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  1. Article: R. D. Laing and long-stay patients: discrepant accounts of the refractory ward and 'rumpus room' at Gartnavel Royal Hospital.

    Abrahamson, David

    History of psychiatry

    2007  Volume 18, Issue 70 Pt 2, Page(s) 203–215

    Abstract: R. D. Laing's mental hospital experience has been considered a formative influence ...

    Abstract R. D. Laing's mental hospital experience has been considered a formative influence on his controversial views. This paper addresses a number of discrepancies in the existing accounts: important aspects of the refractory ward and 'rumpus room' were underestimated; all the 'rumpus room' patients were not discharged and readmitted as repeatedly stated; his interactions with the patients were very limited and the viewpoints of most remain unknown; and the introduction of Largactil (chlorpromazine) was not mentioned. The Kingsley Hall residential project, Laing's first book The Divided Self, and his influence on psychiatrists' attitudes are considered in the light of these findings. Pessimism about long-stay patients may have influenced the acceptance of inaccurate information.
    MeSH term(s) History, 20th Century ; Hospitals, Psychiatric/history ; Humans ; Patient Readmission ; Schizophrenia/history ; Scotland
    Language English
    Publishing date 2007-06
    Publishing country England
    Document type Biography ; Historical Article ; Journal Article
    ZDB-ID 1028145-9
    ISSN 1740-2360 ; 0957-154X
    ISSN (online) 1740-2360
    ISSN 0957-154X
    DOI 10.1177/0957154X06073635
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  2. Article ; Online: Novel ultrasensitive immunoassay for the selective quantification of tau oligomers and related soluble aggregates.

    Islam, Tohidul / Kvartsberg, Hlin / Sehrawat, Anuradha / Kac, Przemysław R / Becker, Bruno / Olsson, Maria / Abrahamson, Eric E / Zetterberg, Henrik / Ikonomovic, Milos D / Blennow, Kaj / Karikari, Thomas K

    Alzheimer's & dementia : the journal of the Alzheimer's Association

    2024  Volume 20, Issue 4, Page(s) 2894–2905

    Abstract: Introduction: Tau aggregation into paired helical filaments and neurofibrillary tangles is characteristic of Alzheimer's disease (AD) and related disorders. However, biochemical assays for the quantification of soluble, earlier-stage tau aggregates are ... ...

    Abstract Introduction: Tau aggregation into paired helical filaments and neurofibrillary tangles is characteristic of Alzheimer's disease (AD) and related disorders. However, biochemical assays for the quantification of soluble, earlier-stage tau aggregates are lacking. We describe an immunoassay that is selective for tau oligomers and related soluble aggregates over monomers.
    Methods: A homogeneous (single-antibody) immunoassay was developed using a novel anti-tau monoclonal antibody and validated with recombinant and brain tissue-derived tau.
    Results: The assay signals were concentration dependent for recombinant tau aggregates in solution but not monomers, and recognized peptides within, but not outside, the aggregation-prone microtubule binding region. The signals in inferior and middle frontal cortical tissue homogenates increased with neuropathologically determined Braak staging, and were higher in insoluble than soluble homogenized brain fractions. Autopsy-verified AD gave stronger signals than other neurodegenerative diseases.
    Discussion: The quantitative oligomer/soluble aggregate-specific assay can identify soluble tau aggregates, including oligomers, from monomers in human and in vitro biospecimens.
    Highlights: The aggregation of tau to form fibrils and neurofibrillary tangles is a key feature of Alzheimer's disease. However, biochemical assays for the quantification of oligomers/soluble aggregated forms of tau are lacking. We developed a new assay that preferentially binds to soluble tau aggregates, including oligomers and fibrils, versus monomers. The assay signal increased corresponding to the total protein content, Braak staging, and insolubility of the sequentially homogenized brain tissue fractions in an autopsy-verified cohort. The assay recognized tau peptides containing the microtubule binding region but not those covering the N- or C-terminal regions only.
    MeSH term(s) Humans ; Alzheimer Disease/diagnosis ; Alzheimer Disease/metabolism ; tau Proteins/metabolism ; Neurofibrillary Tangles ; Immunoassay ; Peptides/metabolism
    Chemical Substances tau Proteins ; Peptides
    Language English
    Publishing date 2024-03-23
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2211627-8
    ISSN 1552-5279 ; 1552-5260
    ISSN (online) 1552-5279
    ISSN 1552-5260
    DOI 10.1002/alz.13711
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  3. Book: International taxation of manufacturing and distribution

