| 1. |
- Albinsson, Eva, et al.
(author)
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Unpredictable supplementation of vitamin D to infants in the neonatal intensive care unit : An experimental study.
- 2024
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In: Acta Paediatrica. - : Wiley-Blackwell Publishing Inc.. - 0803-5253 .- 1651-2227.
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Journal article (peer-reviewed)abstract
- AIM: Extremely premature infants receive nutrition and medication through nasogastric tubes. Breastmilk given accordingly is subject to fat loss. This study aimed to investigate whether this could also apply to vitamin D.METHODS: A questionnaire investigated vitamin D administration at a level III neonatal intensive care unit in Sweden in 2021. Feeding simulations with breastmilk and various vitamin D mixtures were done accordingly. After administration, vitamin D3 concentration was analysed using chromatography with mass spectrometry, followed by repeated simulations with vitamin D mixtures without breastmilk in 2023.RESULTS: The questionnaire was completed by 10 persons. Vitamin D was administered as drops using an enteral syringe and a nasogastric tube in conjunction with a breastmilk meal. In the feeding simulations, vitamin D3 concentration after administration was significantly higher using a syringe alone compared to standard administration. When vitamins were administered according to standard but without breastmilk, 100% of the vitamin D and 40% of the multivitamins were lost. The vitamins adhered to the material, mainly in the nasogastric tube.CONCLUSION: Our findings indicate that standard vitamin D supplementation in the neonatal intensive care unit may be unpredictable when administered by enteral syringe and nasogastric tube. We suggest using direct oral administration whenever possible.
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| 2. |
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| 3. |
- Angsten, Gertrud, et al.
(author)
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Improved outcome in neonatal short bowel syndrome using parenteral fish oil in combination With ω-6/9 Lipid Emulsions
- 2012
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In: JPEN - Journal of Parenteral and Enteral Nutrition. - : Wiley. - 0148-6071 .- 1941-2444. ; 36:5, s. 587-595
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Journal article (peer-reviewed)abstract
- Background:Newborn infants with short bowel syndrome (SBS) represent a high risk group of developing intestinal failure-associated liver disease (IFALD) which may be fatal. However, infants have a great capacity for intestinal growth and adaptation if IFALD can be prevented or reversed. A major contributing factor to IFALD may be the soybean oil-based intravenous lipid emulsions used since the introduction of parenteral nutrition (PN) 40 years ago. Methods:This retrospective study compares the outcome in 20 neonates with SBS treated with parenteral fish oil (Omegaven) in combination with omega-6/9 lipid emulsions (ClinOleic) with the outcome in a historical cohort of 18 patients with SBS who received a soybean oil-based intravenous lipid emulsion (Intralipid).Results:Median gestational age was 26 weeks in the treatment group and 35.5 weeks in the historical group. All patients were started on PN containing Intralipid that was switched to ClinOleic/Omegaven in the treatment group at a median age of 39 gestational weeks. In the treatment group, direct bilirubin levels were reversed in all 14 survivors with cholestasis (direct bilirubin >50 umol/). Median time to reversal was 2.9 months. Only 2 patients died of liver failure (10%). In the historical cohort, 6 patients (33%) died of liver failure and only 2 patients showed normalization of bilirubin levels.Conclusions:Parenteral fish oil in combination with omega-6/9 lipid emulsions was associated with improved outcome in premature neonates with SBS. When used instead of traditional soybean-based emulsions, this mixed lipid emulsion may facilitate intestinal adaptation by increasing the IFALD-free period.
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| 4. |
- Bramer, Tobias, et al.
