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Transdermal Absorption Preparation
Europäisches Patentamt *EP001522316A1* (19) European Patent Office Office européen des brevets (11) EP 1 522 316 A1 (12) EUROPEAN PATENT APPLICATION published in accordance with Art. 158(3) EPC (43) Date of publication: (51) Int Cl.7: A61K 47/34, A61K 47/10, 13.04.2005 Bulletin 2005/15 A61K 47/14, A61K 9/06, A61K 9/08, A61K 9/12, (21) Application number: 03764126.3 A61K 9/70 (22) Date of filing: 02.07.2003 (86) International application number: PCT/JP2003/008400 (87) International publication number: WO 2004/006960 (22.01.2004 Gazette 2004/04) (84) Designated Contracting States: • OMICHI, Katsuhiro AT BE BG CH CY CZ DE DK EE ES FI FR GB GR Saitama-shi, Saitama 338-0832 (JP) HU IE IT LI LU MC NL PT RO SE SI SK TR • OKADA, Minoru Designated Extension States: Inzai-shi, Chiba 270-1323 (JP) AL LT LV MK • KURAZUMI, Toshiaki Narita-shi, Chiba 286-0011 (JP) (30) Priority: 16.07.2002 JP 2002206565 (74) Representative: Hartz, Nikolai F., Dr. (71) Applicant: SSP Co., Ltd. Wächtershäuser & Hartz Chuo-ku, Tokyo 103-8481 (JP) Patentanwälte Weinstrasse 8 (72) Inventors: 80333 München (DE) • NARUI, Takashi Sakura-shi, Chiba 285-0817 (JP) (54) TRANSDERMAL ABSORPTION PREPARATION (57) A transdermal absorption promotion composi- and transdermal absorption preparation not only exhibit tion comprising the following components (a), (b), and an excellent transdermal absorption promotion effect, (c) and a transdermal absorption preparation compris- but also exhibit superior skin-permeability, even if a drug ing the following components (a), (b), (c), and (d) are having a relatively high lipophilic property and poor disclosed. -
Epidural Analgesia Guidelines for the Rhw
LOCAL OPERATING PROCEDURE CLINICAL POLICIES, PROCEDURES & GUIDELINES Approved by Quality & Patient Care Committee 2 June 2016 EPIDURAL ANALGESIA GUIDELINES FOR THE RHW SECTION 1 RATIONAL SECTION 2 EDUCATION OF NURSING/MIDWIFERY STAFF SECTION 3 INDICATIONS/DOSING/OBSERVATIONS SECTION 4 PROCEDURE SECTION 5 MANAGEMENT GUIDELINES SECTION 6 COMPLICATIONS & MANAGEMENT SECTION 7 REMOVAL OF EPIDURAL CATHETER SECTION 8 CONCURRENT USE OF ANTICOAGULANTS APPENDIX 1 EPIDURAL DISCHARGE ADVICE APPENDIX 2 PATIENT DISCHARGE INSTRUCTIONS AFTER EPIDURAL BLOOD PATCH …./2 2. LOCAL OPERATING PROCEDURE CLINICAL POLICIES, PROCEDURES & GUIDELINES Approved by Quality & Patient Care Committee 2 June 2016 EPIDURAL ANALGESIA GUIDELINES FOR THE RHW cont’d SECTION 1 – RATIONAL • The blockade of transmission of pain impulses by the use of local anaesthetic medication can reduce the body’s physiological response to the stress of pain. • Systemic opioids only, although a strong pain reliever, may cause respiratory depression, sedation, nausea, vomiting, confusion, lightheadedness, constipation and immobilisation. • The goal of regional axial blockade (epidural analgesia) in moderate to severe pain is to diminish the development of an efficient pain pathway, by blocking conduction along pain nerve fibers. • Epidural infusions however, requires constant assessment and at times intervention in order to provide this level of pain control. • Vigilance is required as tolerance to local anaesthetic can develop which can require more agent be infused in order to maintain the level of block. • Other factors such as patient position and movement will influence the effectiveness of the infusion, as will the precision of the pump and time spent when changing infusions. • Opioids added to an epidural infusion can augment the analgesic effect of the local anaesthetic block. -
Summary of Product Characteristics
