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Related Concept Videos

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Preclinical Development: Overview

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Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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Drug discovery is a multifaceted process involving extensive screening, testing, and optimization of lead compounds to identify potential new drugs for therapeutic use. It combines several approaches, including screening large numbers of natural products, chemical modification of known active molecules, identification of new drug targets, and rational design based on biological mechanisms and drug-receptor structure. These approaches are carried out in both academic research laboratories and...
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Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
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In vitro dissolution and drug release tests assess how quickly and how much of a drug is released from its dosage form into an aqueous medium under standardized laboratory conditions. These tests are essential tools in pharmaceutical development and quality assurance, offering insight into the drug's performance before clinical use.During formulation development, dissolution testing identifies incomplete or inconsistent drug release issues. It also supports decisions on selecting the optimal...
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Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
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Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
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Drug Development.

Vishal Shivaji Patil1, Bhaskar Jyoti Dutta1, Sanjiv Singh1

  • 1National Institute of Pharmaceutical Education and Research, Hajipur, Bihar, India.

Alzheimer'S & Dementia : the Journal of the Alzheimer'S Association
|December 25, 2025
PubMed
Summary

A novel nanoemulgel formulation of pterostilbene (PTE) effectively improved cognitive function in vascular dementia (VaD) models. This delivery system enhances brain bioavailability, offering a promising strategy for VaD treatment.

Area of Science:

  • Neuroscience
  • Pharmacology
  • Biotechnology

Background:

  • Vascular dementia (VaD) is a major cause of cognitive decline, second only to Alzheimer's disease.
  • Pterostilbene (PTE) shows therapeutic potential for VaD due to its antioxidant and anti-inflammatory properties.
  • PTE's poor solubility and bioavailability limit its clinical use.

Purpose of the Study:

  • To develop a novel nanoemulgel formulation of pterostilbene (PTE) for enhanced brain delivery.
  • To overcome the limitations of poor water solubility and low bioavailability of PTE.
  • To evaluate the efficacy of the nanoemulgel in a rat model of vascular dementia.

Main Methods:

  • Formulation of a PTE-loaded nanoemulsion (PNE) and its conversion into a thermoresponsive mucoadhesive nanoemulgel (PNEG) for nasal delivery.

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  • Characterization of PNEG for physicochemical properties, mucoadhesion, and drug release.
  • In vitro cytotoxicity and cellular uptake studies, followed by in vivo efficacy evaluation in a rat model of VaD induced by bilateral common carotid artery occlusion (BCCAO).

    • Main Results:

    • PNEG exhibited favorable physicochemical properties, including optimal particle size and strong mucoadhesion.
    • In vivo studies demonstrated significant cognitive improvement in VaD rats treated with PNE and PNEG.
    • PNEG effectively reduced oxidative stress, apoptosis, and neuroinflammation, modulating the SIRT1/Nrf2/HO-1 pathway.

    Conclusions:

    • Pterostilbene nanoemulgel (PNEG) represents a promising therapeutic strategy for vascular dementia.
    • This formulation enhances brain bioavailability, addressing limitations of conventional PTE delivery.
    • PNEG offers potential for improved VaD management through targeted neuroprotection and cognitive preservation.