Mucoadhesive oral films: The potential for unmet needs
Tài liệu tham khảo
Adelman, 2003, Meta-analysis of oral triptan therapy for migraine: number needed to treat and relative cost to achieve relief within 2h, J. Manag. Care Pharm., 9, 45, 10.18553/jmcp.2003.9.1.45
Agency for Healthcare Research and Quality, 2012. Acute Migraine Treatment in Emergency Settings: Comparative Effectiveness Review Executive Summary no. 84.
American Diabetes Association, 2010, Diagnosis and classification of diabetes mellitus, Diabetes Care, 33, S62, 10.2337/dc10-S062
American Diabetes Association, 2014. Infographic: A Snapshot of Diabetes in America [WWW Document]. URL http://www.diabetes.org/diabetes-basics/statistics/cdc-infographic.html (accessed 09.08.14.).
American Headache Society Committee on Headache Education (ACHE), 2014. Migraine Treatments [WWW Document]. URL http://www.achenet.org/resources/migraine_treatments/#prevent (accessed 09.08.14.).
Andreani, 2014, Preparation and characterization of PEG-coated silica nanoparticles for oral insulin delivery, Int. J. Pharm., 473, 627, 10.1016/j.ijpharm.2014.07.049
Andrews, 2009, Mucoadhesive polymeric platforms for controlled drug delivery, Eur. J. Pharm. Biopharm., 10.1016/j.ejpb.2008.09.028
Applied Pharma Research, 2014. 2.5mg and 5mg Zolmitriptan ODF [WWW Document]. URL http://www.apr.ch/site/licence/p_pain_zolmitriptan_rf.htm (accessed 09.08.14.).
Arya, 2013, Fast dissolving oral films: an innovative drug delivery system and dosage form, Int. J. ChemTech Res., 2, 14
Atsmon, 2014, Priming by a novel universal influenza vaccine (Multimeric-001)—a gateway for improving immune response in the elderly population, Vaccine, 32, 5816, 10.1016/j.vaccine.2014.08.031
Auxilium Pharmaceuticals, I., 2005. Auxilium Pharmaceuticals Announces Top-Line Results for Phase II Androgen Replacement Transmucosal Film Proof of Concept Study [WWW Document]. Press release. URL http://www.sec.gov/Archives/edgar/data/1182129/000119312505153257/dex991.htm (accessed 09.04.14.).
Auxilium Pharmaceuticals Inc., 2006. Auxilium Pharmaceuticals announces R&D portfolio change [WWW Document]. URL http://phx.corporate-ir.net/phoenix.zhtml?c=142125&p=irol-newsArticle&ID=917882&highlight= (accessed 25.06.15.).
Benowitz, 2014, Emerging nicotine delivery products implications for public health, Ann. Am. Thorac. Soc., 11, 231, 10.1513/AnnalsATS.201312-433PS
Ben-Yedidia, 2010, Multimeric-001: BiondVax’s universal flu vaccine, Expert Rev. Vaccines, 9, 241, 10.1586/erv.10.2
BioDelivery Sciences International (BDSI®), 2011. BioDelivery Sciences Announces Completion of Recruitment in BEMA Buprenorphine Phase 3Chronic Pain Study [WWW Document]. URL http://bdsi.investorroom.com/index.php?s=43&item=19 (accessed 09.11.14).
BioDelivery Sciences International (BDSI®), 2013. 2013 Annual Report to Stockholders.
BioDelivery Sciences International (BDSI®), 2014. Onsolis® (fentanyl buccal soluble film) [WWW Document]. URL http://www.bdsi.com/Onsolis.aspx (accessed 09.03.14.).
BioDelivery Sciences International (BDSI®), 2014. BUNAVAILTM(buprenorphine and naloxone) buccal film [WWW Document]. URL http://www.bdsi.com/Other_BEMA_Products.aspx (accessed 09.03.14.).
BioDelivery Sciences International (BDSI®), 2014. BioDelivery Sciences Announces the Availability of BUNAVAIL™ in the U.S. [WWW Document]. URL http://bdsi.investorroom.com/2014-11-03-BioDelivery-Sciences-Announces-the-Availability-of-BUNAVAIL-in-the-U-S (accessed 04.03.15.).
