DOCSLIB.ORG

(12) Patent Application Publication (10) Pub. No.: US 2011/0281830 A1 Sulur Et Al

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
(12) Patent Application Publication (10) Pub. No.: US 2011/0281830 A1 Sulur Et Al US 2011 (0281830A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2011/0281830 A1 Sulur et al. (43) Pub. Date: Nov. 17, 2011 (54) NOVEL DERMACEUTICAL CREAM MADE (30) Foreign Application Priority Data USING SODIUM FUSDATE AND STEROIDS Jan. 21, 2009 (IN) ........................... 134/MUMA2009 (75) Inventors: Vanangamudi Subramaniam Publication Classification Sulur,r Chennai (IN);: Madhavan (51) Int. Cl. Srinivasan, Chennai (IN); A 6LX 3/575 (2006.01) Neelakandan Narayanan Chulliel, A6IP3L/00 (2006.01) Chennai (IN); Haridas Sankar, A6IP 29/00 (2006.01) Mumbai (IN). Kausik Ghosh, A6IP 700 (2006.01) Chennai (IN) (52) U.S. Cl. ........................................................ S14/17O (73) Assignee: APEX LABORATORIES (57) ABSTRACT PRIVATE LIMITED, CHENNAI, The invention discloses a dermaceutical cream containing TN (IN) steroids and an antibacterial agent in the form of Fusidic acid, which Fusidic acid is formed in situ from Sodium Fusidate as the starting raw material, wherein Sodium Fusidate is con (21) Appl. No.: 13/144.932 verted into Fusidic acid under oxygen-free environment. The cream of the present invention has greater shelf-life stability (22) PCT Filed: Jan. 20, 2010 and the finer particle size of the API than the conventional creams containing Fusidic acid. The cream of the present (86). PCT No.: PCT/B2O1O/OSO242 invention contains Fusidic acid as the API that has been formed in situ from Sodium Fusidate, and steroids in a cream S371 (c)(1), base comprising an acid, a co-solvent, an emulsifier and a (2), (4) Date: Jul.18, 2011 waxy material along with water, preferably purified water. US 2011/028 1830 A1 Nov. 17, 2011 NOVELDERMACEUTICAL CREAM MADE of ointment rather than cream. Drawbacks of ointments over USING SODIUM FUSDATE AND STEROIDS creams are well known and it's generally preferable to use creams rather than ointments for topical application. FIELD OF INVENTION 0008. Several aspects of Fusidic acid as an API are known: 0009. It is thermolabile 0001. The present invention relates to primary & second 0010. It is available in cream formulations ary bacterial skin infections and inflammations and in par 0011. It can be obtained from Sodium Fusidate by dis ticular it relates to the single dose treatment using a steroids Solving the latter in an aqueous phase and adding acid to cream that also contains an antibacterial agent in the form of the solution, whereby Fusidic acid precipitates. How a Fusidic acid wherein the Fusidic acid has been made using ever, the Fusidic acid precipitate is difficult to process Sodium Fusidate as the starting Active Pharmaceutical Ingre into a cream form first due to its coarse and uneven dient (API). particle size and second retrieving Fusidic acid from wet cake involves drying and further handling which dete BACKGROUND OF THE INVENTION riorates the Fusidic acid due to exposure to oxygen 0002. Use of steroids to alleviate inflammation, irritation 0012. The stability of the API in a Fusidic acid cream is and itching caused by skin ailments is well known. It is also unreliable due to the thermolabile nature of Fusidic acid well known that use of Steroids compromises patient's 0013 Stabilization of medicaments containing Fusidic immune system and exposes them to bacterial infections. acid against oxidation involves observing a number of Strin Single dose therapies containing steroids and antibacterials gent precautionary procedures during manufacture and stor are well known. age. These include: 0003) Numerous single dose treatments, both topical and 0014 replacing Oxygen in pharmaceutical containers systemic, are currently employed for the treatment of above with inert gases such as Nitrogen, Carbon dioxide, skin inflammations. Topical and systemic inflammatory treat Helium and the like ment compositions typically employ a combination of corti 0.015 