• Patchless Transdermal Drug Delivery ... - Ecn5.com ecn5

More documents

Recommendations

Info

4 MARCH 2011 • TransDermal pain. Covidien expects to launch the patch in the USA in 25mcg/ hr, 50mcg/hr, 75mcg/hr, and 100mcg/hr strengths. PLEASE–FSH patch provides first successful IVF pregnancy Ruggell, Liechtenstein — A woman conceived successfully after being implanted with a fertilized oocyte (egg cell) and re - ceiving treatment with Pantec Biosolutions’ FSH (follicle stimulating hormone) patch subsequent to skin microporation with the company’s proprietary P.L.E.A.S.E. (Painless Laser Epidermal System) device. The pregnancy is the first to occur using the technology. Inovio and University of Southampton begin vaccine study Blue Bell, Pennsylvania, USA and Southampton, UK — Inovio Pharmaceuticals obtained regulatory approval for a Phase 2 clinical trial that the University of Southampton will run. The study will use Inovio’s automated, ELGEN 1000 vaccine-delivery device and will evaluate a DNA vaccine that the university developed to treat chronic myeloid leukemia and acute myeloid leukemia. Leukaemia and Lymphoma Research (LLR) and the Efficacy and Mechanisms Evaluation (EME) program, which the UK Medical Research Council funds and the UK National Institute for Health Research manages, will provide financial support. Alvogen launches transdermal delivery system Parsippany, New Jersey, USA — Alvogen introduced an AB-1rated nitroglycerin transdermal delivery system. The hypoallergenic, transparent patches are available in 30-count cartons and four dosage strengths, including 0.1, 0.2, 0.4, 0.6 mg/hr. BioSante receives orphan-drug status for vaccine Lincolnshire, Illinois, USA — The US FDA granted orphandrug status for BioSante Pharmaceuticals’ potential skin-cancer vaccine. The company also has received orphan-drug status for other vaccines for pancreatic cancer, acute myeloid leukemia, and chronic myeloid leukemia. Purdue Pharma releases Butrans transdermal system Stamford, Connecticut, USA — Purdue Pharma’s Butrans (bupre - nor phine) Transdermal System CIII is now available by prescription. The drug is indicated for the management of moderate-tosevere chronic pain in patients requiring an around-the-clock opioid analgesic for an extended period of time. Butrans is the first opioid analgesic that continuously releases buprenorphine for seven days. Alliqua completes study for pain patch New York, New York, USA — Alliqua, formerly HepaLife Technologies, successfully completed an initial study for its transdermal pain patch. In the comparative dissolution study, its profile was favorable when compared to the current leading product for treating postherpetic neuralgia (PHN) pain. Alliqua now will start the next developmental stage, including in-vitro testing. Foamix starts Phase 2 clinical trial Rehovot, Israel — Foamix en - rolled the first patient in a Phase 2 trial of its Topical Minocycline Foam. The study aims to demonstrate efficacy and safety in patients suffering from Rosacea. Skin-penetration studies demonstrated a high occurrence of the drug in the viable layers of the skin and also revealed that the drug is not delivered transdermally, indicating that its topical application will not involve any systemic adverse effects. FDA accepts Zelrix NDA for filing Conshohocken, Pennsylvania, USA — NuPathe received notice that the US FDA accepted the company‘s Zelrix NDA, submitted on October 29, 2010, for filing. The company expects the FDA to complete its review of the NDA by August 29, 2011. Zelrix is the first-ever submission to the FDA of a transdermal patch for the treatment of migraine. FDA approves Fortesta gel Newark, Delaware, USA — The US FDA approved Endo Pharmaceuticals’ Fortesta gel for treatment of low testosterone, also known as hypogonadism. The gel comes in a metered-dose pump that delivers the correct dose per complete depression. Endo ex pects to introduce the gel in the USA in early 2011.
TransDermal • MARCH 2011 Patchless Transdermal Drug Delivery (TDD) Bozena B Michniak-Kohn, Rutgers-The State University of New Jersey Kishore R Shah, Polytherapeutics, Inc We can trace the advent of transdermal drug delivery to the FDA’s approval and commercialization of scopolamine (1979) and nitroglycerin (1981) patches. Since then, companies have marketed many transdermal products worldwide, and transdermals have become a multibillion-dollar industry. Some of the advantages of transdermal drug delivery include: 1. A reproducible and prolonged drug-delivery rate 2. Elimination of hepatic first-pass metabolism 3. Minimization of undesirable side effects 4. Increased convenience for and compliance by patients 5. Rapid termination of drug therapy when desired Despite these advantages, the barrier function of the skin, and its irritation and sensitization by many drugs and certain patch components, provide the principal impediments to a wider use of transdermal drug delivery. To some extent, patchless TDD in the form of topically applied gels, creams, lotions, or solutions can overcome the limitations of the skin barrier by application of the drug formulation to a much larger area of skin than is possible with plastic patches. Formulators can use patchless TDD to elicit a therapeutic effect within tissues near the site of product application and/or to distribute the drug throughout the body using the circulatory system. Patchless delivery may be suitable for treatment of various indications, such as pain, hormone replacement therapy, contraception, overactive bladder, CNS disorders, male or female sexual dysfunction, and smoking cessation. Key advantages of patchless transdermal products include: • The potential for expanding the scope of transdermal delivery to drugs requiring significantly higher dosages than possible with patches • Flexibility of dosing • Reduction in skin irritation due to lack of occlusion • Lack of irritation from patch components such as adhesives • Ease of manufacture • Cost effectiveness • Cosmetic elegance The deficiencies of the patchless TDD in contrast to patches may include: • Some variability in precision of dosing • Lack of suitability for drugs having a high skinpermeation rate, such as fentanyl and clonidine • A narrow therapeutic window • Lack of retention of the drug and enhancer at the site of application Formulation Considerations Dosage forms for patchless TDD can be clear solutions, gels, or emulsions. The formulator selects the form with an emphasis on its spreadability on skin, drying time, cosmetic feel, and acceptability to users. A mixture of water and alcohol is often a good medium for the preparation of a solution or gel. A lower alkyl alcohol, such as ethanol or isopropanol, helps to solubilize the drug. Polymeric thickeners can adjust the viscosity of the solution for optimum handling and spreadability. An emulsion (oil-inwater or water-in-oil) is a useful medium for drugs that are hydrophobic and poorly soluble in hydroalcoholic medium. In an emulsion, the drug is solubilized in the oil phase. Key ingredients for the preparation of such emulsions include oils, waxes, emulsifiers, and emollients. 5
Page 1 and 2: VOLUME 3 NUMBER 2 Exclusively for t
Page 3 and 4: EdiTORiAl Peggy Wright Editor pwrig
Page 5: delivery system from ViaDerm to Via
Page 9 and 10: Novavax, Abbot, Auxilium Researcher
Page 11 and 12: Nuvo Research, Covidien, King Pharm
Page 13 and 14: References 1. Quan D, Hui X, and Ma
Page 15 and 16: find their way into circulation in
Page 17 and 18: ISSUE FOCUS pharmadur ® Polytherap
Page 19 and 20: January 2012 Drug Delivery Partners

• Patchless Transdermal Drug Delivery ... - Ecn5.com ecn5

Create successful ePaper yourself

Delete template?

Save as template?