(author)
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Catanionic drug-surfactant mixtures : Phase behavior and sustained release from gels
- 2003
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In: Pharmaceutical research. - 0724-8741 .- 1573-904X. ; 20:10, s. 1661-1667
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Journal article (peer-reviewed)abstract
- PURPOSE: To study mixtures of SDS and the drugs diphenhydramine, tetracaine, and amitriptyline to compile phase diagrams and to investigate the use of interesting phases for sustained release from gels. METHODS: Phase diagrams were composed by studying large numbers of different compositions of negatively charged SDS and positively charged drug compounds visually, rheologically, and by cryotransmission electron microscopy. Drug release from Carbopol 940 and agar gels containing interesting phases, e.g., vesicle and branched micelle phases, was measured in vitro by the USP paddle method. RESULTS: Vesicles and elongated and branched micelles were formed on the SDS-rich side in all three systems examined. The tetracaine system differed from the other two in that it showed a vesicle area in the drug-rich side. Release of diphenhydramine from Carbopol 940 gels was slowed by at least a factor of 10 when in the form of vesicles or branched micelles. The same delay was found for both drug-rich and SDS-rich tetracaine vesicles. CONCLUSIONS: Mixtures of SDS and positively charged drugs form the same interesting phases as traditional catanionic mixtures. This may prove useful in obtaining functional controlled-release systems when using gels as drug carriers.
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| 6. |
- Cappelletto, Elia, et al.
(author)
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Impact of Post Manufacturing Handling of Protein-Based Biologic Drugs on Product Quality and User Centricity
- 2024
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In: Journal of Pharmaceutical Sciences. - : Elsevier B.V.. - 0022-3549 .- 1520-6017.
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Research review (peer-reviewed)abstract
- This article evaluates the current gaps around the impact of post-manufacturing processes on the product qualities of protein-based biologics, with a focus on user centricity. It includes the evaluation of the regulatory guidance available, describes a collection of scientific literature and case studies to showcase the impact of post-manufacturing stresses on product and dosing solution quality. It also outlines the complexity of clinical handling and the need for communication, and alignment between drug providers, healthcare professionals, users, and patients. Regulatory agencies provide clear expectations for drug manufacturing processes, however, guidance supporting post-product manufacturing handling is less defined and often misaligned. This is problematic as the pharmaceutical products experience numerous stresses and processes which can potentially impact drug quality, safety and efficacy. This article aims to stimulate discussion amongst pharmaceutical developers, health care providers, device manufacturers, and public researchers to improve these processes. Patients and caregivers' awareness can be achieved by providing relevant educational material on pharmaceutical product handling.
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| 7. |
- Cappelletto, Elia, et al.
(author)
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Impact of Post Manufacturing Handling of Protein-Based Biologic Drugs on Product Quality and User Centricity
- 2024
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In: Journal of Pharmaceutical Sciences. - : Elsevier. - 0022-3549 .- 1520-6017.
-
Journal article (peer-reviewed)abstract
- This article evaluates the current gaps around the impact of post-manufacturing processes on the product qualities of protein-based biologics, with a focus on user centricity. It includes the evaluation of the regulatory guidance available, describes a collection of scientific literature and case studies to showcase the impact of post-manufacturing stresses on product and dosing solution quality. It also outlines the complexity of clinical handling and the need for communication, and alignment between drug providers, healthcare professionals, users, and patients. Regulatory agencies provide clear expectations for drug manufacturing processes, however, guidance supporting post-product manufacturing handling is less defined and often misaligned. This is problematic as the pharmaceutical products experience numerous stresses and processes which can potentially impact drug quality, safety and efficacy. This article aims to stimulate discussion amongst pharmaceutical developers, health care providers, device manufacturers, and public researchers to improve these processes. Patients and caregivers' awareness can be achieved by providing relevant educational material on pharmaceutical product handling.
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| 8. |
- Fredriksson, Fanny, 1985-, et al.