    Abrahamson, John

    (Series on international taxation ; volume 56)

    2016  

    Abstract: ... interest flows -- Group restructures and taxation issues for capital gains -- R&D and intellectual property ...

    Author's details John Abrahamson
    Series title Series on international taxation ; volume 56
    Abstract Introduction -- Overview of international taxation -- Examples of country tax systems -- Manufacturing -- Procurement companies -- Distribution and regional sales companies -- Shipping and air transport -- Value added tax -- Customs duties and tariffs -- The digital economy -- Social security taxes -- Tax incentives -- Taxation issues for dividends and profit distributions -- Taxation issues for funding and interest flows -- Group restructures and taxation issues for capital gains -- R&D and intellectual property -- Treasury and in-house banking companies -- Group insurance companies : captive insurance -- Taxation issues for mergers and acquisitions -- Acquisitions and sale and purchase agreements -- Tax due diligence for mergers and acquisitions -- Asset leasing -- Derivatives : options, forwards and swaps -- Interest deductions in subsidiaries and thin capitalisation -- Tax havens and controlled foreign corporations rules -- Introduction to transfer pricing -- Transfer pricing issues for manufacturing and distribution -- Intangibles and transfer pricing -- Intra-group services and trnsfer pricing -- Loan financing, interest payments and transfer pricing -- General conclusions -- Case studies -- Case study 1. International tax issues : investing into Malaysia -- Case study 2. Permanent establishments and sales activities -- Case study 3. Tax residence and domestic tax laws -- Case study 4. Permanent establishments and manufacturing -- Case study 5. Repatriating profits : tax treaties and domestic tax laws -- Case study 6. Asset acquisitions and mergers and acquisitions planning -- Case study 7. Analysis of due diligence reports for mergers and acquisitions -- Case study 8. Group funding and treasury structures -- Case study 9. Manufacturing, distribution, and group transfer pricing -- Case study 10. Group intellectual property and transfer pricing
    Keywords Double taxation ; International business enterprises/Taxation/Law and legislation ; Manufacturing industries/Taxation/Law and legislation ; Unternehmensbesteuerung ; Steuerrecht ; Internationales Steuerrecht ; Doppelbesteuerung ; Verrechnungspreis ; Welt
    Language English
    Size XXX, 461 Seiten, Illustrationen
    Publishing place Alphen aan den Rijn
    Document type Book
    ISBN 9789041166647 ; 9041166645
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  4. Article ; Online: Advanced therapeutic inhalation aerosols of a Nrf2 activator and RhoA/Rho kinase (ROCK) inhibitor for targeted pulmonary drug delivery in pulmonary hypertension: design, characterization, aerosolization,

    Acosta, Maria F / Muralidharan, Priya / Grijalva, Carissa L / Abrahamson, Michael D / Hayes, Don / Fineman, Jeffrey R / Black, Stephen M / Mansour, Heidi M

    Therapeutic advances in respiratory disease

    2021  Volume 15, Page(s) 1753466621998245

    Abstract: Inhalable nanostructured microparticles of simvastatin, a Nrf2 activator and RhoA/Rho kinase (ROCK) inhibitor, were rationally designed for targeted pulmonary delivery as dry powder inhalers (DPIs) for the treatment of pulmonary hypertension (PH). ... ...

