Good manufacturing practice- and good distribution practice-compliant cold storage and refrigerated transport of allergen products: what is important?

2021 ◽  
Author(s):  
Johanna Rost ◽  
Steve Langhein ◽  
Detlef Bartel ◽  
Andreas Bonertz ◽  
Vera Mahler
Keyword(s):  
Cold Storage ◽  
Pharmaceutical Formulations ◽  
Storage Conditions ◽  
Good Manufacturing Practice ◽  
Type I ◽  
Regulatory Requirements ◽  
Data Loggers ◽  
Entire Duration ◽  
Refrigerated Transport ◽  
Stability Data

Abstract Background All currently available products for diagnosis and therapy of type I allergies are protein extracts from allergenic source material. The extracted proteins have different properties and their structure is differently labile to temperature variations. Despite various pharmaceutical formulations to increase product stability, with few exceptions, allergen products must be refrigerated to ensure that their quality and native protein structure do not change during storage and transport. Maintaining quality is a challenge in complex distribution chains. Methods Regulatory requirements and guidelines that apply to cold storage and transport of allergen products are summarized and the responsibilities of the stakeholders are explained. Results The storage conditions determined in stability studies correspond to the transport conditions. These stability data can also be used to assess tolerable conditions during transport. According to a good distribution practice (GDP) contracts must be concluded between the responsible pharmaceutical entrepreneur and the qualified distribution service provider that regulate storage and transport in accordance with the product requirements. Conclusion Monitoring of storage and transport conditions is achieved by transport in qualified means of transport (e.g. truck). Alternatively, qualified transport packaging with active or passive cooling (e.g. cold packs) and qualified “data loggers” that record the transport temperatures can be used. Regardless of the system used, it must be demonstrated—by validating the transport conditions, routes and packaging at different times of the year and over the entire duration of transport—that regulatory requirements are met and that the quality of the products is maintained during shipment.

scholarly journals Thermolabile drug storage in an ambulatory setting

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Fernando do Pazo-Oubiña ◽  
Bartomeu Alorda-Ladaria ◽  
Ana Gomez-Lobon ◽  
Bàrbara Boyeras-Vallespir ◽  
María Margalida Santandreu-Estelrich ◽  
...  
Keyword(s):  
Tertiary Care ◽  
Statistical Treatment ◽  
Storage Conditions ◽  
Ambulatory Setting ◽  
Temperature Record ◽  
Care Hospital ◽  
Data Logger ◽  
Data Loggers ◽  
Ambulatory Patients ◽  
Clinical Consequences

AbstractMore thermolabile drugs are becoming available, and in most cases, these medications are dispensed to ambulatory patients. However, there is no regulation once medications are dispensed to patients and little is known with regard to what happens during transport and home storage. Previous studies suggest that these drugs are improperly stored. The present study was designed to determine the storage conditions of thermolabile drugs once they are dispensed to the patient in the Hospital Pharmacy Department. This is a prospective observational study to assess the temperature profile of 7 thermolabile drugs once they are dispensed to ambulatory patients at a tertiary care hospital. A data logger was added to the medication packaging. Temperature was considered inappropriate if one of the following circumstances were met: any temperature record less than or equal to 0 °C or over 25 °C; temperatures between 0–2 or 8–25 °C for a continuous period over 30 min. The time series of temperature measurements obtained from each data logger were analyzed as statistically independent variables. The data shown did not undergo any statistical treatment and must be considered directly related to thermal measurements. One hundred and fourteen patients were included and 107 patients were available for the analysis. On the whole, a mean of 50.6 days (SD 18.3) were measured and the mean temperature was 6.88 °C (SD 2.93). Three data loggers (2.8%) maintained all the measurements between 2 and 8 °C with less than 3 continuous data (< 30 min) out of this range but no data over 25 °C or below or equal to 0 °C. 28 (26.2%) data loggers had at least one measurement below zero, 1 data logger had a measurement greater than 25 °C and 75 (70.1%) were between 0 and 2 °C and/or between 8 and 25 °C for more than 30 min. In conclusion, once dispensed to patients, most thermolabile drugs are improperly stored. Future studies should focus on clinical consequences and possible solutions.

