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MAbs 2023Three critical aspects that define high concentration antibody products (HCAPs) are as follows: 1) formulation composition, 2) dosage form, and 3) primary packaging...
A systematic review of commercial high concentration antibody drug products approved in the US: formulation composition, dosage form design and primary packaging considerations.
Three critical aspects that define high concentration antibody products (HCAPs) are as follows: 1) formulation composition, 2) dosage form, and 3) primary packaging configuration. HCAPs have become successful in the therapeutic sector due to their unique advantage of allowing subcutaneous self-administration. Technical challenges, such as physical and chemical instability, viscosity, delivery volume limitations, and product immunogenicity, can hinder successful development and commercialization of HCAPs. Such challenges can be overcome by robust formulation and process development strategies, as well as rational selection of excipients and packaging components. We compiled and analyzed data from US Food and Drug Administration-approved and marketed HCAPs that are ≥100 mg/mL to identify trends in formulation composition and quality target product profile. This review presents our findings and discusses novel formulation and processing technologies that enable the development of improved HCAPs at ≥200 mg/mL. The observed trends can be used as a guide for further advancements in the development of HCAPs as more complex antibody-based modalities enter biologics product development.
Topics: Pharmaceutical Preparations; Drug Packaging; Excipients; Viscosity
PubMed: 37243580
DOI: 10.1080/19420862.2023.2205540 -
International Journal of Environmental... Sep 2019New drug safety issues are emerging that are beyond the existing medication safety management system. To pre-empt these problems, forecasting future drug safety trends...
New drug safety issues are emerging that are beyond the existing medication safety management system. To pre-empt these problems, forecasting future drug safety trends and issues is a necessity. The objective of this study was to identify issues and future trends impacting drug safety using foresight methodologies. The study started by identifying global megatrends, trends in safety management of medicines, and key issues in drug safety. A total of 25 global megatrends were selected by extracting and clustering keywords from 26 reports concerning the future. Using the text-mining method, 10 trends in drug safety were identified from 3593 news articles. This study derived 60 issues which can arise from the trends, and finally, the 20 key issues with the highest urgency and impact scores were selected. Some examples of issues with high scores were as follows: illegal distribution of medicines, lack of technology for managing and utilizing big data, change in the pharmaceutical trade environment, lack of education and safety management for specific populations, lack of artificial intelligence-based technology for the safety management of medicines, and the prevalence of drug advertisements through social network services. The key issues could be used to establish plans for medication safety management.
Topics: Drug Labeling; Forecasting; Guidelines as Topic; Humans; Prescription Drugs; Republic of Korea; Safety Management
PubMed: 31547245
DOI: 10.3390/ijerph16183368 -
European Journal of Hospital Pharmacy :... Sep 2020The aim of this study was to review the literature regarding the external contamination of commercial vials by antineoplastic drugs. A PubMed and CINAHL searches from 1... (Review)
Review
The aim of this study was to review the literature regarding the external contamination of commercial vials by antineoplastic drugs. A PubMed and CINAHL searches from 1 January 1990 to 1 May 2018 was performed with the terms: « antineoplastic agents », « environmental monitoring », « drug packaging », « vials » and « contamination ». Articles that presented results on the external contamination of commercial vials were included. Twenty-four articles were identified from 11 countries. A total of 4248 vials were sampled from 28 manufacturers. Traces were found on 56% (2379/4248) of vials. A maximum of 150 000 ng was measured on a glass vial of fluorouracil. This literature review showed that the exterior of the majority of commercial antineoplastic vials was contaminated. Manufacturers should limit this contamination. Centres are also encouraged to clean the vials on receipt. Personal protection equipment should be worn at all steps of the drug-use process.
Topics: Antineoplastic Agents; Drug Packaging; Equipment Contamination; Occupational Exposure; Pharmacy Service, Hospital
PubMed: 32839267
DOI: 10.1136/ejhpharm-2018-001705 -
Advanced Materials (Deerfield Beach,... Mar 2020The globalization of drug trade leads to the expansion of pharmaceutical counterfeiting. The immense threat of low quality drugs to millions of patients is considered to... (Review)
Review
The globalization of drug trade leads to the expansion of pharmaceutical counterfeiting. The immense threat of low quality drugs to millions of patients is considered to be an under-addressed global health challenge. Analytical authentication technologies are the most effective methods to identify active pharmaceutical ingredients and impurities. However, most of these analytical testing techniques are expensive and need skilled personnel. To combat counterfeiting of drugs, the package of an increasing number of drugs is being protected through advanced package labeling technologies. Though, package labeling is only effective if the drugs are not repackaged. Therefore "in-drug labeling," instead of "drug package labeling," may become powerful tools to protect drugs. This review aims to overview how advanced micro- and nanomaterials might become interesting markers for the labeling of tablets and capsules. Clearly, how well such identifiers can be integrated into "solid drugs" without compromising drug safety and efficacy remains a challenge. Also, incorporation of tags has so far only been reported for the protection of solid drug dosage forms. No doubts that in-drug labeling technologies for "liquid drugs," like injectables which contain expensive peptides, monoclonal antibodies, vaccines, dermal fillers, could help to protect them from counterfeiting as well.
