DOCSLIB.ORG

Needle-Free Drug Delivery Technology

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Needle-Free Drug Delivery Technology Drug Delivery & Formulation Needle-Free Drug Delivery Technology The needle-free industry now has a broad range of excellent technology to meet customer needs; the only remaining barrier lies with the pharmaceutical and biotechnology companies themselves. By Dr Roger G Harrison, Consultant to Antares Pharma, Inc Dr Roger G Harrison has been a Consultant to Antares Pharma since September 2004. Prior to that he had been the Chief Executive officer, President and member of the Board of the Company since March 2001. Previous to that, he held various positions at Eli Lilly and Company for more than 25 years, with his most recent role being Director of Alliance Management from May 1999 until February 2001. Other positions at Eli Lilly included Global Product Team Leader, Director, Development Projects Management and Technology Development and Planning, and Director of Biochemistry Research. He is the author of numerous publications, has contributed to four books and holds nine patents. Dr Harrison earned a PhD in Organic Chemistry and a BSc in Chemistry from Leeds University in the UK and conducted postdoctoral research work at Zurich University in Switzerland. All parents can relate to the anguish felt when an infant players now compete on the relative sophistication screams and protests at the sight of a vaccination of their delivery technology. If pundits are to be needle. Later in life, the screams may abate but believed, the next innovation in this sector will significant misgivings usually still exist about the be pulmonary inhalation, which is being developed insertion of a needle for delivery of vaccines or (at very significant cost) by Pfizer, Lilly and therapeutic agents, with relief when the process is over. Novo-Nordisk in association with specialty drug For some, especially those suffering from chronic delivery companies. diseases requiring injectable products, this process is an ongoing reality of daily life – accepted, but always with Other companies are recreating drugs by extending their the hope that something new will replace the ritual of apparent half-life through the use of depot injection needle insertion. systems or by making structural changes that delay metabolism and clearance. Interferon and The industry has invested heavily in finding solutions to erythropoietin are two examples of drugs that have this challenge without generating a universal solution. undergone these changes – the result being less frequent The reasons for this investment are obvious – there are injections for the patient. Commercial sales of such an increasing number of biotechnology products that products have reinforced the view that patients and can only be given by injection. It is estimated that there health care providers want to reduce or eliminate the are about 350 biotechnology products currently in need for needles whenever possible. The more elusive clinical trials, and potentially 190 of these will be search for oral delivery approaches for these complex on the market by 2005-2006. This compares with just molecules has also been explored with encouraging 10 such products on the market in the early 1980s. results being generated by Emisphere Technologies, Inc, There is also clear evidence that the market for existing BioSante Pharmaceuticals, Inc and Nobex Corporation, products is being increasingly differentiated through among others. delivery technology. Using the insulin market as an example, the use of conventional vials with needles and syringes by patients with diabetes has dwindled, particularly outside of the US. Pumps and elegant ‘pen’ injectors Figure 1: The Antares Pharma Medi-Jector have increasingly taken market share, and major Vision Needle-Free Injection Device 60 Innovations in Pharmaceutical Technology NEEDLE-FREE INJECTION TECHNOLOGY However, with all of these high-profile efforts to seek a solution to less frequent injections with needles, there has been a ‘sleeper’ technology already in existence – one that offers all of the sought-after benefits. That solution is needle-free or jet injection technology. This technology – first described in 19th Century France and first commercialised in the US in the 1960s – has been relatively dormant in terms of market impact for many years, despite being approved and available for use with insulin and human growth hormone