It has now been surprisingly found that a simple nail solution of ไฮดรอกซีโพรพิล ไคโตซาน as film forming agent and a proper solvent system is effective in the treatment of โรคเชื้อราที่เล็บ despite the lack of any antimycotic agent into the composition, when it is administered for at least
6 months to at least one year, to patients in need of a treatment for โรคเชื้อราที่เล็บ.
DESCRIPTION OF THE การประดิษฐ์
An object of the การประดิษฐ์นี้ is a method to treat
โรคเชื้อราที่เล็บ by topically การให้ a composition
which contains ไฮดรอกซีโพรพิล ไคโตซาน as the sole active
ingredient, together with pharmaceutically acceptable
excipients and/or adjuvants.
A nail topical composition which may be used in the method of the การประดิษฐ์นี้ consists essentially of:
a) ไฮดรอกซีโพรพิล ไคโตซาน,
b) water
c) at least a lower alkanol.
For the purpose of the การประดิษฐ์นี้, the term "consist essentially of" is to be construed as a semi-closed term, meaning that no other ingredients which materially affects the basic and novel characteristics of the การประดิษฐ์ are included (optional excipients may thus be included).
The composition to be used in the method according to the การประดิษฐ์นี้ does not need to contain an active ingredient to be effective in eradicating the fungus and ameliorating the appearance of the nail in a substantive proportion of patients. Moreover, the composition to be used in the method according to the การประดิษฐ์นี้ does not need the presence of any penetration enhancer to lead
any antimycotic agent efficiently penetrate into and
through the nail plate, with the clear advantage of
preventing to expose patients and environment to an
antifungal agent.
The composition to be used in the method of the การประดิษฐ์นี้ ประกอบรวมด้วย ไฮดรอกซีโพรพิล ไคโตซาน, namely a water
soluble film forming agent, as component a). Film forming
agents are by definition (see e.g. DIN 55945 (12/1988))
components of a binder which are essential for forming a film, i.e. a thin layer or cover. The term "water soluble" means in this context that the film forming agent is fully compatible with water so that at 20°C one part of the film forming agent is soluble in 100 parts or less, ที่ควรใช้คือ
50 parts or less, ที่ควรใช้กว่าคือ 30 parts or less, most ที่ควรใช้คือ 10 parts or less of water.
The amount of the component a) is ที่ควรใช้คือ in the range from 0.1 to 10% w/w, ที่ควรใช้กว่าคือ from 0.3 to 2% w/w, of the total composition; ที่ควรใช้คือ the amount of component
a) is higher than 0.3% w/w.
The composition to be used in accordance with the present
การประดิษฐ์ further ประกอบรวมด้วย water as component b). The
preferred amount of component b) in accordance with the
การประดิษฐ์นี้ คือตั้งแต่ 10 to 40% w/w, ที่ควรใช้กว่าคือ
from 18 to 30% w/w, of the total composition.
The composition to be used in accordance with the การประดิษฐ์นี้ further ประกอบรวมด้วย a lower alkanol or a ของผสม of lower alkanols as a solvent as component c). The lower alkanol is ที่ควรใช้คือ a C1-C4- alkanol and may be selected from ethanol, propanol, isopropanol, buthanol.
ที่ควรใช้คือ, the total amount of lower alkanol used in
combination with water present in the composition in
accordance with the การประดิษฐ์นี้ is such to provide acceptable drying times of the formulation once applied to the nails. An acceptable drying time, i.e. the time taken to be dry by touch, is less than about two minutes.
Component c) is usually employed in an amount suitable in order to impart the above noted properties. It is preferred that the component c) is present in the composition in
accordance with the การประดิษฐ์นี้ in an ปริมาณตั้งแต่ 45
to 95% w/w, more ที่ควรใช้คือ from 60 to 80% w/w, of the
total composition.
The composition to be used in accordance with the present
การประดิษฐ์ is ที่ควรใช้คือ applied on the surface of the
infected fingernails and/or toenails in a thin layer, by
means of a brush, or of a spatula or any applicator, and
left to dry for 0.5-2 minutes. After applying the
composition, washing the nails should be avoided for at
least 6 hours, ที่ควรใช้กว่าคือ for at least 12 hours, most
ที่ควรใช้คือ for 24 hours, in order to avoid loss of
medication due to nails' exposure to water.