    Abstract Inhalable nanostructured microparticles of simvastatin, a Nrf2 activator and RhoA/Rho kinase (ROCK) inhibitor, were rationally designed for targeted pulmonary delivery as dry powder inhalers (DPIs) for the treatment of pulmonary hypertension (PH). Advanced particle engineering design technology was employed to develop inhalable dry powders using different dilute feed concentrations and spray drying pump rates. Several analytical techniques were used comprehensively to characterize the physicochemical properties of the resulting powders. Scanning electron microscopy (SEM) was used to visualize particle morphology (shape), surface structure, size, and size distribution. Karl Fischer titration (KFT) was employed to quantify the residual water content in the powders. X-ray powder diffraction (XRPD) was used to determine crystallinity. Hot-stage microscopy (HSM) under cross-polarizing lens was used to observe the presence or absence of birefringence characteristic of crystallinity. Differential scanning calorimetry (DSC) was employed to quantify thermotropic phase behavior. Attenuated total reflectance (ATR)-Fourier-transform infrared (FTIR) spectroscopy and Raman spectroscopy were used to determine the molecular fingerprint of simvastatin powders before and after particle engineering design.
    MeSH term(s) Administration, Inhalation ; Aerosols ; Animals ; Cell Culture Techniques ; Crystallization ; Disease Models, Animal ; Drug Delivery Systems ; Dry Powder Inhalers ; Humans ; Hypertension, Pulmonary/drug therapy ; Hypertension, Pulmonary/physiopathology ; Lung/metabolism ; Lung/physiopathology ; Male ; NF-E2-Related Factor 2/drug effects ; NF-E2-Related Factor 2/metabolism ; Nanostructures ; Particle Size ; Powders ; Rats ; Rats, Sprague-Dawley ; Sheep ; Simvastatin/administration & dosage ; Simvastatin/chemistry ; Simvastatin/pharmacology ; Vascular Resistance/drug effects ; rho-Associated Kinases/antagonists & inhibitors
    Chemical Substances Aerosols ; NF-E2-Related Factor 2 ; Powders ; Simvastatin (AGG2FN16EV) ; rho-Associated Kinases (EC 2.7.11.1)
    Language English
    Publishing date 2021-03-15
    Publishing country England
    Document type Comparative Study ; Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
    ZDB-ID 2476459-0
    ISSN 1753-4666 ; 1753-4658
    ISSN (online) 1753-4666
    ISSN 1753-4658
    DOI 10.1177/1753466621998245
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    Zs.A 6753: Show issues Location:
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  5. Article ; Online: Central line-associated bloodstream infections at the multidisciplinary intensive care unit of Universitas Academic Hospital, Bloemfontein, South Africa.

    Glover, E / Abrahamson, A / Adams, J / Poken, S R / Hainsworth, S-L / Lamprecht, A / Delport, T / Keulder, T / Olivier, T / Maasdorp, S D

    African journal of thoracic and critical care medicine

    2022  Volume 28, Issue 1

    Abstract: Background: Central line-associated bloodstream infections (CLABSIs) are frequently encountered device-related healthcare-associated infections in critically ill patients, causing substantial morbidity, mortality and prolonged hospitalisation.: ... ...

    Abstract Background: Central line-associated bloodstream infections (CLABSIs) are frequently encountered device-related healthcare-associated infections in critically ill patients, causing substantial morbidity, mortality and prolonged hospitalisation.
    Objectives: To determine the incidence of CLABSI, median catheter dwell-time prior to developing CLABSI, as well as the causative microorganisms of CLABSI among patients admitted to the multidisciplinary intensive care unit (MICU) at Universitas Academic Hospital, Bloemfontein.
    Methods: We conducted a retrospective review of medical and laboratory records of all MICU patients who had a central line placed between January and December 2018.
    Results: A total of 377 patients were admitted to the MICU in 2018, of which 182 met the inclusion criteria for the present study. From the cohort of 182 patients, 16.5% (n=30) of patients presented with 32 CLABSI episodes, with two patients having had two independent episodes each. A total of 1 215 central line days were recorded, yielding a CLABSI rate of 26.3/1 000-line days. Laboratory analysis identified microorganisms in 38 blood cultures, with Gram-negative organisms (55.3%; n=21) being predominant over Gram-positive organisms (39.5%; n=15) and fungi (5.3%; n=2).
    Conclusion: The incidence of CLABSI at the MICU at Universitas Academic Hospital is high. Urgent intervention with strict compliance to prevention bundles is required to reduce the high incidence of CLABSI.
    Language English
    Publishing date 2022-05-05
    Publishing country South Africa
    Document type Journal Article
    ZDB-ID 2945902-3
    ISSN 2617-0205 ; 2617-0191
    ISSN (online) 2617-0205
    ISSN 2617-0191
    DOI 10.7196/AJTCCM.2022.v28i1.175
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  6. Article ; Online: Inhalable Nanoparticles/Microparticles of an AMPK and Nrf2 Activator for Targeted Pulmonary Drug Delivery as Dry Powder Inhalers.

