Fast-Fed Variability: Insights into Drug Delivery, Molecular Manifestations, and Regulatory Aspects

Rangaraj, Nagarjun; Sampathi, Sunitha; Junnuthula, Vijayabhaskarreddy; Kolimi, Praveen; Mandati, Preethi; Narala, Sagar; Nyavanandi, Dinesh; Dyawanapelly, Sathish

doi:10.3390/pharmaceutics14091807

Cited by 14 publications

(14 citation statements)

References 149 publications

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“…As a result, spray drying techn permits the adjustment of particle characteristics, namely, size, size distribution, s density, and morphology, as well as macroscopic powder qualities, such as bulk de tap density, powder flowability, and dispersibility. Physicochemical instability, whi cludes particle growth, unanticipated gelation, drug expulsion upon storage, or u pected dynamic polymorphic changes of the lipid particles, is the main drawback of [41,42]. Reprinted with permission from Ref.…”

Section: Spray Drying Methodsmentioning

confidence: 99%

“…Other types of piston-gap homogenizers can, of course, be utilized; nevertheless, the Avestin products are recommended (e.g., C55 and C1000). The potential contamination in the final product by using this equipment has proven to be exceptionally low, typically less than 1 ppm product contamination even under extremely difficult operational conditions, for example, 1500 bar, 20 homogenization cycles, and very hard crystalline materials in the case of drug nanocrystals [1,11,41].…”

Section: High-pressure Homogenizationmentioning

confidence: 99%

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Review on the Scale-Up Methods for the Preparation of Solid Lipid Nanoparticles

et al. 2022

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Solid lipid nanoparticles (SLNs) are an alternate carrier system to liposomes, polymeric nanoparticles, and inorganic carriers. SLNs have attracted increasing attention in recent years for delivering drugs, nucleic acids, proteins, peptides, nutraceuticals, and cosmetics. These nanocarriers have attracted industrial attention due to their ease of preparation, physicochemical stability, and scalability. These characteristics make SLNs attractive for manufacture on a large scale. Currently, several products with SLNs are in clinical trials, and there is a high possibility that SLN carriers will quickly increase their presence in the market. A large-scale manufacturing unit is required for commercial applications to prepare enough formulations for clinical studies. Furthermore, continuous processing is becoming more popular in the pharmaceutical sector to reduce product batch-to-batch differences. This review paper discusses some conventional methods and the rationale for large-scale production. It further covers recent progress in scale-up methods for the synthesis of SLNs, including high-pressure homogenization (HPH), hot melt extrusion coupled with HPH, microchannels, nanoprecipitation using static mixers, and microemulsion-based methods. These scale-up technologies enable the possibility of commercialization of SLNs. Furthermore, ongoing studies indicate that these technologies will eventually reach the pharmaceutical market.

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Section: Spray Drying Methodsmentioning

confidence: 99%

Section: High-pressure Homogenizationmentioning

confidence: 99%

Review on the Scale-Up Methods for the Preparation of Solid Lipid Nanoparticles

et al. 2022

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“…The drugs can be introduced into the internal phase in order to create a microemulsion, or they can form part of an informal mixture upon saturation. By using H2O, taurodeoxycholate sodium salt, butyl lactate and lecithin as components in this process we have developed Griseofulvin nanosuspensions [34][35][36][37][38][39] .…”

Section: D) Lipid Emulsion/microemulsion Templatementioning

confidence: 99%

Contemporary Review on Solubility Enhancement Techniques

NARMADA¹

2023

J. Drug Delivery Ther.

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The limited water solubility of pharmacoactive molecules hinders their ability to be used as pharmacological agents, yet the indispensability of a certain solubility parameter precludes any compromises. To overcome this challenge, various methods are employed in order to increase their bioavailability. Pharmaceutical molecules with lower solubility present an elevated risk of failure for drug development and innovation. Their solubility affects important processes such as pharmacokinetics, pharmacodynamics, distribution, protein binding, and absorption. As a result these parameters are greatly impacted by the dissolution rate of a particular molecule. Out of all pharmaceutical dosage forms, more than half are oral. For the drug molecule to reach its target site and be effective therapeutically, solubility and bioavailability must be taken into consideration. Unfortunately, during screening programs conducted by the pharmaceutical industry it became evident that nearly 40% of new chemical entities (NCEs) face various roadblocks when transitioning from formulation to development due to their poor solubility and bioavailability. The pharmaceutical industry is constantly confronted with the difficulty of improving drug bioavailability and solubility in formulations. This article covers a range of technological advancements to boost the solubility of insoluble drugs, such as complexation, emulsions and micelles production, microemulsion generation with cosolvents, polymeric micelle preparation methods, particle size decrease techniques, pharmaceutical salts application, prodrugs usage, solid-state alteration practices, soft gel technology implementation crystal engineering approaches and nanomorphology. Through this review, we will discuss a variety of more complex methods for improving solubility and bioavailability such as crystal engineering, micronization, solid dispersions, nano sizing, and use of cyclodextrins, solid lipid nanoparticles (SLNPs), colloidal drug delivery systems and drug conjugates. We'll also provide references to studies that have been conducted in connection with these topics. Keywords: Solubility, permeability, bioavailability, nano particles drug delivery systems, microemulsions, low water solubility

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“…The more sensitive 2D-LC-MS/MS method was complemented with the UPLC-MS/MS method that had shorter runtime to improve throughput. Both these methods have been successfully applied to evaluate HPβCD pharmacokinetics in humans [61][62][63].…”

Section: CDmentioning

confidence: 99%

Comprehensive review on nano drug delivery systems bioanalysis

Sujeevan¹

2023

GSC Adv. Res. Rev.

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Nanoparticulate drug delivery systems (NDDSs) offer a revolutionary strategy to fighting ailments. The NDDSs are uniquely and deliberately constructed as vessels for the transport of active pharmaceutical components (APIs), which leverages their distinct physicochemical traits, such as lengthened circulation period, enhanced targeting capability and evasion of drug resistance. Although the last three decades have seen considerable progress, our comprehension of how NDDSs' pharmacokinetics in vivo can affect their safety profiles is still insufficient. Examining NDDSs is way more complex than analyzing small molecules since their structure and composition are completely different, almost making regular analytical techniques inadequate for measuring correctly its behavior within living systems. The following advanced bioanalysis techniques are summarized to trace the in vivo fate of NDDSs: liquid chromatography tandem mass spectrometry (LC-MS/MS), enzyme-linked immunosorbent assay (ELISA), magnetic resonance imaging (MRI), radiolabeling, fluorescence spectroscopy, laser ablation inductively coupled plasma MS (LA-ICP–MS,) and size exclusion chromatography. These tools provide an invaluable way of examining a drug's journey through the body. By leveraging the most modern technologies, we are able to conduct a thorough survey of NDDSs and their various changes in structure, composition and form. This review can be beneficial for accurately assessing pharmacokinetics as well as gauging efficacy and safety profiles of new drug delivery systems. We hope this comprehensive overview will serve as an effective basis for application methodology when analyzing NDDSs.

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Fast-Fed Variability: Insights into Drug Delivery, Molecular Manifestations, and Regulatory Aspects

Cited by 14 publications

References 149 publications

Review on the Scale-Up Methods for the Preparation of Solid Lipid Nanoparticles

Review on the Scale-Up Methods for the Preparation of Solid Lipid Nanoparticles

Contemporary Review on Solubility Enhancement Techniques

Comprehensive review on nano drug delivery systems bioanalysis

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