United States Patent Whittle (1) PHARMAC TICAL FORMULATION (75) Inventor: Brian Whittle, East Yorkshire (GB) GW Pharma Li (73) Assignee: nlted, Wiltshire (GB) (1). Notige: Subject wo any disclaimer the teem of this patent is extended or adjusted under 35 US.C. 154) by 2 days Appl. No. 10/218,989 Filed: Aug. 14, 2002 Prior Publication Data ADIN 65/00; AGIK 35/78, 424/728, 424/435 424/725, 435, 28/434, 449, 443, 447 66) References Cited US. PATENT DOCUMENTS. 66508532 BI * 1/2003. Many eta son 1U$00694615082 (10) Patent No. 5) Date of Patent US 6,946,150 B2 Sep. 20, 2005 6.713048 2 * 200 Pea ta 2gin387s2 AL * 92002 While etal DOCUMENTS 2435 FOREIGN PATENT on 23eiss9 + 11001 Wo wo.amps2an + “4202 * cited by examiner Primary Exaniner—Akon Pryor (74) Attorney, Agent, or Firm—Wolt, Greenfield & Sacks, Pe. on ABSTRACT The iavention relates to pharmaceutical formulations, and ‘more particularly to formulations containing cannabinoids {or administration via a pump action spray. In particular, the invention relates to pharmaceutical formulations, for use in administration of lipophilic medicaments. via_ mucosal Surfaces, comprising: atleast one lipopilie medicament, solvent and a co-salveat, wherein the total amount of solvent fad co-solvent present in the formulation is greater than ‘55% w'wt of the formulation and the Formulstion is absent fof a self emulsifying agent andior # fuorinated propellant. 26 Claims, 9 Drawing SheetsU.S. Patent 20, 2008 Sheet 1 of 9 US 6,946,150 B2 Fig.l GWP09901; Mean Cansbinaid Concentrations, (CBME High THC Fig We GWPD9901: Mean Canabinoid Concentrations, CBME High CADU.S. Patent g 20, 2008 Sheet 2 of 9 US 6,946,150 B2 Conceniration (ng.sot') om 10 0 200 300 3a tent wD THD Tame (min) aca a THe ey drany TH GWPD9801: Mean Canabinaid Concentrations, Placebo Concentration (ng.mt') 22 & 8 ~ a os te 10 20 300 mo eo ceo HO OO) OD Tm Tie (min) en BD eT eye THE