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1.
Zhonghua Liu Xing Bing Xue Za Zhi ; 42(7): 1286-1291, 2021 Jul 10.
Article in Chinese | MEDLINE | ID: mdl-34814545

ABSTRACT

To summarize the development and application of tree-based scan statistic (TreeScan), explain the methodology and provide a reference for future use of this method by reviewing the original pharmacoepidemiological and vaccine studies using the TreeScan. Medline, Embase and Web of Science databases were used for the retrieval of eligible studies using keywords related to TreeScan. A total of 15 eligible studies were included, in which 9 studies explored the adverse events of drugs and 6 studies focused on the safety of vaccines. Three types of models (Poisson probability model, Bernoulli probability model and tree-temporal scan statistic model) of TreeScan were used. The major differences among the three models were 1) whether predefined control was used according to research question, 2) whether the time from exposure to onset of adverse events was considered. Several studies explored its ability by comparing with other methods for adverse event detection or by using known adverse events. This review shows that TreeScan is an effective method for the safety signal detection of drugs or vaccines, which develops rapidly and globally. It is very necessary to promote its use in drug safety monitoring and other related fields in China.


Subject(s)
Pharmaceutical Preparations , Vaccines , Data Mining , Databases, Factual , Humans , Pharmacoepidemiology , Vaccines/adverse effects
2.
Inquiry ; 58: 469580211055630, 2021.
Article in English | MEDLINE | ID: mdl-34818922

ABSTRACT

The current situation of Coronavirus Disease 2019 (COVID-19) worldwide is still very severe. Presently, many breakthroughs have been accomplished in the research and development of drugs for the treatment of COVID-19, especially vaccines; however, some of the so-called COVID-19-specific drugs highlighted in the early stage failed to achieve the expected curative effect. There is no antiviral therapy available, by stimulating protective immunity vaccine is the best choice for the future management of infection. Therefore, we aimed to identify the latest developments in the research and development of these drugs and vaccines and provide a reference for the prevention and treatment of COVID-19.


Subject(s)
COVID-19 , Pharmaceutical Preparations , Vaccines , Antiviral Agents/therapeutic use , COVID-19 Vaccines , Humans , SARS-CoV-2
3.
Internist (Berl) ; 62(10): 1123-1132, 2021 Oct.
Article in German | MEDLINE | ID: mdl-34467425

ABSTRACT

Toxoplasma gondii is a unicellular organism of the Apicomplexa that occurs worldwide and is therefore a close relative of the malaria pathogen Plasmodium. As T. gondii infests every warm-blooded vertebrate species as an intermediate host and has a very high prevalence worldwide, toxoplasmosis is one of the most important international foodborne diseases. Potential vaccines (human as well as veterinary) play a crucial role in controlling this disease.


Subject(s)
Pharmaceutical Preparations , Toxoplasma , Toxoplasmosis , Vaccines , Antibodies, Protozoan , Humans , Toxoplasmosis/prevention & control
4.
Comput Biol Med ; 136: 104701, 2021 09.
Article in English | MEDLINE | ID: mdl-34364258

ABSTRACT

Chlamydia trachomatis is involved in most sexually transmitted diseases. The species has emerged as a major public health threat due to its multidrug-resistant capabilities, and new therapeutic target inferences have become indispensable to combat its pathogenesis. However, no commercial vaccine is yet available to treat the C. trachomatis infection. In this study, we used the publicly available complete genome sequences of C. trachomatis and performed comparative proteomics and reverse vaccinology analyses to explore novel drug and vaccine targets against this devastating pathogen. We identified 713 core proteins from 71 C. trachomatis complete genome sequences and prioritized them based on their cellular essentiality, virulence, and available antibiotic resistance. The analyses led to the identification of 16 pathogen-specific proteins with no resolved 3D structures, though holding significant druggable potential. The sequences of the three shortlisted candidates' membrane proteins were used for designing vaccine constructs. The antigenicity, toxicity, and solubility profile-based lead epitopes were prioritized for multi-epitope-based vaccine constructs in combination with specific linkers, PADRE sequences, and molecular adjuvants for immunogenicity enhancement. The molecular-level interactions of the prioritized vaccine construct with human immune cells HLA and TLR4/MD were validated by molecular docking and molecular dynamic simulation analyses. Furthermore, the cloning and expression potential of the lead vaccine construct was predicted in the E. coli cloning vector system. Additional testing and experimental validation of these multi-epitope constructs appear promising against C. trachomatis-mediated infection.


