Guideline on the Pharmacokinetic and Clinical Evaluation of Modified Release Dosage Forms
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Medical Prescription Market Definitions
Horvath Health Policy Innovations in Healthcare Financing Policy PO Box 196, College Park, MD 20741 202/465-5836 [email protected] Medical Prescription (Rx) Market Definitions Drug Product Terminology Small Molecule Drugs: Drugs with an active chemical ingredient that is not live, but chemically synthesized and typically are taken orally or topically, such as capsules, tablets, powders, ointments, and sprays. Brands: Also referred to “small molecule drugs,” brand drugs require original research and development for FDA licensure (also called “FDA approval”). They are approved (or licensed) under a New Drug Application (NDA). They are patent protected for 20 years total (which usually includes years clinical research before the drug is approved, or licensed). They are still referred to as brands even after the patent has expired (which distinguishes these drugs from generics). A brand can be ‘first in class” if it is a new chemical entity or new mechanism of action. It is a “me too drug” if it is not first in class. The definition of “me too” varies – different chemical composition, different mechanism of action. The drug is quite similar but different enough to get a patent. Generic: Small molecule products that are demonstrated to be clinically equivalent to a branded product (e.g., same active ingredient and route of administration, same mechanism of action). Generics do not require original research for FDA approval. Generics come to market only after the patent has expired on the brand product. Licensed under an Abbreviated New Drug Application (ANDA) by the FDA. Large Molecule Drugs: Commonly referred to as “biologics” and “biosimilars.” They contain live active ingredients and are generally infused or injected, and otherwise not taken orally or topically. -
IND Exemptions Chart
IND EXEMPTIONS Involving Drugs or Biologics Exemption 1 Exemption 4 Drug/Biologic US product Placebo * Drug/biologic product lawfully marketed in US * The clinical investigation involves the use of a placebo and the investigation does not otherwise * The investigation is not intended to be reported to FDA require submission of an IND as a well controlled study in support of a new indication for use nor intended to be used to support any other significant change in the labeling for the drug/biologic. * The investigation proposed is not intended to support a significant change in the advertising for the drug/ Exemption 5 biologic In Vivo Bioavailability or Bioequivalence * The investigation does not involve a route of * Test product does not contain a new chemical administration, dose, patient population, or other factor entity”’ as defined in 21 CFR 314.108(a) [** a drug that significantly increases the risks (or decreases the that contains no active moiety that has been acceptability of the risks) associated with the use of the approved by FDA in any other application. drug/biologic * The study does not involve a radioactively labeled * The investigation will be conducted in compliance with drug product. FDA regulations for the Protection of Human Subjects and Institutional Review Boards 21 CFR 50 & 56 * The study does not involve a cytotoxic drug product. * The investigation will be conducted in compliance with The investigator will conduct a bioavailability or the FDA requirements for Promotion and Charging for bioequivalence study -
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]. -
United States District Court for the District of Columbia
Case 1:15-cv-00802-RC Document 29 Filed 03/15/16 Page 1 of 33 UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA FERRING PHARMACEUTICALS, INC., : : Plaintiff, : Civil Action No.: 15-0802 (RC) : v. : Re Document Nos.: 20, 22 : SYLVIA M. BURWELL, et al., : : Defendants. : MEMORANDUM OPINION GRANTING IN PART AND DENYING IN PART DEFENDANTS’ MOTION FOR SUMMARY JUDGMENT AND DENYING PLAINTIFF’S MOTION FOR SUMMARY JUDGMENT I. INTRODUCTION Plaintiff Ferring Pharmaceuticals, Inc. (“Ferring”) is the manufacturer of PREPOPIK, a fixed-dose combination drug product that contains three drug substances: sodium picosulfate, magnesium oxide, and anhydrous citric acid. When it submitted a New Drug Application (“NDA”) for PREPOPIK to the U.S. Food and Drug Administration (“the FDA”), Ferring sought a five-year period of marketing exclusivity because one of the drug substances, sodium picosulfate, had never previously been approved in a NDA. The Federal Food, Drug, and Cosmetics Act (“FDCA”) provides for a five-year period of marketing exclusivity when a drug application is approved “for a drug, no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application.” 21 U.S.C. § 355(j)(5)(F)(ii). During that five-year period, “no application may be submitted . which refers to the drug for which the subsection (b) application was submitted.” Id. The dispute in this case is whether the statutory term “drug,” as used in this provision of the FDCA, can reasonably be read to refer to a “drug product” (the finished dosage form of a Case 1:15-cv-00802-RC Document 29 Filed 03/15/16 Page 2 of 33 drug), or must be read to refer to a “drug substance” (the active ingredient of the drug). -