    Acosta, Maria F / Abrahamson, Michael D / Encinas-Basurto, David / Fineman, Jeffrey R / Black, Stephen M / Mansour, Heidi M

    The AAPS journal

    2020  Volume 23, Issue 1, Page(s) 2

    Abstract: Metformin is an activator of the AMPK and Nrf2 pathways which are important in the pathology of several complex pulmonary diseases with unmet medical needs. Organic solution advanced spray drying in the absence of water in closed-mode was used to design ... ...

    Abstract Metformin is an activator of the AMPK and Nrf2 pathways which are important in the pathology of several complex pulmonary diseases with unmet medical needs. Organic solution advanced spray drying in the absence of water in closed-mode was used to design and develop respirable dry powders. Following comprehensive characterization, the influence of physicochemical properties was correlated with performance as aerosols using inertial impaction and three different human dry powder inhaler (DPI) devices varying in device properties. In vitro cell assays were conducted to test safety in 2D human pulmonary cell lines and in 3D small airway epithelia comprising primary cells at the air-liquid interface (ALI). In addition, in vitro transepithelial electrical resistance (TEER) was carried out. Metformin remained crystalline following advanced spray drying under these conditions. All SD powders consisted of nanoparticles/microparticles in the solid state. In vitro aerosol dispersion performance showed high aerosolization for all SD metformin powders with all DPI devices tested. High emitted dose for all powders with all three DPI devices was measured. Differences in other aerosol performance parameters and the interplay between the properties of different formulations produced at specific pump rates and the three different DPI devices were correlated with spray drying pump rate and device properties. Safety over a wide metformin dose range was also demonstrated in vitro. Aerosol delivery of metformin nanoparticles/microparticles has the potential to be a new "first-in-class" therapeutic for the treatment of a number of pulmonary diseases including pulmonary vascular diseases such as pulmonary hypertension.
    MeSH term(s) AMP-Activated Protein Kinases/metabolism ; Administration, Inhalation ; Aerosols ; Cell Line ; Drug Compounding/methods ; Dry Powder Inhalers ; Humans ; Hypertension, Pulmonary/drug therapy ; Metformin/administration & dosage ; NF-E2-Related Factor 2/agonists ; Nanoparticles/administration & dosage ; Particle Size ; Powders ; Primary Cell Culture ; Spray Drying
    Chemical Substances Aerosols ; NF-E2-Related Factor 2 ; NFE2L2 protein, human ; Powders ; Metformin (9100L32L2N) ; AMP-Activated Protein Kinases (EC 2.7.11.31)
    Language English
    Publishing date 2020-11-16
    Publishing country United States
    Document type Journal Article ; Research Support, N.I.H., Extramural
    ISSN 1550-7416
    ISSN (online) 1550-7416
    DOI 10.1208/s12248-020-00531-3
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  7. Article ; Online: Development of an item bank for measuring prosthetic mobility in people with lower limb amputation: The Prosthetic Limb Users Survey of Mobility (PLUS-M).

