Article
Pharmacology & Pharmacy
Mellissa Gomez, Joseph McCollum, Hui Wang, Mani Ordoubadi, Chester Jar, Nicholas B. Carrigy, David Barona, Isobel Tetreau, Michelle Archer, Alana Gerhardt, Chris Press, Christopher B. Fox, Ryan M. Kramer, Reinhard Vehring
Summary: This study aimed to develop a stable inhalable dry powder vaccine for respiratory infectious diseases like tuberculosis. Results showed that different additives in the formulations had varying effects on the stability and aerosol performance of the vaccine, providing important insights for vaccine preparation.
INTERNATIONAL JOURNAL OF PHARMACEUTICS
(2021)
Article
Chemistry, Medicinal
Ashlee D. Brunaugh, Li Ding, Tian Wu, Michael Schneider, Ryan Khalaf, Hugh D. C. Smyth
Summary: Monoclonal antibody-based therapies have the potential to be a valuable treatment modality for acute and chronic lung diseases. Direct delivery to the lungs via inhalation can provide higher drug concentrations at the site of disease with reduced off-target effects. However, there is limited understanding of the impact of particle engineering processes on the stability and performance of dry powder inhaler formulations of monoclonal antibodies.
JOURNAL OF PHARMACEUTICAL SCIENCES
(2022)
Article
Engineering, Chemical
Lorena Pasero, Francesca Susa, Riccardo Chiavarino, Tania Limongi, Adamo Sulpizi, Tomaso Guidi, Roberto Pisano
Summary: Spray freeze-drying is a viable alternative to traditional spray drying for producing therapeutic dry microparticles, particularly suitable for pulmonary drug delivery. This study used ultrasonic spray freeze-drying to generate dry microparticles composed of mannitol or a combination of mannitol and salbutamol sulphate. The particle size, morphology, surface area, porosity, and crystallinity were influenced by solid concentration and feed flow rate. The aerodynamic properties for drug deposition were found to depend on solid concentration and feed flow rate.
Review
Chemistry, Multidisciplinary
Susana Farinha, Joao Sa, Paulo Roque Lino, Marco Galesio, Joao Pires, Miguel Angelo Rodrigues, Joao Henriques
Summary: Biopharmaceuticals have become an integral part of the pharmaceutical pipeline, offering highly specific therapeutic options. However, challenges arise in the manufacturing, isolation, and delivery of these complex molecules, especially considering their short shelf-life. Inhalation administration is gaining attention as an alternative to intravenous administration, with dry powder inhalers (DPIs) being considered an appealing option due to improved stability. This review focuses on the application of spray freeze drying (SFD) to produce dry powders of biopharmaceuticals, particularly for inhalation delivery, and provides a comprehensive assessment of its current and future applications.
PHARMACEUTICAL RESEARCH
(2023)
Article
Pharmacology & Pharmacy
Chun Yuen Jerry Wong, Alberto Baldelli, Hanieh Gholizadeh, Hale Oguzlu, Yigong Guo, Hui Xin Ong, Athenea Pascal Rodriguez, Gurpreet Singuera, Andrew Thamboo, Anika Singh, Anubhav Pratap-Singh, Daniela Traini
Summary: Nose-to-brain delivery is a popular route for drug delivery, but it poses challenges in drug targeting and bypassing the central nervous system. This study explores the use of dry powders composed of nanoparticles-in-microparticles for efficient nose-to-brain delivery. The choice of microparticle size and nanoparticle diameter is crucial for reaching the desired areas of drug deposition and penetration through the nose-to-brain barrier.
EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS
(2023)
Review
Engineering, Chemical
Ankit Patil, Pritam Patil, Sagar Pardeshi, Preena Shrimal, Norma Rebello, Popat B. B. Mohite, Aniruddha Chatterjee, Arun Mujumdar, Jitendra Naik
Summary: Drug nanonization and encapsulation efficiency enhancement are crucial for targeted drug delivery. Microfluidic technology is an effective method to achieve these goals by providing intensive mixing and generating uniform nanosized particles. It also enables the development of novel drug delivery systems with controlled size and distribution, reducing batch variation. This comprehensive review discusses the applications of microfluidic systems in synthesizing controlled-sized nanoparticles and recent advancements in micromixers and drug delivery systems. The review also highlights the important role of spray and freeze-drying in nanoparticle production and compares a microreactor-assisted spray and freeze dryer for innovative drug delivery platform development. Additionally, recent patents on microfluidics and drying technologies are critically discussed.
