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Drug Development and Industrial Pharmacy Sep 2021Pharmaceutical products delivered in multidose containers require in-use stability studies. Moreover, those pharmaceutical products requiring dilution or reconstitution... (Review)
Review
Pharmaceutical products delivered in multidose containers require in-use stability studies. Moreover, those pharmaceutical products requiring dilution or reconstitution prior to use also require in-use stability studies. In-use stability can be described as how well a pharmaceutical product remains stable during in-use within a particular closure system. During the in-use period, the pharmaceutical product remains within its physical, chemical, and microbiological specifications and retains its safety, efficacy, and performance. Even though the different guidelines are available, specific information for in-use stability studies that can smoothly guide applicant for regulatory submission is not at par. In-use stability studies should be performed in accordance to the various guidelines published by the regulatory agencies or by appropriate, justifiable ways that satisfy the regulators. This review explores current in-use stability guidelines, numerous examples of performed in-use stability studies, challenges to in-use stability and other relevant aspects.
Topics: Drug Packaging; Drug Stability; Pharmaceutical Preparations
PubMed: 34663148
DOI: 10.1080/03639045.2021.1994991 -
The Annals of Pharmacotherapy Oct 2022There is increasing concern about the quality of pharmaceuticals, especially generics made in Asia. Popular books and news reports have the public questioning the...
There is increasing concern about the quality of pharmaceuticals, especially generics made in Asia. Popular books and news reports have the public questioning the quality of pharmaceuticals. Recalls and import bans shake confidence in medications, particularly for active pharmaceutical ingredients and finished dosage forms made outside the United States. The Food and Drug Administration uses geography to allocate resources for manufacturing surveillance. Site of manufacturing labeling, including the country, could be linked to the facility's quality score to assess the risk of poor quality. Clinicians should advocate for legal and regulatory changes to increase the transparency of pharmaceutical manufacturing of products.
Topics: Asia; Drug Labeling; Drugs, Generic; Humans; Pharmaceutical Preparations; United States; United States Food and Drug Administration
PubMed: 35023388
DOI: 10.1177/10600280211069541 -
PDA Journal of Pharmaceutical Science... 2020
Topics: COVID-19; Drug Contamination; Drug Packaging; Patient Safety; Pharmaceutical Preparations; Quality Control; Risk Assessment; Technology, Pharmaceutical
PubMed: 32737241
DOI: 10.5731/pdajpst.2019.001120 -
Home Healthcare Now
Topics: Humans; Drug Packaging; Medication Errors; Product Packaging; Drug Labeling
PubMed: 37144934
DOI: 10.1097/NHH.0000000000001170 -
CMAJ : Canadian Medical Association... Feb 2020
Topics: Administration, Oral; Anxiety; Cannabis; Cardiovascular Diseases; Dose-Response Relationship, Drug; Dronabinol; Drug Labeling; Drug Packaging; Humans; Marijuana Use; Psychoses, Substance-Induced
PubMed: 32071107
DOI: 10.1503/cmaj.191305 -
Pain Medicine (Malden, Mass.) Sep 2019
Topics: Drug Contamination; Drug Packaging; Equipment Failure; Equipment Safety; Glass; Humans; Injections; Needles; Rubber
PubMed: 31184365
DOI: 10.1093/pm/pnz132 -
International Journal of Molecular... Mar 2022Plastic pollution is currently one of the most pressing environmental problems, especially in countries with a low recycling rate that is mainly due to the insufficient...
Plastic pollution is currently one of the most pressing environmental problems, especially in countries with a low recycling rate that is mainly due to the insufficient collection of plastic waste [...].
Topics: Drug Packaging; Plastics; Product Packaging; Recycling; Waste Management
PubMed: 35408966
DOI: 10.3390/ijms23073611 -
MMW Fortschritte Der Medizin Mar 2020
Review
Topics: Drug Packaging; Humans; Noncommunicable Diseases; Nutrition Assessment
PubMed: 32189270
DOI: 10.1007/s15006-020-0253-x -
International Journal of Biological... May 2022Poly (3-hydroxybutyrate) (PHB) is a valuable bio-based and biodegradable polymer that may substitute common polymers in packaging and biomedical applications provided... (Review)
Review
Poly (3-hydroxybutyrate) (PHB) is a valuable bio-based and biodegradable polymer that may substitute common polymers in packaging and biomedical applications provided that the production cost is reduced and some properties improved. Blending PHB with other biodegradable polymers is the most simple and accessible route to reduce costs and to improve properties. This review provides a comprehensive overview on the preparation, properties and application of the PHB blends with other biodegradable polyesters such as medium-chain-length polyhydroxyalkanoates, poly(ε-caprolactone), poly(lactic acid), poly(butylene succinate), poly(propylene carbonate) and poly (butylene adipate-co-terephthalate) or polysaccharides and their derivatives. A special attention has been paid to the miscibility of PHB with these polymers and the compatibilizing methods used to improve the dispersion and interface. The changes in the PHB morphology, thermal, mechanical and barrier properties induced by the second polymer have been critically analyzed in view of industrial application. The biodegradability and recyclability strategies of the PHB blends were summarized along with the processing techniques adapted to the intended application. This review provides the tools for a better understanding of the relation between the micro/nanostructure of PHB blends and their properties for the further development of PHB blends as solutions for biodegradable packaging.
Topics: 3-Hydroxybutyric Acid; Drug Packaging; Polyesters; Polyhydroxyalkanoates; Product Packaging
PubMed: 35257732
DOI: 10.1016/j.ijbiomac.2022.02.185 -
International Journal of Molecular... Mar 2024Antidepressant drugs play a crucial role in the treatment of mental health disorders, but their efficacy and safety can be compromised by drug degradation. Recent... (Review)
Review
Antidepressant drugs play a crucial role in the treatment of mental health disorders, but their efficacy and safety can be compromised by drug degradation. Recent reports point to several drugs found in concentrations ranging from the limit of detection (LOD) to hundreds of ng/L in wastewater plants around the globe; hence, antidepressants can be considered emerging pollutants with potential consequences for human health and wellbeing. Understanding and implementing effective degradation strategies are essential not only to ensure the stability and potency of these medications but also for their safe disposal in line with current environment remediation goals. This review provides an overview of degradation pathways for amitriptyline, a typical tricyclic antidepressant drug, by exploring chemical routes such as oxidation, hydrolysis, and photodegradation. Connex issues such as stability-enhancing approaches through formulation and packaging considerations, regulatory guidelines, and quality control measures are also briefly noted. Specific case studies of amitriptyline degradation pathways forecast the future perspectives and challenges in this field, helping researchers and pharmaceutical manufacturers to provide guidelines for the most effective degradation pathways employed for minimal environmental impact.
Topics: Humans; Amitriptyline; Antidepressive Agents, Tricyclic; Drug Packaging; Environmental Pollutants; Environmental Restoration and Remediation
PubMed: 38612638
DOI: 10.3390/ijms25073822