avoiding contact of the medicament with heavy costeroids in a base component. The active ingredients typi metal ions which catalyze oxidation, cally comprise Corticosteroids Such as steroids like 0016 storing the API at reduced temperatures through Betamethasone Valerate, Fluticasone Propionate, Mometa out its shelf life before processing Sone Furoate, Dexamethasone Acetate, Hydrocortisone 0017. In practice this means stricter controls during the Acetate, Clobetasol Propionate. Beclomethasone Dipropi manufacture as well as storage of such API (storing it typi onate, Betamethasone Dipropionate and the like. cally at 2°C. to 8°C. in air-tight containers throughout their 0004 Numerous treatments, both topical and systemic, shelf life). are available for the primary and secondary skin infection 0018. There is therefore a need to provide a Fusidic acid caused by sensitive Gram-ve organisms such as Staphylo cream in which Fusidic acid will be of greater stability at the coccus aureus, Streptococcus spp etc. Topical and systemic time of the manufacture of the cream, and which will sustain bacterial infection treatment compositions typically employ its stability at an acceptable level throughout its shelf life. at least one active pharmaceutical ingredient (API) in com 0019. There's a need to provide dermaceutical cream con bination with a base component. In the cream form, the APIs taining steroids, and an antibacterial in the form of Fusidic typically comprise an antibiotic/antibacterial Such as Fusidic acid, and in which Fusidic acid will be of greater stability at acid and the like. the time of the manufacture of the cream, and which will 0005. In the currently available Fusidic acid creams, sustain its stability at an acceptable level throughout its shelf Fusidic acid in fine powder form is used as source API. The life. Small particle size enhances its dermal contact by providing a large specific Surface area and penetration, and provides a OBJECTS AND ADVANTAGES OF THE Smooth feel on application to skin. However, a serious short INVENTION coming of the fine size of Fusidic acid particles is that it 0020. It is therefore one object of the present invention to presents an enormous Surface area for contact and reaction provide a cream which contains Fusidic acid as the active API with molecular Oxygen during manufacture, handling, and but which has greater stability of the API throughout its shelf processing of the cream. This has serious implications to its life. chemical stability and results in rapid reduction in potency of the API (Fusidic acid) in the final cream formulation. Degra 0021. It is a further objective of the present invention to dation due to oxidation is a major cause of instability of provide a dermaceutical cream containing at least one steroid, currently available Fusidic acid creams. Table 1 show that the and an antibacterial agent in the form of Fusidic acid, in which degradation in the API samples (Fusidic acid) exposed to Fusidic acid will be of greater stability at the time of the oxygen ranged between 7.7% and 11% for conditions ranging manufacture of the cream, and which will sustain its stability from room temperature to 45° C. when analysed at three at an acceptable level throughout its shelf life. months of exposure period at the above conditions. 0006. It is known that greater the exposure time of Fusidic BRIEF SUMMARY OF THE INVENTION acid as the raw API to Oxygen, greater the limitations on 0022. The invention discloses a dermaceutical cream con stabilising Fusidic acid in a formulation. However, there is no taining steroids Such as Betamethasone Valerate, Fluticasone published data on the stability of Fusidic acid over a period of Propionate, Mometasone Furoate, Dexamethasone Acetate, time. Hydrocortisone Acetate, Clobetasol Propionate, Beclom 0007 As an alternative to Fusidic acid, Sodium Fusidate is ethasone Dipropionate, Betamethasone Dipropionate and the known to have been used to make dermaceutical medica like, and an antibacterial agent in the form of Fusidic acid, ments for topical