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3. Pharmaceutical Cryogenic Technologies

Author

Sahakijpijarn, Sawittree, Moon, Chaeho, Williams, Robert O., III, Perrie, Yvonne, Series Editor, Williams III, Robert O., editor, Davis Jr., Daniel A., editor, and Miller, Dave A., editor

Published
2022
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6. Correction to “Inhaled JAK Inhibitor GDC-0214 Nanoaggregate Powder Exhibits Improved Pharmacokinetic Profile in Rats Compared to the Micronized Form: Benefits of Thin Film Freezing”

Author

Moon, Chaeho, primary, Sahakijpijarn, Sawittree, additional, Maier, Esther Y., additional, Taft, David R., additional, Jara, Miguel O., additional, Praphawatvet, Tuangrat, additional, Manandhar, Rachana, additional, Shetty, Nivedita, additional, Lubach, Joseph, additional, Narang, Ajit, additional, Nagapudi, Karthik, additional, and Williams, Robert O., additional

Published
2024
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16. Lack of durable protection against cotton smoke-induced acute lung injury in sheep by nebulized single chain urokinase plasminogen activator or tissue plasminogen activator

Author

Satoshi Fukuda, Perenlei Enkhbaatar, Christina Nelson, Robert A. Cox, Marla R. Wolfson, Thomas H. Shaffer, Robert O. Williams, Soraya Hengsawas Surasarang, Sahakijpijarn Sawittree, Galina Florova, Andrey A. Komissarov, Kathleen Koenig, Krishna Sarva, Harrison T. Ndetan, Karan P. Singh, and Steven Idell

Subjects
Plasminogen activators, Fibrinolysins, Plasminogen activator inhibitor-1, Inhalational acute lung injury, Medicine (General), R5-920
Abstract

Abstract Background Airway fibrin casts are clinically important complications of severe inhalational smoke-induced acute lung injury (ISIALI) for which reliable evidence-based therapy is lacking. Nebulized anticoagulants or a tissue plasminogen activator; tPA, has been advocated, but airway bleeding is a known and lethal potential complication. We posited that nebulized delivery of single chain urokinase plasminogen activator, scuPA, is well-tolerated and improves physiologic outcomes in ISIALI. To test this hypothesis, we nebulized scuPA or tPA and delivered these agents every 4 h to sheep with cotton smoke induced ISIALI that were ventilated by either adaptive pressure ventilation/controlled mandatory ventilation (APVcmv; Group 1, n = 14) or synchronized controlled mandatory ventilation (SCMV)/limited suctioning; Group 2, n = 32). Physiologic readouts of acute lung injury included arterial blood gas analyses, PaO2/FiO2 ratios, peak and plateau airway pressures, lung resistance and static lung compliance. Lung injury was further assessed by histologic scoring. Biochemical analyses included determination of antigenic and enzymographic uPA and tPA levels, plasminogen activator and plasminogen activator inhibitor-1 activities and d-dimer in bronchoalveolar lavage (BAL). Plasma levels of uPA, tPA antigens, d-dimers and α-macroglobulin-uPA complex levels were also assessed. Results In Group 1, tPA at the 2 mg dose was ineffective, but at 4 mg tPA or scuPA, the PaO2/FiO2 ratios, peak/plateau pressures improved during evolving injury (p

Published
2018
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27. Niclosamide inhalation powder made by thin-film freezing: Multi-dose tolerability and exposure in rats and pharmacokinetics in hamsters

Author

Jara, Miguel O., primary, Warnken, Zachary N., additional, Sahakijpijarn, Sawittree, additional, Moon, Chaeho, additional, Maier, Esther Y., additional, Christensen, Dale J., additional, Koleng, John J., additional, Peters, Jay I., additional, Hackman Maier, Sarah D., additional, and Williams III, Robert O., additional

Published
2021
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31. Lack of durable protection against cotton smoke-induced acute lung injury in sheep by nebulized single chain urokinase plasminogen activator or tissue plasminogen activator

Author

Krishna Sarva, Perenlei Enkhbaatar, Marla R. Wolfson, Harrison Ndetan, Karan P. Singh, Satoshi Fukuda, Thomas H. Shaffer, Robert A. Cox, Kathleen Koenig, Sahakijpijarn Sawittree, Robert O. Williams, Galina Florova, Soraya Hengsawas Surasarang, Steven Idell, Christina Nelson, and Andrey A. Komissarov

Subjects
0301 basic medicine, medicine.medical_specialty, Medicine (miscellaneous), Lung injury, Gastroenterology, Tissue plasminogen activator, Fibrin, Plasminogen activator inhibitor-1, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Airway resistance, Internal medicine, Fibrinolysins, medicine, 2. Zero hunger, lcsh:R5-920, biology, medicine.diagnostic_test, Plasminogen activators, business.industry, Research, respiratory system, Inhalational acute lung injury, respiratory tract diseases, 030104 developmental biology, Bronchoalveolar lavage, 030228 respiratory system, chemistry, biology.protein, Molecular Medicine, business, Airway, lcsh:Medicine (General), Plasminogen activator, medicine.drug
Abstract

