Triple Drug Fixed Dose Combination Metered Dose Inhaler With Stable And Equivalent Drug Delivery Performance Relative To Individual And Dual Subcomponents

Lechuga‐Ballesteros, David; Vehring, Reinhard; Joshi, Vidya; Noga, Brian; Schultz, Rob; Cummings, Harris; Golden, Michael A.; Orevillo, Chad; Reisner, Colin; Dwivedi, Sarvajna

doi:10.1164/ajrccm-conference.2012.185.1_meetingabstracts.a3966

Cited by 2 publications

(2 citation statements)

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“…Разработка оптимальной системы из комбинации лекарственных форм ГП/ФФ и вида ДАИ подразумевает применение новой технологии косуспензии с улучшенной ингаляционной доставкой в дыхательные пути пациента с целью создания высокой местной концентрации и минимизации системных эффектов. В исследованиях последних лет было установлено, что между пористыми и лекарственными частицами образуются сильные неспецифические ассоциации с образованием стабильных и однородных аэрозолей, которые способны обеспечить эффективную и предсказуемую доставку лекарства на протяжении всего срока службы ингалятора [13,[28][29][30][31].…”

Section: рациональная фармакотерапияunclassified

The double bronchodilation era: new capabilities in a new drug delivery device

et al. 2022

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A literature review presents the efficacy and safety of the new glycopyrronium bromide/formoterol fumarate (GP/FF) combination in the treatment of patients with chronic obstructive pulmonary disease according to the PINNACLE 1, 2, 3, 4 studies. There are 4 fixed LAMA/LABA combinations which used in world practice, as well as in Russia: vilanterol + umeclidinium bromide, glycopyrronium bromide + indacaterol, olodaterol + tiotropium bromide and aclidinium bromide + formoterol. The GP/FF combination also approved in Russia, is currently present in Global Initiative for Chronic Obstructive Lung Disease (GOLD). A new method of co-suspension delivery via the Aerosphere inhaler has been developed for this combination. The efficacy and safety in GP/FF MDI compared to its monocomponents and tiotropium bromide were assessed in phase III clinical trials PINNACLE 1, 2, 3, 4. The GP/FF combination showed an improvement in the morning and after 2 hours parameters of FEV1 compared to monocomponents and placebo. Data from PINNACLE studies showed an improvement in the quality of life associated with a decrease in compared with the baseline level of the overall score on the scale of the St. George’s Hospital Respiratory Questionnaire (SGRQ) in 24 weeks against those taking GP/FF in contrast to monocomponents and placebo. The use of GP/FF showed a significant reduction in theuse of salbutamol compared with placebo. A pooled analysis of PINNACLE 1, 2, 4 demonstrated that GP/FF improved lung functionand reduced the risk of COPD exacerbations compared with monocomponents and placebo. According to the results of the analysis, there was also no increase in the number of the most frequently recorded side effects.

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Section: рациональная фармакотерапияunclassified

The double bronchodilation era: new capabilities in a new drug delivery device

et al. 2022

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“…3A) [25]. This homogenous suspension is maintained for 30 s after shaking [25,38,39], compared with drugcrystal-only-based formulations, which can separate rapidly [40]. The co-suspension delivery technology uses engineered, lowdensity phospholipid particles in HFA propellant to suspend micronized drug crystals uniformly [25,36].…”

Section: Co-suspension Delivery Technologymentioning

confidence: 99%

Co-suspension delivery technology in pressurized metered-dose inhalers for multi-drug dosing in the treatment of respiratory diseases

Ferguson

Hickey

Dwivedi

2018

Respiratory Medicine

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Technologies for long-term delivery of aerosol medications in asthma and chronic obstructive pulmonary disease have improved over the past 2 decades with advancements in our understanding of the physical chemistry of aerosol formulations, device engineering, aerosol physics, and pulmonary biology. However, substantial challenges remain when a patient is required to use multiple inhaler types, multiple medications, and/or combinations of medications. Combining multiple drugs into a single inhaler while retaining appropriate dosing of the individual agents in the combination may enhance patient adherence to therapy and reduce device errors that occur when patients are using multiple inhalers. Pressurized metered-dose inhaler (pMDI) devices are widely used by patients for acute symptom relief as well as maintenance treatment, so the pMDI may be a suitable option with which to explore medication combinations. However, optimizing drug formulation remains a key challenge for pMDI delivery systems. This article introduces a new pMDI formulation approach: co-suspension delivery technology, which uses drug crystals with porous, low-density phospholipid particles engineered to deliver combinations of drugs to the airways with accurate and consistent dosing via pMDIs, independent of medication types and combinations. We describe the key characteristics of pMDIs, and discuss the rationale for the co-suspension delivery technology platform based on the limitations associated with traditional formulations. Finally, we discuss the clinical implications of co-suspension delivery technology for developing combination drug therapies administered by pMDIs.

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Triple Drug Fixed Dose Combination Metered Dose Inhaler With Stable And Equivalent Drug Delivery Performance Relative To Individual And Dual Subcomponents

Cited by 2 publications

References 4 publications

The double bronchodilation era: new capabilities in a new drug delivery device

The double bronchodilation era: new capabilities in a new drug delivery device

Co-suspension delivery technology in pressurized metered-dose inhalers for multi-drug dosing in the treatment of respiratory diseases

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