    Hafner, Brian J / Amtmann, Dagmar / Morgan, Sara J / Abrahamson, Daniel C / Askew, Robert L / Bamer, Alyssa M / Salem, Rana / Gaunaurd, Ignacio A / Gailey, Robert S / Czerniecki, Joseph M / Fatone, Stefania / Fergason, John R / Fothergill, Ian / Kelly, Valerie E / Weber, Eric L / Whiteneck, Gale G

    PM & R : the journal of injury, function, and rehabilitation

    2023  Volume 15, Issue 4, Page(s) 456–473

    Abstract: Background: Achieving mobility with a prosthesis is a common post-amputation rehabilitation goal and primary outcome in prosthetic research studies. Patient-reported outcome measures (PROMs) available to measure prosthetic mobility have practical and ... ...

    Abstract Background: Achieving mobility with a prosthesis is a common post-amputation rehabilitation goal and primary outcome in prosthetic research studies. Patient-reported outcome measures (PROMs) available to measure prosthetic mobility have practical and psychometric limitations that inhibit their use in clinical care and research.
    Objective: To develop a brief, clinically meaningful, and psychometrically robust PROM to measure prosthetic mobility.
    Design: A cross-sectional study was conducted to administer previously developed candidate items to a national sample of lower limb prosthesis users. Items were calibrated to an item response theory model and two fixed-length short forms were created. Instruments were assessed for readability, effective range of measurement, agreement with the full item bank, ceiling and floor effects, convergent validity, and known groups validity.
    Setting: Participants were recruited using flyers posted in hospitals and prosthetics clinics across the United States, magazine advertisements, notices posted to consumer websites, and direct mailings.
    Participants: Adult prosthesis users (N = 1091) with unilateral lower limb amputation due to traumatic or dysvascular causes.
    Interventions: Not applicable.
    Main outcome measures: Candidate items (N = 105) were administered along with the Patient Reported Outcome Measurement Information System Brief Profile, Prosthesis Evaluation Questionnaire - Mobility Subscale, and Activities-Specific Balance Confidence Scale, and questions created to characterize respondents.
    Results: A bank of 44 calibrated self-report items, termed the Prosthetic Limb Users Survey of Mobility (PLUS-M), was produced. Clinical and statistical criteria were used to select items for 7- and 12-item short forms. PLUS-M instruments had an 8th grade reading level, measured with precision across a wide range of respondents, exhibited little-to-no ceiling or floor effects, correlated expectedly with scores from existing PROMs, and differentiated between groups of respondents expected to have different levels of mobility.
    Conclusion: The PLUS-M appears to be well suited to measuring prosthetic mobility in people with lower limb amputation. PLUS-M instruments are recommended for use in clinical and research settings.
    MeSH term(s) Adult ; Humans ; United States ; Artificial Limbs ; Lower Extremity/surgery ; Cross-Sectional Studies ; Amputation, Surgical ; Surveys and Questionnaires ; Amputees/rehabilitation
    Language English
    Publishing date 2023-03-31
    Publishing country United States
    Document type Journal Article ; Research Support, N.I.H., Extramural
    ZDB-ID 2608988-9
    ISSN 1934-1563 ; 1934-1482
    ISSN (online) 1934-1563
    ISSN 1934-1482
    DOI 10.1002/pmrj.12962
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    Zs.A 6951: Show issues Location:
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  8. Article ; Online: Global assessment improves risk stratification for major adverse cardiac events across a wide range of triglyceride levels: Insights from the KP REACH study.

    Wagner, Jeffrey R / Fitzpatrick, Jesse K / Yang, Jingrong / Sung, Sue Hee / Allen, Amanda R / Philip, Sephy / Granowitz, Craig / Abrahamson, David / Ambrosy, Andrew P / Go, Alan S

    American journal of preventive cardiology

    2022  Volume 9, Page(s) 100319

    Abstract: Objective: Patients with risk factors for or established atherosclerotic cardiovascular disease (ASCVD) remain at high risk for subsequent ischemic events despite statin therapy. Triglyceride (TG) levels may contribute to residual ASCVD risk, and the ... ...

