Development and Characterization of Excipient Enhanced Growth (EEG) Surfactant Powder Formulations for Treating Neonatal Respiratory Distress Syndrome

Boc, Susan; Momin, Mohammad A.M.; Farkas, Dale; Longest, P. Worth; Hindle, Michael

doi:10.1208/s12249-021-02001-1

Cited by 13 publications

(6 citation statements)

References 51 publications

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“…Whereas most clinical and synthetic lung surfactant formulations are liquids and consist of SP-B and/or SP-C (peptide mimics) in a phospholipid mixture, dry powder surfactant undergoes spray-drying steps aimed at controlling particle size, density, shape, charge, solid state, and hygroscopicity in order to manipulate agglomeration and powder blending ( 30 ). Formulation strategies may include the addition of hygroscopic excipients, such as sugars (e.g., lactose, trehalose, and mannitol) and sodium chloride, and/or dispersion enhancers, such as l-leucine, to alter particle-particle interaction forces and improve the deagglomeration of the fine particles ( 31 , 32 ). These newer micron-sized dry powder synthetic lung surfactant formulations, such as B-YL:Trehalose surfactant ( 21 , 31 ), are highly surface active, possess the required aerosolization characteristics, and are biophysically stable.…”

Section: Surfactantmentioning

confidence: 99%

Aerosol Delivery of Lung Surfactant and Nasal CPAP in the Treatment of Neonatal Respiratory Distress Syndrome

Walther

Waring²

2022

Front. Pediatr.

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After shifting away from invasive mechanical ventilation and intratracheal instillation of surfactant toward non-invasive ventilation with nasal CPAP and less invasive surfactant administration in order to prevent bronchopulmonary dysplasia in preterm infants with respiratory distress syndrome, fully non-invasive surfactant nebulization is the next Holy Grail in neonatology. Here we review the characteristics of animal-derived (clinical) and new advanced synthetic lung surfactants and improvements in nebulization technology required to secure optimal lung deposition and effectivity of non-invasive lung surfactant administration. Studies in surfactant-deficient animals and preterm infants have demonstrated the safety and potential of non-invasive surfactant administration, but also provide new directions for the development of synthetic lung surfactant destined for aerosol delivery, implementation of breath-actuated nebulization and optimization of nasal CPAP, nebulizer circuit and nasal interface. Surfactant nebulization may offer a truly non-invasive option for surfactant delivery to preterm infants in the near future.

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Section: Surfactantmentioning

confidence: 99%

Aerosol Delivery of Lung Surfactant and Nasal CPAP in the Treatment of Neonatal Respiratory Distress Syndrome

Walther

Waring²

2022

Front. Pediatr.

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“…Our previous studies have described the in vitro performance of a new low air volume small animal air-jet dry powder insufflator (Rat AJ DPI) developed for EEG powder aerosol delivery using small volumes of actuation air. 10,21 In this paper, we describe the in vitro and in vivo aerosol performance of the Rat AJ DPI and benchmark its performance compared with the Penn-Century DP-4 DPI using a model albuterol EEG formulation.…”

Section: Introductionmentioning

confidence: 99%

“…Chai et al conducted a proof-of-concept study to develop an EEG powder aerosol containing mucus-inert nanoparticles for pulmonary delivery . Similarly, a commercial surfactant formulation, Survanta intratracheal suspension, was formulated as a spray-dried powder aerosol using the EEG technology as an alternative means of delivering replacement surfactant therapy for the treatment of respiratory distress syndrome . Tobramycin EEG formulations have been developed and delivered by novel dry powder inhalers that nearly eliminate pediatric extrathoracic aerosol deposition based on in vitro evaluations. , Momin et al studied the long-term storage stability of spray-dried Survanta EEG powders stored at 0% RH/–20 °C and found that the powders remained stable over 18 months with minimal changes in crystallinity .…”

