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(12) United States Patent (10) Patent No.: US 8,815,911 B2 Pettersson Et Al

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(12) United States Patent (10) Patent No.: US 8,815,911 B2 Pettersson Et Al US00881.5911B2 (12) United States Patent (10) Patent No.: US 8,815,911 B2 Pettersson et al. (45) Date of Patent: Aug. 26, 2014 (54) ALFENTANIL COMPOSITION FOR THE WO WO-OOf 16751 A1 3, 2000 TREATMENT OF ACUTE PAIN WO WO-OOf 51539 A1 9, 2000 WO WO-01/30288 A1 5, 2001 WO WO-O2/O67903 A2 9, 2002 (71) Applicant: Orexo AB, Uppsala (SE) WO WOO3,OO5944 A1 1, 2003 WO WO-2004/067004 A1 8, 2004 (72) Inventors: Anders Pettersson, Kode (SE); Barbro WO WO-2006/097361 A1 9, 2006 Johansson, Uppsala (SE); Emil WO WO-2006,103418 A1 10, 2006 Schwan, Uppsala (SE) WO WO-2007/081948 A2 7, 2007 s WO WO-2007/081949 A2 7/2007 WO WO-2007/141328 A1 12/2007 (73) Assignee: Orexo AB, Uppsala (SE) WO WO-2008/068471 A1 6, 2008 - WO WO-2008/085765 A2 7, 2008 (*) Notice: Subject to any disclaimer, the term of this WO WO-2008, 106689 A2 9, 2008 patent is extended or adjusted under 35 W. W838887} h A. 5,588 U.S.C. 154(b) by 0 days. WO WO-2010/059504 A1 5, 2010 WO WO-2010, 132605 A1 11, 2010 (21) Appl. No.: 13/874,762 WO WO-2010/141505 A1 12/2010 WO WO-2011/O17484 A2 2, 2011 (22) Filed: May 1, 2013 WO WO-2011/057199 A1 5, 2011 (65) Prior Publication Data OTHER PUBLICATIONS US 2014/OOO5223 A1 Jan. 2, 2014 FDA Guidance for Industry. Orally Disintegrating Tablets; Dec. 2008. (30) Foreign Application Priority Data Mohanachandran et al. International Journal of Pharmaceutical Sci ences Review and Research, 6, 105 (2011). May 2, 2012 (GB) ................................... 12077.01.2 Palmetal. J. Pharmacol. Exp. Ther. 291,435 (1999). Nov. 23, 2012 (GB) ................................... 1221130.6 Pharmaceutical Dosage Forms. Tablets, vol. 1, 2nd Edition, Lieber man et al (eds.), Marcel Dekker, New York and Basel (1989) p. (51) Int. Cl. 354-356. A6 IK3I/445 (2006.01) “Remington. The Science and Practice of Pharmacy”. Gennaro (ed.), A6 IK9/20 (2006.01) Philadelphia College of Pharmacy & Sciences, 19th edition (1995). (52) U.S. Cl. Rowe et al. Handbook of Pharmaceutical Excipients, 6th ed. (2009). USPC ........................................... 514/329; 424/465 Withing co, (2010) ang et al. Fur J. Finarm. Sci., 59. (58) Fist of Classification Search 514/329: 424/465 Waterman et al. Pharmaceutical Development and Technology, 7, 1 (2002). See application file for complete search history. Pharmaceutics The Science of dosage form design, Aulton (eds) Churchill Livingstone (2000) pp. 312-314. (56) References Cited JRS Pharma Technical Newsletter Issue 2008, 1, 1-4. U.S. PATENT DOCUMENTS Extract from www.medicines.org.uk website RE: Rapifen R, Sep. 26. 2013. 5,785,989 A * 7, 1998 Stanley et al. ................ 424/440 8,119,158 B2* 2/2012 Moe et al. ..................... 424/464 * cited by examiner 2002/016.0043 A1 10, 2002 Coleman 2005/0042281 A1 2/2005 Singh et al. 2005/O142197 A1 6, 2005 Moe et al. Primary Examiner — Raymond Henley, III 2005. O142198 A1 6, 2005 Moe et al. (74) Attorney, Agent, or Firm — Covington & Burling LLP 2006/028.1775 A1* 12/2006 Kelly et al. ................... 514,282 2007/0O36853 A1 2/2007 Agarwal et al. 2007/0104.763 A1 5/2007 Jobdevairakkam et al. (57) ABSTRACT 2008/0268O23 A1 10, 2008 Palmer et al. 2009 OO11030 A1 1/2009 Jouhikainen et al. There is provided pharmaceutical compositions for the treat 2009/0048237 A1 2/2009 Palmer et al. ment of pain e.g. short-term pain, which compositions com 2009,0263476 A1 10, 2009 Jobdevairakkam et al. 2010.0015183 A1 1/2010 Finn et al. ..................... 424/400 prise a mixture comprising: 2010/0093712 A1* 4/2010 Kelley et al. ............... 514,226.5 (a) microparticles of alfentanil, or a pharmaceutically accept 2010/0129443 A1 5, 2010 Pettersson able salt thereof, which microparticles are presented on the 2010/0233257 A1 9/2010 Herry et al. Surfaces of larger carrier particles; 2011, 0071181 A1 3/2011 Moe 2011/009 1544 A1 4/2011 Palmer (b) a water-soluble weak base; and 2011 O150989 A1 6, 2011 Park et al. (c) a compound which is a weak acid, which acid is presented 2012fOO35216 A1 2/2012 Palmer et al. in intimate mixture with the microparticles of alfentanilor salt thereof. FOREIGN PATENT DOCUMENTS The composition may further comprise a disintegrant. The EP 1 115383 A1 T 2001 acid is preferably citric acid. EP 2316 418 A2 5, 2011 WO WO-91/03237 A1 3, 1991 WO WO-99/24023 A2 5, 1999 19 Claims, 2 Drawing Sheets U.S. Patent Aug. 26, 2014 Sheet 1 of 2 US 8,815,911 B2 ..i. S - O.S. O. FG. 1 U.S. Patent Aug. 26, 2014 Sheet 2 of 2 US 8,815,911 B2 x - 1 2. O. 3 ''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''''' Scheduled timepoint (hours) FG 2 US 8,815,911 B2 1. 