Topics: Capsules; Counterfeit Drugs; Drug Labeling; Drug Packaging; Fraud; Nanostructures; Nanotechnology; Tablets
PubMed: 32009266
DOI: 10.1002/adma.201905486 -
Journal of Healthcare Engineering 2021Many clinically important drugs come directly or indirectly from higher plants. People are increasingly aware of the role of the human immune system in maintaining good...
Many clinically important drugs come directly or indirectly from higher plants. People are increasingly aware of the role of the human immune system in maintaining good health. Diseases related to physical dysfunction, such as vertigo, have attracted increasing attention from medical researchers and clinicians. In this paper, some compounds isolated and identified from medicinal fomes showed promising antivertigo properties. Medical images were used to classify and synthesize polysaccharides in the management of drug subpackages of intracellular polysaccharides. The scientific explanation of how these compounds work in animal and human systems is increasing exponentially. Studies have found that all of these compounds can enhance the innate and adaptive immune responses of the host and activate various immune cells that are important for maintaining homeostasis, such as host cells and chemical messengers, triggering complement and acute phase reactions. The antivertigo compounds derived from the intracellular polysaccharides of Phellinus mucronatus had an activity interference of 35% without drug subpackage. Although the antivertigo activity of many intracellular polysaccharides from Fovea xylostella can reach 86%, only a few of them have been proved to have antivertigo activity. In addition, they can be considered as multicytokine inducers that can induce the expression of various immune-regulatory cytokines and cytokine receptor genes. Lymphocytes that control antibody production and cell-mediated cytotoxicity are also stimulated.
Topics: Animals; Drug Packaging; Humans; Orchidaceae; Polysaccharides
PubMed: 34394888
DOI: 10.1155/2021/3793610 -
Journal of Pharmaceutical and... Oct 2023Although the secondary packing materials do not directly contact the finished drug products, compound migration may still happen between them. To ensure drug quality and...
Although the secondary packing materials do not directly contact the finished drug products, compound migration may still happen between them. To ensure drug quality and safety, extractables and leachables of the packing materials should be analyzed. In this study, 2,6-di-tert-butyl-4-methylphenol (BHT) was first found in the labels for pharmaceutical packaging. For the identification of the compound, a strategy combining high performance liquid chromatography (HPLC), ultra-performance liquid chromatography-quadrupole time-of-flight mass (UPLC-Q-TOF-MS) and nuclear magnetic resonance (NMR) spectroscopy was utilized. Afterwards, a effective and sensitive HPLC method for quantification of BHT was developed and validated. Finally, a toxicological risk assessment of BHT was performed to ensure the safety of drugs.
Topics: Drug Packaging; Chromatography, Liquid; Chromatography, High Pressure Liquid; Pharmaceutical Preparations
PubMed: 37523869
DOI: 10.1016/j.jpba.2023.115591 -
American Journal of Preventive Medicine Nov 2022As cannabis increasingly becomes a consumer product in the U.S., its product packaging has become critically important to regulators. This study examined the influence...
INTRODUCTION
As cannabis increasingly becomes a consumer product in the U.S., its product packaging has become critically important to regulators. This study examined the influence of recreational cannabis packaging characteristics.
METHODS
Five online between-subjects experiments were conducted in April 2021, and data were analyzed in May 2021-July 2021. Experiments randomized participants to view different (1) types of cannabis, (2) visual displays of tetrahydrocannabinol content, (3) cannabis packages designed around brand personality research, (4) health warnings, and (5) health claims. Outcomes included cognitive, affective, and behavioral responses.
RESULTS
A total of 841 adults from the U.S. (49% male, 50% young adults, 44% White, 17% Hispanic) were included in the study. Edible gummies were perceived as healthier (β=0.32, 95% CI=0.03, 0.62), less grown up (β= -0.58, 95% CI= -0.86, -0.28), and more socially acceptable to consume (β=0.30, 95% CI=0.01, 0.59) than cannabis concentrate in a medical dropper. Participants also had more interest in trying edible gummies (β=1.33, 95% CI=1.04, 1.62) and trying a free sample (β=1.30, 95% CI=1.01, 1.60) than trying cannabis concentrate. Cannabis packages with a helps-you-relax health claim elicited more happy (β=0.34, 95% CI=0.04, 0.64) and good (β=0.37, 95% CI=0.07, 0.67) feelings than cannabis packages without this claim. Minimal effects were found for visual displays of tetrahydrocannabinol content and health warnings.