Review
Pharmacology & Pharmacy
Mostafa Rostamnezhad, Hossein Jafari, Farzad Moradikhah, Sara Bahrainian, Homa Faghihi, Reza Khalvati, Reza Bafkary, Alireza Vatanara
Summary: This article reviews the application of the spray freeze-drying method in particle engineering of pharmaceutical products. By understanding the various aspects of this method, the processing of particles with good flow properties can be achieved for different pharmaceutical products.
PHARMACEUTICAL DEVELOPMENT AND TECHNOLOGY
(2022)
Article
Pharmacology & Pharmacy
Hui Wang, Patrick Connaughton, Kellisa Lachacz, Nicholas Carrigy, Mani Ordoubadi, David Lechuga-Ballesteros, Reinhard Vehring
Summary: Administration of biologics via the respiratory route is gaining popularity. A new lipid-based inhalable microparticle platform, manufactured using a simplified spray drying method, ensures both powder dispersibility and physicochemical stability, and shows great potential for efficient drug delivery.
EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS
(2022)
Article
Pharmacology & Pharmacy
Mani Ordoubadi, Florence K. A. Gregson, Hui Wang, Mark Nicholas, Sandra Gracin, David Lechuga-Ballesteros, Jonathan P. Reid, Warren H. Finlay, Reinhard Vehring
Summary: The study extensively investigated the particle formation of L-leucine through three experimental methods and theory, providing insights into predicting the properties of spray-dried particles. The research enhanced the understanding of the particle formation process and proposed a model for predicting the properties of spray-dried particles.
INTERNATIONAL JOURNAL OF PHARMACEUTICS
(2021)
Article
Engineering, Chemical
Sagar Pardeshi, Mahesh More, Pritam Patil, Chandrakantsing Pardeshi, Prashant Deshmukh, Arun Mujumdar, Jitendra Naik
Summary: The article discusses the importance of pharmaceutical powder drying and the application of different particle engineering technologies, emphasizing the advancement and potential applications of drying in drug delivery systems. It provides information on commercial, regulatory, and scale-up strategies to help readers, researchers, and industrialists address key issues in drying operations.
Article
Engineering, Chemical
Aijun Di, Shengyu Zhang, Xuan Liu, Zhenbo Tong, Siping Sun, Zengchao Tang, Xiao Dong Chen, Winston Duo Wu
Summary: This study developed microparticles with improved solubility and antioxidant activity using resveratrol as a model drug. Chitosan played a key role in adjusting drug release behavior and enhancing mucoadhesion properties.
Article
Chemistry, Multidisciplinary
Hui Wang, Mani Ordoubadi, Patrick Connaughton, Kellisa Lachacz, Nicholas Carrigy, Scott Tavernini, Andrew R. Martin, Warren H. Finlay, David Lechuga-Ballesteros, Reinhard Vehring
Summary: This study developed a new lipid-based particle formulation platform for respiratory drug delivery applications. Rugose lipid particles were successfully produced using a spray drying method, with good manufacturability and promising aerosol performance. The new technique has the potential to produce rugose particles using various other lipids.
PHARMACEUTICAL RESEARCH
(2022)
Article
Food Science & Technology
Preethi Jayaprakash, Claire Gaiani, Jean-Maxime Edorh, Frederic Borges, Elodie Beaupeux, Audrey Maudhuit, Stephane Desobry
Summary: This study investigates the benefits and drawbacks of electrostatic spray drying (ESD), a novel technique that uses electrostatic charge and lower temperatures to encapsulate lactic acid bacteria. The study compares the viability of Lacticaseibacillus rhamnosus GG (LGG) using different encapsulation agents and finds that ESD preserves more LGG cells during processing and provides better stability during storage compared to traditional spray drying (SD) and freeze drying (FD).
