Lopinavir and ritonavir for the treatment of cervix disorders
The present invention concerns pharmaceutical compositions formulated for topical application that are useful in the treatment of HPV-related pathologies and in particular the treatment of premalignant and malignant conditions of the cervix. The compositions comprise a therapeutically effective amount of lopinavir and ritonavir in a pharmaceutically acceptable vehicle and wherein the weight ratio (w/w) of lopinavir:ritonavir is between 9:1 and 18:1.
1 . A pharmaceutical composition that is formulated for topical application comprising a therapeutically effective amount of lopinavir and ritonavir in a pharmaceutically acceptable vehicle and wherein the weight ratio (w/w) of lopinavir: ritonavir is between 11:1 to 12:1.
2 . The composition according to claim 1 wherein the composition comprises an effective amount of lopinavir and ritonavir for treating a Human Papilloma Virus (HPV) infection with or without attendant abnormal pathology.
3 . The composition according to claim 1 for use as a medicament for treating and/or inhibiting the development of early stage neoplasias.
4 . The composition according to claim 1 for use as a medicament for treating or preventing the development of HPV related cervical neoplasias.
5 . The composition according to claim 1 wherein the composition is formulated as an ointment, gel, paste, cream, lotion, ovule, soft capsule, suppository, pessary, or any combination thereof.
6 . The composition according to claim 1 wherein the pharmaceutically acceptable vehicle is an ointment.
7 . The composition according to claim 6 wherein the composition is an anhydrous composition for topical application comprising:
(a) Lopinavir and ritonavir in a weight ratio of between 11:1 to 12:1; and
(b) a hydrophilic muco-adhesive agent;
wherein upon topical administration of the anhydrous composition to a site of application the anhydrous composition transforms into a muco-adhesive composition.
8 . The composition according to claim 7 wherein the muco-adhesive agent is hydroxypropylmethylcellulose.
9 . The composition according to claim 7 comprising ritonavir, lopinavir, hydroxypropylmethylcellulose, oleic acid, stearic acid; and butylated hydroxytoluene.
10 . The composition according to claim 6 wherein the composition comprises:
(a) an unsaturated free fatty acid;
(b) a stiffening agent; and
(c) lopinavir and ritonavir in a weight ratio of between 11:1 to 12:1;
wherein the unsaturated free fatty acid is present at a level of at least 20% by weight of the total pharmaceutical composition weight and wherein the pharmaceutical composition is a semi-solid at room temperature.