    Abstract Objective: Patients with risk factors for or established atherosclerotic cardiovascular disease (ASCVD) remain at high risk for subsequent ischemic events despite statin therapy. Triglyceride (TG) levels may contribute to residual ASCVD risk, and the performance of global risk assessment calculators across a broad range of TG levels is unknown.
    Methods: We performed a retrospective cohort study of Kaiser Permanente Northern California members aged ≥45 years with ≥1 ASCVD risk factor (primary prevention cohort) or established ASCVD (secondary prevention cohort) between 2010 and 2017 who were receiving statin therapy and had a low-density lipoprotein cholesterol between 41-100 mg/dL. Global ASCVD risk assessment was performed using both the Kaiser Permanente ASCVD Risk Estimator (KPARE) and the ACC/AHA ASCVD Pooled Cohort Equation (PCE). Outcomes included major adverse cardiovascular events (MACE) defined as myocardial infarction, stroke, or peripheral artery disease, and expanded MACE (MACE + coronary revascularization + hospitalization for unstable angina).
    Results: Among 373,389 patients in the primary prevention cohort, median TG was 122 mg/dL (IQR 88-172 mg/dL) and there were 0.2 MACE events and 0.3 expanded MACE events per 100-person years. Among 97,832 patients in the secondary prevention cohort, median TG level was 116 mg/dL (IQR 84-164 mg/dL) and there were 9.6 MACE events and 22.0 expanded MACE events per 100-person years. KPARE and the ACC/AHA PCE stratified patients for MACE and expanded MACE over the entire range of TGs.
    Conclusion: In a cohort receiving statin therapy for primary or secondary prevention, we found global assessment further improves risk stratification for initial and/or recurrent ASCVD events irrespective of baseline TG level.
    Language English
    Publishing date 2022-01-29
    Publishing country Netherlands
    Document type Journal Article
    ISSN 2666-6677
    ISSN (online) 2666-6677
    DOI 10.1016/j.ajpc.2022.100319
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  9. Article ; Online: A novel workflow to fabricate a patient-specific 3D printed accommodative foot orthosis with personalized latticed metamaterial.

    Hudak, Yuri F / Li, Jing-Sheng / Cullum, Scott / Strzelecki, Brian M / Richburg, Chris / Kaufman, G Eli / Abrahamson, Daniel / Heckman, Jeffrey T / Ripley, Beth / Telfer, Scott / Ledoux, William R / Muir, Brittney C / Aubin, Patrick M

    Medical engineering & physics

    2022  Volume 104, Page(s) 103802

    Abstract: Patients with diabetes mellitus are at elevated risk for secondary complications that result in lower extremity amputations. Standard of care to prevent these complications involves prescribing custom accommodative insoles that use inefficient and ... ...

    Abstract Patients with diabetes mellitus are at elevated risk for secondary complications that result in lower extremity amputations. Standard of care to prevent these complications involves prescribing custom accommodative insoles that use inefficient and outdated fabrication processes including milling and hand carving. A new thrust of custom 3D printed insoles has shown promise in producing corrective insoles but has not explored accommodative diabetic insoles. Our novel contribution is a metamaterial design application that allows the insole stiffness to vary regionally following patient-specific plantar pressure measurements. We presented a novel workflow to fabricate custom 3D printed elastomeric insoles, a testing method to evaluate the durability, shear stiffness, and compressive stiffness of insole material samples, and a case study to demonstrate how the novel 3D printed insoles performed clinically. Our 3D printed insoles results showed a matched or improved durability, a reduced shear stiffness, and a reduction in plantar pressure in clinical case study compared to standard of care insoles.
    MeSH term(s) Foot Orthoses ; Humans ; Pressure ; Printing, Three-Dimensional ; Shoes ; Workflow
    Language English
    Publishing date 2022-04-14
    Publishing country England
    Document type Journal Article ; Research Support, U.S. Gov't, Non-P.H.S.
    ZDB-ID 1181080-4
    ISSN 1873-4030 ; 1350-4533
    ISSN (online) 1873-4030
    ISSN 1350-4533
    DOI 10.1016/j.medengphy.2022.103802
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  10. Article ; Online: Comparison of l-Carnitine and l-Carnitine HCL salt for targeted lung treatment of pulmonary hypertension (PH) as inhalation aerosols: Design, comprehensive characterization, in vitro 2D/3D cell cultures, and in vivo MCT-Rat model of PH.