in the US and other parts of the world. Several companies are active in the further development of this technology (including Antares Pharma, Inc, Aradigm Corporation, BioJect Medical Technologies, Inc and BioValve Technologies Inc), and there are industry associations charged with promoting an awareness of the benefits of needle- free systems. Needle-free technology offers the very obvious benefit of reducing patient concern about the use of a needle. Additional benefits include a very fast injection compared with conventional needles and no needle disposal issues. Devices are available in re-usable and disposable forms, for home or physician office use, and also in versions for multiple patient, institutional uses. The re-usable devices are intended for use in association with chronic diseases, such as diabetes, when injections are given on a daily basis for prolonged periods of time. The disposable, single-use devices are pre-filled with drug, used once and then discarded. These are considered ideal for emergency needs (for example, treatment of severe allergic reactions), for intermittent needs (for example, breakthrough pain or migraine attacks), or for office- most effective designs in order to create devices that meet Figure 2: Filling the based vaccinations. Devices are also being developed customer expectations of transparency of use and quality Antares Pharma Medi- for mass vaccination (DCI, Inc, Felton International) of injection. Jector Vision Needle- Free Insulin Injector that could help overcome the challenges of disease transmission through re-use of needles that can occur Perhaps it is this long history in reaching the current The device can be in developing countries. point of sophistication that such devices have now used with all brands achieved that remains a barrier to their widespread of U-100 insulin in standard 10ml vials. All of the devices operate by the same principle of adoption – many physicians and decision-makers within creating a high pressure jet of liquid – containing the the pharmaceutical industry have been aware of some of drug – that penetrates the skin. Through effective the stories associated with needle-free technology, and control of the pressure, the device can deliver the drug have not been prepared to accept that the technology has solution (or suspension) into the subcutaneous, sub- continued to evolve. Such stories include pain on dermal or intramuscular layers, depending on the injection, poor quality of injection, and bruising and required application. Power sources are typically springs bleeding at the injection site. Some of these stories or compressed gas. While the principle of operation is are factual, some exaggerated, others anecdotal – but simple, in reality, many years of engineering effort have most of the past issues appear to have been overcome in been put into understanding ideal pressure curves and the current generation of technologies. Most of the Innovations in Pharmaceutical Technology 61 companies working in this sector have their own or THE IMPACT OF ADVOCACY GROUPS independently generated data showing an overwhelming There are also advocacy groups emphasising the preference for needle-free technology by patients when importance of considering needle-free options that they are given a choice. can begin to influence perceptions. One of these, the Association of Needle-Free Injection Manufacturers How, then, can this preference be converted into a (ANFIM), was established in 1997 to create a significant market presence? There are some signs positive, professional image for the needle-free of progress. For example, Serono uses BioJect’s needle- industry through providing exposure, education and free device (cool-clickTM) in association with its information to health care customers. ANFIM human growth hormone in the US, and Ferring recently announced changes in its board structure Pharmaceuticals uses Antares Pharma’s Vision® device with Mike Kasprick, Executive Director of for its human growth hormone in Europe. Also, Eli Business Development for Antares Pharma, becoming Lilly and Company has licensed Antares Pharma’s chairperson for the group. Commenting for this technology for use with the diabetes and obesity article, Mr Kaspick said: products in its portfolio. The benefits for pharmaceutical companies are obvious in that, “We believe that we have in our hands a general solution compared with investments in other delivery to how injectable drugs can