Inhaled insulin as adjunctive therapy in subjects with type 2 diabetes failing oral agents: a controlled proof‐of‐concept study

Hausmann, M.; Dellweg, Sibylle; Osborn, Chandra Y.; Heinemann, Lutz; Buchwald, A.; Rosskamp, R.; Genova, Pietro; Heise, Tim

doi:10.1111/j.1463-1326.2006.00647.x

Cited by 14 publications

(6 citation statements)

References 28 publications

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“…The propellant mixtures were found to improve the aerosol performance over the pure propellant. This formulation has been shown to provide comparable blood glucose control to subcutaneous insulin injections in type 2 diabetic patients [69]. This formulation has been shown to provide comparable blood glucose control to subcutaneous insulin injections in type 2 diabetic patients [69].…”

Section: Metered Dose Inhalersmentioning

confidence: 93%

“…An aqueous solution of the protein and surfactant was first freeze dried to produce the required particles, which were subsequently suspended in HFA-134a alone or a mixture of this propellant and dimethylether [67] or ethanol [68]. Kos Pharmaceuticals (Florida, USA) has developed an insulin MDI suspension in HFA-134a [69,70]. Kos Pharmaceuticals (Florida, USA) has developed an insulin MDI suspension in HFA-134a [69,70].…”

Section: Metered Dose Inhalersmentioning

confidence: 99%

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Pulmonary Delivery of Peptides and Proteins

Kwok

Chan

2011

Peptide and Protein Delivery

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Section: Metered Dose Inhalersmentioning

confidence: 93%

Section: Metered Dose Inhalersmentioning

confidence: 99%

Pulmonary Delivery of Peptides and Proteins

Kwok

Chan

2011

Peptide and Protein Delivery

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“…The very popular and also highly unstable human insulin has also been formulated as a suspension in HFA-134a propellant by Kos Pharmaceuticals (Weston, FL, USA) which has also been tested in type II diabetics to result in a rapid onset of action and comparable blood glucose levels to insulin glargine at base line and after 28 days when administered pre-prandially. This clearly showed that the structural and functional integrity of insulin was not compromised while remaining suspended in HFA134a [ 79 ].…”

Section: Description Of Pfizer’s Mrna Covid-19 Vaccine Formulation Bn...mentioning

confidence: 99%

Formulation, Device, and Clinical Factors Influencing the Targeted Delivery of COVID-19 Vaccines to the Lungs

Mossadeq

Shah

et al. 2022

AAPS PharmSciTech

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The COVID-19 pandemic has proven to be an unprecedented health crisis in the human history with more than 5 million deaths worldwide caused to the SARS-CoV-2 and its variants ( https://www.who.int/emergencies/diseases/novel-coronavirus-2019 ). The currently authorized lipid nanoparticle (LNP)–encapsulated mRNA vaccines have been shown to have more than 90% vaccine efficacy at preventing COVID-19 illness (Baden et al . New England J Med 384(5):403–416, 2021 ; Thomas et al ., 2021 ). In addition to vaccines, other small molecules belonging to the class of anti-viral and anti-inflammatory compounds have also been prescribed to reduce the viral proliferation and the associated cytokine storm. These anti-viral and anti-inflammatory compounds have also been shown to be effective in reducing COVID-19 exacerbations especially in reducing the host inflammatory response to SARS-CoV-2. However, all of the currently FDA-authorized vaccines for COVID-19 are meant for intramuscular injection directly into the systemic circulation. Also, most of the small molecules investigated for their anti-COVID-19 efficacy have also been explored using the intravenous route with a few of them explored for the inhalation route (Ramakrishnan et al . Lancet Respir Med 9:763–772, 2021 ; Horby et al . N Engl J Med 384(8):693–704, 2021 ). The fact that the SARS-CoV-2 enters the human body mainly via the nasal and airway route resulting in the lungs being the primary organs of infection as characterized by acute respiratory distress syndrome (ARDS)–mediated cytokine storm in the alveolar region has made the inhalation route gain significant attention for the purposes of targeting both vaccines and small molecules to the lungs (Mitchell et al ., J Aerosol Med Pulm Drug Deliv 33(4):235–8, 2020 ). While there have been many studies reporting the safety and efficacy of targeting various therapeutics to the lungs to treat COVID-19, there is still a need to match the choice of inhalation formulation and the delivery device platform itself with the patient-related factors like breathing pattern and respiratory rate as seen in a clinical setting. In that perspective, this review aims to describe the various formulation and patient-related clinical factors that can play an important role in the judicious choice of the inhalation delivery platforms or devices for the development of inhaled COVID-19 vaccines.

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“…The proof of concept for inhaled insulin, a dry powder aerosol delivery system of human insulin, was initially examined in an early phase II study on 69 patients with type 2 diabetes who were randomized to a 3-month treatment period of either continued oral agents alone (sulfonylurea and/ or metformin) or in combination with 1 or 2 puffs of inhaled insulin before meals (121). The inhaled insulin doses were titrated based on glucose testing four times daily.…”

Section: The Mechanical Barriermentioning

confidence: 99%