Semi-solid mucoadhesive formulations
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Accused Products
Abstract
Semisolid mucoadhesive formulations for vaginal application, with improved technical and organoleptic characteristics, which contain at least two bioadhesive gelling polymers and an active ingredient, useful in the prevention and/or treatment of various pathologies and disorders in human beings or animals.
68 Citations
55 Claims
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1-23. -23. (canceled)
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24. A semisolid mucoadhesive formulation comprising:
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a first bioadhesive gelling polymer that is a polyacrylic acid crosslinked with divinyl glycol in a quantity between 0.1% and 5% by weight of the semisolid mucoadhesive formulation;
a second bioadhesive gelling polymer that is a polyacrylic acid crosslinked with allyl sucrose or allyl pentaerythritol in a quantity between 0.1% and 5% by weight of the semisolid mucoadhesive formulation;
a neutralizing agent in sufficient quantity to position the semisolid mucoadhesive formulation'"'"'s pH between 2 and 6;
a pharmacologically active agent; and
water. - View Dependent Claims (25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41)
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42. A process for the preparation of a semisolid mucoadhesive formulation, the process comprising:
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(a) dispersing a first bioadhesive gelling polymer that is a polyacrylic acid crosslinked with divinyl glycol in a quantity between 0.1% and 5% by weight of the semisolid mucoadhesive formulation, and a second bioadhesive gelling polymer that is a polyacrylic acid crosslinked with allyl sucrose or allyl pentaerythritol in a quantity between 0.1% and 5% by weight of the semisolid mucoadhesive formulation in a solution that comprises water and has a pH that prevents gelling of the first and second bioadhesive gelling polymers to form a mixture;
(b) adding a neutralizing agent to the mixture to adjust to the pH of the mixture so that it is suitable for gelling the first and second bioadhesive gelling polymers, thereby transforming the mixture into a gel; and
(c) adding a pharmacologically active agent to the solution, the mixture, the gel, or a combination thereof to form the semisolid mucoadhesive formulation. - View Dependent Claims (43, 44, 45, 46, 47)
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48. A method of administering an effective amount of a pharmacologically active agent to a subject, the method comprising applying to one or more mucous membranes of the subject a semisolid mucoadhesive formulation that comprises:
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a first bioadhesive gelling polymer that is a polyacrylic acid crosslinked with divinyl glycol in a quantity between 0.1% and 5% by weight of the semisolid mucoadhesive formulation;
a second bioadhesive gelling polymer that is a polyacrylic acid crosslinked with allyl sucrose or allyl pentaerythritol in a quantity between 0.1% and 5% by weight of the semisolid mucoadhesive formulation;
a neutralizing agent in sufficient quantity to position the semisolid mucoadhesive formulation'"'"'s pH between 2 and 6;
the pharmacologically active agent; and
water;
thereby administering the effective amount of the pharmacologically active agent to the subject. - View Dependent Claims (49, 50, 51, 52, 53, 54, 55)
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Specification