Quality of Information on Emergency Contraception on the Internet. Br J Fam Plann 2000
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(12) United States Patent (10) Patent No.: US 7,871,995 B2 Bunschoten Et Al
US00787 1995 B2 (12) United States Patent (10) Patent No.: US 7,871,995 B2 Bunschoten et al. (45) Date of Patent: *Jan. 18, 2011 (54) DRUG DELIVERY SYSTEM COMPRISINGA (52) U.S. Cl. ....................................... 514/171; 514/182 TETRAHYDROXYLATED ESTROGEN FOR (58) Field of Classification Search ................. 514/171, USE IN HORMONAL CONTRACEPTION 514f182 See application file for complete search history. (75) Inventors: Evert Johannes Bunschoten, Heesch (NL); Herman Jan Tijmen Coelingh (56) References Cited Bennink, Driebergen (NL); Christian U.S. PATENT DOCUMENTS Franz Holinka, New York, NY (US) 3,440,320 A 4, 1969 Sackler et al. O O 3,797.494. A 3, 1974 Zaffaroni (73) Assignee: Pantarhei Bioscience B.V., Al Zeist 4,460.372 A 7/1984 Campbell et al. (NL) 4,573.996 A 3/1986 Kwiatek et al. 4,624,665 A 1 1/1986 Nuwayser (*) Notice: Subject to any disclaimer, the term of this 4,722,941 A 2f1988 Eckert et al. patent is extended or adjusted under 35 4,762,717 A 8/1988 Crowley, Jr. U.S.C. 154(b) by 1233 days. 4.937,238 A 6, 1990 Lemon 5,063,507 A 1 1/1991 Lindsey et al. This patent is Subject to a terminal dis- 5,130,137 A 7/1992 Crowley, Jr. claimer. 5,211,952 A 5/1993 Spicer et al. 5,223,261 A 6/1993 Nelson et al. 5,340,584 A 8/1994 Spicer et al. (21) Appl. No.: 10/478,357 5,340,585 A 8/1994 Pike et al. 1-1. 5,340,586 A 8, 1994 Pike et al. -
Mifepristone
1. NAME OF THE MEDICINAL PRODUCT Mifegyne 200 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200-mg mifepristone. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Tablet. Light yellow, cylindrical, bi-convex tablets, with a diameter of 11 mm with “167 B” engraved on one side. 4. CLINICAL PARTICULARS For termination of pregnancy, the anti-progesterone mifepristone and the prostaglandin analogue can only be prescribed and administered in accordance with New Zealand’s abortion laws and regulations. 4.1 Therapeutic indications 1- Medical termination of developing intra-uterine pregnancy. In sequential use with a prostaglandin analogue, up to 63 days of amenorrhea (see section 4.2). 2- Softening and dilatation of the cervix uteri prior to surgical termination of pregnancy during the first trimester. 3- Preparation for the action of prostaglandin analogues in the termination of pregnancy for medical reasons (beyond the first trimester). 4- Labour induction in fetal death in utero. In patients where prostaglandin or oxytocin cannot be used. 4.2 Dose and Method of Administration Dose 1- Medical termination of developing intra-uterine pregnancy The method of administration will be as follows: • Up to 49 days of amenorrhea: 1 Mifepristone is taken as a single 600 mg (i.e. 3 tablets of 200 mg each) oral dose, followed 36 to 48 hours later, by the administration of the prostaglandin analogue: misoprostol 400 µg orally or per vaginum. • Between 50-63 days of amenorrhea Mifepristone is taken as a single 600 mg (i.e. 3 tablets of 200 mg each) oral dose, followed 36 to 48 hours later, by the administration of misoprostol. -
Patch Development with New Drugs Versus Generic Development – Principles and Methods
Patch development with new drugs versus generic development – principles and methods Dr. Barbara Schug SocraTec R&D, Oberursel , Germany www.socratec-pharma.de AGAH Workshop, The new European modified Release Guideline- from cook book to interpretation, Bonn, June 15th –16th, 2015 Some basics Physico-chemical properties / conventional patches small molecule < 500kDa lipophilic potent therapeutic concept which requires low fluctuation Skin controls release rate drug substance dispersed in adhesive matrix Patch controls release rate rate controlling membrane between drug reservoir and skin Currently marketed patches Year Generic (Brand) Names Indication 1979 Scopolamine (Transderm Scop®) Motion sickness 1982 Nitroglycerine (Nitroderm TTS) Angina pectoris 1984 Clonidine (Catapress TTS®) Hypertension 1986 Estradiol (Estraderm®) Menopausal symptoms 1990 Fentanyl (Duragesic®) Chronic pain 1991 Nicotine (Nicoderm®, Habitrol®, Prostep®) Smoking cessation 1993 Testosterone (Androderm®) Testosterone deficiency 1995 Lidocaine/epinephrine (Iontocaine®) Local dermal analgesia 1998 Estradiol/norethindrone (Combipatch®) Menopausal symptoms 1999 Lidocaine (Lidoderm®) Post-herpetic neuralgia pain 2001 Ethinyl estradiol/norelgestromin (OrthoEvra®) Contraception 2003 Estradiol/levonorgestrel (Climara Pro®) Menopause 2003 Oxybutynin (Oxytrol®) Overactive bladder 2004 Lidocaine/ultrasound (SonoPrep®) Local dermal anesthesia Source: modified from Wilson EJ, Three Generations: The Past, Present, and Future of Transdermal Drug Delivery Systems, May 2014 -
