Biodissolvable film for localized and efficient treatment of vulvodynia
View Patent ↗Provided are biodissolvable films for localized treatment of a disorder of the female genital tract. The biodissolvable films are made of polymers forming a film suitable for application to a tissue of a female genital tract, where the film has a mucoadhesive property. Such films further include an active ingredient integrated and/or loaded into the biodissolvable film. Methods of treating inflammatory, atrophic and/or irritative disorders, including Vestibulodynia (VBD), are also provided.
1 . A biodissolvable film for localized treatment of a disorder of the female genital tract, the biodissolvable film comprising an active ingredient integrated and/or loaded into the biodissolvable film, wherein the active ingredient comprises lidocaine hydrochloride (LHC);
wherein the biodissolvable film is prepared by (i) casting a formulation comprising the active ingredient and about 3% w/w high molecular weight (HMW) hydroxyethyl cellulose (HEC) to about 5% w/w HMW HEC to provide a wet cast film, wherein the HMW HEC is HEC with a molecular weight of about 250 kilodaltons, and (ii) drying the wet cast film to provide the biodissolvable film; and
wherein the biodissolvable film comprises a mucoadhesive property and forms a substantially u-shaped profile or substantially v-shaped profile, the substantially u-shaped or substantially v-shaped biodissolvable film configured for application to a vulvar vestibule of the female genital tract.
2 . The biodissolvable film of claim 1 , wherein the profile of the biodissolvable film is of a size ranging from about 3 cm to about 5 cm long, and about 2 cm to about 4 cm wide, wherein the biodissolvable film has a wet thickness of about 2, 3, 4 or 5 mm.
3 . The biodissolvable film of claim 1 , wherein the biodissolvable film is substantially biocompatible as defined by causing less than about 5% cell death and/or cell damage when exposed to a cell or tissue.
4 . The biodissolvable film of claim 1 , wherein the active ingredient is loaded at a rate of about 3% to about 12%.
5 . The biodissolvable film of claim 1 , wherein the biodissolvable film is configured to treat inflammatory disorders, atrophic disorders, pain disorders and/or irritative disorders of the female genital tract.
6 . The biodissolvable film of claim 1 , wherein the biodissolvable film is configured to treat Vestibulodynia (VBD).
7 . The biodissolvable film of claim 1 , wherein the LHC is loaded into the film at a rate of about 6% and wherein the film has a wet thickness of about 2 mm.
8 . The biodissolvable film of claim 1 , wherein the biodissolvable film is prepared by (i) casting a formulation comprising the active ingredient and about 5% w/w HMW HEC to provide a wet cast film having a thickness of about 2 mm, and (ii) drying the wet cast film to provide the biodissolvable film.
9 . The biodissolvable film of claim 1 , wherein the biodissolvable film exhibits 100% release of the active ingredient in 5 minutes in simulated vaginal fluid (SVF).
10 . A method of treating an inflammatory, atrophic, painful, and/or irritative disorders of the female genital tract, the method comprising:
providing a subject in need of treatment; and
applying a biodissolvable film of claim 1 to the subject, wherein the biodissolvable film is applied to the vulvar vestibule of the subject.
11 . The method of claim 10 , wherein the inflammatory, atrophic, painful and/or irritative disorder comprises Vestibulodynia (VBD).
12 . A biodissolvable film for localized treatment of a disorder of the female genital tract, the biodissolvable film comprising an active ingredient integrated and/or loaded into the biodissolvable film, wherein the active ingredient comprises lidocaine hydrochloride (LHC) loaded into the biodissolvable film at a rate of about 12%;
wherein the biodissolvable film is prepared by (i) casting a formulation comprising the active ingredient and about 7% w/w hydroxypropyl cellulose (HPC) to about 9% w/w HPC to provide a wet cast film having a wet thickness of about 4 mm or 5 mm and (ii) drying the wet cast film to provide the biodissolvable film; and
wherein the biodissolvable film comprises a mucoadhesive property and forms a substantially u-shaped profile or substantially v-shaped profile, the substantially u-shaped or substantially v-shaped biodissolvable film configured for application to a vulvar vestibule of the female genital tract.
13 . The biodissolvable film of claim 12 , wherein the profile of the biodissolvable film is of a size ranging from about 3 cm to about 5 cm long, and about 2 cm to about 4 cm wide.
14 . The biodissolvable film of claim 12 , wherein the biodissolvable film is substantially biocompatible as defined by causing less than about 5% cell death and/or cell damage when exposed to a cell or tissue.
15 . The biodissolvable film of claim 12 , wherein the biodissolvable film is prepared by (i) casting a formulation comprising about 9% w/w HPC and about 12% w/w LHC to provide a wet cast film having a thickness of about 5 mm and (ii) drying the wet cast film to provide the biodissolvable film.
16 . The biodissolvable film of claim 12 , wherein the biodissolvable film exhibits an extended release duration of the active ingredient in simulated vaginal fluid (SVF), wherein the extended release duration is about 120 minutes.
17 . A method of treating an inflammatory, atrophic, painful, and/or irritative disorders of the female genital tract, the method comprising:
providing a subject in need of treatment; and
applying a biodissolvable film of claim 12 to the subject, wherein the biodissolvable film is applied to the vulvar vestibule of the subject.
18 . The method of claim 17 , wherein the inflammatory, atrophic, painful and/or irritative disorder comprises Vestibulodynia (VBD).