Rivastigmine patch for long-term administration
The present invention relates to a patch comprising a high content of rivastigmine per unit area, which can be continuously administered for a long time. The rivastigmine patch according to the present invention is capable of continuous release of rivastigmine for a long period of time, preferably 3 days, more preferably 4 days or more after attachment, and has excellent physical and chemical stability.
1. A rivastigmine patch for transdermal treatment comprising a backing film; a rivastigmine matrix layer comprising rivastigmine; a self-adhesive matrix layer comprising an adhesive that adheres to the skin; and a release liner that is removed before use,
wherein the content per patch area of the rivastigmine is 5.4 to 15 mg/cm 2 based on the rivastigmine free base,
the rivastigmine matrix layer comprises a hydrophobic silica,
the self-adhesive matrix layer does not include a rubber-based adhesive polymer, and
the hydrophobic silica comprises silica dimethyl silylate.
2. The rivastigmine patch of claim 1 , wherein the content per patch area of the rivastigmine is 5.4 to 10.8 mg/cm 2 based on the rivastigmine free base.
3. The rivastigmine patch of claim 2 , wherein the content per patch area of the rivastigmine is 5.4 to 9 mg/cm 2 based on the rivastigmine free base.
4. The rivastigmine patch of claim 1 , wherein the content of the hydrophobic silica is 10-50% by weight based on the total weight of the rivastigmine matrix layer.
5. The rivastigmine patch of claim 4 , wherein the rivastigmine matrix layer comprises 10-50% by weight of the rivastigmine, 5-30% by weight of the hydrophobic silica, and 30-80% by weight of an acrylic adhesive based on the total weight of the rivastigmine matrix layer.
6. The rivastigmine patch of claim 5 , wherein the acrylic adhesive is a random copolymer of 58-66 parts by weight of 2-ethylhexyl acrylate, 28-36 parts by weight of methyl acrylate, and 4-8 parts by weight of acrylic acid.
7. The rivastigmine patch of claim 4 , wherein the content per patch area of the rivastigmine is 5.4 to 10.8 mg/cm 2 based on the rivastigmine free base.
8. The rivastigmine patch of claim 4 , wherein the content per patch area of the rivastigmine is 5.4 to 9 mg/cm 2 based on the rivastigmine free base.
9. The rivastigmine patch of claim 1 , wherein the rivastigmine matrix layer further comprises an antioxidant.
10. The rivastigmine patch of claim 1 , wherein the rivastigmine patch comprises a release-controlling membrane that is an ethylene vinyl acetate film between the rivastigmine matrix layer and the self-adhesive matrix layer.
11. The rivastigmine patch of claim 1 , wherein the self-adhesive matrix layer comprises a mixture of two or more silicone adhesives having different physical properties.
12. The rivastigmine patch of claim 1 , wherein the rivastigmine patch is capable of continuous release of rivastigmine for at least 3 days after attachment.