Summary of Product Characteristics 1. NAME OF THE MEDICINAL PRODUCT /…/ 2 mg/ml solution for injection /…/ 7.5 mg/ml solution for injection /…/ 10 mg/ml solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION /…/ 2 mg/ml solution for injection: 1 ml contains 2.12 mg ropivacaine hydrochloride monohydrate, equivalent to 2 mg of ropivacaine hydrochloride. Excipient with know effect: sodium 3.6 mg/ml 10 ml amp. contains 21.2 mg ropivacaine hydrochloride monohydrate, equivalent to 20 mg of ropivacaine hydrochloride. 20 ml amp. contains 42.3 mg ropivacaine hydrochloride monohydrate, equivalent to 40 mg of ropivacaine hydrochloride. /…/ 7.5 mg/ml solution for injection: 1 ml contains 7.94 mg ropivacaine hydrochloride monohydrate, equivalent to 7.5 mg of ropivacaine hydrochloride. Excipient with known effect: sodium 3.0 mg/ml 10 ml amp. contains 79.4 mg ropivacaine hydrochloride monohydrate, equivalent to 75 mg of ropivacaine hydrochloride. 20 ml amp. contains 158.7 mg ropivacaine hydrochloride monohydrate, equivalent to 150 mg of ropivacaine hydrochloride. /…/ 10 mg/ml solution for injection: 1 ml contains 10.58 mg ropivacaine hydrochloride monohydrate, equivalent to 10 mg of ropivacaine hydrochloride. Excipient with known effect: sodium 2.9 mg/ml 10 ml amp. contains 105.8 mg ropivacaine hydrochloride monohydrate, equivalent to 100 mg of ropivacaine hydrochloride. 20 ml amp. contains 211.6 mg ropivacaine hydrochloride monohydrate, equivalent to 200 mg of ropivacaine hydrochloride. For thefull list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection Clear, colourless solution with a pH of 3.5 – 6 and an osmolality of 280 – 320 mosmol/kg. -
Biomedical Technology and Devices Handbook
1140_bookreps.fm Page 1 Tuesday, July 15, 2003 9:47 AM 29 Pharmaceutical Technical Background on Delivery Methods CONTENTS 29.1 Introduction 29.2 Central Nervous System: Drug Delivery Challenges to Delivery: The Blood Brain Barrier • Indirect Routes of Administration • Direct Routes of Administration 29.3 Cardiovascular System: Drug Delivery Chronotherapeutics • Grafts/Stents 29.4 Orthopedic: Drug Delivery Metabolic Bone Diseases 29.5 Muscular System: Drug Delivery 29.6 Sensory: Drug Delivery Ultrasound • Iontophoresis/Electroporation 29.7 Digestive System: Drug Delivery GI Stents • Colonic Drug Delivery 29.8 Pulmonary: Drug Delivery Indirect Routes of Administration • Direct Routes of Robert S. Litman Administration Nova Southeastern University 29.9 Ear, Nose, and Throat: Drug Delivery Maria de la Cova The Ear • The Nose • The Throat 29.10 Lymphatic System: Drug Delivery Icel Gonzalez 29.11 Reproductive System: Drug Delivery University of Memphis Contraceptive Implants • Contraceptive Patch • Male Contraceptive Eduardo Lopez References 29.1 Introduction In the evolution of drug development and manufacturing, drug delivery systems have risen to the forefront in the latest of pharmaceutical advances. There are many new pharmacological entities discov- ered each year, each with its own unique mechanism of action. Each drug will demonstrate its own pharmacokinetic profile. This profile may be changed by altering the drug delivery system to the target site. In order for a drug to demonstrate its pharmacological activity it must be absorbed, transported to the appropriate tissue or target organ, penetrate to the responding subcellular structure, and elicit a response or change an ongoing process. The drug may be simultaneously or sequentially distributed to a variety of tissues, bound or stored, further metabolized to active or inactive products, and eventually © 2004 by CRC Press LLC 1140_bookreps.fm Page 2 Tuesday, July 15, 2003 9:47 AM 29-2 Biomedical Technology and Devices Handbook excreted from the body. -
The Role of Deformable Liposome Characteristics on Skin Permeability of Meloxicam: Optimal Transfersome As Transdermal Delivery Carriers
Send Orders for Reprints to [email protected] The Open Conference Proceedings Journal, 2013, 4, 87-92 87 Open Access The Role of Deformable Liposome Characteristics on Skin Permeability of Meloxicam: Optimal Transfersome as Transdermal Delivery Carriers Sureewan Duangjit1,2, Praneet Opanasopit1, Theerasak Rojarata1, Yasuko Obata2, Yoshinori Oniki2, Kozo Takayama2 and Tanasait Ngawhirunpat1,* 1Department of Pharmaceutical Technology, Faculty of Pharmacy, Silpakorn University, Nakhon Pathom 73000, Thailand 2Department of Pharmaceutics, Hoshi University, Ebara 2-4-41, Shinagawa-ku, Tokyo 142-8501, Japan Abstract: The role of deformable liposomes characteristics on skin permeability has evoked considerable interest, since the articles reporting the effectiveness of transfersomes for skin delivery were increasingly published. Several reports focus on the effect of formulation factor which directly affected the transfersome’s skin permeability. However, the effect of formulation factors was not fully understood as the contradictory results. To clarify this problem, the reliable statistical techniques, excellent experimental design and systematical variation were used in this study. Transfersomes loaded meloxicam containing controlled amount of phosphatidylcholine (PC), cholesterol (Chol), type of surfactant (hydrophilic part, lipophilic part ) were prepared and investigated for the physicochemical characteristics (e.g., size, size distribution, charge, elasticity, drug content, morphology) and skin permeability. The results indicated -