Subject(s)
Pharmaceutical Preparations , Vaccines , Chlamydia trachomatis/genetics , Data Mining , Epitopes, T-Lymphocyte , Escherichia coli , Humans , Molecular Docking Simulation
7.
Acta Trop ; 221: 105988, 2021 Sep.
Article in English | MEDLINE | ID: mdl-34058160

ABSTRACT

Leishmaniasis is a Neglected Tropical Diseases caused by protozoan parasites of the genus Leishmania. It is a major health problem in many tropical and subtropical regions of the world and can produce three different clinical manifestations, among which cutaneous leishmaniasis has a higher incidence in the world than the other clinical forms. There are no recognized and reliable means of chemoprophylaxis or vaccination against infections with different forms of leishmaniasis. In addition, chemotherapy, unfortunately, remains, in many respects, unsatisfactory. Therefore, there is a continuing and urgent need for new therapies against leishmaniasis that are safe and effective in inducing a long-term cure. This review summarizes the latest advances in currently available treatments and improvements in the development of drug administration. In addition, an analysis of the in vivo assays was performed and the challenges facing promising strategies to treat CL are discussed. The treatment of leishmaniasis will most likely evolve into an approach that uses multiple therapies simultaneously to reduce the possibility of developing drug resistance. There is a continuous effort to discover new drugs to improve the treatment of leishmaniasis, but this is mainly at the level of individual researchers. Undoubtedly, more funding is needed in this area, as well as greater participation of the pharmaceutical industry to focus efforts on the development of chemotherapeutic agents and vaccines for this and other neglected tropical diseases.


Subject(s)
Leishmania , Leishmaniasis, Cutaneous , Vaccines , Humans , Leishmaniasis , Leishmaniasis, Cutaneous/drug therapy , Leishmaniasis, Cutaneous/prevention & control , Neglected Diseases , Pharmaceutical Preparations
8.
Global Health ; 17(1): 46, 2021 04 14.
Article in English | MEDLINE | ID: mdl-33853631

ABSTRACT

Health innovations are generally oriented on a techno-economic vision. In this perspective, technologies are seen as an end in themselves, and there is no arrangement between the technical and the social values of innovation. This vision prevails in sanitary crises, in which management is carried out based on the search for punctual, reactive, and technical solutions to remedy a specific problem without a systemic/holistic, sustainable, or proactive approach. This paper attempts to contribute to the literature on the epistemological orientation of innovations in the field of public health. Taking the Covid-19 and Ebola crises as examples, the primary objective is to show how innovation in health is oriented towards a techno-economic paradigm. Second, we propose a repositioning of public health innovation towards a social paradigm that will put more emphasis on the interaction between social and health dimensions in the perspective of social change. We will conclude by highlighting the roles that public health could play in allowing innovations to have more social value, especially during sanitary crises.


Subject(s)
Biomedical Technology , COVID-19/therapy , Health Care Reform , Health Priorities , Hemorrhagic Fever, Ebola/therapy , Public Health , Access to Information , COVID-19/prevention & control , Cost-Benefit Analysis , Diffusion of Innovation , Health Equity , Health Services Accessibility , Hemorrhagic Fever, Ebola/prevention & control , Humans , Pharmaceutical Preparations , Social Conditions , Social Environment , Social Values , Technology , Vaccines
9.
Chemistry ; 27(33): 8437-8451, 2021 Jun 10.
Article in English | MEDLINE | ID: mdl-33856737

ABSTRACT

Polysaccharides, due to their outstanding properties, have attracted the attention of researchers, working in the biomedical field and especially of those working in drug delivery. Modified/functionalized polysaccharides further increase the importance for various applications. Delivery of therapeutics for diverse ailments in different endocrine glands and hormones safely, is a focal point of researchers working in the field. Among the routes followed, the transdermal route is preferred due to non-exposure of active moieties to the harsh gastric environment and first-pass metabolism. This review starts with the overview of polysaccharides used for the delivery of various therapeutic agents. Advantages of polysaccharides used in the transdermal route are addressed in detail. Types of polysaccharides will be elaborated through examples, and in this context, special emphasis will be on the polysaccharides being used for synthesis of the membranes/films. Techniques employed for their modification to design novel carriers for therapeutics delivery will also be discussed. The review will end with a brief discussion on recent developments and future perspectives for delivery of therapeutic agents, and vaccine development.