be given less invasively. Not technologies (for example, pulmonary delivery), the only can this benefit the pharmaceutical industry in development of a needle-free system is likely to require increasing product sales, it has the added potential to – from a regulatory viewpoint – the demonstration of increase compliance with dosage regimens and pharmacokinetic equivalence of drug delivery by needle improved outcomes. In the US alone, direct and indirect and needle-free systems, the lack of breakdown of the costs of managing diabetes and its consequences cost drug through shear stress at the jet nozzle and a $132 billion. If poor compliance with injection therapy, conventional device submission. There has been no and hence poor
Load more

Recommended publications
  • Lipid-Based Depots: Manufacturing, Administration and Interactions of Protein Drugs with Lipid Formulations
    Dissertation zur Erlangung des Doktorgrades der Fakultät für Chemie und Pharmazie der Ludwig-Maximilians-Universität München Lipid-based depots: manufacturing, administration and interactions of protein drugs with lipid formulations Michaela Maria Breitsamer aus Starnberg, Deutschland 2019 II ERKLÄRUNG Diese Dissertation wurde im Sinne von § 7 der Promotionsordnung vom 28. November 2011 von Herrn Prof. Dr. Gerhard Winter betreut. EIDESSTATTLICHE VERSICHERUNG Diese Dissertation wurde eigenständig und ohne unerlaubte Hilfe erarbeitet. Wolfratshausen, den 20.05.2019 ________________________________ (Michaela Breitsamer) Dissertation eingereicht am: 20.05.2019 1. Gutachter: Prof. Dr. Gerhard Winter 2. Gutachter: Prof. Dr. Wolfgang Frieß Mündliche Prüfung am: 25.06.2019 III IV FOR MY FAMILY “The way to get started is to quit talking and begin doing” Walt Disney (1901 – 1966) V VI ACKNOWLEDGEMENTS The present thesis was prepared between March 2015 and December 2018 at the Department of Pharmacy, Pharmaceutical Technology and Biopharmaceutics at the Ludwig-Maximilians Universität (LMU) in Munich under the supervision of Prof. Dr. Gerhard Winter. First of all, I would like to express my deepest gratitude to my supervisor Prof. Dr. Gerhard Winter for giving me the opportunity to join his research group and to work on this extremely interesting and interdisciplinary project. I really appreciated his scientific input throughout all phases of this work, his elaborate advice and his guidance, which also contributed to my personal development over the last years. Furthermore, I would like to thank him for the outstanding working and team atmosphere, which he created at the chair, for supporting my participation in scientific conferences and for initiating and motivating me to the numerous collaborations which contributed to a successful thesis.
    [Show full text]
  • Food and Drugs Regulations
    LAWS OF TRINIDAD AND TOBAGO 22 Chap. 30:01 Food and Drugs SUBSIDIARY LEGISLATION FOOD AND DRUGS REGULATIONS ARRANGEMENT OF REGULATIONS REGULATION 1. Citation. 2. Requirements prescribed by regulation. 3. Interpretation. 4. Request to Director. 5. Functions, duties, responsibilities of Inspectors. 6. Certificate of appointment. 7. Taking of photographs. 8. Taking samples and detention pending further examination. 9. Violation of Act or Regulations and relabelling or recondition­ ing of food, drug, cosmetic or device. 10. Issue of certificate. 11. Taking a sample, notification of intention and division of sample. 12. Division an interference and objection to procedure by owner or person. 13. Certificate of Analysis. 14. Definition of terms in Part II. 15. Offence to sell unlabelled food. 16. Labelling of package. 17. Declaration of net contents not required on certain labels. 18. List of ingredients not required on certain labels. 19. Declaration not required. 20. Declaration not required to indicate presence of flavouring. 21. Dried or dehydrated products. 22. Food from vending machine. 23. Non application of regulation 16. 24. Standard for a food. 25. Name of designation given to standard, grade or definition. 26. Adulteration of food. 27. Non-adulteration. 28. Contents of package. 29. Display of information on label. 30. First Schedule. 31. Offence. 32. Definition of terms in Part III. 33. Labelling of drug. 34. Contents of label. 35. Label on bulk package. 36. Drug sold on prescription. 37. Packing cases. LAWS OF TRINIDAD AND TOBAGO Food and Drugs Chap. 30:01 23 Food and Drugs Regulations [Subsidiary} REGULATION 38. Name and proportion of drug to be stated on label.
