301 Part 355—Anticaries Drug Products for Over-The

Total Page:16

File Type:pdf, Size:1020Kb

301 Part 355—Anticaries Drug Products for Over-The Food and Drug Administration, HHS § 355.3 modification or alternative procedure § 355.3 Definitions. shall be submitted as a petition in ac- As used in this part: cord with § 10.30 of this chapter. The pe- tition should contain data to support (a) Abrasive. Solid materials that are the modification or data dem- added to dentifrices to facilitate me- onstrating that an alternative proce- chanical removal of dental plaque, de- dure provides results of equivalent ac- bris, and stain from tooth surfaces. curacy. All information submitted will (b) Anhydrous glycerin. An ingredient be subject to the disclosure rules in that may be prepared by heating glyc- part 20 of this chapter. erin U.S.P. at 150 –C for 2 hours to drive off the moisture content. PART 355—ANTICARIES DRUG (c) Anticaries drug. A drug that aids in the prevention and prophylactic PRODUCTS FOR OVER-THE- treatment of dental cavities (decay, COUNTER HUMAN USE caries). (d) Dental caries. A disease of calcified Subpart A—General Provisions tissues of teeth characterized by Sec. demineralization of the inorganic por- 355.1 Scope. tion and destruction of the organic ma- 355.3 Definitions. trix. (e) Dentifrice. An abrasive-containing Subpart B—Active Ingredients dosage form (gel, paste, or powder) for delivering an anticaries drug to the 355.10 Anticaries active ingredients. teeth. 355.20 Packaging conditions. (f) Fluoride. The inorganic form of the Subpart C—Labeling chemical element fluorine in combina- tion with other elements. 355.50 Labeling of anticaries drug products. (g) Fluoride ion. The negatively 355.55 Principal display panel of all fluoride charged atom of the chemical element rinse drug products. fluorine. 335.60 Professional labeling. (h) Fluoride supplement. A special treatment rinse dosage form that is in- Subpart D—Testing Procedures tended to be swallowed, and is pro- 355.70 Testing procedures for fluoride den- moted to health professionals for use in tifrice drug products. areas where the water supply contains AUTHORITY: 21 U.S.C. 321, 351, 352, 353, 355, 0 to 0.7 parts per million (ppm) fluoride 360, 371. ion. (i) Preventive treatment gel. A dosage SOURCE: 60 FR 52507, Oct. 6, 1995, unless form for delivering an anticaries drug otherwise noted. to the teeth. Preventive treatment gels EDITORIAL NOTE: Nomenclature changes to are formulated in an anhydrous glyc- part 355 appear at 69 FR 13717, Mar. 24, 2004. erin base with suitable thickening agents included to adjust viscosity. Subpart A—General Provisions Preventive treatment gels do not con- tain abrasives. § 355.1 Scope. (j) Treatment rinse. A liquid dosage (a) An over-the-counter anticaries form for delivering an anticaries drug drug product in a form suitable for top- to the teeth. ical administration to the teeth is gen- (k) Treatment rinse concentrated solu- erally recognized as safe and effective tion. A fluoride treatment rinse in a and is not misbranded if it meets each concentrated form to be mixed with condition in this part and each general water before using to result in the ap- condition established in § 330.1 of this propriate fluoride concentration speci- chapter. fied in the monograph. (b) References in this part to regu- (l) Treatment rinse effervescent tablets. latory sections of the Code of Federal A fluoride treatment rinse prepared by Regulations are to chapter I of title 21 adding an effervescent tablet (a con- unless otherwise noted. centrated solid dosage form) to water 301 VerDate Aug<31>2005 14:36 May 08, 2008 Jkt 214069 PO 00000 Frm 00311 Fmt 8010 Sfmt 8010 Y:\SGML\214069.XXX 214069 dwashington3 on PRODPC61 with CFR § 355.10 21 CFR Ch. I (4–1–08 Edition) before using to result in the appro- 0.02-percent or 0.05-percent aqueous so- priate fluoride concentration specified lution with a pH of approximately 7. in the monograph. (b) Sodium monofluorophosphate—(1) (m) Treatment rinse