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7. RETRACTED: Khan et al. Poly (N-vinylcaprolactam-grafted-sodium alginate) Based Injectable pH/Thermo Responsive In Situ Forming Depot Hydrogels for Prolonged Controlled Anticancer Drug Delivery; In Vitro, In Vivo Characterization and Toxicity Evaluation. Pharmaceutics 2022, 14, 1050

Author

Khan, Samiullah, primary, Minhas, Muhammad Usman, additional, Aqeel, Muhammad Tahir, additional, Shah, Ihsan, additional, Khan, Shahzeb, additional, Kazi, Mohsin, additional, and Warnken, Zachary N., additional

Published
2024
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22. 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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33. Teaching an old drug new tricks : exploring formulation and route of delivery methods for repurposing drugs to treat CNS diseases

Author

Warnken, Zachary Nielson and 0000-0002-1028-134X

Subjects
Nasal, Drug delivery, Glioblastoma, Repurposing, Personalized medicine
Abstract

A major barrier to the treatment of central nervous system delivery is the ability to target drug delivery to the brain. The brain is protected by the blood-brain barrier, making it difficult for both small and especially large molecule drugs to reach their sight of action. With recent advancements in high throughput screening, some already marketed drugs have been found to be active in treating central nervous system diseases such as glioblastoma multiforme (GBM), however, some of these drugs are insufficient in their current forms to reach the brain and treat the disease. Nasal drug delivery is a promising route of delivery for treating central nervous system disease as it has shown the ability to directly transport drugs to the brain, bypassing the blood-brain barrier. Critical aspects to using nasal drug delivery to treat central nervous system diseases are the ability to target the formulation to specific sites in the nasal cavity as well as the ability of formulations to drive transport to the brain. In addition to nasal drug delivery, some drugs can benefit from improvements in bioavailability orally to increase brain exposure. Amorphous solid dispersions are a technique widely used to improve the bioavailability of the poorly-water soluble drugs however they are limited in their use for highly lipophilic drugs due to drug loading limitations. This research focuses on better understanding nasal drug delivery to leverage ways to better target sites in the nasal cavity. In addition to this targeting research, research that supports the in vitro tests for analyzing and assessing nasal drug delivery devices has been performed. Personalized nasal drug delivery in 3D-printed casts is shown to be a superior method for targeting a particular region of the nasal cavity due to the variation in individual’s nasal geometry. A large focus of the research has been to repurpose atovaquone for the treatment of glioblastoma. This research provides evidence of the benefits a new formulation strategy which incorporates a spontaneously emulsifying component into the classical amorphous solid dispersion to overcome its limitations with the highly lipophilic nature of atovaquone. The improved formulation alongside results showing activity of atovaquone against GBM present a promising repurposing strategy for atovaquone to be used in the treatment of GBM

Published
2018
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34. Personalized Medicine in Nasal Delivery: The Use of Patient-Specific Administration Parameters To Improve Nasal Drug Targeting Using 3D-Printed Nasal Replica Casts

Author

Warnken, Zachary N., Smyth, Hugh D.C., Davis, Daniel A., Weitman, Steve, Kuhn, John G., and Williams, Robert O.

Abstract

Effective targeting of nasal spray deposition could improve local, systemic, and CNS drug delivery; however, this has proven to be difficult due to the anatomical features of the nasal cavity, including the nasal valve and turbinate structures. Furthermore, nasal cavity geometries and dimensions vary between individuals based on differences in their age, gender, and ethnicity. The effect of patient-specific administration parameters was evaluated for their ability to overcome the barriers of targeted nasal drug delivery. The nasal spray deposition was evaluated in 10 3D-printed nasal cavity replicas developed based on the CT-scans of five pediatric and five adult subjects. Cromolyn sodium nasal solution, USP, modified with varying concentrations of hypromellose was utilized as a model nasal spray to evaluate the deposition pattern from formulations producing a variety of plume angles. A central composite design of experiments was implemented using the formulation with the narrowest plume angle to determine the patient-specific angle for targeting the turbinate region in each individual. The use of the patient-specific angle with this formulation significantly increased the turbinate deposition efficiency compared to that found for all subjects using an administration angle of 30°, around 90% compared to about 73%. Generally, we found turbinate deposition increased with decreases in the administration angle. Deposition to the upper regions of the replica was poor with any formulation or administration angle tested. Effective turbinate targeting of nasal sprays can be accomplished with the use of patient-specific administration parameters in individuals. Further research is required to see if these parameters can be device-controlled for patients and if other regions can be effectively targeted with other nasal devices.

Published
2024
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38. A Safety and Tolerability Study of Thin Film Freeze-Dried Tacrolimus for Local Pulmonary Drug Delivery in Human Subjects.

Author

Sahakijpijarn, Sawittree, Beg, Moeezullah, Levine, Stephanie M., Peters, Jay I., Williams III, Robert O., Giovagnoli, Stefano, Olsson, Bo, Warnken, Zachary, and Moraga-Espinoza, Daniel

Subjects
THIN films, TACROLIMUS, SURVIVAL rate, LUNG transplantation, GRAFT rejection, LACTOSE, FLUTICASONE propionate
Abstract

Due to the low and erratic bioavailability of oral tacrolimus (TAC), the long-term survival rate following lung transplantation remained low compared to other solid organs. TAC was reformulated and developed as inhaled formulations by thin film freezing (TFF). Previous studies reported that inhaled TAC combined with 50% w/w lactose (LAC) was safe and effective for the treatment of lung transplant rejection in rodent models. In this study, we aimed to investigate the safety and tolerability of TFF TAC-LAC in human subjects. The formulation can be delivered to the lung as colloidal dispersions after reconstitution and as a dry powder. Healthy subjects inhaled TAC-LAC colloidal dispersions at 3 mg TAC/dose via a vibrating mesh nebulizer in the first stage of this study and TAC-LAC dry powder at 3 mg TAC/dose via a single dose dry powder inhaler in the second stage. Our results demonstrated that oral inhalation of TAC-LAC colloidal dispersions and dry powder exhibited low systemic absorption. Additionally, they were well-tolerated with no changes in CBC, liver, kidney, and lung functions. Only mild adverse side effects (e.g., cough, throat irritation, distaste) were observed. In summary, pulmonary delivery of TFF TAC-LAC would be a safe and promising therapy for lung transplant recipients. [ABSTRACT FROM AUTHOR]

Published
2021
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