F.8 Ethinylestradiol-Etonogestrel.Pdf
General Items 1. Summary statement of the proposal for inclusion, change or deletion. Here within, please find the evidence to support the inclusion Ethinylestradiol/Etonogestrel Vaginal Ring in the World Health Organization’s Essential Medicines List (EML). Unintended pregnancy is regarded as a serious public health issue both in developed and developing countries and has received growing research and policy attention during last few decades (1). It is a major global concern due to its association with adverse physical, mental, social and economic outcomes. Developing countries account for approximately 99% of the global maternal deaths in 2015, with sub-Saharan Africa alone accounting for roughly 66% (2). Even though the incidence of unintended pregnancy has declined globally in the past decade, the rate of unintended pregnancy remains high, particularly in developing regions. (3) Regarding the use of contraceptive vaginal rings, updated bibliography (4,5,6) states that contraceptive vaginal rings (CVR) offer an effective contraceptive option, expanding the available choices of hormonal contraception. Ethinylestradiol/Etonogestrel Vaginal Ring is a non-biodegradable, flexible, transparent with an outer diameter of 54 mm and a cross-sectional diameter of 4 mm. It contains 11.7 mg etonogestrel and 2.7 mg ethinyl estradiol. When placed in the vagina, each ring releases on average 0.120 mg/day of etonogestrel and 0.015 mg/day of ethinyl estradiol over a three-week period of use. Ethinylestradiol/Etonogestrel Vaginal Ring is intended for women of fertile age. The safety and efficacy have been established in women aged 18 to 40 years. The main advantages of CVRs are their effectiveness (similar or slightly better than the pill), ease of use without the need of remembering a daily routine, user ability to control initiation and discontinuation, nearly constant release rate allowing for lower doses, greater bioavailability and good cycle control with the combined ring, in comparison with oral contraceptives. -
Wellness Benefits
Wellness Benefits University of South Alabama This schedule outlines services and items that the University of South Alabama considers a preventive service under this plan. These services must be performed by a physician in the University of South Alabama Health System provider network or by a dermatologist, endocrinologist, durable medical equipment provider, ancillary service provider, urologist, or rheumatologist provider (as applicable) in the entire VIVA HEALTH network. Many of these services are provided as part of an annual physical. This list does not apply to all VIVA HEALTH plans. Please refer to your Summary Plan Description to determine the terms of your health plan. PREVENTIVE SERVICE FREQUENCY/LIMITATIONS Well Baby Visits (Age 0-2) As recommended per guidelines1 Routine screenings, tests, and immunizations As recommended per guidelines Well Child Visits (Age 3-17) One per year at PCP2 Routine screenings, tests, & immunizations As recommended per guidelines HIV screening and counseling As recommended per guidelines Obesity screening As recommended per guidelines Hepatitis B virus screening As recommended per guidelines Sexually transmitted infection counseling Annually Skin cancer behavioral counseling (Beginning at age 10) As recommended per guidelines Routine Physical (Age 18+) One per year at PCP2 Alcohol misuse screening and counseling Annually Blood pressure screening Annually Cholesterol screening As recommended per guidelines Depression screening Annually Diabetes screening As recommended per -
(12) United States Patent (10) Patent No.: US 7,723,320 B2 Bunschoten Et Al
US007723320B2 (12) United States Patent (10) Patent No.: US 7,723,320 B2 Bunschoten et al. (45) Date of Patent: May 25, 2010 (54) USE OF ESTROGEN COMPOUNDS TO DE 23,36434. A 4, 1975 INCREASE LIBDO IN WOMEN WO WO96 O3929 A 2, 1996 (75) Inventors: Evert Johannes Bunschoten, Heesch OTHER PUBLICATIONS (NL); Herman Jan Tijmen Coelingh Bennink, Driebergen (NL); Christian Holinka CF et al: “Comparison of Effects of Estetrol and Taxoxifen Franz Holinka, New York, NY (US) with Those of Estriol and Estradiol on the Immature Rat Uterus'; Biology of Reproduction; 1980; pp. 913-926; vol. 22, No. 4. (73) Assignee: Pantarhei Bioscience B.V., Al Zeist Holinka CF et al; "In-Vivo Effects of Estetrol on the Immature Rat (NL) Uterus'; Biology of Reproduction; 1979: pp. 242-246; vol. 20, No. 2. Albertazzi Paola et al.; "The Effect of Tibolone Versus Continuous Combined Norethisterone Acetate and Oestradiol on Memory, (*) Notice: Subject to any disclaimer, the term of this Libido and Mood of Postmenopausal Women: A pilot study': Data patent is extended or adjusted under 35 base Biosis "Online!; Oct. 31, 2000: pp. 223-229; vol. 36, No. 3; U.S.C. 154(b) by 1072 days. Biosciences Information Service.: Philadelphia, PA, US. Visser et al., “In vitro effects of estetrol on receptor binding, drug (21) Appl. No.: 10/478,264 targets and human liver cell metabolism.” Climacteric (2008) 11(1) Appx. II: 1-5. (22) PCT Filed: May 17, 2002 Visser et al., “First human exposure to exogenous single-dose oral estetrol in early postmenopausal women.” Climacteric (2008) 11(1): (86). -