scholarly journals Investigation of the Physical, Chemical and Microbiological Stability of Losartan Potassium 5 mg/mL Extemporaneous Oral Liquid Suspension

Molecules ◽  
2021 ◽  
Vol 26 (2) ◽  
pp. 301
Author(s):  
Lisa Foley ◽  
Jennifer Toney ◽  
James W. Barlow ◽  
Maura O’Connor ◽  
Deirdre Fitzgerald-Hughes ◽  
...  
Keyword(s):  
Shelf Life ◽  
Storage Conditions ◽  
Losartan Potassium ◽  
Microbial Count ◽  
E Coli ◽  
Physical Chemical ◽  
Liquid Suspension ◽  
Oral Liquid ◽  
Microbiological Stability ◽  
Stability Data

Extemporaneous oral liquid preparations are commonly used when there is no commercially available dosage form for adjustable dosing. In most cases, there is a lack of stability data to allow for an accurately assigned shelf life and storage conditions to give greater confidence of product safety and efficacy over its shelf life. The aim of this study was to evaluate the physical, chemical and microbiological stability of an extemporaneous oral liquid suspension of losartan potassium, 5 mg/mL, used to treat paediatric hypertension in Our Lady’s Children’s Hospital Crumlin, Ireland. The losartan content of extemporaneous oral suspensions, prepared with and without addition of water, was measured by UV and confirmed by HPLC analysis. Suspensions were stored at 4 °C and room temperature (RT) and were monitored for changes in; pH, colour, odour, re-dispersibility, Total Aerobic Microbial Count, Total Yeast and Mould Count and absence of E. coli. Results showed that suspensions prepared by both methods, stored at 4 °C and RT, were physically and microbiologically stable over 28 days. Initial losartan content of all suspensions was lower than expected at 80–81% and did not change significantly over the 28 days. HPLC and NMR did not detect degradation of losartan in the samples. Suspensions prepared in water showed 100% losartan content. The reduced initial losartan content was confirmed by HPLC and was related to the acidic pH of the suspension vehicle. Physiochemical properties of the drug are important factors for consideration in the selection of suspension vehicle for extemporaneous compounding of oral suspensions as they can influence the quality, homogeneity and efficacy of these preparations.

scholarly journals Influence of cold-storage conditions on renal function of autotransplanted large pig kidneys

2000 ◽  
Vol 58 (2) ◽  
pp. 838-850 ◽  
Author(s):  
Jean Michel Goujon ◽  
Alain Vandewalle ◽  
Herve Baumert ◽  
Michel Carretier ◽  
Thierry Hauet
Keyword(s):  
Renal Function ◽  
Cold Storage ◽  
Storage Conditions

scholarly journals Fruit quality preservation of 'Laetitia' plums under controlled atmosphere storage

2014 ◽  
Vol 86 (1) ◽  
pp. 485-494 ◽  
Author(s):  
CRISTIANO ANDRÉ STEFFENS ◽  
CASSANDRO V.T. DO AMARANTE ◽  
ERLANI O. ALVES ◽  
AURI BRACKMANN
Keyword(s):  
Fruit Quality ◽  
Cold Storage ◽  
Ethylene Production ◽  
Titratable Acidity ◽  
Storage Conditions ◽  
Controlled Atmosphere ◽  
Controlled Atmosphere Storage ◽  
Red Color ◽  
High Incidence ◽  
Atmosphere Storage

The objective of this study was to evaluate the effect of controlled atmosphere (CA) on quality preservation of ‘Laetitia’ plums, mainly on internal breakdown, in order to determine the best CA storage conditions. Two experiments were carried out one in 2010, and another in 2011. In 2010, besides cold storage (CS; 21.0 kPa O2 + 0.03 kPa CO2), the fruits were stored under the following CA conditions (kPa O2+kPa CO2): 1+3, 1+5, 2+5, 2+10, and 11+10. In 2011, the fruits were stored under CS and CA of 1+0, 1+1, 2+1, and 2+2. The fruit stored under different CA conditions had lower respiration and ethylene production, better preservation of flesh firmness, texture and titratable acidity, lower skin red color, and lower incidence of skin cracking than the fruit in CS. In 2010, the fruit under CA with 2+5, 1+5, and 1+3 had a pronounced delay in ripening, although it exhibited a high incidence of internal breakdown. In 2011, the CA conditions with 2+1 and 2+2 provided the best delay in ripening and a reduced incidence of internal breakdown. The best CA condition for cold storage (at 0.5°C) of ‘Laetitia’ plums is 2 kPa O2 + 2 kPa CO2.