Pulmonary Delivery of Biological Drugs
pharmaceutics Review Pulmonary Delivery of Biological Drugs Wanling Liang 1,*, Harry W. Pan 1 , Driton Vllasaliu 2 and Jenny K. W. Lam 1 1 Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, 21 Sassoon Road, Pokfulam, Hong Kong, China; [email protected] (H.W.P.); [email protected] (J.K.W.L.) 2 School of Cancer and Pharmaceutical Sciences, King’s College London, 150 Stamford Street, London SE1 9NH, UK; [email protected] * Correspondence: [email protected]; Tel.: +852-3917-9024 Received: 15 September 2020; Accepted: 20 October 2020; Published: 26 October 2020 Abstract: In the last decade, biological drugs have rapidly proliferated and have now become an important therapeutic modality. This is because of their high potency, high specificity and desirable safety profile. The majority of biological drugs are peptide- and protein-based therapeutics with poor oral bioavailability. They are normally administered by parenteral injection (with a very few exceptions). Pulmonary delivery is an attractive non-invasive alternative route of administration for local and systemic delivery of biologics with immense potential to treat various diseases, including diabetes, cystic fibrosis, respiratory viral infection and asthma, etc. The massive surface area and extensive vascularisation in the lungs enable rapid absorption and fast onset of action. Despite the benefits of pulmonary delivery, development of inhalable biological drug is a challenging task. There are various anatomical, physiological and immunological barriers that affect the therapeutic efficacy of inhaled formulations. This review assesses the characteristics of biological drugs and the barriers to pulmonary drug delivery. -
A New Technique of Epidural and Intrathecal Catheterization to Evaluate Pharmacokinetics of Epidural Administration in Dogs: a Prospective Study
A new technique of epidural and intrathecal catheterization to evaluate pharmacokinetics of epidural administration in dogs: a prospective study Myoung Hoon Kong Korea University Guro Hospital Sang Sik Choi ( [email protected] ) Korea University Guro Hospital https://orcid.org/0000-0002-0260-9886 Jung Eun Kim Korea University Guro Hospital Mi Kyoung Lee Korea University Guro Hospital Chung Hun Lee Korea University Guro Hospital Yeon Joo Lee Korea University Guro Hospital Technical advance Keywords: Canine; Epidural catheterization; Epidural drug administration; Intrathecal catheterization; Yaksh’s model Posted Date: April 19th, 2019 DOI: https://doi.org/10.21203/rs.2.9257/v1 License: This work is licensed under a Creative Commons Attribution 4.0 International License. Read Full License Page 1/10 Abstract Background: Compared to the conventional oral or intravenous drug administration, epidural administration of drugs has signicantly higher ecacy and safety. Experimental research on animals should be performed before applying to humans. Unlike the existing canine model, we describe a new and alternative technique of epidural and intrathecal catheterization to investigate the ecacy and safety of epidural drug administration in dogs. Methods: Twelve adult dogs were used in this study. The procedures were performed with dogs in sternal recumbency under deep sedation. Epidural catheterization was performed at the T1–T2 intervertebral space with C-arm uoroscopy guidance. After conrming loss of resistance, a exible epidural catheter was passed cranially to the C2–C3 level. Intrathecal catheterization was performed through the cisterna magna with the neck slightly exed. An 18-gauge Tuohy needle was inserted into the subarachnoid space through the atlanto-occipital space. -
EXPAREL Briefing Document: 14-15 February 2018