    Acosta, Maria F / Muralidhran, Priya / Abrahamson, Michael D / Grijalva, Carissa L / Carver, Megan / Tang, Haiyang / Klinger, Christina / Fineman, Jeffrey R / Black, Stephen M / Mansour, Heidi M

    Pulmonary pharmacology & therapeutics

    2021  Volume 65, Page(s) 101998

    Abstract: Disrupted l-Carnitine (L-Car) homeostasis has been implicated in the development of pulmonary hypertension (PH). L-Car has been administered orally and intravenously causing systemic side effects. To the authors' knowledge, there are no reports using L- ... ...

    Abstract Disrupted l-Carnitine (L-Car) homeostasis has been implicated in the development of pulmonary hypertension (PH). L-Car has been administered orally and intravenously causing systemic side effects. To the authors' knowledge, there are no reports using L-Car or L-Car HCl as an inhaled aerosol through the respiratory route in a targeted manner either from dry powder inhaler (DPI) or liquid delivery system. The purpose of the comprehensive and systematic comparative study between L-Car and L-Car HCl salt was to design and develop dry powder inhalers (DPIs) of each. This was followed by comprehensive physicochemical characterization, in vitro cell viability as a function of dose on 2D human pulmonary cell lines from different lung regions and in vitro cell viability on 3D small airway epithelia human primary cells at the air-liquid interface (ALI). In addition in vitro transepithelial electrical resistance (TEER) in air-interface culture (AIC) conditions on 2D human pulmonary cell line and 3D small airway epithelia human primary cells was carried out. In vitro aerosol dispersion performance using three FDA-approved human DPI devices with different device properties was also examined. Following advanced spray drying under various conditions, two spray drying pump rates (low and medium) were found to successfully produce spray-dried L-Car powders while four spray drying pump rates (low, medium, medium-high, and high) all resulted in the production of spray-dried L-Car HCl powders. Raw L-Car and L-Car HCl were found to be crystalline. All SD powders retained crystallinity following spray drying and polymorphic interconversion in the solid-state was identified as the mechanism for retaining crystallinity after the advanced spray drying process. All SD powders aerosolized readily with all three human DPI devices. However, the in vitro dispersion parameters for the SD powders was not conducive for in vivo administration to rats in DPIs due to hygroscopicity and nanoaggreation. In vivo rat studies were successfully accomplished using inhaled liquid aerosols. Safety was successfully demonstrated in vivo in healthy Sprague Dawley rats. Furthermore, therapeutic efficacy was successfully demonstrated in vivo in the monocrotaline (MCT)-rat model of PH after two weeks of daily L-Car inhalation aerosol treatment.
    MeSH term(s) Administration, Inhalation ; Aerosols ; Animals ; Carnitine ; Cell Culture Techniques ; Dry Powder Inhalers ; Hypertension, Pulmonary/drug therapy ; Lung ; Monocrotaline ; Particle Size ; Powders ; Rats ; Rats, Sprague-Dawley
    Chemical Substances Aerosols ; Powders ; Monocrotaline (73077K8HYV) ; Carnitine (S7UI8SM58A)
    Language English
    Publishing date 2021-02-05
    Publishing country England
    Document type Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't ; Research Support, U.S. Gov't, Non-P.H.S.
    ZDB-ID 1399707-5
    ISSN 1522-9629 ; 1094-5539
    ISSN (online) 1522-9629
    ISSN 1094-5539
    DOI 10.1016/j.pupt.2021.101998
    Database MEDical Literature Analysis and Retrieval System OnLINE

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