Article
Pharmacology & Pharmacy
Patricia Henriques, Ana Fortuna, Slavomira Doktorovova
Summary: Powders for nasal delivery have advantages over liquids and can be manufactured by spray drying. This review provides an overview of nasal powder formulation and processing, with a focus on the variables that impact on performance.
EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS
(2022)
Article
Pharmacology & Pharmacy
Jie-Liang Wang, Mahmoud S. Hanafy, Haiyue Xu, Jasmim Leal, Yufeng Zhai, Debadyuti Ghosh, Robert O. Williams, Hugh David Charles Smyth, Zhengrong Cui
Summary: Lipid nanoparticles can be transformed into aerosolizable dry powder by thin-film freeze-drying (TFFD), which preserves their physical properties and siRNA functionality. Dry powders prepared by TFFD show better aerosol performance properties compared to those prepared by spray drying.
INTERNATIONAL JOURNAL OF PHARMACEUTICS
(2021)
Review
Pharmacology & Pharmacy
Ashlee D. Brunaugh, Shivam Sharma, Hugh Smyth
Summary: Inhaled fixed-dose combination powders (I-FDCs) offer a promising approach for the treatment of respiratory infections by enabling simultaneous drug delivery at the site of infection. The use of co-spray drying shows potential for the development of composite anti-infective particles for inhalation. Future research may focus on including immunomodulatory agents or repurposed non-antibiotics in fixed-dose combinations.
EXPERT OPINION ON DRUG DELIVERY
(2021)
Article
Multidisciplinary Sciences
Ashlee D. Brunaugh, Hyojong Seo, Zachary Warnken, Li Ding, Sang Heui Seo, Hugh D. C. Smyth
Summary: The co-formulation of Niclosamide with human lysozyme enables the direct aerosol delivery of the drug to the respiratory tract, effectively treating COVID-19 by targeting the primary site of virus acquisition and spread. The novel formulation demonstrates potent activity against various coronavirus strains and may offer protection against secondary inflammatory lung damage, with low-cost development approach ensuring rapid clinical development and widespread utilization.
Article
Chemistry, Medicinal
Ashlee D. Brunaugh, Li Ding, Tian Wu, Michael Schneider, Ryan Khalaf, Hugh D. C. Smyth
Summary: Monoclonal antibody-based therapies have the potential to be a valuable treatment modality for acute and chronic lung diseases. Direct delivery to the lungs via inhalation can provide higher drug concentrations at the site of disease with reduced off-target effects. However, there is limited understanding of the impact of particle engineering processes on the stability and performance of dry powder inhaler formulations of monoclonal antibodies.
JOURNAL OF PHARMACEUTICAL SCIENCES
(2022)
Review
Pharmacology & Pharmacy
Li Ding, Ashlee D. Brunaugh, Sven Stegemann, Scott V. Jermain, Matthew J. Herpin, Justin Kalafat, Hugh D. C. Smyth
Summary: This review aims to provide information on critical factors to be considered for the development of capsule-based dry powder inhalers (cDPIs) using a quality by design (QbD) approach. Defining critical quality attributes is essential in order to understand critical material attributes and critical process parameters.
Article
Pharmacology & Pharmacy
Li Ding, Ashlee D. Brunaugh, Rishi Thakkar, Christian Lee, Qingyan Jenny Zhao, Justin Kalafat, Mohammed Maniruzzaman, Hugh D. C. Smyth
Summary: This study investigates the impact of different types of capsules on the aerosol performance of two DPI formulations. In carrier-based formulations, the capsule type does not significantly affect performance. However, for carrier-free formulations, there are some differences between capsule types.
Article
Pharmacology & Pharmacy
Nazareth E. Ceschan, Sebastian Scioli-Montoto, Maria Laura Sbaraglini, Maria Esperanza Ruiz, Hugh D. C. Smyth, Veronica Bucala, Maria Ramirez-Rigo
Summary: Hypertension is a chronic condition that can cause organ damage and cardiovascular diseases. Atenolol, a commonly used drug for hypertension and arrhythmia, has low oral bioavailability. This study proposes an alternative inhalatory system for Atenolol, which uses a spray-dried ion complex to release the drug. Experimental results showed that the system has good drug release performance and potential for cardiac targeting.
EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES
(2022)
Review
Pharmacology & Pharmacy
Jamie E. Spahn, Feng Zhang, Hugh D. C. Smyth
Summary: This article provides a comprehensive overview of the extensive application of solids mixing in the pharmaceutical science, with a focus on the key factors of ordered mixing in the preparation of dry powder inhalers.
INTERNATIONAL JOURNAL OF PHARMACEUTICS
(2022)
Article
Microbiology
Ashlee D. Brunaugh, Amanda Walz, Zachary Warnken, Camron Pearce, Juan Munoz Gutierrez, John J. Koleng, Hugh D. C. Smyth, Mercedes Gonzalez-Juarrero
Summary: Tuberculosis (TB) is a major disease in low- and middle-income countries. Inhaled drug delivery is a promising method for achieving high drug concentrations at infection sites. This study found that delivering drugs through the lungs can lead to faster bactericidal activity and that the infection status and administration route can affect drug pharmacokinetics. Additionally, the study showed that the formulation produced by air jet milling is stable during storage and aerosol performance.
ANTIMICROBIAL AGENTS AND CHEMOTHERAPY
(2022)
Article
Pharmacology & Pharmacy
Jamie E. Spahn, Amr Hefnawy, Hugh D. C. Smyth, Feng Zhang
Summary: This study assessed the feasibility of using twin-screw extruders as mixers for dry powder inhalation and found that they can effectively function as mixers for inhalable powders, thus enhancing the continuous manufacturing capability of dry powder inhalers.
INTERNATIONAL JOURNAL OF PHARMACEUTICS
(2022)
Article
Chemistry, Medicinal
Angela Ren, John J. Koleng III, Mark Costello, Jamie E. Spahn, Hugh D. C. Smyth, Feng Zhang
Summary: The feasibility of using a twin-screw corotating extruder as a continuous process mixer for preparing dry powder inhalation (DPI) powders was investigated. The study compared the performance of twin-screw mixing with low and high-shear batch mixing methods. The results showed that twin-screw mixing produced homogeneous mixtures with aerosol performance comparable to high-shear batch mixing, and the particles had similar morphology to both low and high-shear batch mixing.
JOURNAL OF PHARMACEUTICAL SCIENCES
(2023)
Article
Pharmacology & Pharmacy
Amr Hefnawy, Matthew J. Herpin, Michael Easton, Shrinidh Joshi, Don Jordan, Hugh D. C. Smyth, Jonathan Tarpy
Summary: This article reports the development and optimization of the ARI(TM) smart pMDI inhaler device with integrated spacer functionality. The design was optimized using simulations and validated through in vitro experiments. The results show that the ARI(TM) device, with its converging-diverging nozzle design, improves airflow and enhances the mixing between inhalation air and the propellent jet, leading to better aerosol performance compared to the unmodified Symbicort inhaler and the OptiChamber spacer.
JOURNAL OF PHARMACEUTICAL INNOVATION
(2023)
Article
Pharmacology & Pharmacy
Zachary Warnken, Andrea Trementozzi, Patricia P. Martins, Jagruti Parekh, John J. Koleng, Hugh D. C. Smyth, Ashlee Brunaugh
Summary: Clofazimine (CFZ) is an essential part of the World Health Organization's (WHO) recommended treatment for multi-drug resistant tuberculosis (MDR-TB). However, the lack of a dividable oral dosage form limits its use in pediatric populations. In this study, pediatric-friendly CFZ mini-tablets were prepared and showed promising results in terms of rapid disintegration and dissolution. Pharmacokinetic tests in rats demonstrated no significant difference between the mini-tablets and oral suspension, providing a proof-of-concept for an alternative, cost-effective oral delivery for CFZ in young children.
EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES
(2023)
Article
Chemistry, Analytical
Amitha K. Hewavitharana, P. Nicholas Shaw, H. D. C. Smyth, L. P. Samaranayake, H. M. H. N. Bandara
Summary: The study found that the use of stable isotope-labeled analogues as internal standards for matrix effects correction in LC-MS is most effective when the analyte and internal standard peaks completely overlap. Measuring the coelution degree between analytes and internal standards can help reduce data scatter and improve the accuracy of the analysis results.
LC GC NORTH AMERICA
(2021)