EXPAREL Briefing Document: 14-15 February 2018 FDA Advisory Committee Meeting FDA ADVISORY COMMITTEE MEETING BRIEFING DOCUMENT ® EXPAREL (bupivacaine liposome injectable suspension) MEETING OF THE ANESTHETIC AND ANALGESIC DRUG PRODUCTS ADVISORY COMMITTEE MEETING DATE: 14-15 February 2018 AVAILABLE FOR PUBLIC RELEASE EXPAREL Briefing Document: 14-15 February 2018 FDA Advisory Committee Meeting TABLE OF CONTENTS Table of Contents ............................................................................................................................ 2 List of Tables .................................................................................................................................. 5 List of Figures ................................................................................................................................. 6 1 Executive Summary ................................................................................................................ 9 1.1 Rationale for the Use of EXPAREL as a Nerve Block .................................................. 10 1.2 Regulatory History ......................................................................................................... 12 1.3 Clinical Pharmacology ................................................................................................... 13 1.4 Efficacy Findings ........................................................................................................... 14 1.5 Safety Findings .............................................................................................................. -
Redalyc.Antinociceptive Effects of Epidural Tramadol Administration In
Acta Scientiae Veterinariae ISSN: 1678-0345 [email protected] Universidade Federal do Rio Grande do Sul Brasil Côrrea Natalini, Cláudio; da Silva Polydoro, Alexandre; Crosignani, Nadia Antinociceptive effects of epidural tramadol administration in dogs as an analgesic technique for experimental stifle surgery Acta Scientiae Veterinariae, vol. 35, núm. 2, 2007, pp. 189-195 Universidade Federal do Rio Grande do Sul Porto Alegre, Brasil Available in: http://www.redalyc.org/articulo.oa?id=289021845008 How to cite Complete issue Scientific Information System More information about this article Network of Scientific Journals from Latin America, the Caribbean, Spain and Portugal Journal's homepage in redalyc.org Non-profit academic project, developed under the open access initiative Acta Scientiae Veterinariae. 35(2): 189-195, 2007. ORIGINAL ARTICLE ISSN 1678-0345 (Print) Pub. 725 ISSN 1679-9216 (Online) Antinociceptive effects of epidural tramadol administration in dogs as an analgesic technique for experimental stifle surgery Efeitos antinociceptivos da administração epidural de tramadol em cães como técnica analgésica para cirurgia experimental do joelho Cláudio Côrrea Natalini1, Alexandre da Silva Polydoro2 & Nadia Crosignani2 ABSTRACT Tramadol is a centrally acting analgesic with µ-opioid and monoaminergic agonist effect. Ten healthy adult dogs were studied (mean ± SEM body weight 17.3 ± 3.8 kg), premedicated with acepromazine (0.05 mg/kg, IM), induced with thiopental (10 mg/kg, IV) and maintained under anesthesia with halothane in oxygen. Twenty minutes after starting halothane anesthesia, tramadol (1.0 mg/kg in 0.22 ml/kg of sterile water) was administered epidurally at the lumbo-sacral space. Surgery began 15 minutes later. -
Assessment and Management of Pain
November 2002 2007 Nursing Best Practice Guideline Shaping the future of Nursing assessment & management of pain Greetings from Doris Grinspun Executive Director Registered Nurses Association of Ontario It is with great excitement that the Registered Nurses Association of Ontario (RNAO) disseminates this nursing best practice guideline to you. Evidence-based practice supports the excellence in service that nurses are committed to deliver in our day-to-day practice. We offer our endless thanks to the many institutions and individuals that are making RNAO’s vision for Nursing Best Practice Guidelines (NBPGs) a reality. The Ontario Ministry of Health and Long-Term Care recognized RNAO’s ability to lead this project and is providing multi-year funding. Tazim Virani --NBPG project director-- with her fearless determination and skills, is moving the project forward faster and