Inhaled PYY(3–36) dry-powder formulation for appetite suppression

Kuehl, Philip J.; Boyden, Tracey; Dobry, Dan E.; Doyle-Eisele, Melanie; Friesen, Dwayne T.; McDonald, Jacob D.; Murri, Brice; Vodak, David T.; K, Lyon, David

doi:10.3109/03639045.2015.1036067

Cited by 9 publications

(4 citation statements)

References 22 publications

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“…An example of the application of PKs to quantify dose to the lungs has been published recently with a biological compound (PYY[3-36]). 11 The utility of a biological compound in the utilization of the PK method is that the oral bioavailability is generally accepted to be 0, which enables the assumption that the systemic exposure is the result of the pulmonary dose. This study utilized subcutaneous (0.1 mg/kg), intraperitoneal (0.1 mg/kg), and inhalation dose delivery.…”

Section: Dose Is Dose Right? Determining Pulmonary Dose In Clinical mentioning

confidence: 99%

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Tepper¹,

Kuehl

Cracknell³

et al. 2016

Int J Toxicol

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Developing inhaled drugs requires knowledge of lung anatomy, cell biology, respiratory physiology, particle physics, and some plumbing. Although dose makes the poison, in the context of an inhaled drug, the "dose" is not easily defined. This lack of clarity around dose poses issues and challenges in the design of inhalation toxicology programs. To better understand dose, the influence of ventilation is discussed as are the perturbations in pulmonary function observed with inhalation exposure that can affect dose. Methods for determining inhaled drug deposition to arrive at an estimate of lung dose are examined. Equally important to understanding dose are the techniques used to deliver aerosols to animals. With a better understanding of dose and inhalation exposure, species-specific histopathologic lesions, both common background and toxicologically significant lesions, are reviewed. Finally, insight into how regulators synthesize and evaluate these complex findings to assess clinical safety risks is presented.

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Section: Dose Is Dose Right? Determining Pulmonary Dose In Clinical mentioning

confidence: 99%

“…PYY systemic concentration versus time profile following intraperitoneal (IP), subcutaneous (SC), and inhalation delivery. Republished with permission from Taylor & Francis Ltd (www.tandfonline.com) 11. …”

mentioning

confidence: 99%

Symposium Summary

Tepper¹,

Kuehl

Cracknell³

et al. 2016

Int J Toxicol

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“…[98] One report describes the successful use of 10 kDa dextran to stabilize an investigational peptide hormone. [152] However, the presence of a larger percentage of reducing groups on smaller molecular weight dextran [150] should be carefully considered when selecting these as excipients.…”

Section: Polysaccharidesmentioning

confidence: 99%

Progress in spray-drying of protein pharmaceuticals: Literature analysis of trends in formulation and process attributes

et al. 2021

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Spray-drying is an inherently continuous and well-established industrial drying process. It can accelerate manufacturing of biopharmaceuticals and vaccine products, resulting in both an economic and health benefit. In this review, we cover a systematic assessment and discuss the spray-drying of diverse protein pharmaceuticals and excipients included therein, solvent systems applicable to these formulations, equipment used and, respective process parameters. Further, key quality aspects of spray-dried protein solids are discussed. Based on the overall trends, we present a concise perspective into the future of protein pharmaceuticals spray-drying.

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“…Inhalation of therapeutic peptides has been examined in the clinic and in preclinical studies; however, in these studies the therapeutic target(s) was present in the lung ( Hartmann et al, 2015 ; Fellner et al, 2016 ; Kuehl et al, 2016 ; Onoue et al, 2011 ; Walker et al, 2017 ). Inhalation studies with peptides have shown that they have the potential to produce local immunogenicity and irritation upon chronic exposure ( Fellner et al, 2016 ).…”

Section: Occupational Exposure Control Banding Considerations For Phamentioning

confidence: 99%

Considerations for setting occupational exposure limits for novel pharmaceutical modalities

Graham

Hillegass

Schulze

2020

Regulatory Toxicology and Pharmacology

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In order to develop new and effective medicines, pharmaceutical companies must be modality agnostic. As science reveals an enhanced understanding of biological processes, new therapeutic modalities are becoming important in developing breakthrough therapies to treat both rare and common diseases. As these new modalities progress, concern and uncertainty arise regarding their safe handling by the researchers developing them, employees manufacturing them and nurses administering them. This manuscript reviews the available literature for emerging modalities (including oligonucleotides, monoclonal antibodies, fusion proteins and bispecific antibodies, antibody-drug conjugates, peptides, vaccines, genetically modified organisms, and several others) and provides considerations for occupational health and safety-oriented hazard identification and risk assessments to enable timely, consistent and well-informed hazard identification, hazard communication and risk-management decisions. This manuscript also points out instances where historical exposure control banding systems may not be applicable (e.g. oncolytic viruses, biologics) and where other occupational exposure limit systems are more applicable (e.g. Biosafety Levels, Biologic Control Categories).

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Inhaled PYY(3–36) dry-powder formulation for appetite suppression

Cited by 9 publications

References 22 publications

Symposium Summary

Symposium Summary

Progress in spray-drying of protein pharmaceuticals: Literature analysis of trends in formulation and process attributes

Considerations for setting occupational exposure limits for novel pharmaceutical modalities

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