Expert opinion on drug delivery
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Expert Opin Drug Deliv · Sep 2017
ReviewTake-home naloxone treatment for opioid emergencies: a comparison of routes of administration and associated delivery systems.
Naloxone reversal of opioid-induced respiratory depression outside of medical facilities has become more prevalent because of the escalating opioid epidemic in the USA. Take-home naloxone for treatment of opioid emergencies is now being recommended by numerous federal, state, and professional organizations. Areas covered: The scope of the opioid overdose epidemic is reviewed along with practical, clinical, regulatory, and usability considerations for take-home naloxone routes of administration currently available and associated delivery systems. ⋯ A clinical overview, including pharmacokinetic and FDA approval information for each take-home naloxone product is discussed in detail as well as the impact of take-home naloxone in the community. Finally, given these products are to be used in a panic-stricken, life-threatening opioid emergency, an analysis of available usability data is provided with proposed directions for further study. Expert opinion: Based on the available clinical evidence, auto-injectable naloxone should be the preferred administration route for take-home naloxone treatment until additional safety, efficacy, and comparative outcomes data are available for unconventional routes of administration that unequivocally provide equal or superior results.
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Expert Opin Drug Deliv · Jan 2016
Highly respirable dry powder inhalable formulation of voriconazole with enhanced pulmonary bioavailability.
To develop and characterize a highly respirable dry powder inhalable formulation of voriconazole (VRZ). ⋯ This study supports the potential of inhaled dry powder VRZ for the treatment of fungal infections.
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Cardiovascular disease (CVD) is the leading cause of mortality globally. Effective CVD preventive medications are available including statin, blood pressure-lowering and antiplatelet medications; however most people do not take these drugs long term. Fixed-dose combination pills ("polypills") have been shown, in several clinical trials, to improve adherence to these recommended medications, with corresponding improvements in risk factors such as blood pressure and LDL-cholesterol. ⋯ Despite the potential benefits for patients and payers, only a few polypills are available due to market failure in the funding of research and development for affordable non-communicable disease medicines. Regulatory paradigms have focused on substitution indications among patients already taking component medications; however, this is the population that is likely to receive the least benefit from a polypill-based strategy. Greater health impact is likely if focus is given to patients who have indications for all polypill components, but currently do not receive the benefits of recommended medicines long term.
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Expert Opin Drug Deliv · Aug 2015
ReviewFactors to consider when selecting a nebulizer for a new inhaled drug product development program.
Nebulizers are a common device choice for use when developing a new drug product, but the range of nebulizer devices available can make it difficult to select the right device. Increasingly, companies are only able to promote a drug with the device that was used during the development program; therefore, choosing the best device at an early stage is important in order to achieve commercial success. Selecting a device that is inappropriate for the intended drug can result in poor drug delivery from the nebulizer to the patient, which would have obvious implications for the development program. As device performance varies, it is important to ensure that the most appropriate device is chosen for the intended drug to ensure optimal drug delivery to the patient population. ⋯ Efficient nebulizer devices that combine electronic monitoring capabilities as a form of telehealth are likely to provide superior drug delivery to patients and accurate clinical trial data. Their use in adaptive clinical trials may help to vastly reduce the time and costs associated with achieving drug approval.
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Expert Opin Drug Deliv · Aug 2015
Multicenter Study Observational StudyAdherence to, and effectiveness of, subcutaneous interferon β-1a administered by RebiSmart® in patients with relapsing multiple sclerosis: results of the 1-year, observational SMART study.
Patients with multiple sclerosis who have poor adherence to treatment have a higher risk of relapse than adherent patients. This study assessed adherence to, and effectiveness and convenience of, treatment with subcutaneous (sc) interferon (IFN) β-1a (Rebif®, Merck Serono SA) 44 or 22 μg three times weekly in patients with relapsing multiple sclerosis (RMS) using the RebiSmart® electronic, multidose, autoinjector for 1 year. ⋯ Patients with RMS self-injecting sc IFN β-1a with RebiSmart had excellent adherence at Month 12/ED, which was associated with good clinical outcomes and no unexpected safety issues. Patients rated RebiSmart as convenient and easy to use.