BioDelivery Sciences International (BDSI®), 2014. BEMA® Technology [WWW Document]. URL http://www.bdsi.com/BEMA_Technology.aspx (accessed 09.04.14.)
BioDelivery Sciences International (BDSI®), 2014. BioDelivery Sciences Provides Business Review and Update in Conjunction with Filing of Second Quarter 2014 Financials—Aug 7, 2014 [WWW Document]. URL http://bdsi.investorroom.com/2014-08-07-BioDelivery-Sciences-Provides-Business-Review-and-Update-in-Conjunction-with-Filing-of-Second-Quarter-2014-Financials (accessed 09.16.14.).
BioDelivery Sciences International (BDSI®), 2015. Product Pipeline—BioDelivery Sciences International (BDSI) [WWW Document]. URL http://www.bdsi.com/Product_Pipeline.aspx (accessed 04.03.15.).
BiondVax Pharmaceuticals, L., 2012. BiondVax and MonoSol Rx to collaborate on developing oral delivery for universal flu vaccine, M-001. [WWW Document]. Press release. URL http://www.biondvax.com/2012/10/18/biondvax-and-monosol-rx-to-collaborate-on-developing-oral-delivery-for-universal-flu-vaccine-m-001/ (accessed 07.02.15.).
BiondVax Pharmaceuticals, L., 2015. BiondVax Announces FDA Acceptance of IND Application for its Investigational Universal Flu Vaccine [WWW Document]. Press release. URL http://www.biondvax.com/2015/06/17/biondvax-announces-fda-acceptance-of-ind-application-for-its-investigational-universal-flu-vaccine/ (accessed 07.02.15.).
Borges, 2015, Oral films: current status and future perspectives, J. Control. Release, 206, 1, 10.1016/j.jconrel.2015.03.006
Borges, 2015, Oral films: current status and future perspectives II—intellectual property, technologies and market needs, J. Control. Release, 206, 108, 10.1016/j.jconrel.2015.03.012
Castillo, 2014, Investigational drugs for the treatment of allergic rhinitis, Expert Opin. Investig. Drugs, 23, 1, 10.1517/13543784.2014.907271
Cortellis, 2014. Auxilium Pharmaceuticals Announces Licensing Agreement with PharmaForm for Transmucosal Film Technology [WWW Document]. URL https://cortellis.thomsonreuterslifesciences.com/ngg/report/ci/sourcesPressRelease/583809 (accessed 09.04.14.).
Cui, 2002, Bilayer films for mucosal (genetic) immunization via the buccal route in rabbits, Pharm. Res., 19, 947, 10.1023/A:1016454003450
CURE Pharmaceutical to Begin Clinical Trials with PediaSUNATE [WWW Document]. Press release. URL http://www.curepharmaceutical.com/docs/news/2012-07-24.pdf (accessed 07.06.15.).
Dadey, 2014
Davies, 2014, Breakthrough cancer pain, Curr. Pain Headache Rep., 18, 420, 10.1007/s11916-014-0420-9
Dixit, 2009, Oral strip technology: overview and future potential, J. Control. Release, 139, 94, 10.1016/j.jconrel.2009.06.014
FDA News, 2006. Auxilium discontines development of TestoFilm [WWW Document]. URL http://www.fdanews.com/articles/63394-auxilium-discontines-development-of-testofilm (accessed 25.06.15.).
Food and Drug Administration, 2013. Guidance for Industry Abuse-Deterrent Opioids-Evaluation and Labeling.
Food and Drug Administration, 2014. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations [WWW Document]. URL http://www.accessdata.fda.gov/scripts/cder/ob/docs/obdetail.cfm?Appl_No=022472&TABLE1=OB_Rx (accessed 09.12.14).
Generex Biotechnology Corp, 2014. Generex Oral-lyn [WWW Document].
GlaxoSmithKline, 2014. NiQuitin® Strips [WWW Document]. URL http://www.niquitin.co.uk/products/niquitin-strips/ (accessed 09.03.14).
