HRT Formulary and Treatment Guidance
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Compositions Comprising Drospirenone Molecularly
(19) & (11) EP 1 748 756 B1 (12) EUROPEAN PATENT SPECIFICATION (45) Date of publication and mention (51) Int Cl.: of the grant of the patent: A61K 9/00 (2006.01) A61K 9/107 (2006.01) 29.04.2009 Bulletin 2009/18 A61K 9/48 (2006.01) A61K 9/16 (2006.01) A61K 9/20 (2006.01) A61K 9/14 (2006.01) (2006.01) (2006.01) (21) Application number: 05708751.2 A61K 9/70 A61K 31/565 (22) Date of filing: 10.03.2005 (86) International application number: PCT/IB2005/000665 (87) International publication number: WO 2005/087194 (22.09.2005 Gazette 2005/38) (54) COMPOSITIONS COMPRISING DROSPIRENONE MOLECULARLY DISPERSED ZUSAMMENSETZUNGEN AUS DROSPIRENON IN MOLEKULARER DISPERSION DES COMPOSITIONS CONTENANT DROSPIRENONE A DISPERSION MOLECULAIRE (84) Designated Contracting States: (72) Inventors: AT BE BG CH CY CZ DE DK EE ES FI FR GB GR • FUNKE, Adrian HU IE IS IT LI LT LU MC NL PL PT RO SE SI SK TR D-14055 Berlin (DE) Designated Extension States: • WAGNER, Torsten AL BA HR MK YU 13127 Berlin (DE) (30) Priority: 10.03.2004 EP 04075713 (74) Representative: Wagner, Kim 10.03.2004 US 551355 P Plougmann & Vingtoft a/s Sundkrogsgade 9 (43) Date of publication of application: P.O. Box 831 07.02.2007 Bulletin 2007/06 2100 Copenhagen Ø (DK) (60) Divisional application: (56) References cited: 08011577.7 / 1 980 242 EP-A- 1 260 225 EP-A- 1 380 301 WO-A-01/52857 WO-A-20/04022065 (73) Proprietor: Bayer Schering Pharma WO-A-20/04041289 US-A- 5 569 652 Aktiengesellschaft US-A- 5 656 622 US-A- 5 789 442 13353 Berlin (DE) Note: Within nine months of the publication of the mention of the grant of the European patent in the European Patent Bulletin, any person may give notice to the European Patent Office of opposition to that patent, in accordance with the Implementing Regulations. -
Drospirenone-Containing Birth Control Pills (Yaz, Yasmin, Ocella, Gianvi and Their Generics)
Drospirenone-Containing Birth Control Pills (Yaz, Yasmin, Ocella, Gianvi and their generics) Drospirenone is a progestin component of some birth control pills that does some blocking of testosterone (the "male hormone" that women have, too, and the hormone that can be a part of making acne worse). This is why drospirenone-containing birth control pills are especially good at helping acne (and why they can theoretically help hirsutism and female-pattern scalp hair loss as well). Drospirenone is also a mild diuretic and is why these birth control pills do not cause the water weight gain that some birth control pills can. Any birth control pill can theoretically help acne just by evening out hormonal fluctuations, but for many birth control pills, the effects on acne is very minimal. Which birth control pills are most likely to help acne? Some birth control pills are more like testosterone and some are less like testosterone. The ones that are less like testosterone can theoretically help acne more. The drospirenone-containing birth control pills go one step further by blocking testosterone, and may show the most benefit on clearing acne. Drospirenone is a progestin that is derived from 17-alpha-spironolactone and is chemically related to the diuretic spironolactone. Spironolactone is a diuretic (used for high blood pressure) that is sometimes used off-label for the treatment of acne, hirsutism or female-pattern hair loss. Often people say that a drospirenone-containing birth control pill may be equivalent to 25mg of spironolactone. Risks : Any estrogen-containing birth control pill increases the risk of a high blood pressure, stroke, or other life-threatening blood clot, and one study showed possibly a slightly higher risk with a drospirenone-containing birth control pill. -