powder. A fluoride Dentifrices containing 850 to 1,150 ppm treatment rinse prepared by adding the theoretical total fluorine in a gel or paste powder (a concentrated solid dosage dosage form. Sodium monofluoro- form) to water before using to result in phosphate 0.654 to 0.884 percent with an the appropriate fluoride concentration available fluoride ion concentration = ¥ specified in the monograph. (consisting of PO3 F and F combined) ≥ 800 ppm. [60 FR 52507, Oct. 6, 1995, as amended at 61 FR 52286, Oct. 7, 1996] (2) Dentifrices containing 1,500 ppm the- oretical total fluorine in a gel or paste dosage form. Sodium monofluoro- Subpart B—Active Ingredients phosphate 1.153 percent with an avail- able fluoride ion concentration (con- § 355.10 Anticaries active ingredients. = ¥ sisting of PO3 F and F combined) ≥ The active ingredient of the product 1,275 ppm. consists of any of the following when (c) Stannous fluoride—(1) Dentifrices used in the concentration and dosage containing 850 to 1,150 ppm theoretical form established for each ingredient: total fluorine in a gel or paste dosage (a) Sodium fluoride—(1) Dentifrices con- form. (i) Stannous fluoride 0.351 to 0.474 taining 850 to 1,150 ppm theoretical total percent with an available fluoride ion fluorine in a gel or paste dosage form. So- concentration ≥ 700 ppm for products dium fluoride 0.188 to 0.254 percent with containing abrasives other than cal- an available fluoride ion concentration cium pyrophosphate. ≥ 650 parts per million (ppm). (ii) Stannous fluoride 0.351 to 0.474 (2) Dentifrices containing 850 to 1,150 percent with an available fluoride ion ppm theoretical total fluorine in a pow- concentration ≥ 290 ppm for products dered dosage form. Sodium fluoride 0.188 containing the abrasive calcium to 0.254 percent with an available fluo- ≥ pyrophosphate. ride ion concentration of 850 ppm for (2) Preventive treatment gel. Stannous products containing the abrasive so- fluoride 0.4 percent in an anhydrous dium bicarbonate and a poured-bulk glycerin gel, made from anhydrous density of 1.0 to 1.2 grams per milli- glycerin and the addition of suitable liter. thickening agents to adjust viscosity. (3) Treatment rinses. (i) An aqueous so- (3) Treatment rinse. Stannous fluoride lution of acidulated phosphate fluoride concentrate marketed in a stable form derived from sodium fluoride and containing adequate directions for acidulated with a mixture of sodium mixing with water immediately before phosphate, monobasic, and phosphoric using to result in a 0.1-percent aqueous acid to a level of 0.1 molar phosphate solution. ion and a pH of 3.0 to 4.5 and which yields an effective fluoride ion con- [60 FR 52507, Oct. 6, 1995, as amended at 61 FR centration of 0.02 percent. 52286, Oct. 7, 1996] (ii) An aqueous solution of acidulated phosphate fluoride derived from so- § 355.20 Packaging conditions. dium fluoride acidulated with a mix- (a) Package size limitation. Due to the ture of sodium phosphate, dibasic, and toxicity associated with fluoride active phosphoric acid to a pH of 3.5 and ingredients, the following package size which yields an effective fluoride ion limitations are required for anticaries concentration of 0.01 percent. drug products: (iii) Sodium fluoride 0.02 percent (1) Dentifrices. Dentifrice (toothpastes aqueous solution with a pH of approxi- and tooth powders) packages shall not mately 7. contain more than 276 milligrams (mg) (iv) Sodium fluoride 0.05 percent total fluorine per package. aqueous solution with a pH of approxi- (2) Preventive treatment gels and treat- mately 7. ment rinses. Preventive treatment gel (v) Sodium fluoride concentrate con- and treatment rinse packages shall not taining adequate directions for mixing contain more than 120 mg total fluo- with water before using to result in a rine per package. 