Analytical Leachables Studies

Feilden, Andrew; Rignall, Andy

doi:10.1002/9781118147672.ch17

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“…Minimum leachable study duration is six months at 40C with 75% relative humidity. 73 Routine Extractable Testing also should be conducted 74 to ensure that leachable levels and profiles are maintained within accepted limits. 70 This is important, as the valve manufacturers may alter the manufacturing process and the residue of new chemicals on the valves such as processing aid additives may affect the aerosol performance of the pMDI.…”

Section: 3extractables and Leachablesmentioning

confidence: 99%

The Potential Use of Cyclosporine Ultrafine Solution Pressurised Metered- Dose Inhaler in the Treatment of COVID-19 Patients

Ehtezazi

2022

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Introduction: Serious COVID-19 respiratory problems start when the virus reaches the alveolar level, where type II cells get infected and die. Therefore, virus inhibition at the alveolar level would help prevent these respiratory complications. Method: A literature search was conducted to collect physicochemical properties of small molecule compounds that could be used for the COVID-19 treatment. Compounds with a low melting point were selected along with those soluble in ethanol, hydrogen-bond donors, and acceptors. Results : There are severe acute respiratory syndrome coronavirus inhibitors with physicochemical properties suitable for the formulation as an ultrafine pressurised metered-dose inhaler (pMDI). Mycophenolic acid, Debio 025, and cyclosporine A are prime candidates among these compounds. Cyclosporine A (hereafter cyclosporine) is a potent SARS-CoV-2 inhibitor, and it has been used for the treatment of COVID-19 patients, demonstrating an improved survival rate. Also, inhalation therapy of nebulised cyclosporine was tolerated, which was used for patients with lung transplants. Finally, cyclosporine has been formulated as a solution ultrafine pMDI. Although vaccine therapy has been started in most countries, inhalation therapies with non-immunological activities could minimise the spread of the disease and be used in vaccine-hesitant individuals. Conclusion: Ultrafine pMDI formulation of cyclosporine or Debio 025 should be investigated for the inhalation therapy of COVID-19.

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Section: 3extractables and Leachablesmentioning

confidence: 99%

The Potential Use of Cyclosporine Ultrafine Solution Pressurised Metered- Dose Inhaler in the Treatment of COVID-19 Patients

Ehtezazi

2022

RADDF

View full text Add to dashboard Cite

show abstract

Analytical Leachables Studies

Cited by 1 publication

References 0 publications

The Potential Use of Cyclosporine Ultrafine Solution Pressurised Metered- Dose Inhaler in the Treatment of COVID-19 Patients

The Potential Use of Cyclosporine Ultrafine Solution Pressurised Metered- Dose Inhaler in the Treatment of COVID-19 Patients

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