application. However, these are in the form which Fusidic acid is formed in situ from Sodium Fusidate as US 2011/028 1830 A1 Nov. 17, 2011 the starting raw material, wherein Sodium Fusidate is con verted into Fusidic acid under oxygen-free environment. The TABLE 1-continued cream of the present invention has greater shelf-life stability and the finer particle size of the API than the conventional Results Of3 Months Old Fusidic Acid (API) Analysis By Stability creams containing Fusidic acid. The cream of the present Indicating HPLC Method And Titration Method invention contains Fusidic acid as the API that has been Name of Sample: FUSIDIC ACID BP: formed in situ from Sodium Fusidate, and steroids such as Pack: Open (O) & Closed (C) Petri dish Betamethasone Valerate, Fluticasone Propionate, Mometa Fusicic Acid Percentage Sone Furoate, Dexamethasone Acetate, Hydrocortisone *In- Assay (% Drop (% Acetate, Clobetasol Propionate. Beclomethasone Dipropi onate, Betamethasone Dipropionate and the like in a cream tial Tiltra- Titra base comprising an acid, a co-solvent, an emulsifier and a S. No Conditions (%) tion HPLC tion HPLC Remarks waxy material along with water, preferably purified water. 3 45° C. (O) 98.52 89.52 2.08 11.08 After 3 4 45° C. (C) 99.10 92.12 150 8.48 Months DETAILED DESCRIPTION OF THE INVENTION 0023. We discussed earlier the known aspects of the topi cal preparations that have Fusidic acid and Sodium Fusidate as the APIs. It is evident from the current state of knowledge Stability Analysis of Sodium Fusidate that: 0032 0024 Creams containing Fusidic acid that are made using Sodium Fusidate as starting API are not available. 0025 Creams containing Fusidic acid that are made TABLE 2 using Sodium Fusidate along with steroids such as Results Of3 Months Old Sodium Fusidate (API) Analysis By Betamethasone Valerate, Fluticasone Propionate, Stability Indicating HPLC Method And Titration Method Mometasone Furoate, Dexamethasone Acetate, Hydro Name of the Sample: Sodium Fusidate BP cortisone Acetate, Clobetasol Propionate, Beclometha Pack: Open & Closed Petri dish Sone Dipropionate, Betamethasone Dipropionate and Sodium Fusidate Percentage the like as starting APIs are not available.
Load more

Recommended publications
  • Steroid Use in Prednisone Allergy Abby Shuck, Pharmd Candidate
    Steroid Use in Prednisone Allergy Abby Shuck, PharmD candidate 2015 University of Findlay If a patient has an allergy to prednisone and methylprednisolone, what (if any) other corticosteroid can the patient use to avoid an allergic reaction? Corticosteroids very rarely cause allergic reactions in patients that receive them. Since corticosteroids are typically used to treat severe allergic reactions and anaphylaxis, it seems unlikely that these drugs could actually induce an allergic reaction of their own. However, between 0.5-5% of people have reported any sort of reaction to a corticosteroid that they have received.1 Corticosteroids can cause anything from minor skin irritations to full blown anaphylactic shock. Worsening of allergic symptoms during corticosteroid treatment may not always mean that the patient has failed treatment, although it may appear to be so.2,3 There are essentially four classes of corticosteroids: Class A, hydrocortisone-type, Class B, triamcinolone acetonide type, Class C, betamethasone type, and Class D, hydrocortisone-17-butyrate and clobetasone-17-butyrate type. Major* corticosteroids in Class A include cortisone, hydrocortisone, methylprednisolone, prednisolone, and prednisone. Major* corticosteroids in Class B include budesonide, fluocinolone, and triamcinolone. Major* corticosteroids in Class C include beclomethasone and dexamethasone. Finally, major* corticosteroids in Class D include betamethasone, fluticasone, and mometasone.4,5 Class D was later subdivided into Class D1 and D2 depending on the presence or 5,6 absence of a C16 methyl substitution and/or halogenation on C9 of the steroid B-ring. It is often hard to determine what exactly a patient is allergic to if they experience a reaction to a corticosteroid.