302 VerDate Aug<31>2005 14:36 May 08, 2008 Jkt 214069 PO 00000 Frm 00312 Fmt 8010 Sfmt 8010 Y:\SGML\214069.XXX 214069 dwashington3 on PRODPC61 with CFR Food and Drug Administration, HHS § 355.50 (3) Exception. Package size limita- tion into interstate commerce of unap- tions do not apply to anticaries drug proved new drugs in violation of sec- products marketed for professional of- tion 505(a) of the act. fice use only and labeled in accord with (c) Warning. The labeling of the prod- § 355.60. uct contains the following warning (b) Tight container packaging. To min- under the heading ‘‘Warning’’: imize moisture contamination, all fluo- (1) For all fluoride dentifrice (gel, paste, ride powdered dentifrices shall be pack- and powder) products. ‘‘Keep out of aged in a tight container as defined as reach of children under 6 years of age. a container that protects the contents [highlighted in bold type] If more than from contamination by extraneous liq- used for brushing is accidentally swal- uids, solids, or vapors, from loss of the lowed, get medical help or contact a article, and from efflorescence, deli- Poison Control Center right away.’’ quescence, or evaporation under the or- These warnings shall be used in place dinary or customary conditions of han- of the general warning statements re- dling, shipment, storage, and distribu- quired by § 330.1(g) of this chapter. tion, and is capable of tight reclosure. (2) For all fluoride rinse and preventive treatment gel products. ‘‘Keep out of Subpart C—Labeling reach of children. [highlighted in bold type] If more than used for’’ (select ap- § 355.50 Labeling of anticaries drug propriate word: ‘‘brushing’’ or ‘‘rins- products. ing’’) ‘‘is accidentally swallowed, get (a) Statement of identity. The labeling medical help or contact a Poison Con- of the product contains the established trol Center right away.’’ These warn- name of the drug, if any, and identifies ings shall be used in place of the gen- the product as: (select one or both of eral warning statements required by the following: ‘anticavity’ or ‘fluoride’) § 330.1(g) of this chapter.
Recommended publications
  • An Introduction to Fast Dissolving Oral Thin Film Drug Delivery Systems: a Review
    Muthadi Radhika Reddy /J. Pharm. Sci. & Res. Vol. 12(7), 2020, 925-940 An Introduction to Fast Dissolving Oral Thin Film Drug Delivery Systems: A Review Muthadi Radhika Reddy1* 1School of pharmacy, Gurunanak Institute of Technical Campus, Hyderabad, Telangana, India and Department of Pharmacy, Gandhi Institute of Technology and Management University, Vizag, Andhra Pradesh, India INTRODUCTION 2. Useful in situations where rapid onset of action Fast dissolving drug delivery systems were first developed required such as in motion sickness, allergic attack, in the late 1970s as an alternative to conventional dosage coughing or asthma forms. These systems consist of solid dosage forms that 3. Has wide range of applications in pharmaceuticals, Rx disintegrate and dissolve quickly in the oral cavity without Prescriptions and OTC medications for treating pain, the need of water [1]. Fast dissolving drug delivery cough/cold, gastro-esophageal reflux disease,erectile systems include orally disintegrating tablets (ODTs) and dysfunction, sleep disorders, dietary supplements, etc oral thin films (OTFs). The Centre for Drug Evaluation [4] and Research (CDER) defines ODTs as,“a solid dosage 4. No water is required for the administration and hence form containing medicinal substances which disintegrates suitable during travelling rapidly, usually within a matter of seconds, when placed 5. Some drugs are absorbed from the mouth, pharynx upon the tongue” [2]. USFDA defines OTFs as, “a thin, and esophagus as the saliva passes down into the flexible, non-friable polymeric film strip containing one or stomach, enhancing bioavailability of drugs more dispersed active pharmaceutical ingredients which is 6. May offer improved bioavailability for poorly water intended to be placed on the tongue for rapid soluble drugs by offering large surface area as it disintegration or dissolution in the saliva prior to disintegrates and dissolves rapidly swallowing for delivery into the gastrointestinal tract” [3].