Vaginal Administration of Contraceptives
Scientia Pharmaceutica Review Vaginal Administration of Contraceptives Esmat Jalalvandi 1,*, Hafez Jafari 2 , Christiani A. Amorim 3 , Denise Freitas Siqueira Petri 4 , Lei Nie 5,* and Amin Shavandi 2,* 1 School of Engineering and Physical Sciences, Heriot-Watt University, Edinburgh EH14 4AS, UK 2 BioMatter Unit, École Polytechnique de Bruxelles, Université Libre de Bruxelles, Avenue F.D. Roosevelt, 50-CP 165/61, 1050 Brussels, Belgium; [email protected] 3 Pôle de Recherche en Gynécologie, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, 1200 Brussels, Belgium; [email protected] 4 Fundamental Chemistry Department, Institute of Chemistry, University of São Paulo, Av. Prof. Lineu Prestes 748, São Paulo 05508-000, Brazil; [email protected] 5 College of Life Sciences, Xinyang Normal University, Xinyang 464000, China * Correspondence: [email protected] (E.J.); [email protected] (L.N.); [email protected] (A.S.); Tel.: +32-2-650-3681 (A.S.) Abstract: While contraceptive drugs have enabled many people to decide when they want to have a baby, more than 100 million unintended pregnancies each year in the world may indicate the contraceptive requirement of many people has not been well addressed yet. The vagina is a well- established and practical route for the delivery of various pharmacological molecules, including contraceptives. This review aims to present an overview of different contraceptive methods focusing on the vaginal route of delivery for contraceptives, including current developments, discussing the potentials and limitations of the modern methods, designs, and how well each method performs for delivering the contraceptives and preventing pregnancy. -
Recommendations for Contraceptive Use, 2013 Adapted from the World Health Organization Selected Practice Recommendations for Contraceptive Use, 2Nd Edition
Morbidity and Mortality Weekly Report Early Release / Vol. 62 June 14, 2013 U.S. Selected Practice Recommendations for Contraceptive Use, 2013 Adapted from the World Health Organization Selected Practice Recommendations for Contraceptive Use, 2nd Edition Continuing Education Examination available at http://www.cdc.gov/mmwr/cme/conted.html. U.S. Department of Health and Human Services Centers for Disease Control and Prevention Early Release CONTENTS CONTENTS (Continued) Introduction ............................................................................................................1 Appendix A: Summary Chart of U.S. Medical Eligibility Criteria for Methods ....................................................................................................................2 Contraceptive Use, 2010 .................................................................................. 47 How To Use This Document ...............................................................................3 Appendix B: When To Start Using Specific Contraceptive Summary of Changes from WHO SPR ............................................................4 Methods .............................................................................................................. 55 Contraceptive Method Choice .........................................................................4 Appendix C: Examinations and Tests Needed Before Initiation of Maintaining Updated Guidance ......................................................................4 Contraceptive Methods -
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. -
VTE Prophylaxis in Gynecologic Surgery
ClinicalProviding Information Evidence-based for 25 Years AHC Media LLC Home Page—www.ahcmedia.com CME for Physicians—www.cmeweb.com EDITOR VTE Prophylaxis in Gynecologic Jeffrey T. Jensen, MD, MPH Leon Speroff Professor and Vice Chair for Research Surgery: Quo Vadis? Department of Obstetrics and Gynecology ABSTRACT & COMMENTARY Oregon Health & Science University InsIde Portland Oligohydram- By Robert L. Coleman, MD ASSOCIATE EDITORS nios: A reason Sarah L. Berga, MD Professor and Chair to deliver? Professor, University of Texas; M.D. Anderson Cancer Center, Houston Department of Obstetrics and page 59 Gynecology Vice President for Women’s Dr. Coleman reports no financial relationships relevant to this field of study. Health Services Wake Forest Baptist Health, Winston-Salem, NC Which is