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Advanced Drug Delivery Reviews Jul 2015This review article includes an introduction to the principals of Raman spectroscopy, an outline of the experimental systems used for Raman imaging and the associated... (Review)
Review
This review article includes an introduction to the principals of Raman spectroscopy, an outline of the experimental systems used for Raman imaging and the associated important considerations and limitations of this method. Common spectral analysis methods are briefly described and examples of interesting published studies which utilised Raman imaging of pharmaceutical and biomedical devices are discussed, along with summary tables of the literature at this point in time.
Topics: Drug Delivery Systems; Drug Design; Humans; Pharmaceutical Preparations; Spectrum Analysis, Raman
PubMed: 25632843
DOI: 10.1016/j.addr.2015.01.005 -
Expert Opinion on Drug Delivery Nov 2017Drug-eluting sutures represent the next generation of surgical sutures since they fulfill their mechanical functions but also deliver the drug in their vicinity after... (Review)
Review
Drug-eluting sutures represent the next generation of surgical sutures since they fulfill their mechanical functions but also deliver the drug in their vicinity after implantation. These implants are produced by a variety of manufacturing processes. Drug-eluting sutures represent the next generation of surgical sutures since they fulfill their mechanical functions but also deliver the drug in their vicinity after implantation. These implants are produced by a variety of manufacturing processes. Two general approaches can be followed: (i) the ones that add the API into the material during the manufacturing process of the suture and (ii) the ones that load the API to an already manufactured suture. Areas covered: This review provides an overview of the current manufacturing processes for drug-eluting suture production and discusses their benefits and drawbacks depending on the type of drugs. The mechanical properties and the drug delivery profile of drug-eluting sutures are highlighted since these implants must fulfill both criteria. Expert opinion: For limited drug contents, melt extrusion and electrospinning are the emerging processes since the drug is added during the suture manufacture process. Advantageously, the drug release profile can be tuned by controlling the processing parameters specific to each process and the composition of the drug-containing polymer. If high drug content is targeted, the coating or grafting of a drug layer on a pre-manufactured suture allows for preservation of the tensile strength requirements of the suture.
Topics: Drug Delivery Systems; Pharmaceutical Preparations; Sutures
PubMed: 28132527
DOI: 10.1080/17425247.2017.1289173 -
Sensors (Basel, Switzerland) Feb 2022All pharmaceutical drugs, vaccines, cosmetic products, and many medical breakthroughs must first be approved through clinical research and trials before advancing to... (Review)
Review
All pharmaceutical drugs, vaccines, cosmetic products, and many medical breakthroughs must first be approved through clinical research and trials before advancing to standard practice or entering the marketplace. Clinical trials are sets of tests that are required to determine the safety and efficacy of pharmaceutical compounds, drugs, and treatments. There is one pre-phase and four main clinical phase requirements that every drug must pass to obtain final approval. Analytical techniques play a unique role in clinical trials for measuring the concentrations of pharmaceutical compounds in biological matrices and monitoring the conditions of patients (or volunteers) during various clinical phases. This review focuses on recent analytical methods that are employed to determine the concentrations of drugs and medications in biological matrices, including whole blood, plasma, urine, and breast milk. Four primary analytical techniques (extraction, spectroscopy, chromatography, and electrochemical) are discussed, and their advantages and limitations are assessed. Subsequent to a survey of evidence and results, it is clear that microelectromechanical system (MEMS) based electrochemical sensor and biosensor technologies exhibit several notable advantages over other analytical methods, and their future prospects are discussed.