    [Show full text]
  • Comprehensive Review on Herbal Toothpaste
    Annals of R.S.C.B., ISSN:1583-6258, Vol. 25, Issue 4, 2021, Pages. 9509 - 9518 Received 05 March 2021; Accepted 01 April 2021. Comprehensive Review on Herbal Toothpaste Divya S1, Dr. J Suresh1*, Dr. S. Meenakshi 2 1. Department of Pharmacognosy, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Mysuru-570015 2.Department of Prosthodontics, JSS Dental College, JSS Academy of Higher Education &Research, Mysuru-570015 Corresponding author Dr. J. Suresh Professor Department of Pharmacognosy, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Mysuru-570015 Email: [email protected] Mobile No: 9480197611 ABSTRACT Herbal products for general as well as for oral health care have gained prominence around worldwide. People who aspire towards the use of herbal products often consider these products are relatively safer than products containing synthetic ingredients. Based on increased usage of herbal cosmetics we tried to make a comprehensive review on herbal toothpaste that helps to maintain a proper oral hygiene and free from periodontal disorder, reduce stain, gingivitis, calculus and caries. The present review gives basic information regarding antimicrobial potential of various herbs, formulationexcipients, that can be used in preparation of toothpaste. Key Words: Herbal toothpaste, Anti-microbial screening, Periodontal disorder, Gingivitis, calculus, Dental caries. INTRODUCTION In developing countries, the intensity of infections caused by certain pathogenic micro- organisms that may leads to mortality as well as morbidity in immune-suppressant patients [1]. Multiple abrasives, scent, green lead was used to remove the stain from teeth until mid- 19thcentury. In Medieval period rock salt, fine sand were the key ingredients used by Arabs for tooth cleaning.In the period 1950 AD, Dr.
    [Show full text]
  • Chapter 1 Controlling Drug Delivery
    chapter 1 Controlling drug delivery Overview In this chapter we will: & differentiate drug delivery systems according to their physical state & differentiate drug delivery systems according to their route of administration & differentiate drug delivery systems according to their type of drug release & discuss drug transport across epithelial barriers. Introduction KeyPoints & Continued developments in Pharmacotherapy can be defined as the treatment chemistry, molecular biology and prevention of illness and disease by means of and genomics support the drugs of chemical or biological origin. It ranks discovery and developments among the most important methods of medical of new drugs and new drug treatment, together with surgery, physical targets. & treatment, radiation and psychotherapy. There The drug delivery system are many success stories concerning the use of employed can control the pharmacological action of a drugs and vaccines in the treatment, prevention drug, influencing its and in some cases even eradication of diseases pharmacokinetic and (e.g. smallpox, which is currently the only subsequent therapeutic human infectious disease completely profile. eradicated). Although it is almost impossible to estimate the exact extent of the impact of pharmacotherapy on human health, there can be no doubt that pharmacotherapy, together with improved sanitation, better diet and better housing, has improved people’s health, life expectancy and quality of life. Tip Unprecedented developments in genomics Combinatorial chemistry is a way to and molecular biology today offer a plethora of build a variety of structurally related new drug targets. The use of modern chemical drug compounds rapidly and synthetic methods (such as combinatorial systematically. These are assembled chemistry) enables the syntheses of a large from a range of molecular entities number of new drug candidates in shorter times which are put together in different ‘ ’ than ever before.