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Ginekologia Polska 2019, vol. 90, no. 9, 520–526 Copyright © 2019 Via Medica ORIGINAL PAPER / GYNECologY ISSN 0017–0011 DOI: 10.5603/GP.2019.0091 Anti-androgenic therapy in young patients and its impact on intensity of hirsutism, acne, menstrual pain intensity and sexuality — a preliminary study Anna Fuchs, Aleksandra Matonog, Paulina Sieradzka, Joanna Pilarska, Aleksandra Hauzer, Iwona Czech, Agnieszka Drosdzol-Cop Department of Pregnancy Pathology, Department of Woman’s Health, School of Health Sciences in Katowice, Medical University of Silesia, Katowice, Poland ABSTRACT Objectives: Using anti-androgenic contraception is one of the methods of birth control. It also has a significant, non-con- traceptive impact on women’s body. These drugs can be used in various endocrinological disorders, because of their ability to reduce the level of male hormones. The aim of our study is to establish a correlation between taking different types of anti-androgenic drugs and intensity of hirsutism, acne, menstrual pain intensity and sexuality . Material and methods: 570 women in childbearing age that had been using oral contraception for at least three months took part in our research. We examined women and asked them about quality of life, health, direct causes and effects of that treatment, intensity of acne and menstrual pain before and after. Our research group has been divided according to the type of gestagen contained in the contraceptive pill: dienogest, cyproterone, chlormadynone and drospirenone. Ad- ditionally, the control group consisted of women taking oral contraceptives without antiandrogenic component. Results: The mean age of the studied group was 23 years ± 3.23. 225 of 570 women complained of hirsutism. -
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. -
Alpha-Fetoprotein: the Major High-Affinity Estrogen Binder in Rat
Proc. Natl. Acad. Sci. USA Vol. 73, No. 5, pp. 1452-1456, May 1976 Biochemistry Alpha-fetoprotein: The major high-affinity estrogen binder in rat uterine cytosols (rat alpha-fetoprotein/estrogen receptors) JOSE URIEL, DANIELLE BOUILLON, CLAUDE AUSSEL, AND MICHELLE DUPIERS Institut de Recherches Scientifiques sur le Cancer, Boite Postale No. 8, 94800 Villejuif, France Communicated by Frangois Jacob, February 3, 1976 ABSTRACT Evidence is presented that alpha-fetoprotein nates in hypotonic solutions, whereas in salt concentrations (AFP), a serum globulin, accounts mainly, if not entirely, for above 0.2 M the 4S complex is by far the major binding enti- the high estrogen-binding properties of uterine cytosols from immature rats. By the use of specific immunoadsorbents to ty. AFP and by competitive assays with unlabeled steroids and The relatively high levels of serum AFP in immature rats pure AFP, it has been demonstrated that in hypotonic cyto- prompted us to explore the contribution of AFP to the estro- sols AFP is present partly as free protein with a sedimenta- gen-binding capacity of uterine homogenates. The results tion coefficient of about 4-5 S and partly in association with obtained with specific anti-AFP immunoadsorbents (12, 13) some intracellular constituent(s) to form an 8S estrogen-bind- provided evidence that at low salt concentrations,'AFP ac-' ing entity. The AFP - 8S transformation results in a loss of antigenic reactivity to antibodies against AFP and a signifi- counts for most of the estrogen-binding capacity associated cant change in binding specificity. This change in binding with the 4-5S macromolecular complex. -
Comparing the Effects of Combined Oral Contraceptives Containing Progestins with Low Androgenic and Antiandrogenic Activities on the Hypothalamic-Pituitary-Gonadal Axis In
JMIR RESEARCH PROTOCOLS Amiri et al Review Comparing the Effects of Combined Oral Contraceptives Containing Progestins With Low Androgenic and Antiandrogenic Activities on the Hypothalamic-Pituitary-Gonadal Axis in Patients With Polycystic Ovary Syndrome: Systematic Review and Meta-Analysis Mina Amiri1,2, PhD, Postdoc; Fahimeh Ramezani Tehrani2, MD; Fatemeh Nahidi3, PhD; Ali Kabir4, MD, MPH, PhD; Fereidoun Azizi5, MD 1Students Research Committee, School of Nursing and Midwifery, Department of Midwifery and Reproductive Health, Shahid Beheshti University of Medical Sciences, Tehran, Islamic Republic Of Iran 2Reproductive Endocrinology Research Center, Research Institute for Endocrine Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Islamic Republic Of Iran 3School of Nursing and Midwifery, Department of Midwifery and Reproductive Health, Shahid Beheshti University of Medical Sciences, Tehran, Islamic Republic Of Iran 4Minimally Invasive Surgery Research Center, Iran University of Medical