Mucosal formulation
First Claim
1. A vaginal formulation comprising a dehydrated vesicle that consists of a phospholipid, a pharmaceutical agent, and a protecting sugar, the phospholipid being formed from an alkyl phosphocholine that comprises hexadecyl thiophosphocholine, tetradecyl phosphocholine, hexadecyl phosphocholine, docosanoyl phosphocholine, or a combination thereof, and the pharmaceutical agent including estradiol or an ester thereof.
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Accused Products
Abstract
A mucosal formulation for administration to mucosal membranes, such as in the mouth, nasal passage, stomach, vagina, etc., is disclosed. The mucosal formulation contains a lipid-pharmaceutical agent complex formed from phospholipids possessing a hydrophobic moiety that orients into a hydrophobic phase and a polar head moiety that orients towards the aqueous phase (i.e., “amphipathic” lipids). When placed in an aqueous medium (e.g., vaginal fluid), the phospholipids form liposomes or other small lipid vesicles (e.g., micelles) that may then be used to deliver pharmaceutical agents into a living organism.
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Citations
22 Claims
- 1. A vaginal formulation comprising a dehydrated vesicle that consists of a phospholipid, a pharmaceutical agent, and a protecting sugar, the phospholipid being formed from an alkyl phosphocholine that comprises hexadecyl thiophosphocholine, tetradecyl phosphocholine, hexadecyl phosphocholine, docosanoyl phosphocholine, or a combination thereof, and the pharmaceutical agent including estradiol or an ester thereof.
- 7. A method for moisturizing and inhibiting the growth of microorganisms in a vagina of a female, the method comprising intravaginally administering a vaginal formulation so that the formulation is placed into contact with vaginal fluid in the vagina, the formulation comprising a vesicle that has been dehydrated in the presence of a protecting sugar, wherein the vesicle consists of the protecting sugar and a complex that inhibits the growth of Candida albicans, wherein the complex consists of a phospholipid and pharmaceutical agent, wherein the phospholipid is formed from an alkyl phosphocholine having the following structure:
Specification