Age-specific biorelevant media have emerged as a crucial advancement in pharmaceutical research, aiming to simulate the distinct gastrointestinal (GI) conditions of different age groups rather than relying solely on standard adult-based media. Physiological differences such as gastric pH, bile salt concentration, enzyme activity, and gastric motility vary significantly across neonates, infants, children, adults, and elderly individuals. For instance, neonates and infants have a higher gastric pH (less acidic) than adults, which can influence the solubility of weakly basic or acidic drugs. Additionally, bile salt and enzyme secretion, which are essential for lipid digestion and drug solubilization, are lower in neonates and increase gradually with age, affecting the dissolution and absorption of lipophilic drugs. Similarly, elderly individuals often experience reduced gastric acid secretion, delayed gastric emptying, and altered enzymatic activity, all of which can impact drug solubility and bioavailability.
A recent study explored these physiological differences by investigating the solubility of lamotrigine, an antiepileptic drug, under age-specific GI conditions. Researchers developed biorelevant media tailored to the fasted and fed states of neonates, infants, children, adults, and elderly individuals to assess variations in drug dissolution. The findings highlighted significant differences in solubility across age groups, demonstrating the necessity of using age-specific media for accurate drug dissolution testing and formulation development. These specialized media enhance the predictive accuracy of in vitro models, ensuring a closer correlation with in vivo drug behavior and reducing the risk of unexpected bioavailability issues.
The development of age-specific biorelevant media holds several advantages. One of the most significant benefits is the ability to optimize drug formulations for pediatric and geriatric populations, ensuring that medications are tailored to their unique physiological conditions. This approach aligns with evolving regulatory guidelines that emphasize the need for age-appropriate drug formulations, particularly for pediatric drug development. Additionally, incorporating these media into standard drug development protocols improves the precision of in vitro-in vivo correlations (IVIVC), ultimately leading to better therapeutic outcomes.
Looking ahead, further research is needed to refine these media by incorporating additional physiological factors such as intestinal microbiota and gastric motility, which play a crucial role in drug dissolution and absorption. The integration of computational modeling and artificial intelligence (AI) could also enhance the predictive power of age-specific media, enabling the development of personalized dissolution models for different patient populations.
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Resource Person: Prakash Amate