Topics: Biosensing Techniques; Clinical Trials as Topic; Electrochemical Techniques; Humans; Pharmaceutical Preparations
PubMed: 35214505
DOI: 10.3390/s22041592 -
The AAPS Journal Aug 2022Oligonucleotide therapeutics (ONTs) are a diverse group of short synthetic nucleic acid-based molecules that exploit innovative intracellular molecular strategies to... (Review)
Review
Oligonucleotide therapeutics (ONTs) are a diverse group of short synthetic nucleic acid-based molecules that exploit innovative intracellular molecular strategies to create novel treatments for a variety of medical conditions. ONT molecules (~7-15 kDa) reside between traditional large and small molecules, and there has been debate regarding their immunogenicity risk. To date, 13 ON drugs have been approved, and as the field is relatively new, there are currently no specific regulatory guidelines to indicate how to develop, validate, and interpret the immunogenicity assays of ONTs. Some investigators do not test for immune responses to ONs while others test for antibodies (Abs) to components within the formulation, which may or may not include aspects of characterization such as domain mapping of ONT conjugates. Similar to other biopharmaceuticals, the immunogenic properties of ONTs could be influenced by sequence, route, dosage, target population, co-medications, etc. The current anti-drug antibody (ADA) data for different approved ONTs suggest that their administration poses a low immunogenicity risk without any significant impact on pharmacokinetics (PK), pharmacodynamics (PD), and safety; nevertheless, until the field matures with data from many more ON drugs, it remains prudent to assess immunogenicity. The emphasis of this article is to highlight how current ADA methodologies might be applied to the development of ONTs, discuss factors that may pose immunogenicity risks, and provide the authors' current position on immunogenicity assessment strategies for ONTs. We also discuss assay parameters that may be appropriate for the detection and characterization of ADAs, including the evaluation of neutralizing ADAs, ADA isotyping, Abs to dsDNA, and pre-existing ADA. Immunogenicity risk assessments (IRAs) and early interactions with regulators will inform how to proceed in late stage/pivotal studies.
Topics: Antibodies; Antibody Formation; Biological Products; Oligonucleotides; Pharmaceutical Preparations
PubMed: 36028587
DOI: 10.1208/s12248-022-00741-x -
Pharmaceutical Research May 2024Currently, the lengthy time needed to bring new drugs to market or to implement postapproval changes causes multiple problems, such as delaying patients access to new...
Currently, the lengthy time needed to bring new drugs to market or to implement postapproval changes causes multiple problems, such as delaying patients access to new lifesaving or life-enhancing medications and slowing the response to emergencies that require new treatments. However, new technologies are available that can help solve these problems. The January 2023 NIPTE pathfinding workshop on accelerating drug product development and approval included a session in which participants considered the current state of product formulation and process development, barriers to acceleration of the development timeline, and opportunities for overcoming these barriers using new technologies. The authors participated in this workshop, and in this article have shared their perspective of some of the ways forward, including advanced manufacturing techniques and adaptive development. In addition, there is a need for paradigm shifts in regulatory processes, increased pre-competitive collaboration, and a shared strategy among regulators, industry, and academia.
Topics: Humans; Drug Approval; Drug Development; Drug Industry; Technology, Pharmaceutical; Pharmaceutical Preparations; Chemistry, Pharmaceutical; Drug Compounding
PubMed: 38698195
DOI: 10.1007/s11095-024-03708-z -
Pharmaceutical Development and... Sep 2020Mucosa has now been recognized as a potential site for both local and systemic delivery of therapeutics. Mucoadhesive drug delivery systems with customizable release... (Review)
Review
Mucosa has now been recognized as a potential site for both local and systemic delivery of therapeutics. Mucoadhesive drug delivery systems with customizable release profiles have recently gained considerable interest among formulation scientists to improve clinical outcomes of drugs. This review summarizes the current development in the processing methods and polymers involved in mucoadhesive drug delivery systems. Mucoadhesive drug delivery systems are suitable for drugs that have a localized effect, undergo extensive pre-systemic metabolism, narrow absorption window, and narrow therapeutic index. Polymer characteristics like surface charge, hydrophilic surface groups, wettability, molecular weight, chain flexibility, molecular conformations, etc. are critical for assessing the extent of mucoadhesiveness and treatment response. The current review focuses on valuable principles, merits, drawbacks, and future outlooks of different mucoadhesive drug delivery systems.
Topics: Adhesiveness; Animals; Drug Administration Routes; Drug Compounding; Drug Delivery Systems; Forecasting; Humans; Mouth Mucosa; Pharmaceutical Preparations
PubMed: 32267180
DOI: 10.1080/10837450.2020.1753771 -
Journal of Pharmaceutical Sciences Feb 2023Regulatory authorities and the scientific community have identified the need to monitor the in vivo stability of therapeutic proteins (TPs). Due to the unique...
Regulatory authorities and the scientific community have identified the need to monitor the in vivo stability of therapeutic proteins (TPs). Due to the unique physiologic conditions in patients, the stability of TPs after administration can deviate largely from their stability under drug product (DP) conditions. TPs can degrade at substantial rates once immersed in the in vivo milieu. Changes in protein stability upon administration to patients are critical as they can have implications on patient safety and clinical effectiveness of DPs. Physiologic conditions are challenging to simulate and require dedicated in vitro models for specific routes of administration. Advancements of in vitro models enable to simulate the exposure to physiologic conditions prior to resource demanding pre-clinical and clinical studies. This enables to evaluate the in vivo stability and thus may allow to improve the safety/efficacy profile of DPs. While in vitro-in vivo correlations are challenging, benchmarking DP candidates enables to identify liabilities and optimize molecules. The in vivo stability should be an integral part of holistic stability assessments during early development. Such assessments can accelerate development timelines and lead to more stable DPs for patients.