    [Show full text]
  • Product Monograph
    PRODUCT MONOGRAPH PrFLUANXOL® Flupentixol Tablets (as flupentixol dihydrochloride) 0.5 mg, 3 mg, and 5 mg PrFLUANXOL® DEPOT Flupentixol Decanoate Intramuscular Injection 2% and 10% flupentixol decanoate Antipsychotic Agent Lundbeck Canada Inc. Date of Revision: 2600 Alfred-Nobel December 12th, 2017 Suite 400 St-Laurent, QC H4S 0A9 Submission Control No : 209135 Page 1 of 35 Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION .........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS ..................................................................................4 ADVERSE REACTIONS ..................................................................................................10 DRUG INTERACTIONS ..................................................................................................13 DOSAGE AND ADMINISTRATION ..............................................................................15 OVERDOSAGE ................................................................................................................18 ACTION AND CLINICAL PHARMACOLOGY ............................................................19 STORAGE AND STABILITY ..........................................................................................21
    [Show full text]
  • Depot Antipsychotic Injections
    Mental Health Services Good Practice Statement For The Use Of DEPOT & LONG ACTING ANTIPSYCHOTIC INJECTIONS Date of Revision: February 2020 Approved by: Mental Health Prescribing Management Group Review Date: CONSULTATION The document was sent to Community Mental Health teams, Pharmacy and the Psychiatric Advisory Committee for comments prior to completion. KEY DOCUMENTS When reading this policy please consult the NHS Consent Policy when considering any aspect of consent National Institute for Clinical Excellence CG178 (2014), Psychosis and schizophrenia in adults: prevention and management NHS Lothian (2011), Depot Antipsychotic Guidance, Maudsley (2015), Prescribing Guidelines in Psychiatry 12th edition. UKPPG (2009) Guidance on the Administration to Adults of Oil based Depot and other Long Acting Intramuscular Antipsychotic Injections Summary of Product Characteristics for: Clopixol (Zuclopethixol Decanoate) Flupenthixol Decanoate Haldol (Haloperidol Decanoate) Risperdal Consta Xeplion (Paliperidone Palmitate) ZypAdhera (Olanzapine Embonate) Abilify Maintena (Aripiprazole) 1 CONTENTS REFERENCES/KEY DOCUMENTS …………………………………………………………… 1 INTRODUCTION …………………………………………………………………………………. 3 SCOPE …………………………………………………………………………………………….. 3 DEFINITIONS ……………………………………………………………………………………... 3 CHOICE OF DRUG AND DOSAGE SELECTION ……………………………………………. 3 SIDE EFFECTS ……………………………………………………………….………………….. 5 PRESCRIBING …………………………………………………………………………………… 5 ADMINISTRATION ………………………………………………………………………………. 7 RECORDING ADMINISTRATION ……………………………………………………………… 7
    [Show full text]
  • North of England Guidance for Long Acting Antipsychotic Injections July 17
    Guidance on the Use of Antipsychotic Long-acting Injections in North of England (TEWV version) This guidance aims to inform and support prescribers within the three mental health service providers in the north of England in the cost-effective use of antipsychotic long-acting injections. Long-acting or “depot” injections are a useful and well-established form of administering antipsychotics in the management of schizophrenia and other psychoses. The introduction of long-acting formulations of second-generation (atypical) antipsychotics has created an additional pressure on drug budgets in mental health services, which may be justified if their use results in reduced hospital admissions, shortened length of stay and improved quality of life compared with the first generation (typical) agents. Advantages of long-acting / depot injections Assured compliance with antipsychotic treatment Increased bioavailability (less first-pass metabolism) Steady plasma levels compared to oral medication Reduction in relapse rate, severity of relapse and rehospitalisation Stable therapeutic effects Better downward titration to minimise side-effects There is some evidence that long-acting injections cause less brain tissue loss and deterioration (CATIE study1) Disadvantages of long-acting / depot injections Treatment cannot be stopped quickly if severe side-effects develop (dystonia, EPSE, NMS) Perception by the patient of “being controlled”, losing control over their treatment, or possibly being punished. Pain at the site of injection, lasting possibly 10 days Tissue necrosis - over time hard plaques may form, which will reduce the ease of administration and the efficacy of the injection as well as causing discomfort. Loss of dignity with the gluteal route Over and above these factors, NICE2 recommend that consideration should be given to offering a depot / long-acting injectable antipsychotic to people with psychosis or schizophrenia who express a preference for such treatment after an acute episode.
