DOCSLIB.ORG

United States Patent (19) 11 Patent Number: 4,704,278 Wu Et Al

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
United States Patent (19) 11 Patent Number: 4,704,278 Wu Et Al United States Patent (19) 11 Patent Number: 4,704,278 Wu et al. (45) Date of Patent: " Nov. 3, 1987 54) FLUIDZED MAGALDRATE SUSPENSION 4,117,116 9/1978 Buehler et al....................... 424/158 (75) Inventors: Chien-Chin Wu, Wilmington, Del.; OTHER PUBLICATIONS Gerald L. Reuter, Plattsburgh, N.Y. Handbook on Nonprescription Drugs, Fifth Edition (73) Assignee: American Home Products Corp (Del), (1977), p. 16, American Pharmaceutical Assoc., Wash. New York, N.Y. D.C. * Notice: The portion of the term of this patent Primary Examiner-Frederick E. Waddell subsequent to Jun. 30, 2004 has been disclaimed. 57 ABSTRACT 21) Appl. No.: 895,012 An aqueous antacid composition of magaldrate gel and a process for preparing same are described by the inven 22 Filed: Aug. 8, 1986 tion. The composition is prepared from and contains precipitated and undried magaldrate gel and a fluidizing Related U.S. Application Data of a first and second fluidizer. On fluidizer is provided 63 Continuation of Ser. No. 661,648, Oct. 17, 1984, aban by an aluminum hydroxide gel having colloidal proper doned. ties and the second by a pharmaceutically acceptable Int. Cl:".............................................. A61K 33/08 citrate ion source including citric acid. The process and (51) 52) U.S. Cl. ................. ... 424/157; 424/158 composition are characterized in providing a fluid, (58 Field of Search ....... o se 424/157, 158 resuspendible, pharmaceutically elegant suspension pos sessing high antacid capacity and stability at even ele (56) References Cited vated magaldrate concentrations in addition to the abil U.S. PATENT DOCUMENTS ity to fluidize stiff, paste-like magaldrate gel cakes. 4,112,072 9/1978 Rubino et al. ...................... 424/158 4,115,553 9/1978 Rubino et al. ...................... 424/158 3 Claims, No Drawings 4,704,278 1. 2 colloidal properties and a loss of fluidity or mobility. FLUIDZED MAGALDRATE SUSPENSION Even where fluidity is initially maintained or achieved, further requirements of pharmaceutically acceptable This is a continuation of application Ser. No. 661,648, aqueous antacid suspensions call for a smooth (non filed Oct. 17, 1984, now abondoned. gritty) mouth feel and maintenance of a gel structure for both suspendibility and resuspendibility. In general, BACKGROUND OF THE INVENTION resuspendible, aqueous antacid suspensions are typically 1. Field of the Invention de-flocculated products which contain a deflocculant This invention relates to resuspendible, pharmaceuti or suspending agent to arrest or control further agglom cally elegant high concentration, low viscosity, aqueous G eration or flocculation and settling. In the absence of a antacid suspension dosage forms for oral administration deflocculant or suspending agent type additive, the and to methods for their preparation and use. antacid in a suspension forms a hard cake or a gel struc 2. Decription of the Antacid Art ture which can no longer be resuspended with its origi Antacids are widely used in the treatment of gastroin nal desirable characteristics. The formation of such a testinal disorders. Their effectiveness in promoting the 15 cake or gel structure is independent of antacid concen healing of gastric and duodenal ulcers has been well tration except for low antacid concentration. documented. Essentially, antacids exert their positive The deflocculants and suspending agents have been effects by neutralizing the gastric acid secreted in the frequently included in the formulation of aqueous ant stomach. When the pH of stomach contents is raised acid suspensions containing solid antacid concentrations above 3, most gastric acid is neutralized and the proteo 20 in the range of about 6 to 12 percent to prevent caking. lytic activity of pepsin is inhibited. The recent elevation With the growing interest in providing antacid suspen of antacids to a major therapeutic role, particularly in sion dosage forms with a greater acid neutralizing ca ulcer therapy, rather than a merely pallative role, has pacity, means were sought to provide highly concen emphasized the importance of providing antacid prod trated but fluid systems. ucts featuring a high neutralization (and buffer) capac 25 U.S. Pat. No. 