Field of the Disclosure
The present disclosure relates generally to pharmaceutical compositions, and more particularly, to pharmaceutical compositions natural components for treating ear diseases.
Background Information
An example of an ear disease is cauliflower ear, which is a deformity of the ear that results from an untreated aural hematoma. The fluid-filled swelling of the hematoma is often caused by chronic allergies and ear infections, and becomes firm and thickened over time, thus resulting in the cauliflower ear. Ear infections may lead to hematomas. Hematomas in the earflaps (aural hematomas) cause swelling that is created by a broken blood vessel after bleeding has occurred inside a tissue.
The cartilage of the ear has no other blood supply except that supplied by the overlying skin. When the skin is pulled from the cartilage and/or separated from the cartilage by blood (as with accumulated blood from injury or inflammation or infection), the cartilage is deprived of important nutrients. Ultimately, the cartilage dies and the risk of infection is increased. Additionally, an untreated ear infection leads to head shaking of the affected subject that breaks blood vessels within the earflap. An aural hematoma occurs when the blood accumulates within the cartilage layers of the ear. The earflap may partially or completely swell with the blood vessel and block off the ear canal; therefore, the earflap feels fluid-filled. Hematomas in the earflaps are found not only in humans but also in animals (e.g., in dogs with long, floppy ears). Generally, in mammals, hematomas do not heal without treatment.
Treatment of ear hematomas in mammals begins by identifying and treating the underlying condition that promoted the swelling (e.g., ear infection or the presence of mites). A conventional technique employed to reduce the hematoma is the needle aspiration. A drawback of employing aforementioned procedure is that the hematoma usually re-forms. Therefore, the veterinarian usually performs surgery on the ear to ensure the hematoma does not come back. The surgery generally involves making an S-shaped incision on the surface of the ear, and flushing out the blood and clots that caused the swelling. Common treatments for ear diseases include topical or transdermal compositions with active pharmaceutical ingredients (APIs) that are in contact with the swollen or infected tissue, but these topical or transdermal compositions cause irritation on the ear tissue. Conventional topical or transdermal compositions for ear diseases require long treatment periods of about 6 months to a year in order to see improvement of the ear condition.
Additionally, cartilage damage may result from piercing the upper ear in the cartilage. Piercing can lead to a type of ear cartilage infection called auricular perichondritis, which can result in cauliflower ear. Another cause of cauliflower ear results from the inflammation of ear cartilage in relapsing polychondritis.
FIG. 1 is a graphical representation illustrating a canine ear anatomy. In FIG. 1, canine ear anatomy 100 includes vertical canal 102, horizontal canal 104, and tympanic membrane 106. Canines have very unique ear anatomy and ear canals are difficult to treat because of its shape. Vertical canal 102 takes a short turn in order to end up in horizontal canal 104; and horizontal canal 104 ends up in tympanic membrane 106. The average volume of a dog's ear canal is generally filled with about 1.5 mL. Conventional otic preparations generally have a dosage of about 4 to 6 drops, or about 6 to 10 drops once or twice a day; therefore, since about 20 drops are needed to make one mL, dosages of 10 drops or less are not enough to fill the vertical canal 102 or the horizontal canal 104 of a dog. Consequently, there is a need for delivering the right amount of otic compositions needed to fill in the ear canals. Furthermore, some animals tend to shake out the otic composition from their ear after the otic composition has been delivered; therefore, the treatment may not be effective.