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Long-Term Toxicity and Regulations for Bioactive-Loaded Nanomedicines
Published in Mahfoozur Rahman, Sarwar Beg, Mazin A. Zamzami, Hani Choudhry, Aftab Ahmad, Khalid S. Alharbi, Biomarkers as Targeted Herbal Drug Discovery, 2022
Iqbal Ahmad, Sobiya Zafar, Shakeeb Ahmad, Suma Saad, S. M. Kawish, Sanjay Agarwal, Farhan Jalees Ahmad
The regulation of Nanotechnology product in the United States is carried out by the FDA, which coordinates the legislative supervision by the Office of Science and Health Coordination through the Office of Commissioners. The working group suggests the scientific proposals and regulations for development, evaluation, and promotion of new pharmaceutical products (Demetzos, 2016). FDA has approved several nanomedicine products including lipo-somes, nanocrystals, albumin-based nanoparticles, polymeric nanoparticles. The important decision-making centers within FDA include Center for Drug Evaluation and Research (CDER), Center for Biological Evaluations and Research (CBER), Center for Device and Radiological Health (CDRH) and Center for Veterinary (CVM). The office for control and compliance is the office of regulatory affairs (ORA). According to CDER, the controls for the nanomedicinal products should be similar to the controls of new medicine safety, as described by FDA (Zolnik and Sadrieh, 2009).
Granulation of Poorly Water-Soluble Drugs
Published in Dilip M. Parikh, Handbook of Pharmaceutical Granulation Technology, 2021
Albert W. Brzeczko, Firas El Saleh, Hibreniguss Terefe
Nanoparticles are materials that are less than or equal to 1 μm in one dimension, and more specifically, a nanocrystal is a single crystalline in nature. In colloidal chemistry, nanoparticles are further limited to 100 nm or less; however, in the pharmaceutical area, nanoparticles can range in size from approximately 10 nm to 100 nm. Nanoparticle delivery systems are reported for oral, parenteral, and pulmonary drug delivery. Junghanns and Müller [15] report not only an increase in dissolution rate by surface area enlargement but also an increase in saturation solubility related to the dissolution pressure increase associated with nanoparticles. Optimal drug nanoparticles with the highest increase in saturation solubility have a 20- to 50-nm particle size and would be amorphous. Stabilization of the nanoparticle amorphous drug is required to confer adequate product shelf life.
Drug Nanocrystals
Published in Carla Vitorino, Andreia Jorge, Alberto Pais, Nanoparticles for Brain Drug Delivery, 2021
M. Ermelinda S. Eusébio, Ricardo A. E. Castro, Joäo Canotilho
Drug nanocrystals, according to the most common concept within the scientific community, are particles of nanometric size (ranging from a few nm to 1000 nm) composed of the active pharmaceutical ingredient (API) arranged in a crystalline structure [1–6]. They are most commonly produced as nanosuspensions in a liquid medium, usually stabilised by a thin adsorbed layer (typically 2–5 nm thick) formed of either a surfactant or a sterically stabilising polymer [3, 4]. The United States Food and Drug Administration (USFDA) [7], European Commission (EC) and European Medicines Agency (EMA) [8, 9] all propose a smaller size limit of <100 nm in their nanoparticle definitions, which encompasses only those particles which can be internalised through endocytosis by all cells in the body - therefore also including the blood-brain barrier (BBB) - and not only by the mononuclear phagocytic system (MPS). The term nanocrystal has been extended by some authors to also describe suspensions of nanosized, partially crystalline and - in some cases-even amorphous drugs [1, 4, 10–13], although, strictly speaking, this wider definition is not correct.
Factors affecting the preparation of nanocrystals: characterization, surface modifications and toxicity aspects
Published in Expert Opinion on Drug Delivery, 2023
Shirleen Miriam Marques, Lalit Kumar
Drug nanocrystals are pure drug crystals, having a particle size ranging from 1 to 1000 nm, generally stabilized by polymeric or surfactant-based stabilizers [6,7]. Due to the decrease in size and increase in surface area, they impart properties such as improved dissolution velocity and enhanced saturation solubility [3,8,9]. The advantages of nanocrystals as a drug delivery system include improved absorption rate, decreased fasted-fed state variability, high efficiency of drug-loading, low toxicity, reduced cost for preparation, and manufacturing scale-up is straightforward [10–13]. The physicochemical characteristics of the nanocarriers, such as crystalline nature, size, shape, surface charge, and the type of stabilizer, can significantly impact the therapeutic outcome of the final nanocrystal product [14]. The effect of stabilizers on the in-vivo effectiveness and bioavailability of paclitaxel nanocrystals was established by Sharma et al. Chitosan copolymer with pluronic grafting served as a stabilizer. Owing to the P-gp inhibition by the pluronic-grafted chitosan stabilizer, investigation using a Caco-2 cell line demonstrated that paclitaxel accumulation inside the cells was more significant. The stabilizer also facilitated the reversible opening of the tight junctions between the cells, permitting drug delivery via the paracellular route [15].
Folate-functionalized SMMC-7721 liver cancer cell membrane-cloaked paclitaxel nanocrystals for targeted chemotherapy of hepatoma
Published in Drug Delivery, 2022
Wenwen Shen, Shuke Ge, Xiaoyao Liu, Qi Yu, Xue Jiang, Qian Wu, YuChen Tian, Yu Gao, Ying Liu, Chao Wu
The rapid development of nanotechnology provides new ideas for the treatment and diagnosis of cancer (Manzur et al., 2017; He et al., 2018; Dong et al., 2019). Currently, various nanocarriers, such as mesopore silica (He et al., 2017), liposomes (Eloy et al., 2020), carbon nanotubes (Soleyman et al., 2015), polymer nanoparticles (Levit et al., 2020), and cyclodextrin nanoparticles (Yan et al., 2019), have been widely incorporated with PTX to improve its solubility and targeting ability. However, these methods generally have problems including low drug loading and targeting ability. In recent years, PTX nanocrystals (PNs) have attracted extensive research interest due to their high drug content and good water solubility (Ni et al., 2015; Lu et al., 2016; Huang et al., 2021). The principle is that nanocrystals have nanoscale dimensions. According to the Ostwald–Freundlich and Noyes–Whitney equations, the smaller the particle size is, the larger the specific surface area (Lu et al., 2014; Wu et al., 2018). This is closely related to the water solubility of the drug. Moreover, due to passive targeting of nanocrystals, more drug is delivered and accumulates in tumor tissue. However, this is not sufficient. The low specificity of passive targeting makes it impossible to distinguish normal cells and tumor cells, which leads to severe adverse reactions.
Nanocrystals based pulmonary inhalation delivery system: advance and challenge
Published in Drug Delivery, 2022
Pengfei Yue, Weicheng Zhou, Guiting Huang, Fangfang Lei, Yingchong Chen, Zhilin Ma, Liru Chen, Ming Yang
Nanocrystals have been widely used in the oral, topical and parenteral route of drug delivery. To date, more than 20 nanocrystal-based formulations are in the market and in clinical trials. Nanocrystals also provide an effective strategy for pulmonary delivery of poorly soluble drugs. Nanocrystal-based inhalation formulations can be applied to the administration of topical as well as systemic disease by immediate and controlled release of the drugs, which can improve the dissolution rate and saturation solubility of poorly soluble drug and reduce the pulmonary clearance as well as enhance the adsorption of drug. These breakthroughs have inspired the researchers and industry to develop nanocrystal-based inhalation formulation. With the development of nanocrystals technologies for manufacturing drug inhalable formulations, we can predict many nanocrystal-based drug products on market in the near future.