Flocculated pharmaceutical suspensions and methods for actives
OwnerSubhas C. Kundu, Vivek Desai +1inventors
InventorsSubhas C. Kundu, Vivek Desai, Andrea Cameron
Life of this patent
Estimating the term…
Abstract
An aqueous pharmaceutical composition suitable for oral delivery has an insoluble active substance and one or more wetting agents in liquid suspension. The composition contains floccules of the active ingredient and is substantially free of polyethelyne glycol, propylene glycol, glycerol and sorbitol. The formulation has an excellent shelf-life in which caking and sedimentation are inhibited. The composition may be resuspended upon light to moderate shaking.
Claims46
A composition comprising at least one insoluble active substance together with at least one wetting agent, wherein the concentration of said wetting agent is sufficient to form a stable, flocculated suspension of said active substance, wherein said composition contains substantially no polyethylene glycol, propylene glycol, sorbitol or glycerol.
A method for forming an aqueous flocculated suspension containing an insoluble micronized active substance together with a wetting agent to form a stable, resuspendable flocculated suspension of said active substance, which comprises adding said wetting agent in an amount below which the floccule size of said active substance in said suspension starts to increase, wherein substantially no polyethylene glycol, propylene glycol, sorbitol or glycerol is included in said suspension.
An oral pharmaceutical composition, comprising:
- a) about 0.5 to about 10% w/v of megestrol acetate;
- b) about 0.001 to about 2% w/w of at least one wetting agent selected from the group consisting of docusate sodium and ethylene oxide/propylene oxide copolymers and block copolymers;
- and
- c) about 0.05 to about 0.5% w/w of at least one suspending agent, wherein said composition contains substantially no polyethylene glycol, propylene glycol, sorbitol or glycerol.
An oral composition, comprising about 1 to about 8% w/v of megestrol acetate, wetting agents consisting essentially of about 0.005 to about 1% w/w of docusate sodium and about 0.005 to about 1% w/w of at least one ethylene oxide propylene oxide copolymer;
- and further comprising from about 0.1 to about 0.3% w/w of at least one hydrocolloid material.
A method of forming an oral pharmaceutical composition, comprising:
- combining a first portion of a pharmaceutical grade gum and water in a first vessel;
- combining a second portion of megestrol acetate and at least one wetting agent in a second vessel;
- combining the contents of said first vessel with the contents of said second vessel, wherein said wetting agent is at least one member selected from the group consisting of docusate sodium and ethylene oxide/propylene oxide copolymers and block copolymers, and further wherein said composition contains substantially no polyethylene glycol, propylene glycol, sorbitol or glycerol.
A method of forming an oral pharmaceutical composition, comprising:
- admixing megestrol acetate and at least one wetting agent, said wetting agent consisting essentially of at least one member selected from the group of docusate sodium and ethylene oxide/propylene oxide copolymers, wherein said composition contains substantially no polyethylene glycol, propylene glycol, sorbitol or glycerol.
An oral composition, comprising about 1 to about 8% w/v of megestrol acetate, a wetting agent consisting essentially of docusate sodium;
- and further comprising from about 0.1 to about 0.3% w/w of at least one hydrocolloid material.
An oral composition, comprising about 1 to about 8% w/v of megestrol acetate, a wetting agent consisting essentially of an ethylene oxide/propylene oxide block copolymer;
- and further comprising from about 0.1 to about 0.3% w/w of at least one hydrocolloid material.
Dependencies are inferred from the claim text.