Section: Introductionmentioning

confidence: 99%

“…This was designed to deliver small masses of powder to test animals using a low volume of dispersion air. , This device is no longer available commercially for purchase, and alternative devices with equivalent or improved delivery efficiency are needed. Our previous studies have described the in vitro performance of a new low air volume small animal air-jet dry powder insufflator (Rat AJ DPI) developed for EEG powder aerosol delivery using small volumes of actuation air. , In this paper, we describe the in vitro and in vivo aerosol performance of the Rat AJ DPI and benchmark its performance compared with the Penn-Century DP-4 DPI using a model albuterol EEG formulation.…”

Section: Introductionmentioning

confidence: 99%

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New Air-Jet Dry Powder Insufflator for High-Efficiency Aerosol Delivery to Rats

et al. 2023

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Pulmonary deposition of lung-targeted therapeutic aerosols can achieve direct drug delivery to the site of action, thereby enhancing the efficacy and reducing systemic exposure. In this study, we investigated the in vitro and in vivo aerosol performance of the novel small animal air-jet dry powder insufflator (Rat AJ DPI) using spray-dried albuterol excipient-enhancedgrowth (EEG) powder as a model formulation. The in vitro aerosolization performance of the optimized albuterol EEG powder was first assessed using the Rat AJ DPI. The performance of Rat AJ DPI to deliver albuterol EEG aerosol to rat lungs was then compared to that of the Penn-Century Insufflator. Albuterol EEG powders dispersed using the Rat AJ DPI demonstrated narrow unimodal aerosol size distribution profiles, which were independent of the loaded powder dose (1, 2, and 5 mg). In addition, the span value for Rat AJ DPI (5 mg powder mass) was 1.32, which was 4.2fold lower than that for Penn-Century insufflator (5 mg powder mass). At a higher loaded mass of 5 mg, the Rat AJ DPI delivered significantly larger doses to rat lungs compared with the Penn-Century DPI. The Rat AJ DPI with hand actuation delivered approximately 85% of the total emitted dose (2 and 5 mg loadings), which was comparatively higher than that for Penn-Century DPI (approximately 75%). In addition, percentage deposition in each of the lung lobes for the Rat AJ DPI was observed to be independent of the administration dose (2 and 5 mg loadings) with coefficients of variation below 12%, except in the right middle lobe. Automatic actuation of a 5 mg powder mass using the Rat AJ DPI demonstrated a similar delivered dose compared to manual actuation of the same dose, with 82% of the total emitted dose reaching the lung lobes. High-efficiency delivery of the aerosol to the lobar lung region and low sensitivity of the interlobar delivery efficiency to the loaded dose highlight the suitability of the new air-jet DPI for administering therapeutic pharmaceutical aerosols to small test animals.

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“…21,22 Surfactant molecule self-organisation and effects on water uptake in aerosols have much more general signicance in different medical and commercial contexts. Inhaled therapeutic aerosols may deliver surfactants as active ingredients (as in the treatment of infant respiratory distress syndrome) 23,24 or excipients, where they effect hygroscopicity. 25 Hygroscopic growth and water uptake in inhaled drugs affects efficient delivery to the lungs.…”

Section: Introductionmentioning

confidence: 99%

Acoustic levitation with polarising optical microscopy (AL-POM): water uptake in a nanostructured atmospheric aerosol proxy

Milsom,

Squires,

Brasnett

et al. 2023

Environ. Sci.: Atmos.

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Development and Characterization of Excipient Enhanced Growth (EEG) Surfactant Powder Formulations for Treating Neonatal Respiratory Distress Syndrome

Cited by 13 publications

References 51 publications

Aerosol Delivery of Lung Surfactant and Nasal CPAP in the Treatment of Neonatal Respiratory Distress Syndrome

Aerosol Delivery of Lung Surfactant and Nasal CPAP in the Treatment of Neonatal Respiratory Distress Syndrome

New Air-Jet Dry Powder Insufflator for High-Efficiency Aerosol Delivery to Rats

Acoustic levitation with polarising optical microscopy (AL-POM): water uptake in a nanostructured atmospheric aerosol proxy

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