Subject(s)
Pharmaceutical Preparations , Vaccines , Drug Carriers , Drug Delivery Systems , Polysaccharides
10.
J Control Release ; 331: 503-514, 2021 03 10.
Article in English | MEDLINE | ID: mdl-33516755

ABSTRACT

There is a dire need for innovative solutions to address global health needs. Polymeric systems have been shown to provide substantial benefit to all sectors of healthcare, especially for their ability to extend and control drug delivery. Herein, we review polymeric drug delivery devices for vaccines, tuberculosis, and contraception.


Subject(s)
Nanoparticles , Pharmaceutical Preparations , Vaccines , Drug Delivery Systems , Global Health , Polymers
11.
Curr Pharm Biotechnol ; 22(14): 1848-1856, 2021 Oct 06.
Article in English | MEDLINE | ID: mdl-33148151

ABSTRACT

BACKGROUND: The COVID-19 pandemic had infected more than 3.5M people around the world and more than 250K people died in 187 countries by May 2020. The causal agent of this disease is a coronavirus whose onset of symptoms to death range from 6 to 41 days with a median of 14 days. This period is dependent on several factors such as the presence of comorbidities, age and the efficiency of the innate or adaptive immune responses. METHODS: The effector mechanisms of both types of immune responses depend on the pathogen involved. In the case of a viral infection, the innate immune response may approach the harmful virus through pattern recognition receptors inducing an antiviral state. RESULTS: On the other hand, the adaptive immune response activates antibody production to neutralize or eliminate the virus. Phenolics are plant secondary metabolites with many biological activities for plants and humans against infection. Chemical modification of proteins may enhance their biological properties; thus, a protein of medical interest, for instance, a viral protein can be used as a scaffold to build a biopharmaceutical conjugated or complexated with phenolics exhibiting structural complexity or biological activities to achieve effective phenolic-protein-based therapeutics like vaccine adjuvant complexes, immunogen conjugates, and antiviral conjugates. CONCLUSION: Pharmaceutical biotechnology applies the principles of biotechnology to develop biopharmaceuticals for protein-based therapeutics; such as adjuvants, recombinant proteins, monoclonal antibodies, and antivirals. As neither a vaccine nor a treatment for COVID-19 is currently available, this manuscript focuses on insights from pharmaceutical biotechnology into phenolic biopharmaceuticals against COVID-19.


Subject(s)
COVID-19 , Pharmaceutical Preparations , Vaccines , Biotechnology , Humans , Pandemics , SARS-CoV-2
12.
Expert Opin Drug Deliv ; 18(7): 929-947, 2021 07.
Article in English | MEDLINE | ID: mdl-32975144

ABSTRACT

INTRODUCTION: A microneedle array patch (MAP) has been studied as a means for delivering drugs or vaccines and has shown superior delivery efficiency compared to the conventional transdermal drug delivery system (TDD). This paper reviews recent advancements in the development of MAPs, with a focus on their size, shapes, and materials in preclinical and clinical studies for pharmaceutics. AREA COVERED: We classified MAPs for drug delivery into four types: coated, dissolving, separable, and swellable. We covered their recent developments in materials and geometry in preclinical and clinical studies. EXPERT OPINION: The design of MAPs needs to be determined based on what properties would be effective for the target diseases and purposes. In addition, in preclinical studies, it is necessary to consider not only the novelty of the formulations but also the feasibility of clinical application. Currently, clinical studies of microneedles loaded with various drugs and vaccines are in progress. When the regulation of pharmaceutical microneedles is established and more clinical studies are published, more drugs will be developed as microneedle products and clinical research will proceed. With these considerations, the microneedle array patch will be a better option for drug delivery.


