Composition and device structure for iontophoresis
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experimental example 1
A Preparation Example when Aminoalkylmethacrylate Copolymer E is Used as a pH Adjusting Agent
[0133] Experimental Example 1 shows a preparation example when aminoalkylmethacrylate copolymer E is used as a pH adjusting agent. The pH of a preparation in this Experimental Example was adjusted to around 4.5-6.5. In this step, hydrochloric acid was charged to add chloride ion as a reactant with an active electrode.
example 1
[0134]
5 Component Content (%(w / w)) Fentanyl citrate 1.00 Agar 1.00 Aminoalkylmethacrylate copolymer E 5.60 Hydrochloric acid 0.55 Methyl para-oxybenzoate 0.20 Distilled water for injection Appropriate amount Total 100.00
[0135] Fentanyl citrate, aminoalkylmethacrylate copolymer E and hydrochloric acid were added to distilled water and stirred until these were dissolved. Further, agar and methyl para-oxybenzoate were added with stirring followed by heating at about 90.degree. C. to dissolve. After cooled near to about 60.degree. C., about 0.8 g of this solution was charged into an electrode cup made of polyethylene terephthalate (thereinafter, abbreviated as PET). The pH of the prepared formulation was 4.9.
experimental example 2
Influence of Aminoalkylmethacrylate Copolymer E Affecting Aniontophoresis-Releasing Test of Fentanyl Citrate
[0140] Next, using the above described formulations (Example 1 and Comparative Example 2), a releasing test by iontophoresis was performed. Using a sideways type cell in the releasing test, 3% (w / w) agarose gel (3 mm) was used as a release control layer. The experiment was conducted at a room temperature, and after electrically energizing with current for 1 hr, the drug amount transferred into a receptor layer was measured by high-performance liquid chromatography. The electrically energizing with current was performed at 0.2 mA / cm.sup.2 constant-current for 1 hr of the total energizing time using direct-current energizing for pulse depolarization (50 kHz frequency, 50% duty) by a short-circuit switch. FIG. 2 is a graph showing the results of the releasing test of fentanyl citrate by iontophoresis. As clarified from FIG. 2, the releasing amount of fentanyl by ionyophoresis is ...
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