CONCLUSIONS
Edibles are a unique type of cannabis that should be given special consideration under state laws, and lawmakers should consider limiting and governing the use of both implicit and explicit health claims on recreational cannabis packages when implementing laws.
Topics: Young Adult; Male; Humans; Female; Cannabis; Dronabinol; Intention; Product Packaging; Drug Packaging
PubMed: 35835626
DOI: 10.1016/j.amepre.2022.04.030 -
BMC Pharmacology & Toxicology Aug 2021Antiretroviral drugs (ARVs) have significantly reduced morbidity, mortality and improved the quality of life of people living with HIV infection. Poor quality ARVs may...
BACKGROUND
Antiretroviral drugs (ARVs) have significantly reduced morbidity, mortality and improved the quality of life of people living with HIV infection. Poor quality ARVs may result in harmful consequences such as adverse drug reactions, treatment failure and development of drug resistant strains and sometimes death, which in turn may undermine the healthcare delivery system. To ensure optimal treatment outcomes, medicines quality control must be undertaken regularly. This study was aimed at evaluating the quality of ARVs circulating on the Tanzania Mainland market.
METHODS
This was a survey study. ARVs samples were collected in 20 regions of Tanzania Mainland, between 2012 and 2018. All sampled ARVs were subjected to screening testing using the Global Pharma Health Fund® Mini-Lab kits. Sampled ARV's that failed screening test or yielded doubtful results and 10 % (10 %) of all that complied with the screening test requirements were selected for full quality control testing. Quality control testing was conducted at the Tanzania Medicines and Medical Devices Authority (TMDA) laboratory a World Health Organisation prequalified. Samples collected from the medicine distribution outlets were also, subjected to product information review.
RESULTS
A total of 2,630 samples were collected, of which 83.7 % (2200/2630) were from port of entry (POEs). All sampled ARVs were screened and conformed to the specifications, except of the fixed dose combination (FDC) lopinavir/ritonavir 0.27 % (7/2630) and lamivudine/zidovudine/nevirapine 0.27 % (7/2630) that failed the disintegration test. Out of the 100 samples selected for full quality control testing, 3 % of them failed to comply with the specifications, of which FDC stavudine/lamivudine/nevirapine failed disintegration and assay tests 2 % (2/100) and 1 % (1/100), respectively. Samples failing the assay test had low content of stavudine (86.6 %) versus specification limits (90 -110 %). Out of the 430 samples which were subjected to product information review, 25.6 % (110/430) failed to comply with the TMDA packaging and labelling requirements.
CONCLUSIONS
The quality of majority of ARVs circulating on the Tanzania Mainland market was good, even so, significant deficiencies on labelling and packaging were observed. These results call for continuous monitoring of quality of medicines circulating on the Tanzania Mainland market.
Topics: Anti-HIV Agents; Drug Combinations; Drug Labeling; Drug Packaging; Quality Control; Tanzania
PubMed: 34446094
DOI: 10.1186/s40360-021-00514-w -
International Journal of Biological... Mar 2024The limitation of conventional packaging in demonstrating accurate and real-time food expiration dates leads to food waste and foodborne diseases. Real-time food quality... (Review)
Review
The limitation of conventional packaging in demonstrating accurate and real-time food expiration dates leads to food waste and foodborne diseases. Real-time food quality monitoring via intelligent packaging could be an effective solution to reduce food waste and foodborne illnesses. This review focuses on recent technological advances incorporated into food packaging for monitoring food spoilage, with a major focus on paper-based sensors and their combination with smartphone. This review paper offers a comprehensive exploration of advanced macromolecular technologies in biodegradable packaging, a general overview of paper-based probes and their incorporation into food packaging coupled with intelligent sensing mechanisms for monitoring food freshness. Given the escalating global concerns surrounding food waste, our manuscript serves as a pivotal resource, consolidating current research findings and highlighting the transformative potential of these innovative packaging solutions. We also highlight the current intelligent paper-based food freshness sensors and their various advantages and limitations. Examples of implementation of paper-based sensors/probes for food storage and their accuracy are presented. Finally, we examined how intelligent packaging can be an alternative to reduce food waste. Several technologies discussed here have good potential to be used in food packaging for real-time food monitoring, especially when combined with smartphone diagnosis.
Topics: Humans; Food Loss and Waste; Food; Refuse Disposal; Drug Packaging; Food Packaging; Foodborne Diseases
PubMed: 38281527
DOI: 10.1016/j.ijbiomac.2024.129647 -
Annals of Internal Medicine Apr 2024
Topics: United States; Humans; Food Labeling; United States Food and Drug Administration; Drug Labeling
PubMed: 38466998
DOI: 10.7326/M23-3266