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US 200901 10724A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2009/0110724 A1 Giordano (43) Pub. Date: Apr. 30, 2009 (54) COMPOSITIONS AND METHODS FOR Publication Classification TREATMENT OF PAN (51) Int. Cl. A6II 3/19 (2006.01) (75) Inventor: John A. Giordano, West Orange, A6II 3/55 (2006.01) NJ (US) A6II 3/522 (2006.01) A69/64 (2006.01) Correspondence Address: A6IP 43/00 (2006.01) DON.J. PELTO (52) U.S. Cl. ...................... 424/456; 514/263.3: 514/270; Sheppard, Mullin, Richter & Hampton LLP 5147568 1300 ISTREET, NW, 11TH FLOOR EAST WASHINGTON, DC 20005 (US) (57) ABSTRACT The present invention relates to compositions and methods (73) Assignee: Everett Laboratories, Inc. for treatment of various forms of pain. Specifically, the method involves administering to a patient a composition (21) Appl. No.: 11/932,237 comprising butalbital, acetaminophen and caffeine in the gel cap dosage form, to treat and/or alleviate the occurrence or (22) Filed: Oct. 31, 2007 negative effects of various forms of headaches. US 2009/01 1 0724 A1 Apr. 30, 2009 COMPOSITIONS AND METHODS FOR 0008 Caffeine is used in combination with other drugs for TREATMENT OF PAN the treatment of headaches because of its role as an analgesic adjunct. Caffeine on its own does not have any known anal FIELD OF THE INVENTION gesic activity. 0001. The present invention relates to compositions that 0009 Acetaminophen, also known as paracetamol and may be in a form of a gel caplet (gelcap), comprising a sold under the trade name Tylenol R, is a clinically proven barbiturate, a non-Salicylate analgesic/antipyretic, and an analgesic/antipyretic. Acetaminophen produces analgesia by analgesic adjunct, and methods for administering these com elevation of the pain threshold and antipyresis through action positions for treatment of patients suffering from various on the hypothalamic heat-regulating center. forms of pain. 0010 Delivery systems of over the counter or prescription drugs come in a variety of shapes and dosage forms, such as BACKGROUND OF THE INVENTION in a capsule, tablet, caplet, gel caplet (gelcap) or in a syrup form if a pill is impractical. However, due to consumer per 0002 Pain is an unpleasant sensation with a wide range in ception and patient preference, certain dosage forms have severity that can be localized or prevalent throughout the particular advantages over others. Until the 1980's, capsules body. The Merck Manual of Medical Information (M. Beers et were the preferred form for the delivery of active drugs. al., 2"Home ed., Merck Research Laboratories, 2003). Pain Capsules area dosage form in which the drug is housed within is affected by nerve stimulation that carries impulses to the two halves of gelatin shells that are banded together. Due to brain and is a symptom of an underlying disease, disorder, or the ability of taking apart the capsule gelatin shell halves and physical injury. Id. then resealing the halves, tampering of the capsule became a 0003. It is estimated that 75 million Americans currently major problem. For this reason, the pharmaceutical industry suffer with pain. NATIONAL CTR. FOR HEALTH STATISTICS, withdrew many of their capsule products from the market, HEALTH, UNITED STATES, 2006 WITH CHARTBOOKONTRENDS often replacing them with tablets or caplets. IN THE HEALTH OF AMERICANS 68-71 (2006). Pain can be classified into two groups: acute pain or chronic pain. Accord 0011 Tablets and caplets are compressed solid pills where ing to the National Centers for Health Statistics, more than 50 the dosage forms are cylindrical or the oblong shape similar to million Americans experience chronic pain. Id. Chronic pain capsules. Although both dosage forms are presently used in is a persisting or reoccurring pain that can last for months and the market, tablets and caplets have not reached the same level even years. It is more common for chronic pain to be due to a of consumer acceptance that capsules once had. Consumer disorder Such as sickle cell anemia or a serious physical Surveys Suggest that a dosage form with the like appearance injury. of a gelatin coated capsule is easier to Swallow and that the 0004 Alternatively, acute paintends to come on quickly, drug contained in the capsule form will be more effective. but subsides after a short time. Acute pain serves a useful 0012. The gelcap is a drug product that may itself encom purpose by alerting humans of a physiological hazard or a pass many forms. For example, the gelcap may contain a filler need for treatment. Therefore, acute paintends to be caused containing the active drug in a liquid form that is encapsulated from a sudden physical injury or infection. in a gelatin capsule like shell. Also, a gelcap can contain the 0005 Clinical complaints due to pain come in many vari active drug in a solid form, which has the shape of a caplet and eties. Such complaints may be due to Such ailments as arthri a gelatin coating or covering to create the appearance and tis, back pain, neuropathy, or a headache. therefore, the consumer acceptability of the capsule. 