    [Show full text]
  • Etats Rapides
    List of European Pharmacopoeia Reference Standards Effective from 2015/12/24 Order Reference Standard Batch n° Quantity Sale Information Monograph Leaflet Storage Price Code per vial Unit Y0001756 Exemestane for system suitability 1 10 mg 1 2766 Yes +5°C ± 3°C 79 ! Y0001561 Abacavir sulfate 1 20 mg 1 2589 Yes +5°C ± 3°C 79 ! Y0001552 Abacavir for peak identification 1 10 mg 1 2589 Yes +5°C ± 3°C 79 ! Y0001551 Abacavir for system suitability 1 10 mg 1 2589 Yes +5°C ± 3°C 79 ! Y0000055 Acamprosate calcium - reference spectrum 1 n/a 1 1585 79 ! Y0000116 Acamprosate impurity A 1 50 mg 1 3-aminopropane-1-sulphonic acid 1585 Yes +5°C ± 3°C 79 ! Y0000500 Acarbose 3 100 mg 1 See leaflet ; Batch 2 is valid until 31 August 2015 2089 Yes +5°C ± 3°C 79 ! Y0000354 Acarbose for identification 1 10 mg 1 2089 Yes +5°C ± 3°C 79 ! Y0000427 Acarbose for peak identification 3 20 mg 1 Batch 2 is valid until 31 January 2015 2089 Yes +5°C ± 3°C 79 ! A0040000 Acebutolol hydrochloride 1 50 mg 1 0871 Yes +5°C ± 3°C 79 ! Y0000359 Acebutolol impurity B 2 10 mg 1 -[3-acetyl-4-[(2RS)-2-hydroxy-3-[(1-methylethyl)amino] propoxy]phenyl] 0871 Yes +5°C ± 3°C 79 ! acetamide (diacetolol) Y0000127 Acebutolol impurity C 1 20 mg 1 N-(3-acetyl-4-hydroxyphenyl)butanamide 0871 Yes +5°C ± 3°C 79 ! Y0000128 Acebutolol impurity I 2 0.004 mg 1 N-[3-acetyl-4-[(2RS)-3-(ethylamino)-2-hydroxypropoxy]phenyl] 0871 Yes +5°C ± 3°C 79 ! butanamide Y0000056 Aceclofenac - reference spectrum 1 n/a 1 1281 79 ! Y0000085 Aceclofenac impurity F 2 15 mg 1 benzyl[[[2-[(2,6-dichlorophenyl)amino]phenyl]acetyl]oxy]acetate
    [Show full text]
  • Report 752 by Category Description
    PAs by Category Description Sorted by Descending Count Date Range: 04/01/2006 through 06/30/2006 Number Number Category of Category of Description PAs Description PAs Cetirizine HCl 792 Ziprasidone HCl 43 Duloxetine HCl 784 Norelgestromin-Ethinyl Estradiol 42 Methylphenidate HCl 646 Nicotine 41 Venlafaxine HCl 620 Levofloxacin 41 Atomoxetine HCl 472 Carisoprodol 41 Quetiapine Fumarate 430 Albuterol 40 Gabapentin 422 Amylase-Lipase-Protease 40 Nutritional Supplements 378 Famotidine 40 Montelukast Sodium 326 Levothyroxine Sodium 39 Zolpidem Tartrate 288 Enoxaparin Sodium 37 Amphetamine-Dextroamphetamine 286 Norgestimate-Ethinyl Estradiol (Triphasic) 37 Aripiprazole 271 Tretinoin 37 Desloratadine 191 Modafinil 36 Fexofenadine HCl 188 Pioglitazone HCl 36 Topiramate 186 Citalopram Hydrobromide 36 Polyethylene Glycol 3350 182 Budesonide (Inhalation) 36 Fentanyl 175 Epoetin Alfa 33 Eszopiclone 174 Etanercept 33 Esomeprazole Magnesium 172 Botulinum Toxin Type A 32 Celecoxib 157 Somatropin 31 Pregabalin 148 Metformin HCl 31 Escitalopram Oxalate 142 Oxycodone w/ Acetaminophen 31 Sertraline HCl 135 Morphine Sulfate 30 Risperidone 127 Levetiracetam 30 Bupropion HCl 118 Clonazepam 30 Tiotropium Bromide Monohydrate 112 Phenobarbital 30 Oxycodone HCl 110 Drospirenone-Ethinyl Estradiol 29 Ezetimibe 105 Rosiglitazone Maleate 29 Clopidogrel Bisulfate 103 Valsartan 29 Ondansetron HCl 97 Memantine HCl 28 Olanzapine 93 Sumatriptan Succinate 28 Temazepam 92 Buprenorphine HCl 28 Oxcarbazepine 82 B-Complex w/ C & Folic Acid 28 Rabeprazole Sodium 74 Ranitidine
    [Show full text]
  • OHIO STATE BOARD of PHARMACY 77 South High Street, Room 1702; Columbus, OH 43215-6126 -Equal Opportunity Employer and Service Provider
