IP Library › Granted Patent US 12,453,707
Granted Patent B2
US 12,453,707 · App. 18/367,869 · Granted Oct 28, 2025

Vaginal films

Inventor: Lisa Cencia Rohan (Pittsburgh, PA)
Assignee: UNIVERSITY OF PITTSBURGH—OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION
A61K9/7007A61K9/0031A61K9/0034A61K31/505A61K31/675A61K47/10A61K47/38A61P31/18
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 12,453,707
App. No.
18/367,869
Granted
Oct 28, 2025
Kind
B2
Abstract

Provided herein are stable, dissolvable films containing active ingredients, such as antimicrobial composition, antiviral compositions, or anti-retroviral compositions for intravaginal or intrarectal placement to provide prophylaxis against viral infections.

Claims (9)

1. A dissolvable film formed from an aqueous solution comprising 6% wt. hydroxyethyl cellulose, 6% wt. hydroxypropyl methyl cellulose, 2% wt. carboxymethyl cellulose, 0.5 to 2.4% wt. of a plasticizer, and a nucleoside reverse transcriptase inhibitor and lacking polyvinyl pyrrolidone, wherein said plasticizer is glycerin, and wherein said film comprises 10 mg or more of said nucleoside reverse transcriptase inhibitor as the only pharmaceutically active agent of said film.

2. The dissolvable film of claim 1 , wherein the nucleoside reverse transcriptase inhibitor comprises tenofovir or a pharmaceutically-acceptable salt thereof.

3. The dissolvable film of claim 1 , wherein the dissolvable film comprises 20 mg or more of said nucleoside reverse transcriptase inhibitor.

4. The dissolvable film of claim 1 , wherein the carboxymethyl cellulose is sodium carboxymethyl cellulose.

5. The dissolvable film of claim 1 , wherein the aqueous solution comprises 2% wt. glycerin.

6. The dissolvable film of claim 1 , wherein the nucleoside reverse transcriptase inhibitor is tenofovir.

7. The dissolvable film of claim 6 , wherein the tenofovir is tenofovir disoproxil.

8. The dissolvable film of claim 1 , wherein the dissolvable film comprises 30 mg or more of said nucleoside reverse transcriptase inhibitor.