3,579,634 describes an antacid composi ity as well as a rapid rate of gastric acid neutralization. tion containing as the essential ingredients an antacid These features particularly that of rapid rate of neutral and a water dispersible, colloidal anionic ether or ester ization to the neutralization capacity of the antacid derivative of a low polymer of a monosaccharide as a define the more effective antacid in vivo since it is less gelation agent, the gelation agent being such that a likely that unconsumed antacids will be removed by 30 thickened gel-like consistency occurs upon interaction normal gastric emptying. of the composition with gastro-intestinal mucous so as Most antacids are available in both liquid and solid to adhere thereto. The gelation agent in vitro is de dosage forms. The liquid antacids, as aqueous suspen scribed as providing fluidity to concentrated suspen sions, are, generally, more effective than the same ant sions, and the starting actacid may be selected from acids in Solid dosage forms and are more commonly 35 powder, granule or paste forms of certain calcium, alu prescribed in the hospital. The greater effectiveness of minum, magnesium, sodium and bismouth antacids. The liquid antacids is partially due to the large surface area antacid suspension compositions disclosed therein ap available in liquid suspensions to react with gastric acid pear to initially require milling, high energy agitation or and partially due to the great amount of colloidal parti homogenization to eliminate the grittiness of the antacid cles in aqueous suspension which can more easily reach ingredient. the affected area where treatment is needed. Moreover, In U.S. Pat. No. 3,591,680, high concentration ant aqueous suspensions of undehydrated antacids are more acid suspensions are disclosed containing about 25 to 50 reactive than dry or solid antacids. percent weight/volume of certain selected solid antacid While liquid antacids possess these advantages, the materials suspended in an aqueous vehicle containing same require administration of relatively large volumes 45 certain specified suspending agents of which a defind of liquid suspension. The ingestion of such large vol hydroxypropyl cellulose is preferred. While these sus umes is inconvenient, however, making the normal pension are said to provide stable and palatable, high problem of assuring patient compliance outside the concentration suspensions, the preferred composition is hospital environment even more difficult. Since high stated to provide only a minimum of 2 months of contin dose regimes of liquid antacid have recently been 50 ued fluidity and pourability. Such standards are not shown to be effective both in promoting the healing of acceptable for a commercial product in which shelf life duodenal ulcers and in preventing the acute upper gas stability should extend for at least 1-2 years. trointestinal bleeding in critically ill patients, the use of U.S. Pat. No. 3,347,744 discloses a high concentration regular liquid antacid suspensions with the usual solid magnesium hydroxide suspension containing up to 30% antacid content in the 6-12 percent range has become 55 of that antacid with a cellulosic suspending agent and even more impractical for such therapeutic indications. submicroscopic silica. The suspension is said to avoid The most widely used antacids can be described as the clumping and caking common among even lower mineral type, insoluble inorganic salts that are hydrated, concentration magnesium hydroxide suspensions, al possess colloidal properties, and contain, for example, though there is no disclosure that the suspension is aluminum, magnesium, bismouth and the like. Com thereby rendered more fluid. pounds of the described mineral variety in their freshly More recently, in U.S. Pat. No. 4,117,116, there is prepared, hydrated form and in suspensions therefrom disclosed a method for lowering the viscosity of a com provide some of the characteristics desired in an ant mercially available aqueous antacid gel cake to render acid. To provide liquid antacids with a high neutraliza the same pumpable in the production environment. The tion capacity it is necessary to increase the solids con 65 gel cake represents a magnesium hydroxide antacid, an centration of the antacid components. Such increases in aluminum hydroxide antacid or a mixture thereof and concentration, however, are