New Chemical Entity Exclusivity Determinations for Certain Fixed- Combination Drug Products
New Chemical Entity Exclusivity Determinations for Certain Fixed- Combination Drug Products Guidance for Industry U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) October 2014 Procedural New Chemical Entity Exclusivity Determinations for Certain Fixed- Combination Drug Products Guidance for Industry Office of Communications, Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration 10001 New Hampshire Ave., Hillandale Bldg., 4th Floor Silver Spring, MD 20993 Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353 [email protected] http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) October 2014 Procedural Contains Nonbinding Recommendations TABLE OF CONTENTS I. INTRODUCTION............................................................................................................. 1 II. BACKGROUND ............................................................................................................... 2 III. STATUTORY AND REGULATORY FRAMEWORK ............................................... 2 IV. FDA’S HISTORICAL INTERPRETATION OF THE 5-YEAR NCE EXCLUSIVITY PROVISIONS ....................................................................................... 5 V. REVISED AGENCY INTERPRETATION OF THE 5-YEAR NCE EXCLUSIVITY PROVISIONS ................................................................................................................... -
An Overview On: Sublingual Route for Systemic Drug Delivery
International Journal of Research in Pharmaceutical and Biomedical Sciences ISSN: 2229-3701 __________________________________________Review Article An Overview on: Sublingual Route for Systemic Drug Delivery K. Patel Nibha1 and SS. Pancholi2* 1Department of Pharmaceutics, BITS Institute of Pharmacy, Gujarat Technological university, Varnama, Vadodara, Gujarat, India 2BITS Institute of Pharmacy, Gujarat Technological University, Varnama, Vadodara, Gujarat, India. __________________________________________________________________________________ ABSTRACT Oral mucosal drug delivery is an alternative and promising method of systemic drug delivery which offers several advantages. Sublingual literally meaning is ''under the tongue'', administrating substance via mouth in such a way that the substance is rapidly absorbed via blood vessels under tongue. Sublingual route offers advantages such as bypasses hepatic first pass metabolic process which gives better bioavailability, rapid onset of action, patient compliance , self-medicated. Dysphagia (difficulty in swallowing) is common among in all ages of people and more in pediatric, geriatric, psychiatric patients. In terms of permeability, sublingual area of oral cavity is more permeable than buccal area which is in turn is more permeable than palatal area. Different techniques are used to formulate the sublingual dosage forms. Sublingual drug administration is applied in field of cardiovascular drugs, steroids, enzymes and some barbiturates. This review highlights advantages, disadvantages, different sublingual formulation such as tablets and films, evaluation. Key Words: Sublingual delivery, techniques, improved bioavailability, evaluation. INTRODUCTION and direct access to systemic circulation, the oral Drugs have been applied to the mucosa for topical mucosal route is suitable for drugs, which are application for many years. However, recently susceptible to acid hydrolysis in the stomach or there has been interest in exploiting the oral cavity which are extensively metabolized in the liver. -
Liposome-Based Drug Delivery Systems in Cancer Immunotherapy
pharmaceutics Review Liposome-Based Drug Delivery Systems in Cancer Immunotherapy Zili Gu 1 , Candido G. Da Silva 1 , Koen van der Maaden 2,3, Ferry Ossendorp 2 and Luis J. Cruz 1,* 1 Department of Radiology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, The Netherlands 2 Tumor Immunology Group, Department of Immunology, Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, The Netherlands 3 TECOdevelopment GmbH, 53359 Rheinbach, Germany Received: 1 October 2020; Accepted: 2 November 2020; Published: 4 November 2020 Abstract: Cancer immunotherapy has shown remarkable progress in recent years. Nanocarriers, such as liposomes, have favorable advantages with the potential to further improve cancer immunotherapy and even stronger immune responses by improving cell type-specific delivery and enhancing drug efficacy. Liposomes can offer solutions to common problems faced by