| 摘要 |
A hydrophilic matrix is disclosed which comprises:;a) at least one polyacrylic acid derivative in preferred amounts of 0.5-40%,;b) at least one cellulose ether in preferred amounts of 30-90% and;c) at least one disintegrant in preferred amounts of 2-50%,;with respect to the weight of the matrix.;This matrix is used in combination with at least one pharmaceutically acceptable active principle for manufacturing solid bioadhesive controlled release formulations for the treatment of vaginal disorders, such as vulvovaginal candidiasis, bacterial vaginosis or trichomoniasis.;According to a preferred embodiment, the matrix is used in amounts of about 5-60% and the active principle in amounts of about 2-70%, with respect to the weight of the formulation. |
| 主权项 |
1. A method for the treatment of female genital disorders in a patient in need of such a treatment, wherein the female genital disorder(s) selected from the group consisting of genital hypotrophy, genital atrophy, genital loss of elasticity, vaginal dryness and/or a cervical and/or vaginal infection caused fungi, bacteria, protozoa or viruses, which method comprises administering to the patient a bioadhesive controlled release monolithic tablet containing a hydrophilic matrix, wherein the matrix is present in an amount of 20-40% with respect to the weight of the tablet, said hydrophilic matrix comprising:
a) at least one polyacrylic acid polymer, wherein the polyacrylic acid polymer is present in an amount of 1-20% with respect to the weight of the matrix; b) at least one cellulose ether, wherein the cellulose ether is present in an amount of 40-80% with respect to the weight of the matrix; and c) a disintegrant which is cross-linked sodium carboxymethylcellulose, wherein the disintegrant is present in an amount of 5-40% with respect to the weight of the matrix; and at least one pharmaceutically acceptable active principle selected from the group consisting of antimycotic, antibiotic, antiviral, antimicrobial or chemotherapeutic agents and hormones, wherein the active principle is present in an amount of 5-50% with respect to the weight of the tablet. |