Topics: Humans; Pharmaceutical Preparations; Protein Stability; Drug Stability
PubMed: 36202247
DOI: 10.1016/j.xphs.2022.09.032 -
Physical Review. E Jan 2022During the outbreak of a virus, perhaps the greatest concern is the future evolution of the epidemic: How many people will be infected and which regions will be affected...
During the outbreak of a virus, perhaps the greatest concern is the future evolution of the epidemic: How many people will be infected and which regions will be affected the most? The accurate prediction of an epidemic enables targeted disease countermeasures (e.g., allocating medical staff and quarantining). But when can we trust the prediction of an epidemic to be accurate? In this work we consider susceptible-infected-susceptible (SIS) and susceptible-infected-removed (SIR) epidemics on networks with time-invariant spreading parameters. (For time-varying spreading parameters, our results correspond to an optimistic scenario for the predictability of epidemics.) Our contribution is twofold. First, accurate long-term predictions of epidemics are possible only after the peak rate of new infections. Hence, before the peak, only short-term predictions are reliable. Second, we define an exponential growth metric, which quantifies the predictability of an epidemic. In particular, even without knowing the future evolution of the epidemic, the growth metric allows us to compare the predictability of an epidemic at different points in time. Our results are an important step towards understanding when and why epidemics can be predicted reliably.
PubMed: 35193247
DOI: 10.1103/PhysRevE.105.014302 -
Physical Review. E Apr 2023In competitive settings that entail several populations, individuals often engage in intra- and interpopulation interactions that determine their fitness and...
In competitive settings that entail several populations, individuals often engage in intra- and interpopulation interactions that determine their fitness and evolutionary success. With this simple motivation, we here study a multipopulation model where individuals engage in group interactions within their own population and in pairwise interactions with individuals from different populations. We use the evolutionary public goods game and the prisoner's dilemma game to describe these group and pairwise interactions, respectively. We also take into account asymmetry in the extent to which group and pairwise interactions determine the fitness of individuals. We find that interactions across multiple populations reveal new mechanisms through which the evolution of cooperation can be promoted, but this depends on the level of interaction asymmetry. If inter- and intrapopulation interactions are symmetric, the sole presence of multiple populations promotes the evolution of cooperation. Asymmetry in the interactions can further promote cooperation at the expense of the coexistence of the competing strategies. An in-depth analysis of the spatiotemporal dynamics reveals loop-dominated structures and pattern formation that can explain the various evolutionary outcomes. Thus, complex evolutionary interactions in multiple populations reveal an intricate interplay between cooperation and coexistence, and they also open up the path toward further explorations of multipopulation games and biodiversity.
Topics: Humans; Cooperative Behavior; Biological Evolution; Game Theory; Prisoner Dilemma
PubMed: 37198848
DOI: 10.1103/PhysRevE.107.044301 -
European Cells & Materials Mar 2021The aim of this scoping review was to summarise current knowledge about the effects of bone anabolic drugs on periodontitis, in order to identify new therapeutic... (Review)
Review
The aim of this scoping review was to summarise current knowledge about the effects of bone anabolic drugs on periodontitis, in order to identify new therapeutic strategies for preventing disease progression and reducing tooth loss. A technical expert panel (TEP) was established of 11 medical specialists, including periodontists and bone specialists that followed the PRISMA-ScR model to perform the scoping review and considered for eligibility both pre-clinical and clinical studies published in the English language up to September 2020. 716 items were initially found. After duplicate removal and screening of articles for eligibility criteria, 25 articles published between 2001 and 2019 were selected. Only studies concerning teriparatide, strontium ranelate, sclerostin antibodies and DKK1 antibodies met the eligibility criteria. In particular, only for teriparatide were there both clinical studies and experimental studies available, while for other bone anabolic drugs only animal studies were found. Available evidence about the use of bone anabolic drugs in periodontology demonstrates beneficial effects of these agents on biological pathways and histological parameters involved in periodontal tissue regeneration that suggest relevant clinical implications for the management of periodontitis.
Topics: Animals; Bone and Bones; Humans; Periodontitis; Pharmaceutical Preparations
PubMed: 33733451
DOI: 10.22203/eCM.v041a20