accompanied at higher the antacid is 25-35% weight by weight of the gel cake levels with exponential increases in viscosity, a loss in before processing. The method comprises mixing into 4,704,278 3 4 the gel cake a fluidizing agent selected from acacia, equivalent of not less than 18.0 percent and not more citric acid, sodium citrate, sodium lauryl sulfate or dioc than 26.0 percent of aluminum oxide (Al2O3). tyl sodium sulfosuccinate and the fluidizing agent The preparation of magaldrate is described in U.S. amounts to 0.1-4% of the final total mixture. Pat. No. 2,923,660. A commercially suitable procedure It is an object of this invention to provide magaldrate, is described in said patent, for example, beginning in aqueous antacid suspensions with high antacid capacity column 2, line 40, although to maintain a low sodium and good mouth feel characteristics. content for the final product, the use of potassium oxide Another
Load more

Recommended publications
  • Par Drugs and Chemicals Limited
    +91-8048372739 PAR DRUGS AND CHEMICALS LIMITED https://www.indiamart.com/pardrugs/ We are one of the leading Manufacturer of various Inorganic Molecules such as-Magnesium Hydroxide, Aluminium Hydroxide, Magnesium & Aluminum Silicates as well the blends of these molecules such as Magaldrate, Almagate, Hydrotalcite etc. About Us Par Drugs & Chemicals Private Limited incorporated in the year 1982 and proved its competency as the known Manufacturer of various Inorganice Molecules such as- Magnesium Hydroxide, Aluminium Hydroxide, Magnesium Trisilicate, Magnesium & Aluminum Silicates as well the blends of these molecules such as Magaldrate, Almagate, Hydrotalcite etcs. Our products stand high in terms of quality and low whereas price is concerned. Mr. F. V. Savani (Marketing Director) has enabled us to gain prominent position in industry. He ensures that the customer’s needs are efficiently fulfilled in an appropriate manner and they are served as per their demands. We do not compromises in terms of quality of our range and ensure that the customers are served accordingly. Our team ensures that products are manufactured in confirmation with the specific quality standards. Packaging of our range is done carefully so that products may reach the clients end in safe manner. Regular training sessions keep our employees aware of the changes taking place in industry and ensure that they also perform accordingly. Our well-equipped infrastructure has enabled us to carry our business operations in smooth and efficient manner. We have efficiently segregated
    [Show full text]
  • United States Patent [19] [11] Patent Number: 4,704,278 Wu Et Al
    United States Patent [19] [11] Patent Number: 4,704,278 Wu et al. [45] Date of Patent: :1: Nov. 3, 1987 [54] FLUIDIZED MAGALDRATE SUSPENSION 4,117,116 9/1978 Buehler et a1. .................... .. 424/158 [75] Inventors: Chien-Chin Wu, Wilmington, Del.; OTHER PUBLICATIONS Gerald L‘ Renter’ Plattsburgh’ NY‘ Handbook on Nonprescription Drugs, Fifth Edition [73] Assignee: American Home Products Corp (Del), (1977), p. 16, American Pharmaceutical Assoc, Wash. New York, N.Y. D.C. [ * 1 Notice The portion of the term of this patent Primary Examiner-Frederick E. Waddell subsequent to Jun. 30, 2004 has been disclaimed. [57] ABSTRACT , [211 App], N03 395,012 An aqueous antacid composition of magaldrate gel and _ . a process for preparing same are described by the inven [22] F11e d'' A ug' 8 ’ 1986 t1on.- The composltlon- - is prepared from and contains _ . precipitated and undried magaldrate gel and a ?uidizing Related U‘S' Apphcatlon Data of a ?rst and second ?uidizer. On fluidizer is provided [63] Continuation of Ser. No. 661,648, Oct. 17, 1984, aban~ by an aluminum hydroxide gel having colloidal proper doned’ ties and the second by a pharmaceutically acceptable [51] Int. (:1.4 ............................................ .. A61K 33/08 citrate ion source including citric acid- The Process and [52] US. Cl. .............. .. 424/157; 424/158 compositiw are characterized in Providing a ?uid, [5 8] Field of Search .............................. .. 424/157, 158 resuspendlble, pharmaceutically elegant suspension POS _ ' sessing high antacid capacity and stability at even ele [56] References cued vated magaldrate concentrations in addition to the abil U.S. PATENT DOCUMENTS ity to ?uidize stiff, paste-like magaldrate gel cakes.