Hoffmann, 2011, Advances in orodispersible films for drug delivery, Expert Opin. Drug Deliv., 8, 299, 10.1517/17425247.2011.553217
ICH, 1997. General Considerations for Clinical Trials- E8 [WWW Document]. URL http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E8/Step4/E8_Guideline.pdf (accessed 10.28.14.).
Ìkinci, 2004, Development of a buccal bioadhesive nicotine tablet formulation for smoking cessation, Int. J. Pharm., 277, 173, 10.1016/j.ijpharm.2003.10.040
Jackson, 2014, New mechanisms and perspectives in nicotine withdrawal, Neuropharmacology, 96, 223, 10.1016/j.neuropharm.2014.11.009
Jonsson-Razdan, 2011, Sublingual immunotherapy (SLIT), Ann. Respir. Med.
Kraan, 2014, Buccal and sublingual vaccine delivery, J. Control. Release, 190, 580, 10.1016/j.jconrel.2014.05.060
Laffleur, 2014, Mucoadhesive polymers for buccal drug delivery, Drug Dev. Ind. Pharm., 40, 591, 10.3109/03639045.2014.892959
Lam, 2013, Oral transmucosal drug delivery for pediatric use, Adv. Drug Deliv. Rev.
Landová, 2013, Mucoadhesive films as perspective oral dosage form, Czech Slovak Pharm., 62, 4
Mack, 2007, Pfizer dumps Exubera, Nat. Biotechnol., 25, 1331, 10.1038/nbt1207-1331
Madhav, 2009, Orotransmucosal drug delivery systems: a review, J. Control. Release, 140, 2, 10.1016/j.jconrel.2009.07.016
Mastropietro, 2013, Commercial abuse-deterrent dosage forms: clinical status, J. Dev. Drugs, 2, 1, 10.4172/2329-6631.1000103
Meda Pharmaceuticals, 2011. Breakyl 400mcg buccal film—Summary of Product Characteristics (SPC)—(eMC) [WWW Document]. URL https://www.medicines.org.uk/emc/medicine/28360 (accessed 09.11.14.).
Midatech Pharma Plc, 2015. Midatech Pharma—Therapeutic Areas [WWW Document]. URL http://www.midatechpharma.com/therapeutic-areas/endocrinology (accessed 07.02.15.).
Midatech Pharma Plc, 2015. Research Collaboration Signed With Global Pharmaceutical Company [WWW Document]. URL http://www.monosolrx.com/content/media/releases/030615.htm (accessed 07.02.15.).
MonoSol RX LLC, 2010. MonoSol Rx Announces Reckitt Benckiser FDA Approval of Suboxone® Sublingual Film for Treatment of Opioid Dependence [WWW Document]. URL http://www.monosolrx.com/content/media/releases/news_083110.htm (accessed 09.04.14.).
MonoSol RX LLC, 2012. MonoSol Rx and BiondVax collaborate to develop oral film delivery of flu vaccine [WWW Document]. Press release. URL http://www.monosolrx.com/content/media/releases/news_110712.htm (accessed 07.02.15.).
MonoSol RX LLC, 2014. PharmFilm® Drug Delivery Platform [WWW Document]. URL http://www.monosolrx.com/content/technology/pharmfilm-drug-delivery-platform.htm (accessed 09.04.14.).
MonoSol RX LLC, 2014. MonoSol Rx and the PharmFilm pipeline [WWW Document]. URL http://www.monosolrx.com/content/pipeline/overview.htm (accessed 09.04.14.).
MonoSol RX LLC, 2015. MonoSol Rx and the PharmFilm pipeline 2015 [WWW Document]. URL http://www.monosolrx.com/content/pipeline/overview.htm (accessed 07.01.15.).
MonoSol RX LLC, 2015. MonoSol Rx leadership presented PharmFilm buccal delivery clinical update at leading pharmaceutical technology meeting [WWW Document]. Press release. URL http://www.monosolrx.com/content/media/releases/news_020915.htm (accessed 07.06.15.).