    [Show full text]
  • WO 2010/044736 Al
    (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date 22 April 2010 (22.04.2010) WO 2010/044736 Al (51) International Patent Classification: (74) Agents: Bratt, Henrik et al; Jarnvagsgatan 10 A, S-251 A61K 9/24 (2006.01) A61P 25/34 (2006.01) 10 Helsingborg (SE). (21) International Application Number: (81) Designated States (unless otherwise indicated, for every PCT/SE2009/05 1163 kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, (22) Date: International Filing CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, 13 October 2009 (13.10.2009) DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, (25) Filing Language: English HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, (26) Publication Language: English ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, (30) Priority Data: NO, NZ, OM, PE, PG, PH, PL, PT, RO, RS, RU, SC, SD, 0802 189-1 14 October 2008 (14.10.2008) SE SE, SG, SK, SL, SM, ST, SV, SY, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (71) Applicant (for all designated States except US): McNeil AB [SE/SE]; Box 941, S-25 1 09 Helsingborg (SE). (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, (72) Inventors; and GM, KE, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM, (75) Inventors/Applicants (for US only): LINDELL, Katari- ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, na [SE/SE]; Skarhult 1325, S-241 93 Eslδv (SE).
    [Show full text]
  • Dosage Form Description CODE
    Dosage Form Description CODE DOSAGE_FORM DOSAGE_FORM DESCRIPTION AERO Aerosol AEPB Aerosol Powder, Breath Activated AERB Aerosol, Breath Activated AERP Aerosol, Powder AERS Aerosol, Solution AUIJ Auto-injector AJKT Auto-injector Kit BAR Bar BEAD Beads CAPS Capsule CAPA Capsule Abuse- Deterrent CPCW Capsule Chewable CPDR Capsule Delayed Release CPEP Capsule Delayed Release Particles CSDR Capsule Delayed Release Sprinkle CDPK Capsule Delayed Release Thereapy Pack C12A Capsule ER 12 Hour Abuse-Deterrent CS12 Capsule ER 12 Hour Sprinkle C2PK Capsule ER 12 Hour Therapy Pack C24A Capsule ER 24 Hour Abuse-Deterrent CS24 Capsule ER 24 Hour Sprinkle C4PK Capsule ER 24 Hour Therapy Pack CP12 Capsule Extended Release 12 Hour CP24 Capsule Extended Release 24 Hour CPEA Capsule Extended Release Abuse-Deterrent CSER Capsule Extended Release Sprinkle CEPK Capsule Extended Release Therapy Pack CPCR Capsule Extended Release* CPSP Capsule Sprinkle CPPK Capsule Therapy Pack CART Cartridge CTKT Cartridge Kit CONC Concentrate CREA Cream CRYS Crystals DEVI Device TEST Diagnostic Test DPRH Diaphragm DISK Disk ELIX Elixir EMUL Emulsion ENEM Enema EXHA Exhaler EXHL Exhaler Liquid Dosage Form Description CODE DOSAGE_FORM DOSAGE_FORM DESCRIPTION EXHP Exhaler Powder EXHS Exhaler Solution EXHU Exhaler Suspension FILM Film FLAK Flakes EXTR Fluid Extract FOAM Foam GAS Gas GEL Gel SOLG Gel Forming Solution GRAN Granules GREF Granules Effervescent GUM Gum IMPL Implant INHA Inhaler INJ Injectable INST Insert IUD Intrauterine Device JTAJ Jet-injector (Needleless) JTKT Jet-injector
    [Show full text]
  • Formulation and Evaluation of Liposomal Drug Delivery System for Doxorubicin Hydrochloride
    FORMULATION AND EVALUATION OF LIPOSOMAL DRUG DELIVERY SYSTEM FOR DOXORUBICIN HYDROCHLORIDE A dissertation submitted to THE TAMILNADU Dr. M.G.R.MEDICAL UNIVERSITY, CHENNAI. In partial fulfillment of the requirements for the award of degree of MASTER OF PHARMACY IN PHARMACEUTICS BY REG.NO: 26091390 Under the Guidance of Prof. S.P.SENTHIL, M.Pharm., ( Ph.D.,) OCTOBER -2011 THE ERODE COLLEGE OF PHARMACY AND RESEARCH INSTITUTE ERODE -638112, TAMILNADU DEDICATED TO My Beloved Family, Teachers & Friends CERTIFICATES The Erode College Of Pharmacy and Research Institute Prof.S.P.SENTHIL, M.Pharm.,( Ph.D.,) Department of pharmaceutics, Perundurai Main Road, Veppampalayam, Erode-638112, India. e-mail : [email protected] CERTIFICATE This is to