9. The dissolvable film of claim 1 , wherein the aqueous solution further comprises 0.28% wt. sodium hydroxide.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 16, 2023
From: ROHAN, LISA CENCIA
To: UNIVERSITY OF PITTSBURGH - OF THE COMMONWEALTH SYSTEM OF HIGHER EDUCATION
Reel/Frame 065226/0001 →
Continuity (4)
Continuation 16494804
Provisional Application 62573437 · Oct 17, 2017
Provisional Application 62477164 · Mar 27, 2017
Related Publication 20240099986A1 · Mar 28, 2024
References Cited (34)
US 5587175A · Viegas · 1996 [cited by examiner]
US 11793765B2 · Rohan · 2023 [cited by examiner]
US 20110112292A1 · Phull · 2011 [cited by examiner]
US 20130216590A1 · Karim et al. · 2013 [cited by applicant]
US 20140128345A1 · Woodrow · 2014 [cited by examiner]
US 20200253885A1 · Rohan · 2020 [cited by applicant]
Akil et al (Pharmaceutical Research, Jul. 2014, vol. 32, pp. 458-468) (Year: 2014). [cited by examiner]
Agashe et al., “Quick Dissolving Vaginal Film Formulation for Tenofovir”, Poster, University of Pittsburgh, Magee-Womens Research Institute, Presented on Apr. 3, 2012, 1 page. [cited by applicant]
Baeten et al., “Antiretroviral Prophylaxis for Hiv Prevention in Heterosexual Men and Women,” N. Engl. J. Med., Aug. 2012, 367(5):399-410. [cited by applicant]
Bender Ignacio et al., “Oral and Vaginal Tenofovir for Genital Herpes Simplex Virus Type 2 Shedding in Immunocompetent Women: A Double-Blind, Randomized, Cross-Over Trial,” J. Infect. Dis., Dec. 2015, 212(12):1949-1956. [cited by applicant]
Bunge et al., “A Phase 1 Trial to Assess The Safety, Acceptability, Pharmacokinetics, and Pharmacodynamics of a Novel Dapivirine Vaginal Film,” J. Acquir. Immune Defic. Syndr., Apr. 2016, 71(5):498-505. [cited by applicant]
Coggins, “Women's Preferences Regarding The Formulation of Over-The-Counter Vaginal Spermicides,” AIDS, Jul. 1998, 12(11):1389-1391. [cited by applicant]
Dai et al., “Pharmacological Measures of Treatment Adherence and Risk of Hiv Infection in The Voice Study,” J. Infect. Dis., Feb. 2016, 213(3):335-342. [cited by applicant]
Dezzutti et al., “HIV-1 Infection of Female Genital Tract Tissue for Use in Prevention Studies,” J. Acquir. Immune Defic. Syndr., Aug. 2013, 63(5):548-554. [cited by applicant]
Hendrix et al., “Dose Frequency Ranging Pharmacokinetic Study of Tenofovir-Emtricitabine After Directly Observed Dosing in Healthy Volunteers to Establish Adherence Benchmarks (Hptn 066),” AIDS Res. Hum. Retroviruses, J… [cited by applicant]
Hendrix et al., “Mtn-001: Randomized Pharmacokinetic Cross-Over Study Comparing Tenofovir Vaginal Gel and Oral Tablets in Vaginal Tissue and Other Compartments,” PLoS One, Jan. 2013, 8(1):E55013. [cited by applicant]
International Preliminary Report on Patentability in International Appln. No. PCT/US2018/024505, mailed on Oct. 10, 2019, 9 pages. [cited by applicant]
International Search Report and Written Opinion in International Appln. No. PCT/US2018/024505, mailed on Jun. 13, 2018, 11 pages. [cited by applicant]
Karim et al., “Effectiveness and Safety of Tenofovir Gel, An Antiretroviral Microbicide, for The Prevention of Hiv Infection in Women,” Science, Sep. 2010, 329(5996):1168-1174. [cited by applicant]
Kashuba et al., “Genital Tenofovir Concentrations Correlate With Protection Against HIV Infection in The Caprisa 004 Trial: Importance of Adherence For Microbicide Effectiveness,” J. Acquir. Immune Defic. Syndr., Jul. 2… [cited by applicant]
Keller et al., “A Randomized Trial to Assess Anti-Hiv Activity in Female Genital Tract Secretions and Soluble Mucosal Immunity Following Application of 1% Tenofovir Gel,” PLoS One, Jan. 2011, 6(1):E16475. [cited by applicant]
Marrazzo et al., “Tenofovir-Based Preexposure Prophylaxis for Hiv Infection Among African Women,” N. Engl. J. Med., Feb. 2015, 372(6):509-518. [cited by applicant]
Mngadi et al., “Disclosure of microbicide gel use to sexual partners: influence on adherence in the Caprisa 004 trial,” AIDS Behav., May 2014, 18(5):849-854. [cited by applicant]
Piret et al., “Resistance of Herpes Simplex Viruses to Nucleoside Analogues: Mechanisms, Prevalence, and Management,” Antimicrob. Agents Chemother., Feb. 2011, 55(2):459-472. [cited by applicant]
Raymond et al., “Acceptability of Five Nonoxynol-9 Spermicides,” Contraception, Jun. 2005, 71(6):438-442. [cited by applicant]
Rees et al., “Facts 001 Phase III Trial of Pericoital Tenofovir 1% Gel for Hiv Prevention in Women,” Abstract, Presented at Proceedings of the Conference on Retroviruses and Opportunistic Infections, Feb. 23-26, 2015, S… [cited by applicant]
Remington: The Science and Practice of Pharmacy, 21st ed., Beringer (ed)., 2005, pp. 871-888, 929-964, 1018-1046, and 1626-1684. [cited by applicant]
Ross et al., “Access to Contraceptive Methods and Prevalence of Use,” J. Biosoc. Sci., Nov. 2013, 45(6):761-778. [cited by applicant]
Ross et al., “Use of modern contraception increases when more methods become available: analysis of evidence from 1982-2009,” Glob. Health Sci. Pract., Jul. 2013, 1(2):203-212. [cited by applicant]
rsc.niaid.nih.gov [online], “Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events,” Jul. 2017, retrieved no later than Jun. 24, 2020, retrieved from URL<https://rsc.niaid.nih.gov… [cited by applicant]
Schwartz et al., “A Multi-Compartment, Single and Multiple Dose Pharmacokinetic Study of The Vaginal Candidate Microbicide 1% Tenofovir Gel,” PLoS One, Oct. 2011, 6(10):E25974. [cited by applicant]
Schwartz et al., “Fourteen-Day Safety and Acceptability Study of The Universal Placebo Gel,” Contraception, Feb. 2007, 75(2):136-141. [cited by applicant]
Siemann, “Solvent Cast Technology—A Versatile Tool for Thin Film Production,” Progress in Colloid Polymer Science, Jun. 2005, 130:1-14. [cited by applicant]
Succop et al., “Trial Participation Disclosure and Gel Use Behavior in The Caprisa 004 Tenofovir Gel Trial,” AIDS Care, Oct. 2014, 26(12):1521-1525. [cited by applicant]