    [Show full text]
  • Pharmaceutical Manufacturing Formulations Liquid Products V () L UME Sarfaraz K
    HANDBOOK OF Pharmaceutical Manufacturing Formulations Liquid Products V () L UME Sarfaraz K. Niazi CRC PRESS Boca Raton London New York Washington, D.C. Table of Contents PART I Regulatory and Manufacturing Guidance 1 Chapter 1 Current Good Manufacturing Practice Considerations in Liquid Manufacturing 3 I. Introduction 3 II. Facilities 3 III. Equipment 3 IV. Raw Materials 4 V. Compounding 4 VI. Microbiological Quality 4 VII. Oral Suspensions 5 VIII. Product Specifications 5 IX. Process Validation 5 X. Stability 5 XI. Packaging 6 Chapter 2 Stability Testing of New Drug Substances and Products 7 I. Introduction 7 II. Drug Substance 7 A. General Case 8 B. Drug Substances Intended for Storage in a Refrigerator 8 C. Drag Substances Intended for Storage in a Freezer 8 D. Drug Substances Intended for Storage below -20°C 9 HI. Drag Product 10 A. General Case •' B. Drag Products Packaged in Impermeable Containers 11 C. Drag Products Packaged in Semipermeable Containers 11 D. Drag Products Intended for Storage in a Refrigerator 12 E. Drag Products Intended for Storage in a Freezer 13 F. Drag Products Intended for Storage below -20"C 13 IV Glossary 14 References 1() Chapter 3 Container Closure Systems '7 I. Introduction '7 A. Definitions '7 B. Current Good Manufacturing Practice, the Consumer Product Safety Commission, and Requirements on Containers and Closures 17 C. Additional Considerations 17 II. Qualification and Quality Control of Packaging Components 18 A. Description 21 B. Information about Suitability 21 C. Stability Data (Packaging Concerns) 22 D. Inhalation Drag Products 23 E. Injection and Ophthalmic Drag Products 23 F.
    [Show full text]
  • Name Acicone-S Magaldrate Simethicone Antacid, Antiflatulent / Fast, Sustained Relief Suspension - Chewable Tablet Composition Sodium-Free / Sugar-Free
    Name Acicone-S Magaldrate Simethicone Antacid, Antiflatulent / Fast, Sustained Relief Suspension - Chewable Tablet Composition Sodium-Free / Sugar-Free Active: Each 5 ml suspension contains: Magaldrate 540 mg, Simethicone 40 mg Each tablet contains: Magaldrate 720 mg, Simethicone 25 mg Inactives: - Suspension: Propyl paraben, Methyl paraben, Saccharine, Polysorbate 80, Spearmint natural flavour, Sorbitol 70% solution, Propylene glycol, Xanthan gum, Methyl cellulose, Glycerin and Purified water. - Tablet: Sorbitol powder, Gelatin powder, Peppermint dry flavour, Colloidal silicon dioxide, Aspartam fine powder, Polysorbate 80, Magnesium stearate and Mannitol powder. Pharmacological Action Antacid &Anti-flatulent. Acicone-S is an antacid containing a combination of magaldrate and simethicone as active ingredients. Magaldrate (aluminium magnesium hydroxide sulfate) is a chemical entity of aluminium and magnesium hydroxides (not a physical mixture), while simethicone (activated dimethicone) is an anti flatulent. Acicone-S provides a true buffering action with high acid consuming properties allowing an immediate and sustained relief of symptoms associated with oesophageal and gastric hyperacidity with no alkalinization or acid rebound effect. Acicone-S is distinguished by a strong acid insulating power forming a thin film covering the gastric mucous membranes to resist the transfer of hydrogen ions across the film, allowing more protection to the wall of the stomach. Acicone-S effectively adsorbs and binds a considerable amount of substances contained in the duodeno-gastric reflux, such as pepsin, bile acids and lysolecithin; all these substances are aggressor factors in the case of gastritis, peptic ulcer and oesophagitis. Acicone-S thus offers a better protection to the walls of the upper gastro-intestinal tract. Acicone-S assures a higher safety margin especially for both hypertensive and diabetic patients as being sodium-free and sugar-free, respectively.