(author)
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Improved Outcome of Intestinal Failure in Preterm Infants
- 2020
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In: Journal of Pediatric Gastroenterology and Nutrition - JPGN. - : Wolters Kluwer. - 0277-2116 .- 1536-4801. ; 71:2, s. 223-231
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Journal article (peer-reviewed)abstract
- OBJECTIVE: The aims were to evaluate the outcome and to identify predictors for survival and enteral autonomy in neonatal intestinal failure (IF).METHODS: A retrospective observational study in a Swedish tertiary centre of children born between 1995 and 2016 with neonatal IF, defined as dependency on parenteral nutrition (PN) ≥60 days, starting with PN before the age of 44 gestational weeks. Data were extracted from medical records and predictors for survival and enteral autonomy were identified by the Cox regression model. Time to death and weaning off PN analysis were performed with Kaplan-Meier curves including log rank test.RESULTS: In total, 105 children were included. Median gestational age was 28 weeks (22-42), 50% were born extremely preterm (<28 gestational weeks). PN started at a median age of two days (0-147) with a median duration of 196 days (60-3091). Necrotising enterocolitis was the dominating cause of IF (61%). Overall survival was 88%, five children died of sepsis and four of intestinal failure-associated liver disease. Survival increased from 75% during 1995-2008 to 96% during 2009-2016 (p = 0.0040). Age-adjusted small bowel length of >50% and birth 2009-2016 were predictors for survival. Enteral autonomy was achieved in 87%, with positive prediction by small bowel length of >25% of expected for gestational age and remaining ileocaecal valve.CONCLUSION: Preterm neonates with IF, at high risk of IF associated morbidity, showed a high overall survival rate. Small-bowel length and being born 2009-2016 were predictors for survival and remaining ICV and small-bowel length were predictors for enteral autonomy.
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| 9. |
- Gallagher, Valery, et al.
(author)
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Parenteral nutrition : a call to action for harmonization of policies to increase patient safety.
- 2020
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In: European Journal of Clinical Nutrition. - : Springer Science and Business Media LLC. - 0954-3007 .- 1476-5640. ; 75:1, s. 3-11
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Journal article (peer-reviewed)abstract
- Unsafe medication practices and medication errors are leading causes of injury and avoidable harm worldwide and are highest in vulnerable groups. In 2017, the World Health Organization launched the third Medication Without Harm Global Patient Safety Challenge to try to reduce risks related to medical treatment. Parenteral nutrition (PN) is in the unique position that, although licensed products are available from manufacturers, formulas may be prepared ad hoc for first-line use that might not be subject to the same regulatory oversight. Safety issues around PN can arise through lack of harmonization in practices, misinterpretation and product unfamiliarity and can occur at any stage from prescription to preparation to administration. Government legislation and regulation vary considerably, with PN not explicitly handled in many countries. We therefore call on policy leaders in all countries to establish policies that ensure patient safety, and that these include PN along with medicines. The available evidence supports obtaining industry prepared PN as first-line therapy for reasons of safety, primarily, and of cost. If a suitable industry prepared ready-to-use PN is not available, standardized all-in-one PN admixtures should be the next line of care, with individualized PN being reserved for patients whose complex nutritional needs cannot be met using standardized admixtures.
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| 10. |
- Hyrenius-Wittsten, Axel, et al.
(author)
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De novo activating mutations drive clonal evolution and enhance clonal fitness in KMT2A-rearranged leukemia
- 2018
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In: Nature Communications. - : Springer Science and Business Media LLC. - 2041-1723. ; 9:1
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Journal article (peer-reviewed)abstract
- Activating signaling mutations are common in acute leukemia with KMT2A (previously MLL) rearrangements (KMT2A-R). These mutations are often subclonal and their biological impact remains unclear. Using a retroviral acute myeloid mouse leukemia model, we demonstrate that FLT3 ITD, FLT3 N676K, and NRAS G12D accelerate KMT2A-MLLT3 leukemia onset. Further, also subclonal FLT3 N676K mutations accelerate disease, possibly by providing stimulatory factors. Herein, we show that one such factor, MIF, promotes survival of mouse KMT2A-MLLT3 leukemia initiating cells. We identify acquired de novo mutations in Braf, Cbl, Kras, and Ptpn11 in KMT2A-MLLT3 leukemia cells that favored clonal expansion. During clonal evolution, we observe serial genetic changes at the Kras G12D locus, consistent with a strong selective advantage of additional Kras G12D . KMT2A-MLLT3 leukemias with signaling mutations enforce Myc and Myb transcriptional modules. Our results provide new insight into the biology of KMT2A-R leukemia with subclonal signaling mutations and highlight the importance of activated signaling as a contributing driver.
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