stronger than ever imagined. The nursing community, with its commitment and passion for excellence in nursing care, is providing the knowledge and countless hours essential to the creation and evaluation of each guideline. Employers have responded enthusiastically to the request for proposals (RFP), and are opening their organizations to pilot test the NBPGs. Now comes the true test in this phenomenal journey: will nurses utilize the guidelines in their day-to-day practice? Successful uptake of these NBPGs requires a concerted effort of four groups: nurses themselves, other health-care colleagues, nurse educators in academic and practice settings, and employers. After lodging these guidelines into their minds and hearts, knowledgeable and skillful nurses and nursing students need healthy and supportive work environments to help bring these guidelines to life. -
Thin Films As an Emerging Platform for Drug Delivery
View metadata, citation and similar papers at core.ac.uk brought to you by CORE provided by Elsevier - Publisher Connector asian journal of pharmaceutical sciences 11 (2016) 559–574 HOSTED BY Available online at www.sciencedirect.com ScienceDirect journal homepage: www.elsevier.com/locate/ajps Review Thin films as an emerging platform for drug delivery Sandeep Karki a,1, Hyeongmin Kim a,b,c,1, Seon-Jeong Na a, Dohyun Shin a,c, Kanghee Jo a,c, Jaehwi Lee a,b,c,* a Pharmaceutical Formulation Design Laboratory, College of Pharmacy, Chung-Ang University, Seoul 06974, Republic of Korea b Bio-Integration Research Center for Nutra-Pharmaceutical Epigenetics, Chung-Ang University, Seoul 06974, Republic of Korea c Center for Metareceptome Research, Chung-Ang University, Seoul 06974, Republic of Korea ARTICLE INFO ABSTRACT Article history: Pharmaceutical scientists throughout the world are trying to explore thin films as a novel Received 21 April 2016 drug delivery tool. Thin films have been identified as an alternative approach to conven- Accepted 12 May 2016 tional dosage forms. The thin films are considered to be convenient to swallow, self- Available online 6 June 2016 administrable, and fast dissolving dosage form, all of which make it as a versatile platform for drug delivery. This delivery system has been used for both systemic and local action via Keywords: several routes such as oral, buccal, sublingual, ocular, and transdermal routes. The design Thin film of efficient thin films requires a comprehensive knowledge of the pharmacological and phar- Film-forming polymer maceutical properties of drugs and polymers along with an appropriate selection of Mechanical properties manufacturing processes. -
Hormone Replacement Therapy (HRT)
Hormone replacement therapy (HRT) The leaflet aims to answer your questions about taking HRT to treat your menopausal symptoms. If you have any questions or concerns, please speak to the doctor or nurse caring for you. This leaflet should be read alongside any patient information provided by the manufacturer. What is HRT and why do I need it? HRT is medication aimed at relieving the symptoms that some women experience during the menopause, also known as the change of life. These symptoms could include hot flushes, night sweats, vaginal dryness, tiredness and irritability, and decreased sex drive. HRT works by replacing the hormone (oestrogen) that your body stops producing when you go through the menopause or when you have had surgery to remove your ovaries. Used long-term, HRT may help to reduce the risk of osteoporosis (thinning of the bones) and bowel cancer. However, there are also known risks including an increased risk of certain types of cancer. These risks are described in more detail later in this leaflet. As new research is available this will be discussed with you in your clinic appointment. When you start HRT, the doctor or nurse will discuss your age, symptoms and medical conditions before looking at the risks and benefits of HRT which are specific to you. These risks and benefits could change and will be discussed at your yearly review. Some women have a medical menopause (a menopause caused by medical treatment) and may be offered HRT. Some women are not able to take HRT – usually these are women with cancers that have been caused by hormones and women who have had a blood clot.