    [Show full text]
  • Photometric Method for Estimation of Magaldrate
    The Pharma Innovation Journal 2015; 4(6): 60-63 ISSN: 2277- 7695 TPI 2015; 4(6): 60-63 Photometric method for estimation of Magaldrate © 2015 TPI www.thepharmajournal.com Received: 18-06-2015 Krishnasis Chakraborty, Mubeen G, Ritu Kimbahune, Lalitha N, Yajnesh Pai Accepted: 19-07-2015 Abstract Krishnasis Chakraborty The complex formation between Magaldrate, Magnesium and Aluminium hydroxide salt, and Department of Quality Eriochrome Black T at pH10 has been proposed for photometric estimation of Magaldrate. The Assurance, Al-Ameen College of absorbance of stable violet colored complex of Eriochrome Black T and Magnesium and Aluminium ions Pharmacy, Opposite to Lalbagh of Magaldrate was measured at 527 nm and used for quantitation by single point method. The method has Main Gate, Hosur road, been successfully employed for Magaldrate tablets and the obtained results were found complying with Bangalore-27, India. official specification. The method has been validated as per ICH guidelines and the results for all the Mubeen G parameters were found in the recommended limits. Department of Quality Assurance, Al-Ameen College of Keywords: Magaldrate, Eriochrome Balck T, Chemical derivatization. Pharmacy, Opposite to Lalbagh Main Gate, Hosur road, Introduction Bangalore-27, India. Current life style and diet regime have increased the use of Antacids which are available in different dosage forms. Magaldrate is one of the commonly prescribed antacid which provides Ritu Kimbahune fast and long lasting acid neutralization, long term stability and distinct adsorption capability Department of Quality [1, 2] Assurance, Al-Ameen College of with respect to pepsin, bile acid and lysolecithin . 3 Pharmacy, Opposite to Lalbagh Magaldrate (MG), Al5Mg10(OH)31(SO4)2.X H2O, a Magnesium and Aluminium hydroxide salt Main Gate, Hosur road, is converted rapidly in gastric acid to Mg(OH)2 and Al(OH)3, which are absorbed poorly and Bangalore-27, India.
    [Show full text]
  • Malta Medicines List April 08
    Defined Daily Doses Pharmacological Dispensing Active Ingredients Trade Name Dosage strength Dosage form ATC Code Comments (WHO) Classification Class Glucobay 50 50mg Alpha Glucosidase Inhibitor - Blood Acarbose Tablet 300mg A10BF01 PoM Glucose Lowering Glucobay 100 100mg Medicine Rantudil® Forte 60mg Capsule hard Anti-inflammatory and Acemetacine 0.12g anti rheumatic, non M01AB11 PoM steroidal Rantudil® Retard 90mg Slow release capsule Carbonic Anhydrase Inhibitor - Acetazolamide Diamox 250mg Tablet 750mg S01EC01 PoM Antiglaucoma Preparation Parasympatho- Powder and solvent for solution for mimetic - Acetylcholine Chloride Miovisin® 10mg/ml Refer to PIL S01EB09 PoM eye irrigation Antiglaucoma Preparation Acetylcysteine 200mg/ml Concentrate for solution for Acetylcysteine 200mg/ml Refer to PIL Antidote PoM Injection injection V03AB23 Zovirax™ Suspension 200mg/5ml Oral suspension Aciclovir Medovir 200 200mg Tablet Virucid 200 Zovirax® 200mg Dispersible film-coated tablets 4g Antiviral J05AB01 PoM Zovirax® 800mg Aciclovir Medovir 800 800mg Tablet Aciclovir Virucid 800 Virucid 400 400mg Tablet Aciclovir Merck 250mg Powder for solution for inj Immunovir® Zovirax® Cream PoM PoM Numark Cold Sore Cream 5% w/w (5g/100g)Cream Refer to PIL Antiviral D06BB03 Vitasorb Cold Sore OTC Cream Medovir PoM Neotigason® 10mg Acitretin Capsule 35mg Retinoid - Antipsoriatic D05BB02 PoM Neotigason® 25mg Acrivastine Benadryl® Allergy Relief 8mg Capsule 24mg Antihistamine R06AX18 OTC Carbomix 81.3%w/w Granules for oral suspension Antidiarrhoeal and Activated Charcoal
