Archimedes Development Limited

West Pharmaceutical Services Drug Delivery & Clinical Research Centre Limited

Depomed, Inc.

Vernalis &r&d) Ltd.

Danbiosyst UK Limited

West Pharmaceutical Services Drug Delivery and Clincal Research Centre, Limited

Peter James Watts

Alan Smith

Jonathan David Castile

Lisbeth Illum

Yu-Hui Cheng

Ann Margaret Dyer

William Columbus Ian Lafferty

Philip Walsh

Stanley Stewart Davis

Paul George Jenkins

Phillip John Birch

Ann Gail Hayes

Ian Lafferty

William Columbus Lafferty

An intranasal spray device contains a composition for the intranasal delivery of fentanyl or a pharmaceutically acceptable salt thereof to an animal includes an aqueous solution of fentanyl or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable additive selected from (i) a pectin and (ii) a poloxamer and chitosan or a salt or derivative thereof; provided that when the composition comprises a pectin it is substantially free of divalent metal ions; and which, in comparison to a simple aqueous solution of fentanyl administered intranasally at the same dose, provides a peak plasma concentration of fentanyl (C) that is from 10 to 80% of that achieved using a simple aqueous solution of fentanyl administered intranasally at an identical fentanyl dose. A method for treating or managing pain by intranasally administering the composition is also disclosed.

Intranasal spray device containing pharmaceutical composition

A container (), comprising a thread () arranged around an opening () for engaging a corresponding thread () of a closure (), more than four retention members () arranged around the opening (), each retention member () having an end-face for abutting a member () on an interior surface of the closure () to impede unthreading of the closure (), the retention members () being arranged such that a tangent () to each end-face of the retention members () intersects a plane () bisecting the container () at an obtuse angle (), wherein the retention members () are arranged in first and second groups, the first group () comprising one retention member () having an end-face substantially parallel to the plane bisecting the container (), and the second group () comprising two or more retention members (), the first and second groups being arranged on one side of the plane (), each in a respective quadrant of the container (), the teeth of the second group () have a first inter-tooth spacing, and a second inter-tooth spacing is provided between an end-face of the retention member of the first group () and a first retention member of the second group (), and the second inter-tooth spacing is larger than the first inter-tooth spacing.

Container

An intrasnal spray device contains a composition for the intranasal delivery of fentanyl or a pharmaceutically acceptable salt thereof to an animal includes an aqueous solution of fentanyl or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable additive selected from (i) a pectin and (ii) a poloxamer and chitosan or a salt or derivative thereof; provided that when the composition comprises a pectin it is substantially free of divalent metal ions; and which, in comparison to a simple aqueous solution of fentanyl administered intranasally at the same dose, provides a peak plasma concentration of fentanyl (C) that is from 10 to 80% of that achieved using a simple aqueous solution of fentanyl administered intranasally at an identical fentanyl dose. A method for treating or managing pain by intranasally administering the composition is also disclosed.

A composition for intranasal delivery of a drug comprising: includes: (i) the drug; and (ii) a non-aqueous vehicle containing (a) propylene glycol and at least one additional solvent selected from N-methylpyrrolidone, propylene carbonate, dimethyl sulfoxide and at least one propylene glycol fatty acid ester; (b) from about 40 to 100% by volume of N-methylpyrrolidone; or (c) from about 40 to 100% by volume of dimethyl sulfoxide (DMSO).

Non-aqueous pharmaceutical composition

A composition for the intranasal delivery of fentanyl or a pharmaceutically acceptable salt thereof to an animal includes an aqueous solution of fentanyl or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable additive selected from (i) a pectin and (ii) a poloxamer and chitosan or a salt or derivative thereof; provided that when the composition comprises a pectin it is substantially free of divalent metal ions; and which, in comparison to a simple aqueous solution of fentanyl administered intranasally at the same dose, provides a peak plasma concentration of fentanyl (C) that is from 10 to 80% of that achieved using a simple aqueous solution of fentanyl administered intranasally at an identical fentanyl dose. A method for treating or managing pain by intranasally administering the composition is also disclosed.

Method of managing or treating pain

A powder composition for intranasal delivery includes a benzodiazepine drug and chitosan, a salt of chitosan, a derivative of chitosan or a salt of a derivative of chitosan.

Pharmaceutical powder compositions

An oral drug delivery composition includes a sustained release component which includes a corticosteroid drug and which is contained within a capsule that has been treated so that the sustained release component is predominately released from the capsule in the intestine following oral administration. A drug delivery composition for delivering a corticosteroid drug to the intestine also includes: (a) a sustained release component comprising a corticosteroid drug, an alkali-containing ethylcellulose material and an acid; and (b) a delayed release component which substantially prevents release of the sustained release component until the composition reaches the intestine following oral administration. The compositions of the invention are useful for treating inflammatory diseases of the gastrointestinal tract, such as Crohn's disease and ulcerative colitis, and for treating glomerulonephritis.

Compositions for the oral delivery of corticosteroids

There is provided a powder formulation for nasal delivery including a protein having a molecular weight of 10 kDa or greater and chitosan or a derivative thereof or a salt of chitosan or a salt of a derivative of chitosan. Preferably the protein is human growth hormone.

Pharmaceutical formulations for intranasal administration of protein comprising a chitosan or a derivative thereof

A liquid aqueous formulation for the intranasal administration of apomorphine includes:

Intranasal compositions

The present invention provides compositions for the intranasal administration of zolpidem or a pharmaceutically acceptable salt thereof. Preferred compositions of the invention are in the form of aqueous solutions. Optionally the compositions of the invention comprise a cyclodextrin and/or chitosan, a salt or derivative thereof or a salt of a derivative of chitosan. The compositions can be used for the treatment or prevention insomnia or the treatment of neurological disorders such as those arising from brain trauma, stroke and spinocerebellar ataxia or in the treatment of Parkinson's disease.

Compositions are provided for the intranasal administration of granisetron or a pharmaceutically acceptable salt thereof. Preferred compositions are in the form of an aqueous solution. Optionally, the compositions comprise chitosan, a salt or derivative thereof or a salt of a derivative of chitosan. The compositions can be used for the treatment or prevention of nausea and/or vomiting.

Method of intranasal administration of granisetron

Aqueous formulations suitable for intranasal administration comprise buprenorphine or a physiologically acceptable salt or ester thereof and (a) a pectin having a degree of esterification of less than 50%, (b) chitosan and a polyoxyethylene-polyoxypropylene copolymer (poloxamer) or (c) chitosan and hydroxypropylmethylcellulose. Such formulations can induce rapid and prolonged analgesia when delivered intranasally to a patient. The buprenorphine or buprenorphine salt or ester may be delivered to the bloodstream to produce within 30 minutes a therapeutic plasma concentration of buprenorphine, C, of 0.2 ng/ml or greater which is maintained for a duration Tof at least 2 hours.

Buprenorphine formulations for intranasal delivery

A drug delivery composition for nasal administration is provided which comprises the antiviral agent ICAM-1 and a bioadhesive material. The bioadhesive material may be a chitosan solution, a liquid formulation comprising a polymeric material or a plurality of bioadhesive microspheres. The polymeric material is preferably gellan gum or alginate. The microspheres may comprise starch, chitosan, hyaluronic acid, or gelatin.

Growing community of inventors

Nottingham, United Kingdom

Peter James Watts