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Biphasic lipid-vesicle composition and method for treating cervical dysplasia by intravaginal delivery

a lipid-vesicle and composition technology, applied in the direction of peptide/protein ingredients, organic active ingredients, pharmaceutical non-active ingredients, etc., can solve the problems of examining the hpv status post, unable to immediately treat women with hpv, and undergone such treatment options may carry an increased risk of abortion and premature labor

Inactive Publication Date: 2013-08-22
HELIX BIOPHARMA CORP
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Problems solved by technology

At present, there is no immediate therapy available for women with HPV presenting with LSIL.
Women who have undergone such treatment options may carry an increased risk of abortion and premature labor.
While these studies show that interferon therapy is effective in treating CIN associated HPV infections as measured by colposcopy confirmed by cytological and histological examination of random biopsies, none of these studies examine the HPV status post therapy.

Method used

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  • Biphasic lipid-vesicle composition and method for treating cervical dysplasia by intravaginal delivery
  • Biphasic lipid-vesicle composition and method for treating cervical dysplasia by intravaginal delivery
  • Biphasic lipid-vesicle composition and method for treating cervical dysplasia by intravaginal delivery

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Embodiment Construction

I. Biphasic Liposome Composition and Method of its Preparation

[0021]The invention relates to a lipid-bilayer or liposome or lipid vesicle composition for use in delivering an interferon, e.g., interferon alpha-2b by transmucosal delivery, e.g., by intravaginal administration, particularly in the treatment of cervical dysplasia.

[0022]A preferred method of preparing a multilamellar lipid vesicle of the invention is as follows. An oil and a consistency enhancer are admixed. Separately, water and a surfactant are admixed. A water-soluble antimicrobial agent, for example methyl paraben or propylparaben, a buffering agent, such as phosphates, and a chelating agent, such as EDTA, can also be dissolved in the water. These are heated gently, say to about 70° C., and then admixed and homogenized with the oil and consistency enhancer. This results in formation of an emulsion with water as the continuous phase and the oil and consistency enhancer as the dispersed phase. It is desirable that the...

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Abstract

A biphasic lipid vesicle composition for treating cervical displasia by intravaginal delivery. The composition includes a suspension of lipid-bilayer vesicles having entrapped therein, an oil-in-water emulsion, human interferon alpha-2b and L-methionine, the composition having an interferon alpha-2b specific activity of between about 1-10 MIU (million international units) per gram composition, and between 0.01 to 0.5 weight percent L-methionine. In the treatment method, the composition is administered at a dose of between about 1-20 MIU interferon alpha-2b, and this dose is administered at least 3 days / week, for a period of at least 4 weeks.

Description

FIELD OF THE INVENTION[0001]The present invention relates a biphasic lipid-vesicle composition and method for treating cervical displasia by intravaginal delivery.BACKGROUND OF THE INVENTION[0002]Of the estimated 55 million Pap smears performed each year in the United States, more than 5% are reported as abnormal (ALTS study 2003). An estimated 800,000 women each year present with low-grade squamous intraepithelial lesions (LSIL) (Jones, B A, Davey D D. Quality management in gynaecologic cytology using interlaboratory comparison. Arch Pathol Lab Med 2000; 124(5):672-81).[0003]These lesions will either progress with time to CIN 2-3 or invasive cancer, especially in women that present with the high-risk HPV-subtype, or regress with time in the absence of treatment. Of women diagnosed with LSIL, 25% will progress to cervical intraepithelial neoplasia (CIN) grade 2 or 3, 22-32% will have persistent CIN 1 and approximately 50%-70% will experience spontaneous regression of LSIL within 2 y...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K9/127A61K38/21
CPCA61K9/0034A61K9/10A61K9/1075A61K9/127A61K38/212A61K31/198A61K38/21A61K47/183A61K9/1277A61K47/20A61P15/00A61P31/12A61P35/00A61K9/06A61K9/107
Inventor FOLDVARI, MARIANNAKUMAR, PRAVEENDOCHERTY, JOHN M.
Owner HELIX BIOPHARMA CORP
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