certify that the investigation in this thesis entitled “FORMULATION AND EVALUATION OF LIPOSOMAL DRUG DELIVERY SYSTEM FOR DOXORUBICIN HYDROCHLORIDE” submitted to The Tamilnadu Dr. M.G.R. Medical University Chennai. For partial fulfillment of the award of degree of Master of pharmacy in Pharmaceutics was carried out by Reg. No: 26091390 in the department of pharmaceutics, The Erode College of pharmacy, Erode, under my guidance and supervision This work is original and has not been submitted in part or full to any other degree or diploma of this or any other university. Place: Erode Prof. S.P.SENTHIL, M.Pharm.,(Ph.D.,) Date: The Erode College Of Pharmacy and Research Institute Dr.V.Ganesan, M.Pharm., Ph.D., Professor and HOD of Pharmaceutics, Perundurai Main Road, Veppampalayam, Erode-638112, India. CERTIFICATE This is to certify that the investigation in this thesis entitled “FORMULATION AND EVALUATION OF LIPOSOMAL DRUG DELIVERY SYSTEM FOR DOXORUBICIN HYDROCHLORIDE ” submitted to the Tamil Nadu Dr.
    [Show full text]
  • Medicinal Cannabis Dosage Forms in California an Overview of Cannabis Dosage Forms
    Mica Gross President Sante Botanica / COO MDBioLogics Medicinal Cannabis Dosage Forms in California An Overview of Cannabis Dosage Forms Forms of dosage are the specific vehicles by which cannabis, or cannabinoids, are delivered into the body. Cannabis (drug-containing plant) —> The “form” in which THC and other cannabinoids Extracted Oil (drug substance) —> are administered determines how they moves and Delivery / Intake (drug product) works medicinally inside the body: ie the pharmacokinetics of cannabis. Both the plant material and the oils yielded through the extraction process influence the performance of the different forms of intake, which each have a particular set of benefits. An Overview of Cannabis Dosage Forms The medicinal effect experienced by the end- user is a function of the quality of the raw material – the cannabinoid and terpene profile of the cannabis – and of the derived oil yielded during extraction. The goal is to preserve the fidelity of the volatile medicinal compounds – such as the cannabinoids, terpenes, and flavonoids – throughout the entire chain of custody so that the therapeutic effect is intact and the dose is delivered in the most efficacious means possible. An Overview of Cannabis Dosage Forms Each form of intake is formulated to take advantage of the pharmacokinetic pathways as effectively as possible in delivering a therapeutic dose of cannabinoids (e.g. THC or CBD). An Overview of Cannabis Dosage Forms Important factors when considering each form of intake: • Bioavailability – the fraction of the administered
    [Show full text]
  • Aqueous Emulsion Coating for Pharmaceutical Dosage Form
    Europaisches Patentamt 0 347 024 3> European Patent Office J) Publication number: Dffice europeen des brevets 3) EUROPEAN PATENT APPLICATION © Application number: 89303290.4 © Int. CI.4: A61K 9/32 , A61K 9/36 , A61K 9/22 © Date of filing: 04.04.89 The title of the invention has been amended © Applicant: ALZA CORPORATION (Guidelines for Examination in the EPO, A-lll, 950 Page Mill Road P.O. Box 10950 7.3). Palo Alto California 94303-0802(US) © Inventor: Wong, Patrick S.-L. © Priority: 21.04.88 US 184478 2030 Cornell Street Palo Alto California 94306(US) © Date of publication of application: Inventor: Theeuwes, Felix 20.12.89 Bulletin 89/51 1634 Fallen Leaf Lane Los Altos California 94022(US) © Designated Contracting States: AT BE CH DE ES FR GB GR IT LI LU NL SE © Representative: Evans, David Charles et al F.J. CLEVELAND & COMPANY 40-43, Chancery Lane London, WC2A UQ(GB) © Aqueous emulsion coating for pharmaceutical dosage form. © A dosage form is disclosed comprising a cured emulsion coat that surrounds a drug. The emulsion comprises a lower alkyl acrylate-lower alkyl methacrylate copolymer and ethyl cellulose. The emulsion optionally comprises a