    [Show full text]
  • Formulary Update
    PEI Drug Programs Formulary Update Issue 06-04 October, 2006 The following changes and additions to the July 2006 edition of the PEI Drug Programs Formulary will be effective October 16th, 2006 unless otherwise noted within this update. If there are any questions regarding the information presented in this update please call the Drug Program office at 368-4947 or toll free at 1-877-577-3737. 1.0 Changes and Additions To The Formulary & MAC Pricing ALMOTRIPTAN (new addition) EDS Criteria: For the treatment of migraine headaches where other standard therapies, such as analgesics and/or ergotamine products have failed. Eligibility is restricted to persons over the age of 18 and under 65 years of age. Coverage is limited to 6 tablets per 30 day period. Persons requiring more than 6 doses per 30 day period should be considered for migraine prophylaxis therapy if they are not already receiving such therapy. 6.25mg tablet 02248128 AXERT (EDS) JAN FW 12.5mg tablet 02248129 AXERT (EDS) JAN FW DILTIAZEM HYDROCHLORIDE (new addition) 120mg capsule 02231150 TIAZAC BVL FNSW 180mg capsule 02231151 TIAZAC BVL FNSW 240mg capsule 02231152 TIAZAC BVL FNSW 300mg capsule 02231154 TIAZAC BVL FNSW 360mg capsule 02231155 TIAZAC BVL FNSW PEI Drug Programs Formulary Update Issue 06-04 October 2006 Page 1 DILTIAZEM HYDROCHLORIDE (new addition) 120mg extended release tablet 02256738 TIAZAC XC BVL FNSW 180mg extended release tablet 02256746 TIAZAC XC BVL FNSW 240mg extended release tablet 02256754 TIAZAC XC BVL FNSW 300mg extended release tablet 02256762 TIAZAC XC BVL FNSW 360mg extended release tablet 02256770 TIAZAC XC BVL FNSW ETHINYL ESTRADIOL/DROSPIRENONE (new addition) 3.0mg/0.03mg tablets 02261723 YASMIN 21 DAY BEX FW 02261731 YASMIN 28 DAY BEX FW ESPROSARTAN MESYLATE & HYDROCHLOROTHIAZIDE (new addition) 600mg & 12.5mg tablet 02253631 TEVETEN PLUS SLV FNSW GABAPENTIN (change) There is no longer an EDS restriction on this drug.
    [Show full text]
  • Regencerx Preferred Medication List/Formulary Regencerx Preferred Effective February 1, 2008 ©2008
    RegenceRx Preferred Medication List/Formulary Help to stretch your prescription dollar February1, 2008 ©2008. RegenceRx. All Rights Reserved. ©2008. RegenceRx. Effective February 1,2008 Effective 2 Your Preferred Medication List/Formulary 3 Common Questions and Answers Preferred/Formulary Medications 4-11 • By Category • A to Z Listing 12-17 – Generics 18-22 – Preferred/Formulary Brands Non-Preferred/Non-Formulary Brands 23-27 • Generic and Preferred Brand Alternatives Table of Contents Table Effective February 1, 2008 ©2008. RegenceRx. All Rights Reserved. RegenceRx is dedicated to provide the tools you need to understand your options and be a more informed consumer. This preferred medication list/formulary will help—with the answers you need to access affordable prescription benefits. Determining Cost Newly-introduced How much you pay for a prescription generic medications depends on whether it’s a: When a generic is introduced to the • Generic marketplace, it immediately becomes • Preferred/formulary brand name available at the lowest copay. After a • Non-preferred/non-formulary generic is available, the brand name brand name (brand name medication will only be available at the medication not on the list) non-preferred/non-formulary copay. Your cost is lowest for generic Preferred/formulary medications and highest for non- brand name medications preferred/non-formulary brand name Brand name medications on the medications. You can find specific preferred medication list (PML) coverage and copay information in have been chosen because our your summary of benefits. professional review has shown each Generic medications of them to be high-quality, effective, Generics provide the same and affordable. Preferred/formulary therapeutic benefits of their brand brand name medications are either name counterparts, without the more effective or equally effective—at brand name price.