Moorman-Li, 2012, A review of abuse-deterrent opioids for chronic nonmalignant pain, P T., 37, 412
Morales, 2011, Manufacture and characterization of mucoadhesive buccal films, Eur. J. Pharm. Biopharm., 77, 187, 10.1016/j.ejpb.2010.11.023
Müller-Schwefe, 2014, Pain in the cancer patient: different pain characteristics CHANGE pharmacological treatment requirements, Curr. Med. Res. Opin., 30, 10.1185/03007995.2014.925439
Myers Garry, 2011
Nair, 2013, In vitro techniques to evaluate buccal films, J. Control. Release, 166, 10, 10.1016/j.jconrel.2012.11.019
NAL Pharma, 2014. Bio-FX Sublingual Orally-Dissolving Film (ODF) DDS [WWW Document]. URL http://nalpharma.com/our-technology/bio-fx/ (accessed 09.04.14.).
National Institute on Drug Abuse, 2014. Medication-Assisted Treatment for Opioid Addiction [WWW Document]. URL http://www.drugabuse.gov/publications/topics-in-brief/medication-assisted-treatment-opioid-addiction (accessed 09.23.14.)
Nielsen, 2014, In vivo proof of concept of oral insulin delivery based on a co-administration strategy with the cell-penetrating peptide penetratin, J. Control. Release, 189, 19, 10.1016/j.jconrel.2014.06.022
Norgine, 2013. Norgine announces the launch of Setofilm® ondansetron oral dispersible film [WWW Document]. INT/SET/0513/0028. URL http://www.norgine.com/get-file/files/pressrelease/2013/PRAPRNorgineSetofilm.launchFinal_28_May2013_1.pdf. (accessed 09.03.14.)
Nowak Edward, 2005
Orexo, 2014. OX27 [WWW Document]. URL http://www.orexo.com/en/Portfolio/OX27/ (accessed 17.09.14.).
Patel, 2011, Advances in oral transmucosal drug delivery, J. Control. Release, 153, 106, 10.1016/j.jconrel.2011.01.027
PATH, 2012. Vaccines in fast-dissolving tablets [WWW Document]. URL http://www.path.org/vaccineresources/files/FDT_Fact_Sheet_7March12.pdf (accessed 09.08.14.).
PATH, 2014. Mass campaign with first vaccine allowed outside cold chain in Africa protects remotest African regions from deadly meningitis epidemics—PATH [WWW Document]. URL http://www.path.org/news/press-room/669/ (accessed 15.09.14.).
Pather, 2008, Current status and the future of buccal drug delivery systems, Expert Opin. Drug Deliv., 5, 531, 10.1517/17425247.5.5.531
Preis, 2015, Perspective: concepts of printing technologies for oral film formulations, Int. J. Pharm., 10.1016/j.ijpharm.2015.02.032
Preis, 2013, Oromucosal film preparations: classification and characterization methods, Expert Opin. Drug Deliv., 10, 1303, 10.1517/17425247.2013.804058
Reis, 2012, Nanotechnology as a promising strategy for alternative routes of insulin delivery, Methods Enzymol., 508, 271, 10.1016/B978-0-12-391860-4.00014-8
Research and Markets, 2014. PharmaPoint: Migraine—Global Drug Forecast and Market Analysis to 2023 [WWW Document]. URL http://www.researchandmarkets.com/research/l4p364/pharmapoint (accessed 12.09.14.).
Research and Markets, 2014. Vaccine Market by Technology & Types, Various Classes & Indications—Global Forecasts To 2022 [WWW Document]. URL http://www.researchandmarkets.com/research/g422mm/vaccine_market_by (accessed 15.09.14.).
Research and Markets, n.d. Smoking Cessation and Nicotine De-addiction Products Market – Global Industry Analysis, Size, Share, Growth, Trends and Forecast, 2013–2019 [WWW Document]. 2014. URL http://www.researchandmarkets.com/research/6ctxcw/smoking_cessation (accessed 07.15.15.).
