Hydrogel compositions demonstrating phase separation on contact with aqueous media
A composition and phase separation technology, applied in the field of hydrogel compositions of tooth whitening agents, can solve the problems of harming patients and doctors, and achieve the effect of easy modification and simple preparation and operation
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[0147] Melt extrusion is the preferred method when a viscous hydrogel composition is desired, although solution casting can still be used. Solution casting is preferred for the preparation of substantially non-tacky compositions. Furthermore, melt extrusion can be used with any of the compositions of the present invention. Also, melt extrusion or solution casting techniques may be used to prepare translucent compositions, although solution casting is generally preferred for these embodiments. Accordingly, another embodiment of the present invention is a method of forming a composition comprising the steps of: melt processing a water-swellable water-insoluble polymer or a water-soluble polymer, a hydrophilic polymer, a mixture of a complementary oligomer capable of hydrogen bonding to the hydrophilic polymer and a second water-swellable water-insoluble polymer to form an extruded composition; extruding the composition as a film of desired thickness on On a suitable substrate,...
Embodiment 1
[0177] Preparation of solid compositions
[0178] One embodiment of a tooth whitening composition is prepared using melt extrusion from the following ingredients:
[0179] Eudragit L-100-55 9% by weight
[0180] PVP90 44% by weight
[0181] PEG 22% by weight
[0182] Hydrogen peroxide 6% by weight
[0183] Water, stabilizer, pH adjuster 19% by weight
[0184] The ingredients were melt processed in a Brabender single screw extruder as follows: Eudragit L-100-55 was first fed into the extruder at a temperature of 100-150°C, followed by the addition of PVP90 and PEG. The composition was extruded between two polyethylene terephthalate release liners to a thickness of 0.35 mm. The hydrogen peroxide solution was added to the extruded film.
Embodiment 2
[0186] Release of hydrogen peroxide from solid compositions in vitro
[0187] The release of hydrogen peroxide from the tooth whitening composition of the present invention in a buffer solution of pH 7.0 was studied in vitro, and compared with the commercially available product Crest Whitestrips TM (Proctor & Gamble Co., Cincinnati, OH product, referred to as "Crest product") peroxide release comparison. Crest products contain 5.3% hydrogen peroxide in Carbopol 956 gel on polyethylene film.
[0188] The release of hydrogen peroxide from compositions containing 3%, 6% or 9% peroxide (formulated as described in Example 1) was compared in vitro with the release of hydrogen peroxide from Crest products. Peroxide from the test composition or Crest product is released into solution through the filter paper and the peroxide is determined using standard analytical techniques. For the Crest product, the observed peroxide levels dropped to baseline within about 30 minutes. This data ...
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