Subject(s)
Pharmaceutical Preparations , Vaccines , Administration, Cutaneous , Drug Delivery Systems , Humans , Microinjections , Needles
13.
Hum Vaccin Immunother ; 17(1): 316-327, 2021 01 02.
Article in English | MEDLINE | ID: mdl-32667239

ABSTRACT

A microneedle array patch (MAP) has been developed as a new delivery system for vaccines. Preclinical and clinical trials with a vaccine MAP showed improved stability, safety, and immunological efficacy compared to conventional vaccine administration. Various vaccines can be delivered with a MAP. Currently, microneedle manufacturers can mass-produce pharmaceutical MAP and cosmetic MAP and this mass-production system can be adapted to produce a vaccine MAP. Clinical trials with a vaccine MAP have shown comparable efficacy with conventional administration, and discussions about regulations for a vaccine MAP are underway. However, there are concerns of reasonable cost, mass production, efficacy, and safety standards that meet FDA approval, as well as the need for feedback regarding the best method of administration. Currently, microneedles have been studied for the delivery of many kinds of vaccines, and preclinical and clinical studies of vaccine microneedles are in progress. For the foreseeable future, some vaccines will continue to be administered with syringes and needles while the use of a vaccine MAP continues to be improved because of the advantages of less pain, self-administration, improved stability, convenience, and safety.


Subject(s)
Pharmaceutical Preparations , Vaccines , Administration, Cutaneous , Drug Delivery Systems , Needles , Vaccination
14.
Assay Drug Dev Technol ; 19(2): 97-114, 2021.
Article in English | MEDLINE | ID: mdl-33297823

ABSTRACT

Over the last decade, microneedle (MN) induced microporation multifunctional approaches to enhance the delivery of drugs through the skin. MN technology included micron-sized needles to create microchannels into the Stratum corneum of skin, the most significant protective layer. Delivery of drugs and vaccines through the transdermal route is an alternative route for hypodermic and oral. It overcomes the problems associated with gastrointestinal along with drug deterioration. It is affordable, noninvasive, painless, simple, and self-administered techniques that provide prolonged release of drugs to enhance patient compliance. The MN delivery focused on biopharmaceuticals like proteins or peptides. The novel concepts have drawn interest in using these techniques in tandem with other enhancement approaches. This review article discussed the latest advancements in MN technology. It emphasized types of MNs, methodology, mechanisms, strategies for delivery of several drugs and vaccines, and significant challenges in the marketing of biopharmaceuticals. Furthermore, relevant U.S. patents and clinical trials based on MNs are also accentuated. Therefore, MN techniques will play a pivotal role in promoting clinical applications and innovative research for scientists and researchers working in the pharmaceutical field.


Subject(s)
Drug Delivery Systems , Needles , Pharmaceutical Preparations/metabolism , Skin/metabolism , Vaccines/metabolism , Animals , Pharmaceutical Preparations/administration & dosage , Pharmaceutical Preparations/chemistry , Rats , Skin/chemistry , Swine , Vaccines/administration & dosage , Vaccines/chemistry
20.
Regul Toxicol Pharmacol ; 118: 104813, 2020 Dec.
Article in English | MEDLINE | ID: mdl-33144077

ABSTRACT

In order to develop new and effective medicines, pharmaceutical companies must be modality agnostic. As science reveals an enhanced understanding of biological processes, new therapeutic modalities are becoming important in developing breakthrough therapies to treat both rare and common diseases. As these new modalities progress, concern and uncertainty arise regarding their safe handling by the researchers developing them, employees manufacturing them and nurses administering them. This manuscript reviews the available literature for emerging modalities (including oligonucleotides, monoclonal antibodies, fusion proteins and bispecific antibodies, antibody-drug conjugates, peptides, vaccines, genetically modified organisms, and several others) and provides considerations for occupational health and safety-oriented hazard identification and risk assessments to enable timely, consistent and well-informed hazard identification, hazard communication and risk-management decisions. This manuscript also points out instances where historical exposure control banding systems may not be applicable (e.g. oncolytic viruses, biologics) and where other occupational exposure limit systems are more applicable (e.g. Biosafety Levels, Biologic Control Categories).


Subject(s)
Biological Products/adverse effects , Drug Industry , Occupational Exposure/adverse effects , Pharmaceutical Preparations , Bacteria/genetics , Biological Products/pharmacokinetics , Decision Trees , Humans , Occupational Exposure/prevention & control , Occupational Health , Oligonucleotides/adverse effects , Oncolytic Viruses/genetics , Proteins/adverse effects , Radiopharmaceuticals/adverse effects , Risk Assessment , Safety Management , Vaccines/adverse effects
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