several cancer immunotherapies, including the following: (1) Vaccination: Liposomes can improve the delivery of antigens and other stimulatory molecules to antigen-presenting cells or T cells; (2) Tumor normalization: Liposomes can deliver drugs selectively to the tumor microenvironment to overcome the immune-suppressive state; (3) Rewiring of tumor signaling: Liposomes can be used for the delivery of specific drugs to specific cell types to correct or modulate pathways to facilitate better anti-tumor immune responses; (4) Combinational therapy: Liposomes are ideal vehicles for the simultaneous delivery of drugs to be combined with other therapies, including chemotherapy, radiotherapy, and phototherapy. In this review, different liposomal systems specifically developed for immunomodulation in cancer are summarized and discussed. Keywords: liposome; drug delivery; cancer immunotherapy; immunomodulation 1. The Potential of Immunotherapy for the Treatment of Cancer Cancer immunotherapy has been widely explored because of its durable and robust effects [1]. -
Intra-Luminal Focused Ultrasound for Augmentation of Gastrointestinal Drug Delivery
Editorial Page 1 of 2 Intra-luminal focused ultrasound for augmentation of gastrointestinal drug delivery Ezekiel Maloney1, Joo Ha Hwang2 1Department of Radiology, 2Division of Gastroenterology, Department of Medicine, University of Washington, Seattle, WA, USA Correspondence to: Joo Ha Hwang, MD, PhD. Division of Gastroenterology, Department of Medicine, University of Washington, Box 359773, 325 Ninth Avenue, Seattle, WA 98104, USA. Email: [email protected]. Provenance: This is a Guest Editorial commissioned by Section Editor Hui Kong, MD, PhD (Department of Respiratory Medicine, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China). Comment on: Schoellhammer CM, Schroeder A, Maa R, et al. Ultrasound-mediated gastrointestinal drug delivery. Sci Transl Med 2015;7:310ra168. Submitted Feb 01, 2017. Accepted for publication Feb 06, 2017. doi: 10.21037/atm.2017.03.42 View this article at: http://dx.doi.org/10.21037/atm.2017.03.42 The recent article by Schoellhammer et al., “Ultrasound- intensity ultrasound frequencies followed by quantification mediated gastrointestinal drug delivery” primarily of delivery of permeants (e.g., glucose, dextran, insulin). addresses practical limitations in drug delivery for medical Treated tissues showed enhanced transport. Similar management of inflammatory bowel disease (IBD), and findings were demonstrated in small and large bowel tissue presents pre-clinical data demonstrating that intra- for radiolabeled mesalamine and hydrocortisone. With 1 luminal, sub-ablative focused ultrasound (FUS), delivered minute of ultrasound treatment time, 3–5-fold improved via a trans-rectal transducer, can overcome some of these drug delivery was observed versus control. Additional limitations (1). The clinical application and benefit of such a ex vivo experiments utilizing variable FUS protocols to device is clear. -
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. -
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. -
Natural Products As Leads to Potential Drugs: an Old Process Or the New Hope for Drug Discovery?
J. Med. Chem. 2008, 51, 2589–2599 2589 Natural Products as Leads to Potential Drugs: An Old Process or the New Hope for Drug Discovery? David J. Newman† Natural Products Branch, DeVelopmental Therapeutics Program, DCTD, National Cancer InstitutesFrederick, P.O. Box B, Frederick, Maryland 21702 ReceiVed April 5, 2007 I. Introduction From approximately the early 1980s, the “influence of natural products” upon drug discovery in all therapeutic areas apparently has been on the wane because of the advent of combinatorial chemistry technology and the “associated expectation” that these techniques would be the future source of massive numbers of novel skeletons and drug leads/new chemical entities (NCEa) where the intellectual property aspects would be very simple. As a result, natural product work in the pharmaceutical industry, except for less than a handful of large pharmaceutical compa- nies, effectively ceased from the end of the 1980s. Figure 1. Source of small molecule drugs, 1981–2006: major What has now transpired (cf. evidence shown in Newman categories, N ) 983 (in percentages). Codes are as in ref 1. Major and Cragg, 20071 and Figures 1 and 2 below showing the categories are as follows: “N”, natural product; “ND”, derived from a natural product and usually a semisynthetic modification; “S”, totally continued influence of natural products as leads to or sources synthetic drug often found by random screening/modification of an of drugs over the past 26 years (1981–2006)) is that, to date, existing agent; “S*”, made by total synthesis, but the pharmacophore there has only been one de novo combinatorial NCE approved is/was from a natural product. -
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).