    [Show full text]
  • Pharmaceutical Appendix to the Tariff Schedule 2
    Harmonized Tariff Schedule of the United States (2007) (Rev. 2) Annotated for Statistical Reporting Purposes PHARMACEUTICAL APPENDIX TO THE HARMONIZED TARIFF SCHEDULE Harmonized Tariff Schedule of the United States (2007) (Rev. 2) Annotated for Statistical Reporting Purposes PHARMACEUTICAL APPENDIX TO THE TARIFF SCHEDULE 2 Table 1. This table enumerates products described by International Non-proprietary Names (INN) which shall be entered free of duty under general note 13 to the tariff schedule. The Chemical Abstracts Service (CAS) registry numbers also set forth in this table are included to assist in the identification of the products concerned. For purposes of the tariff schedule, any references to a product enumerated in this table includes such product by whatever name known. ABACAVIR 136470-78-5 ACIDUM LIDADRONICUM 63132-38-7 ABAFUNGIN 129639-79-8 ACIDUM SALCAPROZICUM 183990-46-7 ABAMECTIN 65195-55-3 ACIDUM SALCLOBUZICUM 387825-03-8 ABANOQUIL 90402-40-7 ACIFRAN 72420-38-3 ABAPERIDONUM 183849-43-6 ACIPIMOX 51037-30-0 ABARELIX 183552-38-7 ACITAZANOLAST 114607-46-4 ABATACEPTUM 332348-12-6 ACITEMATE 101197-99-3 ABCIXIMAB 143653-53-6 ACITRETIN 55079-83-9 ABECARNIL 111841-85-1 ACIVICIN 42228-92-2 ABETIMUSUM 167362-48-3 ACLANTATE 39633-62-0 ABIRATERONE 154229-19-3 ACLARUBICIN 57576-44-0 ABITESARTAN 137882-98-5 ACLATONIUM NAPADISILATE 55077-30-0 ABLUKAST 96566-25-5 ACODAZOLE 79152-85-5 ABRINEURINUM 178535-93-8 ACOLBIFENUM 182167-02-8 ABUNIDAZOLE 91017-58-2 ACONIAZIDE 13410-86-1 ACADESINE 2627-69-2 ACOTIAMIDUM 185106-16-5 ACAMPROSATE 77337-76-9
    [Show full text]
  • A Review on Pharmacology and Therapeutic Uses of Antacids
    International Journal for Environmental Rehabilitation and Conservation ISSN: 0975 — 6272 XI (SP2): 114 — 119 www.essence-journal.com Review Article A review on pharmacology and therapeutic uses of Antacids Saraswat Renu1, Chatterji Nupur1 and Saraswat Devesh2 1Department of Chemistry, Meerut college, Meerut, India 2Department of chemistry, Eicher School, Faridabad, India Corresponding Author: [email protected]; [email protected] A R T I C L E I N F O Received: 20 July 2020 | Accepted: 15 August 2020 | Published Online: 30 September 2020 EOI: 10.11208/essence.20.11.SP2.136 Article is an Open Access Publication. This work is licensed under Attribution-Non Commercial 4.0 International (https://creativecommons.org/licenses/by/4.0/) ©The Authors (2020). Publishing Rights @ MANU—ICMANU and ESSENCE—IJERC. A B S T R A C T Antacids have been used since the last more than hundred years for the symptomatic relief by raising the pH of the stomach and without hampering the gastric condition of the body namely killing of bacteria. Sodium bicarbonate, aluminium hydroxide, magnesium hydroxide besides ranitidine and the prazoles react with the HCL present in the stomach and have become the ready choice of physicians to treat all kinds of gastric disorders. This study sheds a light on the pharmacokinetics of various antacids, their advantages, disadvantages and the chemical conditions which they help to subside. Present paper specifically focuses on the study of clinical uses and side effects of long run use of antacids K E Y W O R D S Antacids | Gastric pH | GERD | Ulcer C I T A T I O N Saraswat, Renu; Chatterji, Nupur and Saraswat, Devesh (2020): A review on pharmacology and therapeutic uses of Antacids.