0006. A headache, also known as cephalalgia, ranks amongst the most common clinical pain complaints and can 0013 There are numerous advantages to a drug being be caused from a wide variety of physiological effects. Such administered in the form of a solid gelcap. The gelcap can be causes range from hormonal changes, muscle tension in the manufactured in a wide variety of sizes, shapes and colors that back of the neck, or from dehydration. Because headaches consumers tend to find aesthetically appealing. Moreover, it come in many forms, they may be treated or prevented by has also been established that patient compliance is improved various methods. These methods may include maintaining a if a gelcap is used to administer the drug because of its soft healthy lifestyle, reducing stress or making use of various and elastic nature, which makes it easierto Swallow compared medications. Such medications can be antianxiety drugs, to a hard tablet or caplet. antidepressants or nonsteroidal anti-inflammatories 0014 A liquid gelcap also has numerous advantages. (NSAIDs). However, when these drugs are ineffective or not First, it retains many of the advantages of consumer accep possible to use due to allergic reactions, other drug combina tance and is easier to Swallow due to the outer coating being tions may be prescribed. An effective medication for treat a soft and elastic gelatin shell. Also, concentrated liquid com ment of headaches is the combination ofbutalbital, acetami positions are well Suited for encapsulation within a softgela nophen and caffeine in the capsule form. McCrory et al., 41 tin shell, creating flexibility that further assists in the capsule HEADACHE 953-967 (2001). Although the role of each com being easier to Swallow. The active drug contained in the pound in the relief of headaches is incompletely understood, liquid form also provides advantages by dispersing the drug the combination of these three compounds due to their syn to the active site. For example, the active drug does not first ergistic effects has been widely accepted as a treatment for have to dissolve in the gastrointestinal tract, thereby facilitat various forms of headache. ing absorption of the pharmacologically active Substance. 0007 Butalbital is a short to intermediate-acting barbitu See, for example, U.S. Pat. No. 6,689.382, which is expressly rate that acts as a depressant of the central nervous system. It incorporated by reference herein. Other formulations take is used in combination with other drugs for its sedative and advantage of the liquid form by creating a Sustained release relaxant effects in the treatment of headaches. gelatin capsule, thereby permitting the delivery of the drug in US 2009/01 1 0724 A1 Apr. 30, 2009 a controlled fashion. See, for example, U.S. Pat. Nos. 5,324. one or more of the group consisting of S (+)-ketamine, meto 280 and 6,929.803, which are expressly incorporated by ref clopramide, ciramadol, Sulfentanil and remifentanil. erence herein. 0022. In another embodiment, the compositions of the present invention may comprise one or more of about 25 mg SUMMARY OF THE INVENTION to about 75 mg ofbutalbital; about 200 mg to about 600 mg of 0015 The present invention provides compositions and acetaminophen; and about 20 mg to about 60 mg of caffeine. methods of using the compositions for the therapeutic treat 0023. In another embodiment, the compositions of the ment of pain. Specifically, the present invention comprises a present invention may comprise one or more of about 37.5 mg composition of a barbiturate, an analgesic/antipyretic and an to about 62.5 mg ofbutalbital; about 300 mg to about 500 mg analgesic adjunct in the form of a gelcap. of acetaminophen; and about 30 mg to about 50 mg of caf 0016. In another embodiment of the present invention, the feine. compositions may comprise a barbiturate from one or more of 0024. In another embodiment, the compositions of the the group consisting of amobarbital, butalbital aprobarbital, present invention may comprise one or more of about 45 mg butabarbital, butethal, cyclobarbital, mephobarbital, metho to about 55 mg ofbutalbital; about 360 mg to about 440 mg of hexital, methylphenobarbital, pentobarbital, phenobarbital, acetaminophen; and about 36 mg to about 44 mg of caffeine. secobarbital, talbutal, thiobarbital, thiamylal, thiopental and 0025. In another embodiment, the compositions of the thiopental sodium. present invention may comprise one or more of about 50 mg 0017. In another embodiment of the present invention, the of butalbital, about 400 mg of acetaminophen, and about 40 compositions may comprise an analgesic/antipyretic from mg of caffeine.
