(12) United States Patent (10) Patent No.: US 8,722,636 B2 Rock Et Al
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USOO8722636B2 (12) United States Patent (10) Patent No.: US 8,722,636 B2 Rock et al. (45) Date of Patent: May 13, 2014 (54) ANIMAL TREATMENTS 2004/0248942 A1* 12/2004 Hepburn et al. .............. 514,338 2007/0042023 A1 2/2007 Puri et al. 2007. O1841.06 A1 8/2007 Schellenger et al. (75) Inventors: s G "Eby, S.S); 2007/0275058 A1* 11/2007 Tanaka et al. ................. 424/465 ark Ridall, Princeton, NJ (US) 2008, 0096971 A1* 4/2008 Baxter et al. .................. 514,646 (73) Assignee: New Market Pharmaceuticals, LLC, OTHER PUBLICATIONS Princeton, NJ (US) Glossary of medical education terms, Institute of International Medi (*) Notice: Subject to any disclaimer, the term of this cal Education. http://www.iime.org/glossary.htm Accessed on Jan. patent is extended or adjusted under 35 2013.* U.S.C. 154(b) by 0 days. Chubineh et al. Proton pump inhibitors: the good, the bad, and the unwanted. South Med J 105:613-618, Nov. 2012.* (21) Appl. No.: 13/343,692 www.fda.gov/AnimalVeterinary/NewsEvents/FDAVeterinarian Newsletter/ucm100268.htm, Mar/Apr. 2003. (22) Filed: Jan. 4, 2012 Veterinary Compounding Brochure, American Veterinary Medical 9 Association (AVMA) Jun. 2001. O O Nagar, Mona et al., “Formulation, Evaluation and Comparison of (65) Prior Publication Data Fast-Dissolving Tablet of Nimesulide by Using Crospovidone as US 2012/O196819 A1 Aug. 2, 2012 Superdisintegrant.” International Journal of Pharmaceutical Sciences and Drug Research. 2009, 1(3), pp. 172-175. Related U.S. Application Data Panigrahi. R et al., “A Review On Fast Dissolving Tablets.” WebmedCentral Pharmaceutical Sciences. Sep. 29, 2010, 1(9), pp. (60) Provisional application No. 61/437,763, filed on Jan. 1-15. 31, 2011. “International Preliminary Report on Patentability” for International Application No. PCT/US2012/020242 mailed Aug. 6, 2013. (51) Int. Cl. A6 IK3I/7048 (2006.01) * cited by examiner A6 IK3I/35 (2006.01) A6 IK3I/55 (2006.01) Primary Examiner — Brandon Fetterolf (52) U.S. Cl. Assistant Examiner — Yih-Horng Shiao CPC ............. A6 IK3I/135 (2013.01); A61 K3I/155 (74) Attorney, Agent, or Firm — J.A. Lindeman & Co., (2013.01) PLLC USPC .......................................... 514/28: 514/226.2 (58) Field of Classification Search (57) ABSTRACT CPC ........................... A61K31/135; A61K31/155 Compositions and methods for the treatment and control of USPC ................................................. 514/28, 226.2 various conditions in an animal which comprises administer See application file for complete search history. ing to said animal an effective amount of a immediate release composition of about 0.5% to 50% wit/wt of active ingredient (56) References Cited together with excipients to a total of about 100%, wherein said composition dissolves in a relatively short period of time, U.S. PATENT DOCUMENTS e.g., 75 seconds or less, 5 seconds or less, or 3 seconds or less, 6,471.992 B1 10/2002 Yoo et al. upon administration to said animal. 6,596.311 B1 7, 2003 Dobetti 7,122,198 B1 10/2006 Singh et al. 4 Claims, No Drawings US 8,722,636 B2 1. 2 ANMAL TREATMENTS tion. Since the clearance of a drug administered via the meth ods of the present disclosure is more rapid, the animal may BACKGROUND only need to discontinue therapy for a relatively short period of time, thus minimizing the effect of discontinuance for Therapeutic agents for animals, for example equines, several days, resulting in a re-establishment or increased bovines, canines, felines, Ovines, and porcines, Suffer from severity of the disease under treatment. numerous drawbacks for a variety of reasons. For example, Disclosed herein are animal treatment methods and com injectable formulations, which may be preferred because they positions, for example for the treatment of animals, for provide rapid onset of activity, are most preferably adminis example equines, bovines, canines, felines, Ovines, and por tered in an environment of cleanliness to prevent infections at 10 cines. Various embodiments comprise administration of a the injection site. However, with domesticated animals this therapeutic agent into the bloodstream of the animal via a may be difficult to ensure in a typical barn, farm, field or formulation administered via the oral cavity. In various racetrack environment where such injectable formulations embodiments, a majority of the formulation may be absorbed may be administered. A further drawback of an injectable prior to reaching the gastric mucosa. In certain embodiments, formulation is that a typical injectable therapeutic may suffer 15 the formulation may be adapted for animals, for example from a relatively short duration of activity. Oral dosing for equines, bovines, canines, felines, Ovines, and