    [Show full text]
  • Anaesthetic Antacids: a Review of Its Pharmacological Properties and Therapeutic Efficacy
    International Journal of Research in Medical Sciences Parakh RK et al. Int J Res Med Sci. 2018 Feb;6(2):383-393 www.msjonline.org pISSN 2320-6071 | eISSN 2320-6012 DOI: http://dx.doi.org/10.18203/2320-6012.ijrms20180005 Review Article Anaesthetic antacids: a review of its pharmacological properties and therapeutic efficacy Rajendra Kumar Parakh*, Neelakanth S. Patil Department of Medicine, SDM College of Medical Sciences and Hospital, Sattur, Dharwad, Karnataka, India Received: 13 December 2017 Accepted: 27 December 2017 *Correspondence: Dr. Rajendra Kumar Parakh, E-mail: [email protected] Copyright: © the author(s), publisher and licensee Medip Academy. This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. ABSTRACT Anaesthetic antacids, combination of antacids (Aluminium hydroxide, Magnesium hydroxide) with an anaesthetic (oxethazaine), is becoming a choice of physicians and is re-emerging across all types of GI disorders (esophagitis, peptic ulcer, duodenal ulcer, heartburn, gastritis, functional dyspepsia), despite the discovery of potent and efficacious acid suppressants like H2 receptor blockers and proton pump inhibitors (PPIs). The reason being that anaesthetic antacids increase the gastric pH and provide relief from pain for a longer period of duration at considerably a lower dosage. Furthermore, it significantly increases the duration between the time of medication and the peak pH as compared to antacid alone. Oxethazaine, an anaesthetic component, produces a reversible loss of sensation and provides a prompt and prolonged relief of pain, thereby broadening the therapeutic spectrum of antacids.
    [Show full text]
  • Alphabetical Listing of ATC Drugs & Codes
    Alphabetical Listing of ATC drugs & codes. Introduction This file is an alphabetical listing of ATC codes as supplied to us in November 1999. It is supplied free as a service to those who care about good medicine use by mSupply support. To get an overview of the ATC system, use the “ATC categories.pdf” document also alvailable from www.msupply.org.nz Thanks to the WHO collaborating centre for Drug Statistics & Methodology, Norway, for supplying the raw data. I have intentionally supplied these files as PDFs so that they are not quite so easily manipulated and redistributed. I am told there is no copyright on the files, but it still seems polite to ask before using other people’s work, so please contact <[email protected]> for permission before asking us for text files. mSupply support also distributes mSupply software for inventory control, which has an inbuilt system for reporting on medicine usage using the ATC system You can download a full working version from www.msupply.org.nz Craig Drown, mSupply Support <[email protected]> April 2000 A (2-benzhydryloxyethyl)diethyl-methylammonium iodide A03AB16 0.3 g O 2-(4-chlorphenoxy)-ethanol D01AE06 4-dimethylaminophenol V03AB27 Abciximab B01AC13 25 mg P Absorbable gelatin sponge B02BC01 Acadesine C01EB13 Acamprosate V03AA03 2 g O Acarbose A10BF01 0.3 g O Acebutolol C07AB04 0.4 g O,P Acebutolol and thiazides C07BB04 Aceclidine S01EB08 Aceclidine, combinations S01EB58 Aceclofenac M01AB16 0.2 g O Acefylline piperazine R03DA09 Acemetacin M01AB11 Acenocoumarol B01AA07 5 mg O Acepromazine N05AA04
    [Show full text]
  • Federal Register / Vol. 60, No. 80 / Wednesday, April 26, 1995 / Notices DIX to the HTSUS—Continued