scholarly journals Evaluation of the Isotopic Abundance Ratio of Consciousness Energy Healing Treated L-Tryptophan Using LC-MS Spectrometry

2021 ◽  
Vol 2 (4) ◽  
pp. 10-18
Author(s):  
Dahryn Trivedi ◽  
Mahendra Kumar Trivedi ◽  
Alice Branton ◽  
Snehasis Jana
Keyword(s):  
Indole Alkaloids ◽  
Control Sample ◽  
Normal Growth ◽  
Pharmaceutical Formulations ◽  
Abundance Ratio ◽  
Type I ◽  
Isotopic Abundance ◽  
Analytical Technique ◽  
Energy Healing ◽  
The Impact

L-tryptophan is an essential α-amino acid, necessary for the normal growth in newborns, nitrogen balance in adults, protein synthesis, precursor of serotonin, melatonin, niacin, and albeit inefficiently in human, also the precursor of indole alkaloids and auxins in plants. This current study was designed to investigate the impact of the Trivedi Effect®-Biofield Energy Healing Treatment (Blessing) on the structural properties and the isotopic abundance ratio of L-tryptophan using LC-MS analytical technique. L-tryptophan sample was divided into two parts, one part of L-tryptophan was considered as the control sample (no Biofield Energy Treatment was provided), while the second part was treated with the Trivedi Effect®-Consciousness Energy Healing Treatment/Blessing remotely by a renowned Biofield Energy Healer, Dahryn Trivedi and termed as the treated sample. The mass spectra of both the control and treated samples with respect to the chromatographic peak at retention time (Rt) 2.1 minutes exhibited the mass of the molecular ion peak adduct with hydrogen ion at m/z 205.08 (calcd for C11H13N2O2+, 205.1), along with low molecular fragmented mass peaks at m/z 188, 159, and 102 for C11H12N2O2+, C10H11N2+, and C8H6+, respectively were also observed. The isotopic abundance ratio of PM+1/PM (2H/1H or 13C/12C or 15N/14Nor17O/16O) in the treated L-tryptophan was significantly increased by 35.93% compared with the control sample. Hence,the 13C, 2H, 15N, and 17O contributions from C11H13N2O2+ to m/z 206.08 in the treated L-tryptophan was significantly increased compared to the control sample. It could be hypothesized that the changes in the isotopic abundance and mass peak intensities due to the modification in nuclei possibly through the interference of neutrino particles using the Trivedi Effect®-Consciousness Energy Healing Treatment. The Biofield Energy Treated/Blessed L-tryptophan with increased stable isotopic abundance ratio might have changed the physicochemical properties with higher force constant in the molecule. The new form of treated L-tryptophan would be a better and more stable in the supplements, nutraceutical, and pharmaceutical formulations, which would be advantageous for the prevention and treatment of pellagra, depression, kynurenine. It could also maintain the normal label of tryptophan and avoid increase of its metabolite, lower the neurotoxin and a metabotoxin behavior, glutaric aciduria type I (glutaric acidemia type I) disorder, eosinophilia-myalgia syndrome (EMS), incurable and sometimes fatal flu-like neurological condition, etc. As tryptophan is the precursor for the plant hormones like indole alkaloids and auxins, hence, this treated L-tryptophan would be advantageous for the improvement of yield, productivity, and quality of crops and other plants.

scholarly journals Effect of 1-Methyl Cyclopropane and Modified Atmosphere Packaging on the Storage of Okra (Abelmoschus esculentus L.): Theory and Experiments