Sciences, Tehran, Islamic Republic Of Iran 5Endocrine Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Islamic Republic Of Iran Corresponding Author: Fahimeh Ramezani Tehrani, MD Reproductive Endocrinology Research Center Research Institute for Endocrine Sciences Shahid Beheshti University of Medical Sciences 24 Parvaneh Yaman Street, Velenjak, PO Box 19395-4763 Tehran, 1985717413 Islamic Republic Of Iran Phone: 98 21 22432500 Email: [email protected] Abstract Background: Different products of combined oral contraceptives (COCs) can improve clinical and biochemical findings in patients with polycystic ovary syndrome (PCOS) through suppression of the hypothalamic-pituitary-gonadal (HPG) axis. Objective: This systematic review and meta-analysis aimed to compare the effects of COCs containing progestins with low androgenic and antiandrogenic activities on the HPG axis in patients with PCOS. -
Estriol (Ess-Trye-Ol) Description: Estrogen Hormone Other Names for This Medication: Incurin® Common Dosage Forms: Veterinary: 1 Mg Tablets
Prescription Label Patient Name: Species: Drug Name & Strength: Directions (amount to give how often & for how long): Prescribing Veterinarian's Name & Contact Information: Refills: [Content to be provided by prescribing veterinarian] Estriol (ess-trye-ol) Description: Estrogen Hormone Other Names for this Medication: Incurin® Common Dosage Forms: Veterinary: 1 mg tablets. Human: None. This information sheet does not contain all available information for this medication. It is to help answer commonly asked questions and help you give the medication safely and effectively to your animal. If you have other questions or need more information about this medication, contact your veterinarian or pharmacist. Key Information Estrogen hormone used in dogs to treat estrogen-responsive urinary incontinence. Most common side effects include lack of appetite, vomiting, greater thirst, and swollen vulva. May give with or without food. If your animal vomits or acts sick after receiving the drug on an empty stomach, try giving the next dose with food or a small treat. If vomiting continues, contact your veterinarian. Pregnant women and those who are breastfeeding should use caution when handling; they should wear disposable gloves when handling the drug. How is this medication useful? The FDA (U.S. Food & Drug Administration) has approved estriol for use in ovariohysterectomized (spayed) female dogs for the control of estrogen-responsive urinary incontinence (urine leaking). The FDA allows veterinarians to prescribe and use products containing this drug in different species or for other conditions in certain situations. You and your veterinarian can discuss why this drug is the most appropriate choice. What should I tell my veterinarian to see if this medication can be safely given? Many things might affect how well this drug will work in your animal. -
Estrogen Pharmacology. I. the Influence of Estradiol and Estriol on Hepatic Disposal of Sulfobromophthalein (BSP) in Man
Estrogen Pharmacology. I. The Influence of Estradiol and Estriol on Hepatic Disposal of Sulfobromophthalein (BSP) in Man Mark N. Mueller, Attallah Kappas J Clin Invest. 1964;43(10):1905-1914. https://doi.org/10.1172/JCI105064. Research Article Find the latest version: https://jci.me/105064/pdf Journal of Clinical Investigation Vol. 43, No. 10, 1964 Estrogen Pharmacology. I. The Influence of Estradiol and Estriol on Hepatic Disposal of Sulfobromophthalein (BSP) inMan* MARK N. MUELLER t AND ATTALLAH KAPPAS + WITH THE TECHNICAL ASSISTANCE OF EVELYN DAMGAARD (From the Department of Medicine and the Argonne Cancer Research Hospital,§ the University of Chicago, Chicago, Ill.) This report 1 describes the influence of natural biological action of natural estrogens in man, fur- estrogens on liver function, with special reference ther substantiate the role of the liver as a site of to sulfobromophthalein (BSP) excretion, in man. action of these hormones (5), and probably ac- Pharmacological amounts of the hormone estradiol count, in part, for the impairment of BSP dis- consistently induced alterations in BSP disposal posal that characterizes pregnancy (6) and the that were shown, through the techniques of neonatal period (7-10). Wheeler and associates (2, 3), to result from profound depression of the hepatic secretory Methods dye. Chro- transport maximum (Tm) for the Steroid solutions were prepared by dissolving crystal- matographic analysis of plasma BSP components line estradiol and estriol in a solvent vehicle containing revealed increased amounts of BSP conjugates 10% N,NDMA (N,N-dimethylacetamide) 3 in propylene during estrogen as compared with control pe- glycol. Estradiol was soluble in a concentration of 100 riods, implying a hormonal effect on cellular proc- mg per ml; estriol, in a concentration of 20 mg per ml. -
