cathode electrodes;
• said electrodes electrically connected to said output circuit and providing when placed upon the skin of a subject being treated a current path through the intervening tissue of the subject being treated;
• and
• 6) a programmable control element electrically integrated within said device to preprogram and to control said iontotherapeutic administration on an automated basis.