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Therapeutic modulation of vaginal epithelium boundary lubrication

A technology of interfacial lubrication and vaginal application in the field of diseases related to pharmaceutical compositions and interfacial lubrication

Inactive Publication Date: 2012-05-02
LUBRIS +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

PRG4 has been shown to be present at the surface of the synovium, tendons, and menisci, but the use of PRG4 as a vaginal lubricant has not been described

Method used

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  • Therapeutic modulation of vaginal epithelium boundary lubrication
  • Therapeutic modulation of vaginal epithelium boundary lubrication
  • Therapeutic modulation of vaginal epithelium boundary lubrication

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0078] In vivo treatment of vaginal interface lubrication deficiency

[0079] A 65-year-old postmenopausal patient complained of vaginal surface irritation, burning sensation during urination, dyspareunia, and intermittent light bleeding after intercourse. Regular vaginal discharge examinations ruled out active infection and confirmed atrophic vaginitis. Specifically, a pelvic examination reveals the appearance of thin, pale vaginal walls.

[0080] The patient was administered weekly intravaginal PRG4 / 17?-sterediol suppositories, which provided doses of 100 μg / mL PRG4 and 1 μg 17?-sterediol, although their total concentrations were much lower than typical steroidal Diol treatment, but delivered directly to the vaginal wall via PRG4 co-transporter. In certain instances, endometrial histopathology during annual follow-up reveals improved labial and vulvar fullness, flushed urethral and vaginal epithelium, and / or symptoms (eg, where symptoms are no longer present).

Embodiment 2

[0082] Treatment of Vaginal Interfacial Lubrication Deficiency in Cancer Patients

[0083] A 60-year-old postmenopausal breast cancer patient (who had recently completed a course of tamoxifen chemotherapy) presented with an inflamed vaginal epithelium, plaque-like erythema, petechiae and increased fragility and small vulvar lesions. Additionally, transvaginal ultrasound revealed a thin endometrium approximately 4 mm wide. No signs of Trichomonas, Candida, or other bacteria were found. Papanicolaou smear reveals immature parabasal squamous epithelial cells with enlarged nuclei in a background of amorphous basophilic granular debris and inflammatory exudate.

[0084] A daily dose of 200 μg / mL of buffered PRG4 gel was administered vaginally to the patient. At the 6-month follow-up, Pap smears were prepared to visualize squamous cells from the superficial and intermediate layers of the vaginal epithelium. In some cases, unlike on initial presentation, many cells exhibited abund...

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Abstract

The present invention relates to the management of vaginal health. In particular, the present invention relates to pharmaceutical compositions, and methods of use thereof, for treating diseases associated with compromised boundary lubrication at the vaginal epithelium.

Description

[0001] cross reference [0002] This application claims the benefit of U.S. Provisional Application No. 61 / 144,344, filed January 13, 2009, and U.S. Provisional Application No. 61 / 260,402, filed November 12, 2009, which are hereby incorporated by reference in their entirety. technical field [0003] The present invention relates to the management of vaginal health. In particular, the invention relates to pharmaceutical compositions and methods of use thereof, including for the treatment of disorders associated with impaired interfacial lubrication at vaginal surfaces (eg, epithelium). Background technique [0004] Proteoglycan 4 ( prg4 ) genes encode highly glycosylated proteins called megakaryocyte stimulating factor (MSF), lubricin and surface zone protein (SZP). Lubricant was first isolated from synovial fluid and exhibited in vitro a lubricating capacity similar to that of synovial fluid at the cartilage-glass interface. Lubricant was later identified as a product of ...

Claims

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Application Information

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IPC IPC(8): A61K38/16A61K31/70A61K31/715A61K9/06A61K9/22A61P17/00A61P29/00
CPCA61K38/20A61K9/02A61K38/13A61K9/0034A61K38/24A61K38/1793A61K31/715A61K9/06A61K38/1709A61K45/06A61K31/70A61P5/24A61P5/26A61P5/30A61P15/00A61P15/02A61P15/08A61P15/12A61P15/14A61P17/00A61P17/06A61P25/00A61P29/00A61P31/04A61P31/10A61P31/22A61P35/00A61P37/06A61P37/08A61P43/00A61K2300/00
Inventor E.R.特瑞特三世B.萨利文D.萨利文
Owner LUBRIS
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