    20558 Federal Register / Vol. 60, No. 80 / Wednesday, April 26, 1995 / Notices DEPARMENT OF THE TREASURY Services, U.S. Customs Service, 1301 TABLE 1.ÐPHARMACEUTICAL APPEN- Constitution Avenue NW, Washington, DIX TO THE HTSUSÐContinued Customs Service D.C. 20229 at (202) 927±1060. CAS No. Pharmaceutical [T.D. 95±33] Dated: April 14, 1995. 52±78±8 ..................... NORETHANDROLONE. A. W. Tennant, 52±86±8 ..................... HALOPERIDOL. Pharmaceutical Tables 1 and 3 of the Director, Office of Laboratories and Scientific 52±88±0 ..................... ATROPINE METHONITRATE. HTSUS 52±90±4 ..................... CYSTEINE. Services. 53±03±2 ..................... PREDNISONE. 53±06±5 ..................... CORTISONE. AGENCY: Customs Service, Department TABLE 1.ÐPHARMACEUTICAL 53±10±1 ..................... HYDROXYDIONE SODIUM SUCCI- of the Treasury. NATE. APPENDIX TO THE HTSUS 53±16±7 ..................... ESTRONE. ACTION: Listing of the products found in 53±18±9 ..................... BIETASERPINE. Table 1 and Table 3 of the CAS No. Pharmaceutical 53±19±0 ..................... MITOTANE. 53±31±6 ..................... MEDIBAZINE. Pharmaceutical Appendix to the N/A ............................. ACTAGARDIN. 53±33±8 ..................... PARAMETHASONE. Harmonized Tariff Schedule of the N/A ............................. ARDACIN. 53±34±9 ..................... FLUPREDNISOLONE. N/A ............................. BICIROMAB. 53±39±4 ..................... OXANDROLONE. United States of America in Chemical N/A ............................. CELUCLORAL. 53±43±0
    [Show full text]
  • Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act
    Updated June 07, 2021 Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act Three categories of bulk drug substances: • Category 1: Bulk Drug Substances Under Evaluation • Category 2: Bulk Drug Substances that Raise Significant Safety Risks • Category 3: Bulk Drug Substances Nominated Without Adequate Support Updates to Categories of Substances Nominated for the 503B Bulk Drug Substances List1 • Add the following entry to category 2 due to serious safety concerns of mutagenicity, cytotoxicity, and possible carcinogenicity when quinacrine hydrochloride is used for intrauterine administration for non- surgical female sterilization: 2,3 o Quinacrine Hydrochloride for intrauterine administration • Revision to category 1 for clarity: o Modify the entry for “Quinacrine Hydrochloride” to “Quinacrine Hydrochloride (except for intrauterine administration).” • Revision to category 1 to correct a substance name error: o Correct the error in the substance name “DHEA (dehydroepiandosterone)” to “DHEA (dehydroepiandrosterone).” 1 For the purposes of the substance names in the categories, hydrated forms of the substance are included in the scope of the substance name. 2 Quinacrine HCl was previously reviewed in 2016 as part of FDA’s consideration of this bulk drug substance for inclusion on the 503A Bulks List. As part of this review, the Division of Bone, Reproductive and Urologic Products (DBRUP), now the Division of Urology, Obstetrics and Gynecology (DUOG), evaluated the nomination of quinacrine for intrauterine administration for non-surgical female sterilization and recommended that quinacrine should not be included on the 503A Bulks List for this use. This recommendation was based on the lack of information on efficacy comparable to other available methods of female sterilization and serious safety concerns of mutagenicity, cytotoxicity and possible carcinogenicity in use of quinacrine for this indication and route of administration.
    [Show full text]