2 ALFENTANL COMPOSITION FOR THE form is adhered to the surfaces of larger carrierparticles in the TREATMENT OF ACUTE PAIN presence of a bioadhesive and/or mucoadhesive promoting agent. This application claims the benefit under 35 U.S.C. 119 of Prior art documents, including international patent appli United Kingdom patent application serial no. 1207701.2 filed 5 cations WO 03/005944, WO 02/067903, WO 2007/141328, on May 2, 2012, and of United Kingdom patent application WO 2010/132605, WO 01/30288 and US patent application serial no. 1221130.6 filed on Nov. 23, 2012, the disclosures of US 2009/0263476A1 employ pH modifying agents to pro which are each incorporated by reference herein in their mote dissolution and/or absorption of active ingredients. entireties. European patent application EP2114383, US patent appli This invention relates to new pharmaceutical compositions 10 cations US 2008/0268023, US 2009/0048237 and US 2011/ comprising alfentanil that are useful in the treatment of pain, 009 1544, and international patent applications WO 2007/ particularly acute, short-term pain associated with Surgical, 08.1949 and WO 2008/085765 on the other hand relate to diagnostic and/or care-related procedures, and may be formulations comprising (specifically-stated) non-ordered administered transmucosally and in particular Sublingually. mixtures of opioids, for example Sufentanil, bioadhesive and Opioids are widely used in medicine as analgesics. Indeed, 15 Stearic acid, which form a hydrogel in use (Sublingual deliv it is presently accepted that, in the palliation of moderate to ery). International patent application WO 2010/059504 severe pain, no more effective therapeutic agents exist. relates to a Sufentanil formulation comprising oxygen Scav Opioid agonist analgesics are used to treat moderate to engers in packaging to minimise degradation. It stated in that severe, chronic cancer pain, often in combination with non document that the use of antioxidants. Such as butylated steroidal anti-inflammatory drugs (NSAIDs), as well as acute hydroxytoluene (BHT) in solid sufentanil formulations do pain (e.g. during recovery from Surgery and breakthrough not stop degradation of the API. pain). Further, their use is increasing in the management of Dissolvable lozenges, in which drug is embedded in a chronic, non-malignant pain. matrix, are disclosed in US patent application US 2002/ Additionally, invasive Surgical and/or diagnostic proce 016.0043 and international patent application WO91/03237. dures often give rise to short-lasting but nonetheless intense 25 International patent application WO 2008/106689 and US pain, which it is desirable to control if possible. Painful, patent application US 2009/0011030 disclose powders for invasive diagnostic procedures such as Soft tissue biopsies are inhalation, but also cross-reference the fentanyl lollipop frequently performed, particularly on elderly patients. Pain ActiqR). ful therapeutic procedures Such as orthopedic manipulations, Layered tablets are disclosed in international patent appli fracture repositions, minor Surgery and invasive endoarterial 30 cation WO 2006/097361 and US patent application 2010/ interventions are frequent events in the hospital setting. Addi 0233257. In WO 2006/097361, a single compacted core is tionally, routine care procedures such as wound dressing, made from mannitol and microcrystalline cellulose (and bedside examinations, turning, transportation, mobilization optionally other excipients). This core is then coated with and various imaging procedures are other examples where active ingredient (such as an opioid) in a solution or Suspen short-lasting, moderate to severe pain is frequently reported. 35 Sion. A pH-modifying component may be added at this stage. Such pain is self-evidently a problem in itself. If particu Spray-coated formulations are also disclosed in US 2010/ larly intense, such pain, even if it is very short-lasting, can 0233257. Compressible interactive mixtures are neither men cause undesirable stress/trauma in patients. Furthermore, the tioned nor Suggested in either of these documents. fear/anticipation of Such pain can in itself give rise to stress/ pH dependent transport of cationic drugs has been studied anxiety in Some patients in need of Surgical and/or diagnostic 40 (see e.g. Palmetal, J. Pharmacol. Exp. Then, 291,435 (1999) procedures, and in Some cases may even result on non-com and Wang etal, Eur: J. Pharm. Sci., 39,272 (2010)). US patent pliance (i.e. consent not being given for the procedure). A application 2007/0104763 discloses a lozenge for intraoral particularly problem exists in those patients with a low toler delivery comprising micronized fentanyl dispersed in a ance to pain, Such as children. matrix comprising dextrose. US patent application 2009/ Moreover, for many of the above-mentioned procedures, 45 0263.476 refers to opioid-containing (e.g. fentanyl) buccal the quality of the intervention may depend upon effective pain tablets in which a filler is employed, which is an alkaline management. metal oxide or hydroxide to improve transmucosal drug There is thus a presently unmet clinical need for useful and absorption.
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