Synopsis: Venous thromboembolism (VTE) prophylaxis better: Open, Robert L. Coleman, MD interventions in gynecologic surgery are meritorious, supported Professor, University of laparoscopic, by Level 1 evidence and the subject of multiple guidelines, including Texas; M.D. Anderson Cancer Center, Houston or robotic? those published by the American College of Obstetricians and Gynecologists. However, new evidence suggests nearly Alison Edelman, MD, MPH page 60 Associate Professor, one-third of women undergoing hysterectomy in this country Assistant Director of the still receive no VTE prophylaxis, placing thousands of women at Family Planning Fellowship Special Department of Obstetrics & unnecessary risk for preventable morbidity. Gynecology, Oregon Health feature: & Science University, Portland Do we have a Source: Wright JD, et al. Quality of perioperative venous thromboembolism John C. Hobbins, MD problem? prophylaxis in gynecologic surgery. Obstet Gynecol 2011;118:978-986. Professor, Department of Obstetrics and Gynecology, Obesity and University of Colorado Health contraception he objective of this study was to estimate the use of vte pro- Sciences Center, Denver page 61 Tphylaxis in women undergoing major gynecologic surgery and to Frank W. -
Research Article Biomarkers & Prevention
Published OnlineFirst March 14, 2014; DOI: 10.1158/1055-9965.EPI-13-0944 Cancer Epidemiology, Research Article Biomarkers & Prevention Oral Contraceptives and Breast Cancer Risk Overall and by Molecular Subtype Among Young Women Elisabeth F. Beaber1,3, Kathleen E. Malone1,3, Mei-Tzu Chen Tang1, William E. Barlow1,4, Peggy L. Porter1,2,5, Janet R. Daling1,3, and Christopher I. Li1,3 Abstract Background: Evidence suggests that recent oral contraceptive (OC) use is associated with a small increased breast cancer risk; yet risks associated with contemporary OC preparations and by molecular subtype are not well characterized. Methods: We conducted a population-based case–control study of invasive breast cancer among women ages 20 to 44 residing in the Seattle–Puget Sound area from 2004 to 2010 (985 cases and 882 controls). We collected information on contraceptive use and participant characteristics via an in-person interview. Mul- tivariable-adjusted logistic regression was used to calculate odds ratios (OR) and 95% confidence intervals (CI). Results: Lifetime duration of OC use for 15 years was associated with an increased breast cancer risk (OR, 1.5; 95% CI, 1.1–2.2). Current OC use (within 1 year of reference date) for 5 years was associated with an increased risk (OR, 1.6; 95% CI, 1.1–2.5) and there were no statistically significant differences in risk by OC preparation. Risk magnitudes were generally greater among women ages 20 to 39, and for estrogen receptor– À À negative (ER ) and triple-negative breast cancer (current use for 5 years among ages 20–39: ER OR, 3.5; 95% CI, 1.3–9.0; triple-negative OR, 3.7; 95% CI, 1.2–11.8), although differences between groups were not statistically significant. -
Emergency Contraception: History, Methods, Mechanisms, Misconceptions and a Philosophical Evaluation
logy & Ob o st ec e tr n i y c s G Gynecology & Obstetrics Goldstuck, Gynecol Obstet (Sunnyvale) 2014, 4:5 DOI: 10.4172/2161-0932.1000224 ISSN: 2161-0932 Review Article Open Access Emergency Contraception: History, Methods, Mechanisms, Misconceptions and a Philosophical Evaluation Norman D Goldstuck* Department of Obstetrics and Gynaecology, Faculty of Medicine and Health Sciences, Stellenbosch University and Tygerberg Hospital, Cape Town 7505, South Africa *Corresponding author: Norman D Goldstuck, Department of Obstetrics and Gynaecology, Faculty of Medicine and Health Sciences, Stellenbosch University and Tygerberg Hospital, Cape Town 7505, South Africa, Tel: +27823418200; E-mail: [email protected] Received: Apr 07, 2014; Accepted: May 28, 2014; Published: May 31, 2014 Copyright: © 2014 Goldstuck. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Abstract Humans have attempted to disrupt the progression of pregnancy for a very long time. This dates back to the realization that it was a sexual activity which started the reproductive cycle. Folk methods for preventing pregnancy after unprotected sexual activity are physiologically unable to be effective and we now have chemical, mainly hormonal methods, and a mechanical method the intrauterine device which do work in the very early stages before conception can be diagnosed with certainty. These methods are impeded by those who worry that fertilisation of the ovum may have occurred, and that the method may then be abortifacient. Considering that it is possible to easily disrupt an established pregnancy by medical or surgical means depending on the duration, this would be no different than any other means of abortion induction.