    OHIO STATE BOARD OF PHARMACY 77 South High Street, Room 1702; Columbus, OH 43215-6126 -Equal Opportunity Employer and Service Provider- TEL: 614/466-4143 E-MAIL: [email protected] FAX: 614/752-4836 TTY/TDD: Use the Ohio Relay Service: 1-800/750-0750 www.pharmacy.ohio.gov ORDER OF THE STATE BOARD OF PHARMACY (Docket No. D-031110-034) In The Matter Of: CHRISTOPHER KIEL, R.Ph. 8260 Cyrus Lane Sagamore Hills, Ohio 44067 (R.Ph. No. 03-1-12367) INTRODUCTION THE MATTER OF CHRISTOPHER KIEL CAME FOR HEARING ON MAY 4, 2004, BEFORE THE FOLLOWING MEMBERS OF THE BOARD: ROBERT P. GIACALONE, R.Ph. (presiding); DIANE C. ADELMAN, R.Ph.; GREGORY BRAYLOCK, R.Ph.; SUZANNE R. EASTMAN, R.Ph.; ELIZABETH I. GREGG, R.Ph.; LAWRENCE J. KOST, R.Ph.; NATHAN S. LIPSYC, R.Ph.; DOROTHY S. TEATER, PUBLIC MEMBER; AND JAMES E. TURNER, R.Ph. CHRISTOPHER KIEL WAS REPRESENTED BY JOSEPH W. DIEMERT, JR. AND DIANE A. CALTA AND THE STATE OF OHIO WAS REPRESENTED BY SALLY ANN STEUK, ASSISTANT ATTORNEY GENERAL. SUMMARY OF EVIDENCE State’s Witnesses 1. Joann Predina, R.Ph., Ohio State Board of Pharmacy 2. Frederick Lochner, U.S. Food and Drug Administration (FDA) Respondent's Witnesses 1. Christopher Kiel, R.Ph., Respondent State's Exhibits 1K. Copy of Notice of Opportunity For Hearing letter [11-10-03] 1A-1K-E. Procedurals 1K-F. Copy of Amendment Notice [03-03-04] 1G-1K-K. Procedurals 2. Copy of Ohio State Board of Pharmacy Compliance Bulletin 93-002 [09-15-93] 2A.
    [Show full text]
  • Rapid Detection of Six Glucocorticoids Added Illegally to Dietary Supplements by Combining TLC with Spot-Concentrated Raman Scattering
    molecules Article Rapid Detection of Six Glucocorticoids Added Illegally to Dietary Supplements by Combining TLC with Spot-Concentrated Raman Scattering Li Li, Xin Liang * ID , Tao Xu, Feng Xu and Wei Dong College of Pharmacy, Qiqihar Medical University, Qiqihar 161006, China; [email protected] (L.L.); [email protected] (T.X.); [email protected] (F.X.); [email protected] (W.D.) * Correspondence: [email protected]; Tel.: +86-0452-2663172 Received: 16 May 2018; Accepted: 19 June 2018; Published: 21 June 2018 Abstract: The objective of this study was to establish a novel method for rapid detection of six glucocorticoids (prednisone, prednisone acetate, prednisolone, hydrocortisone, hydrocortisone acetate, and dexamethasone) added illegally in dietary supplements simultaneously by combining thin layer chromatography (TLC) with spot-concentrated Raman scattering (SCRS). The doping ingredients were separated by TLC, and viewed and located with UV light (254 nm), enriched by chromatography, then Raman spectra were directly detected by a Raman Imagine microscope with 780 nm laser source. This method had complementary advantages of TLC and Raman spectroscopy, which enhanced the specificity of the test results. The limit of detection (LOD) of the reference substances were 4 µg, 4 µg, 4 µg, 6 µg, 6 µg, and 4 µg, respectively. The method was used to study the six glucocorticoids added illegally in five dietary supplements. Fake drugs had been detected. The study showed that the TLC-SCRS method is simple, rapid, specific, sensitive, and reliable. The method could be used for effective separation and detection of six chemical components used in dietary supplement products, and would have good prospects for on-site qualitative screening of dietary supplement products for adulterants.