Ryoo Je, 2010
Sattar, 2014, Oral transmucosal drug delivery—current status and future prospects, Int. J. Pharm., 471, 498, 10.1016/j.ijpharm.2014.05.043
Schobel, 2015
Schwedt, 2014, Chronic migraine, BMJ, 348, g1416, 10.1136/bmj.g1416
Şenel, 2012, Recent developments in buccal and sublingual delivery systems, Expert Opin. Drug Deliv., 9, 615, 10.1517/17425247.2012.676040
Shahab, 2013, Novel delivery systems for nicotine replacement therapy as an aid to smoking cessation and for harm reduction: rationale, and evidence for advantages over existing systems, CNS Drugs, 27, 1007, 10.1007/s40263-013-0116-4
Shakya, 2011, Palatal mucosa as a route for systemic drug delivery: a review, J. Control. Release, 151, 2, 10.1016/j.jconrel.2010.11.003
Sharp Andrew, 2006
Soares, 2012, Novel non-invasive methods of insulin delivery, Expert Opin. Drug Deliv., 9, 1, 10.1517/17425247.2012.737779
Tesa Labtec GmbH, 2012. APR, the drug developer and drug delivery technology provider headquartered in Balerna, Switzerland and its partner Labtec, the drug delivery technology developer headquartered in Langenfeld, Germany announce the approval of Zolmitriptan Oral Dispersible [WWW Document] URL; http://www.tesa-labtec.com/eng/company/press/apr-and-labtec-announce-approval-in-europe-of-zolmitriptan-rapidfilm,3097354,1.html.
Tfelt-Hansen, 2014, Drugs targeting 5-hydroxytryptamine receptors in acute treatments of migraine attacks. A review of new drugs and new administration forms of established drugs, Expert Opin. Investig. Drugs, 23, 375, 10.1517/13543784.2014.861817
Thomson Reuters, 2014. Cortellis [WWW Document]. URL (accessed 09.03.14). http://lifesciences.thomsonreuters.com/products/cortellis.
Thomson Reuters, 2014b. Cortellis Data Fusion [WWW Document]. URL http://thomsonreuters.com/cortellis-data-fusion/ (accessed 09.03.14.).
Thomson Reuters, 2015. DBP-118.
TrisPharma, 2014. ABUSE RESISTANCE: NobuseTM [WWW Document]. URL http://www.trispharma.com/technologies_nobuse.php (accessed 09.16.14.).
U.S. National Institutes of Health, ClinicalTrials.gov [WWW Document]. URL https://clinicaltrials.gov/ (accessed 09.04.14.) 2014.
Uluru Inc., 2009a. Uluru Inc. Announces Revised Business Plan [WWW Document]. URL http://www.prnewswire.com/news-releases/uluru-inc-announces-revised-business-plan-61919897.html.
Uluru Inc., 2009b. Uluru Inc. reports second quarte 2009 financial results.
UNICEF, 2014. Vaccines Supply and Market Overview | Supplies and Logistics | UNICEF [WWW Document]. URL http://www.unicef.org/supply/index_vaccines.html (accessed 9.15.14.).
Visiongain, 2014. Diabetes drugs market will reach $55.3bn in 2017. with further growth to 2023. predicts visiongain in new report [WWW Document]. URL https://www.visiongain.com/Press_Release/405/Diabetes-drugs-market-will-reach-55-3bn-in-2017-with-further-growth-to-2023-predicts-visiongain-in-new-report (accessed 9.12.14.).
WHO, 2005. Treatment of opioid dependence [WWW Document]. URL http://www.who.int/substance_abuse/activities/treatment_opioid_dependence/en/ (accessed 23.09.14.).
WHO, 2014. Vaccine Market [WWW Document]. URL http://www.who.int/immunization/programmes_systems/procurement/market/en/ (accessed 15.09.14.).
.Williams, P., Rademacher, T., Schobel, A.M., Dadey, E., 2012. Combination peptide-nanoparticles and delivery systems incorporating same.Wipo patentscope.
Woertz, 2013, Assessment of test methods evaluating mucoadhesive polymers and dosage forms: an overview, Eur. J. Pharm. Biopharm., 85, 843, 10.1016/j.ejpb.2013.06.023
World Allergy Organization, 2014. Allergen Immunotherapy: A Synopsis [WWW Document]. URL http://www.worldallergy.org/professional/allergic_diseases_center/immunotherapy/immunotherapysynopsis.php (accessed 09.08.14).
Zeng, 2009