porcines to mulations for animals suffer from different drawbacks, in that dissolve in a relatively short period of time, e.g., 75 seconds or the animal can spit the formulation out of its mouth before it less. Such administration of the formulation may, in at least is ingested, resulting in a loss of the full dosage. In a circum certain embodiments, result in faster onset of the therapy, stance where the oral formulation is administered by intuba diminished occurrences of the side-effects due to non-unifor tion, the dosing may suffer from variability of bioavailability mity of bioavailability of the active agent, and/or more accu due to the inherent and unique characteristics of each ani rate dosing, which may, in at least Some embodiments, result mals digestive system, i.e., the amount of food in the ani in dose lowering. Further, in at lease some embodiments, such mals stomach, the length of time since its last feeding, and administration may result in a greater portion of the therapeu the animal’s levels of digestive enzymes, which may vary due 25 tic agent actually being directly introduced systemically into to other environmental conditions, etc. Further limitations of the circulatory system for its therapeutic effect. existing formulations include stability of the active ingredient Also disclosed herein are methods for the treatment and in the formulation, and possible inadvertent or incorrect dos control of various diseases afflicting animals, for example ing of the human administrator with the drug Substance. equines, bovines, canines, felines, Ovines, and porcines, with Most veterinary therapeutics are off-shoots of drugs devel 30 improved safety for the both the animaland the person admin oped for humans rather than being specifically developed for istering the therapeutic agent. the unique characteristics of a specific animal, for example In at least certain exemplary embodiments, the composi equines, bovines, canines, felines, Ovines, and porcines. Due tions and methods are useful for administration to humans. to the high costs associated with developing formulations tailored precisely for animals, and obtaining regulatory 35 DETAILED DESCRIPTION approval of Such formulations for animals, many veterinar ians have a limited repertoire of drugs to utilize in the therapy Therapeutic agents, such as, for example, clenbuterol, imi of various animal diseases. Thus, the FDA allows "extra-label prazole, omeprazole, detomidine, acepromazine, flunixin, use of human drugs. See, “Extra-label Drug Use in Veteri moxidectin and praziquantel have been typically adminis nary Medicine', available from www.fda.gov/AnimalVeteri 40 tered orally. For example, in domesticated animals these nary/NewsEvents/FDAVeterinarianNewsletterfucm1 agents may be administered in the form offeed concentrates, 00268.htm. This practice has resulted in formulations of feed additives, tablets, oblets, boluses, gels, pastes, or the like, human drugs by compounding pharmacists at the request of or have been administered parenterally as an injectable. Of Veterinarians, i.e., so-called "custom compounding.” in order the above-mentioned formulation types, arguably the most to enlarge therapeutic armamentarium available to veterinar 45 suitable for ease of administration, efficiency, and effective ians. See, for instance, the brochure published by the FDA dosage, as well as economic and practical application of the entitled “Veterinary Compounding available from www.av endoparasiticidal agents moxidectin and praziquantel which ma.org/issues/drugs/compounding/veterinary compounding are often included, is an oral gel or paste. Feed additives and brochure.asp feed concentrates are unsuitable due to the lack of stability of Therefore, there exists a need to provide improved thera 50 many active ingredients in the presence of moisture and/or peutic methods for animals, for example equines, bovines, excipients utilized in feeds, and the lack of packaging and ovines, canines, felines and porcines which obviate many of storage conditions ensuring accurate dosing to animals of the disadvantages and side effects of the commonly used variable weight. Tablets, boluses, oblets, and drenches are injectable and oral formulations. often cumbersome to administer to large numbers of animals There further exists a need to provide methods for the 55 effectively, and parenteral injection is more stressful for the treatment of animals, for example equines, bovines, canines, animal and the handler. felines, Ovines, and porcines with drug products which give Further, oral administration of therapeutic agents suffer the an earlier onset of action, along with a concomitant reduction disadvantages of exposure to the gastric environment which in side effects including risk of infection at injection sites or results in degradation