    [Show full text]
  • 20 Official Journal of the European Union 23.9.2003
    20EN Official Journal of the European Union 23.9.2003 Appendix referred to in Chapter 1 of Annex VII (*) List as provided by Cyprus in one language of pharmaceutical products for which a marketing authorisation issued under Cypriot law prior to the date of accession shall remain valid until it is renewed in compliance with the acquis or until 31 December 2005, whichever is the earlier. Mention on this list does not prejudge whether or not the pharmaceutical product in question has a marketing authorisation in compliance with the acquis. The attached lists A and B indicate the pharmaceutical products for human use and the veterinary medicinal products respectively, which are currently in circulation in Cyprus. These products were granted their initial marketing author- isation/licence based on the old, non-harmonised legislation. The marketing authorisations of all pharmaceutical products listed, will be renewed (if requested by the manufacturers and/or importers) during 2004 and 2005 in accordance with the provisions of the new, harmonised legislation and eventually, fully harmonised dossiers will be achieved by 31 December 2005. LIST A: MEDICINAL PRODUCTS FOR HUMAN USE Code No Product 9900231 4-WAY NASAL FAST ACTING SPRAY 1% 9800571 5-FLUOROURACIL ‘EBEWE’ VIALS 50MG/ML, 10ML 9800570 5-FLUOROURACIL ‘EBEWE’ VIALS 50MG/ML, 5ML 9700037 -5-FLUOROURACIL INJECTION 50MG/ML 9800572 5-FLUOROURACIL‘EBEWE’ VIALS 50MG/ML, 20ML 20050619 99F0165 HAIR & NAILCARE CAPSULES 97F0150 ABC SPEKTRUM TABLETS 9800252 ABERNIL TABLETS 50MG 9800252 ABERNIL TABLETS
    [Show full text]
  • 2019 Careoregon Advantage Plus Comprehensive Formulary
    2019 CareOregon Advantage Customer Service CALL: 503-416-4279 or toll-free 888-712-3258 Drug List (Formulary) TTY/TDD: 711 HOURS OF OPERATION: every day, 8 a.m. to 8 p.m. CareOregon Advantage Plus (HMO-POS SNP) For Oregon counties: Clackamas, Columbia, Jackson, Multnomah, Tillamook and Washington facebook.com/careoregon twitter.com/careoregon careoregonadvantage.org H5859_PH2019_1085_C CMS ACCEPTED COA-18422.05-0820 CareOregon Advantage Plus HMO-POS SNP 2019 Formulary (List of Covered Drugs) PLEASE READ: THIS DOCUMENT CONTAINS INFORMATION ABOUT THE DRUGS WE COVER IN THIS PLAN H5859_PH2019_1085_C FORMULARY ID 00019571, VERSION 27 This formulary was updated on December 1, 2019. For more recent information or other questions, please contact CareOregon Advantage Customer Service at 888-712-3258 or, for TTY/TDD users, 711, 8 a.m. to 8 p.m., daily, or visit careoregonadvantage.org Note to existing members: This formulary has changed since last year. Please review this document to make sure that it still contains the drugs you take. When this drug list (formulary) refers to “we,” “us”, or “our,” it means Health Plan of CareOregon, Inc. When it refers to “plan” or “our plan,” it means CareOregon Advantage Plus. This document includes a list of the drugs (formulary) for our plan which is current as of December 1, 2019. For an updated formulary, please contact us. Our contact information, along with the date we last updated the formulary, appears on the front and back cover pages. You must generally use network pharmacies to use your prescription drug benefit. Benefits, formulary, pharmacy network, and/or copayments/coinsurance may change on January 1, 2020, and from time to time during the year.