    [Show full text]
  • Patent Application Publication ( 10 ) Pub . No . : US 2019 / 0192440 A1
    US 20190192440A1 (19 ) United States (12 ) Patent Application Publication ( 10) Pub . No. : US 2019 /0192440 A1 LI (43 ) Pub . Date : Jun . 27 , 2019 ( 54 ) ORAL DRUG DOSAGE FORM COMPRISING Publication Classification DRUG IN THE FORM OF NANOPARTICLES (51 ) Int . CI. A61K 9 / 20 (2006 .01 ) ( 71 ) Applicant: Triastek , Inc. , Nanjing ( CN ) A61K 9 /00 ( 2006 . 01) A61K 31/ 192 ( 2006 .01 ) (72 ) Inventor : Xiaoling LI , Dublin , CA (US ) A61K 9 / 24 ( 2006 .01 ) ( 52 ) U . S . CI. ( 21 ) Appl. No. : 16 /289 ,499 CPC . .. .. A61K 9 /2031 (2013 . 01 ) ; A61K 9 /0065 ( 22 ) Filed : Feb . 28 , 2019 (2013 .01 ) ; A61K 9 / 209 ( 2013 .01 ) ; A61K 9 /2027 ( 2013 .01 ) ; A61K 31/ 192 ( 2013. 01 ) ; Related U . S . Application Data A61K 9 /2072 ( 2013 .01 ) (63 ) Continuation of application No. 16 /028 ,305 , filed on Jul. 5 , 2018 , now Pat . No . 10 , 258 ,575 , which is a (57 ) ABSTRACT continuation of application No . 15 / 173 ,596 , filed on The present disclosure provides a stable solid pharmaceuti Jun . 3 , 2016 . cal dosage form for oral administration . The dosage form (60 ) Provisional application No . 62 /313 ,092 , filed on Mar. includes a substrate that forms at least one compartment and 24 , 2016 , provisional application No . 62 / 296 , 087 , a drug content loaded into the compartment. The dosage filed on Feb . 17 , 2016 , provisional application No . form is so designed that the active pharmaceutical ingredient 62 / 170, 645 , filed on Jun . 3 , 2015 . of the drug content is released in a controlled manner. Patent Application Publication Jun . 27 , 2019 Sheet 1 of 20 US 2019 /0192440 A1 FIG .
    [Show full text]
  • AMRI India Pvt
    WE’VE GOT API DEVELOPMENT AND MANUFACTURING DOWN TO AN EXACT SCIENCE API Commercial Product Catalogue PRODUCT CATALOGUE API Commercial US EU Japan US EU Japan API Name Site CEP India China API Name Site CEP India China DMF DMF DMF DMF DMF DMF Rozzano Quinto de Adenosine Betaine Citrate Anhydrous Bon Encontre, France A Stampi, Italy • Betametasone-17,21- Alcaftadine Valladolid, Spain Valladolid, Spain • Dipropionate Sterile • Alclometasone-17,21- Valladolid, Spain Betamethasone Acetate Valladolid, Spain Dipropionate • • • Altrenogest Valladolid, Spain • • Betamethasone Base Valladolid, Spain Aminobisamide HCl Rensselaer, US Betamethasone Benzoate Valladolid, Spain Amphetamine Aspartate Betamethasone Valerate Rensselaer, US Valladolid, Spain Monohydrate Milled • Acetate Betamethasone-17,21- Amphetamine Sulfate Rensselaer, US Valladolid, Spain • Dipropionate • • • • Rozzano Quinto de Argatroban Betamethasone-17-Valerate Valladolid, Spain Stampi, Italy • • • • Betamethasone-21- Atenolol Aurangabad, India Valladolid, Spain • • • Phosphate Disodium Salt • • Rozzano Quinto de Bromfenac Monosodium Atracurium Besylate Lodi, Italy Stampi, Italy • Salt Sesquihydrate • • Rozzano Quinto de Atropine Sulfate Grafton, US Bromocriptine Mesylate • Stampi, Italy • • • Rozzano Quinto de Azelastine HCl Budesonide Valladolid, Spain Stampi, Italy • • • • • Rozzano Valleambrosia, Aztreonam (not sterile) Budesonide Sterile Valladolid, Spain Italy • • • • B Bamifylline HCl Bon Encontre, France • C Capecitabine Lodi, Italy • • Beclomethasone-17,21- Valladolid, Spain
    [Show full text]
  • AHFS Therapeutic