Background Airway fibrin casts are clinically important complications of severe inhalational smoke-induced acute lung injury (ISIALI) for which reliable evidence-based therapy is lacking. Nebulized anticoagulants or a tissue plasminogen activator; tPA, has been advocated, but airway bleeding is a known and lethal potential complication. We posited that nebulized delivery of single chain urokinase plasminogen activator, scuPA, is well-tolerated and improves physiologic outcomes in ISIALI. To test this hypothesis, we nebulized scuPA or tPA and delivered these agents every 4 h to sheep with cotton smoke induced ISIALI that were ventilated by either adaptive pressure ventilation/controlled mandatory ventilation (APVcmv; Group 1, n = 14) or synchronized controlled mandatory ventilation (SCMV)/limited suctioning; Group 2, n = 32). Physiologic readouts of acute lung injury included arterial blood gas analyses, PaO2/FiO2 ratios, peak and plateau airway pressures, lung resistance and static lung compliance. Lung injury was further assessed by histologic scoring. Biochemical analyses included determination of antigenic and enzymographic uPA and tPA levels, plasminogen activator and plasminogen activator inhibitor-1 activities and d-dimer in bronchoalveolar lavage (BAL). Plasma levels of uPA, tPA antigens, d-dimers and α-macroglobulin-uPA complex levels were also assessed. Results In Group 1, tPA at the 2 mg dose was ineffective, but at 4 mg tPA or scuPA, the PaO2/FiO2 ratios, peak/plateau pressures improved during evolving injury (p

Published
2018

34. Perfluorochemical‐facilitated plasminogen activator delivery to the airways: A novel treatment for inhalational smoke‐induced acute lung injury

Author

Wolfson, Marla R., primary, Enkhbaatar, Perenlei, additional, Fukuda, Satoshi, additional, Nelson, Christina L., additional, Williams, Robert O., additional, Surasarang, Soraya Hengsawas, additional, Sahakijpijarn, Sawittree, additional, Calendo, Gennaro, additional, Komissarov, Andrey A., additional, Florova, Galina, additional, Sarva, Krishna, additional, Idell, Steven I., additional, and Shaffer, Thomas H., additional

Published
2020
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37. Inhalable dosage forms containing difficult-to-formulate drugs : compositions and processing design space

Author

Sahakijpijarn, Sawittree

Subjects
Pulmonary drug delivery, Nebulization, Dry powder for inhalation, Lyophilization, Proteins, Peptide, Tacrolimus, Idiopathic pulmonary fibrosis, Lung transplantation, Ordered mixture
Abstract

Pulmonary drug delivery has recently gained much importance in the health care research area as it enables to target the drug delivery directly to lung both for local and systemic treatment. Despite extensive studies in the last decade, the development of inhaled formulations is still challenging, especially for difficult-to-formulate drugs such as macromolecule drugs and amorphous small molecule drugs. Due to the fragile nature of macromolecules, they are prone to degrade when exposed to physicochemical stress such as temperatures, pH, storage humidity, formulation component, atomization. The first two studies demonstrate the strategies to overcome the stability challenge of proteins and peptide in order to deliver a drug to the lung by nebulization. By the right selection of nebulizer and formulation optimization, the stability of fibrinolysins can be preserved after lyophilization, reconstitution, and nebulization using vibrating mesh nebulizers. Furthermore, the effect of counterion on the stability of peptide was studied in the second study. The formulation and processing were optimized to preserve volatile counterions, thus minimizing the pH change of reconstituted solutions and maintaining the stability of peptide. In addition to macromolecules, amorphous small molecules drug is another type of difficult-to-formulate drugs since they are thermodynamically unstable and thus tend to undergo crystallization during storage, which can affect the drug aerosolization and drug release upon deposition in the airway. The third study aimed to investigate the feasibility of thin film freezing to prepare dry powder for inhalation containing a high potency of amorphous tacrolimus. We found that using ultra-rapid freezing can increase drug loading up to 95% while maintaining good aerosol performance and stability. Finally, a new strategy to overcome the challenge in developing ordered mixture dry powder for inhalation was developed in the last study. We found that powders made by TFF ordered mixing process exhibited superior aerosol performance and less variation in content uniformity, compared to powders made by conventional powder blending. Throughout these studies, we can conclude that the right design of formulation and process can help to overcome the challenges in developing inhaled formulations of difficult-to-formulate drugs

Published
2020

38. MOESM1 of Lack of durable protection against cotton smoke-induced acute lung injury in sheep by nebulized single chain urokinase plasminogen activator or tissue plasminogen activator

Author

Fukuda, Satoshi, Perenlei Enkhbaatar, Nelson, Christina, Cox, Robert, Wolfson, Marla, Shaffer, Thomas, Williams, Robert, Surasarang, Soraya, Sahakijpijarn Sawittree, Florova, Galina, Komissarov, Andrey, Koenig, Kathleen, Sarva, Krishna, Ndetan, Harrison, Singh, Karan, and Idell, Steven

Subjects
3. Good health
Abstract

Additional file 1. Supplemental data.

39. MOESM1 of Lack of durable protection against cotton smoke-induced acute lung injury in sheep by nebulized single chain urokinase plasminogen activator or tissue plasminogen activator

Author

Fukuda, Satoshi, Perenlei Enkhbaatar, Nelson, Christina, Cox, Robert, Wolfson, Marla, Shaffer, Thomas, Williams, Robert, Surasarang, Soraya, Sahakijpijarn Sawittree, Florova, Galina, Komissarov, Andrey, Koenig, Kathleen, Sarva, Krishna, Ndetan, Harrison, Singh, Karan, and Idell, Steven

Subjects
3. Good health
Abstract

Additional file 1. Supplemental data.

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