    [Show full text]
  • Review of Painless Injection Technology Pooja A
    International Journal of Innovative and Emerging Research in Engineering Volume 2, Issue 9, 2015 Available online at www.ijiere.com International Journal of Innovative and Emerging Research in Engineering e-ISSN: 2394 - 3343 p-ISSN: 2394 - 5494 Review of Painless Injection Technology a b Pooja A. Kshirsagar , Abhijit G. Kalbande a Student- Pooja A. Kshirsagar, PRMCEAM, Bandera, Amravati, Maharashtra b Lecturer - Abhijit G.Kalbande, PRMCEAM, Bandera, Amravati, Maharashtra ABSTRACT: The Painless Injection Technology play the important role in our life because in our country we have seen the so many people who are having a phobia for giving an injection which has a needle, that’s why in Painless Injection Technology we used the needle free injection. This painless injection has the electronic circuit for making injection devices. Today, this is a very rising technology that avoids the pain and infection having needle based injection. This painless injection technology is very easiest way to delivering the vaccines into skin. Keywords: Needle Free,Injection,Phobia,Technology,Vaccine,Drug I. INTRODUCTION Since 150 years we have seen the needle based injection for giving an injection into the skin. They form the major part of perenteral dosage form [1, 2]. To overcome problems related to needle based injection there is one technology that has received constant attention during the past few years that has all of the sought after benefits i.e. Needle free injection. The needle free injection don’t have needle but make use of electronic circuit to drive drugs through skin. These needle free injections are available in the form of power sprays, edible products, Inhaler’s and skin patches [1, 3].
    [Show full text]
  • 202971Orig1s000
    CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 202971Orig1s000 CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S) NDA202971 Aripiprazole IM Depot Formulation Clinical Pharmacology Review NDA #: 202,971 Proposed Brand Name: ABILIFY MAINTENA Generic Name: Aripiprazole Dosage Form: IM Depot (Extended-Release Suspension for IM Injection) Dosage Strength: 300-mg Vial, 400-mg Vial Indication: Maintenance Treatment of Schizophrenia Sponsor: Otsuka Submission Type: 505(b)(1) Submission Date: Sep. 26, 2011 Huixia Zhang, Satjit Brar, Mike Pacanowski, Atul Bhattaram, OCP Review Team: Hao Zhu OCP Required Inter-Division Briefing was held on May 14, 2012. Table of Contents 1. Executive Summary......................................................................................................... 3 1.1. Recommendation ........................................................................................................... 3 1.1.1. Labeling Recommendations .......................................................................................... 3 1 Indications and Usage...................................................................................................... 3 2.3 Dosage Adjustments for Dosage Adjustments for Missed Doses ......................................... 4 1.2. Phase IV Requirements/Commitments .......................................................................... 4 1.3. Summary of Clinical Pharmacology Findings.............................................................. 4 2. Question Based Review ..................................................................................................
    [Show full text]
  • Investigation of Depot Neuroleptic Injection Site Reactions
    ORIGINAL PAPERS Investigation of depot neuroleptic injection site reactions Julie C. Jones, Jennifer C. Day, John R. Taylor and Christophers. Thomas Aims and method A cross-sectional survey was ship between reactions and other related vari performed on 318 patients receiving depot ables such as dose, volume, concentration and medication. The presence or absence of a depot site frequency of injection, age, gender and body reaction was recorded by psychiatric nursing staff on a mass index. All patients prescribed depot standardised form. neuroleptic medication attending the depot clinic Results Seventeen per cent of patients were found to at Withington Hospital in south Manchester and have clinically significant depot site reactions. Such from a defined catchment area of south Liverpool reactions were associated with increased frequency of were included in the study. All patients who injection and increased total volume of depot participated gave informed consent, and the administered in the previous 12 months. The severity of study was approved by the local ethics commit a depot site reaction was unrelated to the tees. The following demographic and clinical concentration of depot preparation administered. details were recorded: age, gender, case note Clinical implications Depot site reactions may be diagnosis, date of first episode, dose and reduced by maximising the interval between frequency of depot and all other current medic injections and using low volume (highly concentrated) ation. Details relating to depot administration preparations of depot neuroleptic medication. were systematically collected on a standard form (available from the author upon request), includ ing the volume of depot administered at the time The use of depot neuroleptics in patients suffer of survey, total volume of depot administered in ing from schizophrenia has been associated with the previous year, total number of injections improved compliance and reduced rates of administered in the previous year and any relapse (Hirsch et al 1973; Gottfries & Green.
    [Show full text]