    AHFS Therapeutic AHFS Therapeutic Class Description HICL HICL Description Program Edit Criteria 1 Edit Criteria 2 Edit Criteria 3 Edit Criteria 4 Edit Criteria 5 Class 240408 CARDIOTONIC AGENTS 000004 DIGOXIN PACE MAX DAILY UNITS : 0.667000 240408 CARDIOTONIC AGENTS 000004 DIGOXIN PACE MAX DAILY UNITS : 0.750000 240408 CARDIOTONIC AGENTS 000004 DIGOXIN PACE MAX DAILY UNITS : 1.500000 240408 CARDIOTONIC AGENTS 000004 DIGOXIN PACE MAX DAILY UNITS : 2.000000 240408 CARDIOTONIC AGENTS 000004 DIGOXIN PACE MAX DAILY UNITS : 2.500000 240408 CARDIOTONIC AGENTS 000004 DIGOXIN PACE MAX DAILY UNITS : 3.000000 240408 CARDIOTONIC AGENTS 000004 DIGOXIN PACE MAX DAILY UNITS : 3.750000 240408 CARDIOTONIC AGENTS 000004 DIGOXIN PACE MAX DAILY UNITS : 6.000000 240408 CARDIOTONIC AGENTS 000004 DIGOXIN PACE MAX DAILY UNITS : 7.500000 240408 CARDIOTONIC AGENTS 000004 DIGOXIN PACE Medical Exception Required 282032 RESPIRATORY AND CNS STIMULANTS 000007 CAFFEINE/DEXTROSE PACE Cannnot co‐administer inhaled Insulin and Asthma/COPD/Smoking Cessation agents 282032 RESPIRATORY AND CNS STIMULANTS 000008 CAFFEINE/MULTIVITAMIN PACE Cannnot co‐administer inhaled Insulin and Asthma/COPD/Smoking Cessation agents 282032 RESPIRATORY AND CNS STIMULANTS 000009 CAFFEINE/ETHYL ALCOHOL PACE Cannnot co‐administer inhaled Insulin and Asthma/COPD/Smoking Cessation agents 282032 RESPIRATORY AND CNS STIMULANTS 000010 CAFFEINE/SODIUM BENZOATE PACE Cannnot co‐administer inhaled Insulin and Asthma/COPD/Smoking Cessation agents 282032 RESPIRATORY AND CNS STIMULANTS 000011 CAFFEINE CITRATE
    [Show full text]
  • EUROPEAN PHARMACOPOEIA 10.0 Index 1. General Notices
    EUROPEAN PHARMACOPOEIA 10.0 Index 1. General notices......................................................................... 3 2.2.66. Detection and measurement of radioactivity........... 119 2.1. Apparatus ............................................................................. 15 2.2.7. Optical rotation................................................................ 26 2.1.1. Droppers ........................................................................... 15 2.2.8. Viscosity ............................................................................ 27 2.1.2. Comparative table of porosity of sintered-glass filters.. 15 2.2.9. Capillary viscometer method ......................................... 27 2.1.3. Ultraviolet ray lamps for analytical purposes............... 15 2.3. Identification...................................................................... 129 2.1.4. Sieves ................................................................................. 16 2.3.1. Identification reactions of ions and functional 2.1.5. Tubes for comparative tests ............................................ 17 groups ...................................................................................... 129 2.1.6. Gas detector tubes............................................................ 17 2.3.2. Identification of fatty oils by thin-layer 2.2. Physical and physico-chemical methods.......................... 21 chromatography...................................................................... 132 2.2.1. Clarity and degree of opalescence of
    [Show full text]
  • Drugs and Health Products
    Notice: Prescription Drug List (PDL): Fluticasone propionate http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/pdl_ldo_consul... Home > Drugs & Health Products > Public Involvement & Consultations > Drug Products Drugs and Health Products Notice: Prescription Drug List (PDL): Fluticasone propionate November 27, 2015 Our file number: 15-112766-443 The purpose of this Notice of Consultation is to provide an opportunity to comment on the proposal to revise the listing for Adrenocortical Hormones or their salts or derivatives on the Human Prescription Drug List (PDL) to permit the non-prescription use of Fluticasone propionate for the conditions listed below. Only the human part of the PDL is proposed to be revised. The proposed qualifier for the listing on the Human List is: Drugs containing the following: Adrenocortical hormones or their salts or derivatives Including (but not limited to): Betamethasone valerate, betamethasone sodium, betamethasone phosphate, betamethasone dipropionate, budesonide, ciclesonide, clobetasone, cortisone, dexamethasone sodium, dexamethasone phosphate, dexamethasone acetate, difluprednate, fludrocortisone acetate, flunisolide, fluticasone propionate, fluticasone furoate, hydrocortisone acetate, hydrocortisone aceponate, hydrocortisone sodium, methylprednisolone acetate, methylprednisolone, methylprednisolone succinate, methylprednisolone sodium, mometasone furoate, prednisolone acetate, prednisolone sodium, prednisolone phosphate, prednisone, triamcinolone acetonide, triamcinolone hexacetonide Qualifier:
    [Show full text]
  • Joint Injection Workshop
    Joint Injection Workshop Dr Laurel Young Redcliffe and Northside Rheumatology (RNR) Joint injections • Indications • Type of steroid and why • Technique • Complications • Consent – verbal, written • Imaging? Indications for aspirating or injecting joints/soft tissues Reasons for joint aspirations Reasons for injections Exclude infection (mandatory) Diagnostic – eg. LA Therapeutic Diagnostic e.g crystals, (relieve symptoms) inflammation Joints, tendon sheaths, bursa, CTS What to inject? Type of steroid Duration in joint - solubility Corticosteroid Solubility Cost Betamethasone sodium phosphate Most soluble Dexamethasone sodium phosphate Soluble Prednisone sodium phosphate Soluble Methylprednisolone acetate Slightly soluble $4.72 (40mg/vial) Betamethasone sodium phosphate + Slightly soluble $5.34 Bethamethasone acetate (2.96/2.71mg/vial) Triamcinolone diacetate Slightly soluble Prednisolone tebutate Slightly soluble Trimancinolone acetonide Relatively insoluble $27.25 (10mg/vial) $81.39 (40mg/vial) Triamcinolone hexacetonide Relatively insoluble Hydrocortisone acetate Relatively insoluble Dexamethasone acetate Relatively insoluble Fluorinated vs non-fluorinated steroids Methylprednisolone acetate Triamcinolone acetonide Betamethasone Fluorinated steroids risk in s/c injections – fat necrosis, hypopigmentation Corticosteroid Fluorinated Betamethasone sodium phosphate Yes Betamethasone sodium Yes phosphoate/Betamethasone acetate Dexamethasone sodium phosphate Yes Triamcinolone diacetate Yes Trimancinolone acetonide Yes Triamcinolone hexacetonide
    [Show full text]
  • Triamcinolone Aqueous Suspensions After Autoclaving
    US 20060094700A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2006/0094700 A1 Lyons (43) Pub. Date: May 4, 2006 (54) HEAT STERILIZATION OF A STEROID IN (22) Filed: Nov. 2, 2004 THE PRESENCE OF PHOSPHATE Publication Classi?cation (75) Inventor: Robert T. Lyons, Laguna Hills, CA (Us) (51) Int. Cl. A61K 31/5 73 (2006.01) Correspondence Address: (52) US. Cl. ............................................................ .. 514/179 ALLERGAN, INC., LEGAL DEPARTMENT 2525 DUPONT DRIVE, T2-7H (57) ABSTRACT IRVINE CA 92612-1599 US a ( ) A process for sterilizing a Water-insoluble steroid composi (73) Assigneej ALLERGAN, INC" Irvine’ C A (Us) tion comprising heat sterilizing the steroid in the presence of phosphate is disclosed herein. Compositions related thereto (21) Appl. No.: 10/980,026 are also disclosed. Effect of Additives on Particle Size Distribution of 20% Triamcinolone Aqueous Suspensions After Autoclaving 25 l I I l E -Mean =- zo- E9001 P'tile . 1:“ .2 ‘I 5 \ g 15- - a .2 n g 10- . (D 2 .2 t 5- - N n- I c I Non-Aut'oclaved Autocl I+ None Autocl'+ NaCl Autocl + NaCl + PQ Additives to Triamcinolone Acetonide Suspension Patent Application Publication May 4, 2006 US 2006/0094700 A1 Figure 1 Effect of Additives on Particle Size Distribution of 20% Triamcinolone Aqueous Suspensions After Autoclaving a: l I I l ‘v E -Mean =5 20- 90th P'tile . .5 ‘I g \ I: 15" ' H .2 D .8 10- - w 2 .2 ‘E 5- - N n- o I Non-Aut'oclaved Autocl I+ None Autocl'+ NaCl Autocl + NaCl + Pq Additives to Triamcinolone Acetonide Suspension US 2006/0094700 A1 May 4, 2006 HEAT STERILIZATION OF A STEROID IN THE presence of phosphate is disclosed herein.
    [Show full text]