Pharmaceutical delivery system
AssigneePerrigo Pharma International Designated Activity Company
InventorsThomas C. Riley, R. Saul Levinson, Robert C. Cuca, Elio Mariani
Life of this patent
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Abstract
A pharmaceutical formulation to treat vaginal conditions in a human patient comprises: at least one active agent; a modified release dosage form which provides extended release of the anti-infective agent upon vaginal administration to the patient; and wherein the formulation, when containing a total dose of the anti-infective agent of about 25 μg to about 500 mg based on the active agent will produce a plasma concentration versus time curve (ng/mL versus hours) having an area under the curve (AUC) of less than about 600 ng/mL·hr.
Claims17
A pharmaceutical formulation to treat vaginal conditions in a human patient comprising:
- an effective amount of clindamycin phosphate;
- and
- a modified release dosage form which provides modified release of said clindamycin phosphate upon vaginal administration to said patient;
- wherein said formulation, when containing a total dose of clindamycin phosphate of about 25 μg to about 500 mg based on clindamycin will produce a plasma concentration versus time curve (ng/ml versus hours) having an area under the curve (AUC) of less than about 600 ng/mL·hr;
- and
- wherein said dosage form comprises:
- a. an emulsion comprising an external lipoidal phase and an internal non-lipoidal phase wherein said lipoidal phase is continuous and said non-lipoidal phase comprises at least 70% by volume of said emulsion;
- b. one or more lecithins as primary stabilizing surfactants;
- and
- c. one or more auxiliary stabilizing surfactants.
A method of stabilizing a clindamycin phosphate formulation by adding one or more lecithins as primary stabilizing surfactants and one or more auxiliary stabilizing surfactants.
Dependencies are inferred from the claim text.