hydrophilic poly- mer. eg < CM CO CL LU Xerox Copy Centre 1 EP 0 347 024 A2 2 AQUEOUS EMULSION FOR PHARMACEUTICAL DOSAGE FORM This invention pertains to a pharmaceutical final dosage form. dosage form comprising an aqueous emulsion coat It will be appreciated by those skilled in the and to an aqueous emulsion coat. drug dispensing art that if a coating is provided that is substantially free of organic solvents when coat- 5 ing drugs, drug granules, drug powders, drug dis- BACKGROUND OF THE INVENTION pensers, and the like, such a coating would have an immediate positive value and, concomitantly, represent an advancement in the drug coating art.
    [Show full text]
  • Draft Guidance on Nicotine Active Ingredient
    Contains Nonbinding Recommendations Draft Guidance on Nicotine This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA, or the Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the Office of Generic Drugs. Active Ingredient: Nicotine Dosage Form; Route: Film, extended release; transdermal Recommended Studies: Three studies 1. Type of study: Bioequivalence (BE) study with pharmacokinetic (PK) endpoints Design: Single-dose, two-treatment, two-period crossover in vivo Strength: 21 mg/24 hr Subjects: Males and non-pregnant, non-lactating females, smokers Additional comments: In this document, this dosage form is referred to as a transdermal delivery system (TDS) and includes products that may be described elsewhere or known as patches or extended release films. Unless otherwise justified, the nicotine TDS should be applied to the same anatomical site on all subjects, selected from among those recommended for dosing in the approved labeling for the reference listed drug (RLD) product, and worn for 24 hours. Applicants should randomize subjects to receive either the test or RLD product in a given study period. When possible, the TDS administered in the second study period should be applied to the same anatomical site as in the first study period, but on the contralateral side of the body. Contact of the TDS with the skin is essential for the in vivo performance of the TDS, and the PK may be altered when a TDS loses its adherence to the skin.
    [Show full text]
  • Dosage Form FDA Data Element Number
    Home Drugs Development & Approval Process (Drugs) Forms & Submission Requirements Electronic Submissions to CDER Data Standards Manual (monographs) Drugs Dosage Form FDA Data Element Number. None. CDER Data Element Number. C-DRG-00201 Data Element Name. Dosage Form. Data Element OID: 2.16.840.1.113883.3.26.1.1.2 Data Element NCI Concept ID: C42636 Version Number. 008 Description. This standard provides for all drug dosage forms. The granularity of data often requires that more specific dosage form terms be stored in automated databases than are represented in publications. These dosage form terms are available not only for use in databases that track approved drug products, but also for drug products such as: those that have not been approved, investigational drug products, homeopathic drug products, biologic products, veterinary drug products, and bulk drug products. A ‘use restrictions’ column is being added to help identify where a particular dosage form set or subset should be used (a=CDER Databases, b=NDC Directory, c=Orange Book). The definitions for Lotion, Cream, Ointment, and Paste were revised on June 21, 2006 to include information that would assist the user in differentiating between these dosage forms. These changes were the result of discussions during an FDA Advisory Committee with an open public forum, scientific studies that were published in refereed pharmaceutical journals, and internal discussions by Agency personnel, including the usual adherence to the criteria that are specified in MaPP 7600.4. A 1999 Food and Drug Administration Draft Guidance for Industry states: "A dosage form is the way of identifying the drug in its physical form.