2020 ◽  
Vol 12 (18) ◽  
pp. 7547 ◽  
Author(s):  
Rabia Kanwal ◽  
Hadeed Ashraf ◽  
Muhammad Sultan ◽  
Irrum Babu ◽  
Zarina Yasmin ◽  
...  
Keyword(s):  
Shelf Life ◽  
Cold Storage ◽  
Combined Treatment ◽  
Chilling Injury ◽  
Modified Atmosphere Packaging ◽  
Storage Conditions ◽  
Modified Atmosphere ◽  
Overall Acceptability ◽  
Reduce Weight Loss ◽  
The Individual

Okra possesses a short shelf-life which limits its marketability, thereby, the present study investigates the individual and combined effect of 1-methylcyclopropene (1-MCP) and modified atmosphere packaging (MAP) on the postharvest storage life of okra. The treated/ untreated okra samples were stored at ambient (i.e., 27 °C) and low (i.e., 7 °C) temperatures for eight and 20 days, respectively. Results revealed that the 1-MCP and/or MAP treatment successfully inhibited fruit softening, reduction in mucilage viscosity, and color degradation (hue angle, ∆E, and BI) in the product resulting in a longer period of shelf-life. However, MAP with or without 1-MCP was more effective to reduce weight loss in okra stored at both ambient and cold storage conditions. Additionally, ascorbic acid and total antioxidants were also retained in 1-MCP with MAP during cold storage. The 1-MCP in combination with MAP effectively suppressed respiration rate and ethylene production for four days and eight days at 27 °C and 7 °C temperature conditions, respectively. According to the results, relatively less chilling injury stress also resulted when 1-MCP combined with MAP. The combined treatment of okra pods with 1-MCP and MAP maintained the visual quality of the product in terms of overall acceptability for four days at 20 °C and 20 days at 7 °C.

scholarly journals Control of Gray Mold on Clamshell-Packaged ‘Benitaka’ Table Grapes Using Sulphur Dioxide Pads and Perforated Liners

Pathogens ◽  
2019 ◽  
Vol 8 (4) ◽  
pp. 271 ◽  
Author(s):  
Osmar Jose Chaves Junior ◽  
Khamis Youssef ◽  
Renata Koyama ◽  
Saeed Ahmed ◽  
Allan Ricardo Dominguez ◽  
...  
Keyword(s):  
Mass Loss ◽  
Cold Storage ◽  
Storage Period ◽  
Storage Conditions ◽  
International Markets ◽  
Gray Mold ◽  
Additional Treatment ◽  
Table Grapes ◽  
Randomized Design ◽  
Dual Release

The use of vented clamshells has become popular in the packaging of grapes for local and international markets. The aim of this study is to evaluate the postharvest preservation of ‘Benitaka’ table grapes individually packaged in vented clamshells using different types of SO2-generating pads and perforated plastic liners during cold storage. A completely randomized design with four replications in a two-factor arrangement with an additional treatment [(4 × 3) + 1] was used. The trials were carried out under two situations: Artificial or natural infections with Botrytis cinerea, which is the causal agent of gray mold on table grapes. The incidence of gray mold, shattered berries, and stem browning were evaluated at 30 and 45 days of cold storage at 1 ± 1 °C and 3 days of shelf-life at 22 ± 1 °C after the period of cold storage. Mass loss and berry firmness were also examined at the end of the cold storage period. The use of dual-release SO2-generating pads containing 5 or 8 g of a.i. and slow-release pads with 7 g of a.i. was effective in controlling the incidence of gray mold in grapes packaged in vented clamshells and kept under cold storage for up to 45 days. Under these storage conditions, perforated plastic liners with 0.3% ventilation area or micro-perforated liners with 1.0% ventilation area reduced the percentage of mass loss and shattered berries.

Dissipation rates of procymidone and azoxystrobin in greenhouse grown lettuce and under cold storage conditions

2008 ◽  
Vol 88 (10) ◽  
pp. 737-746 ◽  
Author(s):  
José Fenoll ◽  
Pilar Hellín ◽  
María del Mar Camacho ◽  
Josefa López ◽  
Alberto González ◽  
...  
Keyword(s):  
Cold Storage ◽  
Storage Conditions ◽  
Dissipation Rates
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