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    National Institute Drug Abuse MONOGRAPH SERIES Problems of Drug Dependence 1982 Proceedings of the 44th Annual Scientific Meeting The Committee on Problems of Drug Dependence, Inc. U. S. DEPARTMENT OF HEALTH AND HUMAN SERVICE • Public Health Service • Alcohol, Drug Abuse, and Mental Health Administration Problems of Drug Dependence, 1982 Proceedings of the 44th Annual Scientific Meeting, The Committee on Problems of Drug Dependence, Inc. Editor, Louis S. Harris, Ph.D. NIDA Research Monograph 43 April 1983 DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Alcohol, Drug Abuse, and Mental Health Administration National Institute on Drug Abuse Office of Science 5600 Fishers Lane Rockville, Maryland 20657 NIDA Research Monographs are prepared by the research divisions of the National Institute on Drug Abuse and published by its Office of Science. The primary objective of the series is to provide critical reviews of research problem areas and techniques, the content of state-of-the-art confer- ences, integrative research reviews and significant original research. Its dual publication emphasis is rapid and targeted dissemination to the scientific and professional community. Editorial Advisory Board Avram Goldstein, M.D. Addiction Research Foundation Palo Alto, California Jerome Jaffe, M.D. University of Connecticut School of Medicine Farmington, Connecticut Reese T. Jones, M.D. Langley Porter Neuropsychiatric Institute University of California San Francisco, California Jack Mendelson, M.D. Alcohol and Drug Abuse Research Center Harvard Medical School McLean Hospital Belmont, Massachusetts Helen Nowlis, Ph.D. Rochester, New York Lee Robins, Ph.D. Washington University School of Medicine St. Louis, Missouri NIDA Research Monograph Series William Pollin, M.D.
  • Introduced B.,Byhansen, 16

    Introduced B.,Byhansen, 16

    LB301 LB301 2021 2021 LEGISLATURE OF NEBRASKA ONE HUNDRED SEVENTH LEGISLATURE FIRST SESSION LEGISLATIVE BILL 301 Introduced by Hansen, B., 16. Read first time January 12, 2021 Committee: Judiciary 1 A BILL FOR AN ACT relating to the Uniform Controlled Substances Act; to 2 amend sections 28-401, 28-405, and 28-416, Revised Statutes 3 Cumulative Supplement, 2020; to redefine terms; to change drug 4 schedules and adopt federal drug provisions; to change a penalty 5 provision; and to repeal the original sections. 6 Be it enacted by the people of the State of Nebraska, -1- LB301 LB301 2021 2021 1 Section 1. Section 28-401, Revised Statutes Cumulative Supplement, 2 2020, is amended to read: 3 28-401 As used in the Uniform Controlled Substances Act, unless the 4 context otherwise requires: 5 (1) Administer means to directly apply a controlled substance by 6 injection, inhalation, ingestion, or any other means to the body of a 7 patient or research subject; 8 (2) Agent means an authorized person who acts on behalf of or at the 9 direction of another person but does not include a common or contract 10 carrier, public warehouse keeper, or employee of a carrier or warehouse 11 keeper; 12 (3) Administration means the Drug Enforcement Administration of the 13 United States Department of Justice; 14 (4) Controlled substance means a drug, biological, substance, or 15 immediate precursor in Schedules I through V of section 28-405. 16 Controlled substance does not include distilled spirits, wine, malt 17 beverages, tobacco, hemp, or any nonnarcotic substance if such substance 18 may, under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.