    [Show full text]
  • Thin Films As an Emerging Platform for Drug Delivery
    View metadata, citation and similar papers at core.ac.uk brought to you by CORE provided by Elsevier - Publisher Connector asian journal of pharmaceutical sciences 11 (2016) 559–574 HOSTED BY Available online at www.sciencedirect.com ScienceDirect journal homepage: www.elsevier.com/locate/ajps Review Thin films as an emerging platform for drug delivery Sandeep Karki a,1, Hyeongmin Kim a,b,c,1, Seon-Jeong Na a, Dohyun Shin a,c, Kanghee Jo a,c, Jaehwi Lee a,b,c,* a Pharmaceutical Formulation Design Laboratory, College of Pharmacy, Chung-Ang University, Seoul 06974, Republic of Korea b Bio-Integration Research Center for Nutra-Pharmaceutical Epigenetics, Chung-Ang University, Seoul 06974, Republic of Korea c Center for Metareceptome Research, Chung-Ang University, Seoul 06974, Republic of Korea ARTICLE INFO ABSTRACT Article history: Pharmaceutical scientists throughout the world are trying to explore thin films as a novel Received 21 April 2016 drug delivery tool. Thin films have been identified as an alternative approach to conven- Accepted 12 May 2016 tional dosage forms. The thin films are considered to be convenient to swallow, self- Available online 6 June 2016 administrable, and fast dissolving dosage form, all of which make it as a versatile platform for drug delivery. This delivery system has been used for both systemic and local action via Keywords: several routes such as oral, buccal, sublingual, ocular, and transdermal routes. The design Thin film of efficient thin films requires a comprehensive knowledge of the pharmacological and phar- Film-forming polymer maceutical properties of drugs and polymers along with an appropriate selection of Mechanical properties manufacturing processes.
    [Show full text]
  • API & Dosage Form Development
    API and Dosage Development W I T H D A LT O N Peter Pekos [ C O M P A N Y V I S I O N ] "To make the impossible possible. Dalton Pharma Services uses its scientific and pharmaceutical expertise to bring customer ideas to life. We develop their new drug products, optimize the synthesis of therapeutic candidates, and manufacture them at the highest level of quality." [ S E R V I C E S ] Contract Research Custom Synthesis Medicinal and Flow Chemistry API Process Development Formulation Development cGMP API Manufacturing cGMP Sterile Filling Analytical and Microbiology Services FDA inspected, HC approved, & MRA with EMA API Form Development API Definition Active pharmaceutical ingredient (API) – the substance(s) in pharmaceutical drugs that is/are responsible for the beneficial health effects experienced by consumers. (1) API Selection Key factors that drive API selection (2): Crystallinity: Influences the dissolution rate and transport characteristics of the drug (3) Polymorphism: The ability of a drug substance to Solubility: take on more than one form/ The ability of a solute to dissolve in crystalline phase. Influences drug solvent. Influences desired dissolution and drug stability (i.e., concentration and drug premature degradation) (4) absorption (6) Density: Influences flow properties and Stability: compressibility (5) Influenced by moisture, excipients, temperature, pH, oxygen, light (7) Particle size distribution: Influences the ability of the drug to Density: cross blood barriers, enter cells, Influences flow properties and and absorbed by the human body compressibility (5) (2) The development stage and needs API & CTD Note: In any clinical application or new drug submission the 1) description of manufacturing (including flowcharts) is required along with 2) physiochemical characteristics (melting point, boiling point, denaturation temperature, solubility) (2.3.S.2, 2.3.S.3 and 2.3.P.3) (4) Once the API form is determined, the dosage form must be selected.
    [Show full text]