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. -
Drugs Contraindicated in Pregnancy
DRUGS CONTRAINDICATED IN PREGNANCY (Part 1 of 2) This chart represents information on select drugs that are contraindicated (Pregnancy category X) for women who are pregnant. This is not an inclusive list of products that carry that pregnancy category. Those drugs that are contraindicated at a certain phase of the pregnancy are listed next to the product name. For more information on specific drug monographs, see product entries or consult the manufacturer. ALLERGIC DISORDERS Tazorac (tazarotene) METABOLIC DISORDERS Tilia Fe (norethindrone acetate/ethinyl Vistaril (hydroxyzine) Early pregnancy estradiol) Zavesca (miglustat) CARDIOVASCULAR SYSTEM Tri-Legest Fe (norethindrone acetate/ MUSCULOSKELETAL DISORDERS ethinyl estradiol) Advicor (niacin ext-rel/lovastatin) Tri-previfem (norgestimate/ethinyl Advil (ibuprofen) 3rd trimester Aggrenox (dipyridamole/aspirin) 3rd estradiol) Aleve (naproxen sodium) 3rd trimester trimester Tri-sprintec (norgestimate/ethinyl estradiol) Ansaid (flurbiprofen) Late pregnancy Altoprev (lovastatin) Yaz (drospirenone/ethinyl estradiol) Arava (leflunomide) Bayer (aspirin) 3rd trimester Arthrotec (diclofenac sodium/ Caduet (amlodipine/atorvastatin) ENDOCRINE SYSTEM misoprostol) Coumadin (warfarin sodium) 3rd trimester Androderm (testosterone) Bayer (aspirin) Crestor (rosuvastatin) Androgel (testosterone) BC Arthritis Strength (aspirin/ Ecotrin (aspirin) 3rd trimester 3rd trimester Android (methyltestosterone) caffeine/salicylamide) Lescol (fluvastatin) 3rd Axiron (testosterone) Carisoprodol/aspirin/codeine Lescol -
Vaginal Estriol to Overcome Side-Effects of Aromatase Inhibitors in Breast Cancer Patients
CLIMACTERIC 2011;14:339–344 Vaginal estriol to overcome side-effects of aromatase inhibitors in breast cancer patients G. Pfeiler, C. Glatz, R. Ko¨ nigsberg*, T. Geisendorfer{, A. Fink-Retter, E. Kubista**, C. F. Singer and M. Seifert Department of Gynecology and Gynecological Oncology, Medical University of Vienna; *Applied Cancer Research – Institution for Translational Research Vienna (ACR-ITR VIEnna)/CEADDP, Vienna; {Chemical Analytics Seibersdorf Labor GmbH, Seibersdorf; **Department of Special Gynecology, Medical University of Vienna, Austria Key words: BREAST CANCER, VAGINAL ESTRIOL, AROMATASE INHIBITOR, VAGINAL DRYNESS, DYSPAREUNIA ABSTRACT Objective Aromatase inhibitors are essential as endocrine treatment for hormone receptor-positive postmenopausal breast cancer patients. Menopausal symptoms are often aggravated during endocrine treatment. We investigated whether vaginal estriol is a safe therapeutic option to overcome the urogenital side- effects of aromatase inhibitors. Serum hormone levels were used as the surrogate parameter for safety. Methods Fasting serum hormone levels of ten postmenopausal breast cancer patients receiving aromatase inhibitors were prospectively measured by electro-chemiluminescence immunoassays and gas chromatography/ mass spectrometry before and 2 weeks after daily application of 0.5 mg vaginal estriol (Ovestin1 ovula), respectively. Results Two weeks of daily vaginal estriol treatment did not change serum estradiol or estriol levels. However, significant decreases in levels of serum follicle stimulating hormone (p ¼ 0.01) and luteinizing hormone (p ¼ 0.02) were observed. Five out of six breast cancer patients noticed an improvement in vaginal dryness and/or dyspareunia. Conclusions The significant decline in gonadotropin levels, indicating systemic effects, has to be kept in mind when offering vaginal estriol to breast cancer patients receiving an aromatase inhibitor.