Amantadine, despite being on the market for 55 years, has several unknown aspects of its pharmacokinetics especially related to the influence of covariates such as age, disease, or interactions linked to amantadine's renal elimination. As amantadine is used in Parkinson's disease and is considered a potential candidate in COVID treatment and other diseases, there is an unmet need for thorough understanding of its pharmacokinetic in special populations, such as the elderly. We aimed to mechanistically describe amantadine pharmacokinetics in healthy subjects and shed some light on the differences in drug behavior between healthy volunteers (18-65 years) and an elderly/geriatric population (65-98 years) using PBPK modeling and simulation.
View Article and Find Full Text PDFAs the field of personalized dosing develops, the pharmaceutical manufacturing industry needs to offer flexibility in terms of tailoring the drug release and strength to the individual patient's needs. One of the promising tools which have such capacity is 3D printing technology. However, manufacturing small batches of drugs for each patient might lead to huge test burden, including the need to conduct bioequivalence trials of formulations to support the change of equipment or strength.
View Article and Find Full Text PDFPrecision medicine requires selecting the appropriate dosage regimen for a patient using the right drug, at the right time. Model-Informed Precision Dosing (MIPD) is a concept suggesting utilization of model-based prediction methods for optimizing the treatment benefit-harm balance, based on individual characteristics of the patient, disease, treatment method, and other factors. Here, we discuss a theoretical workflow comprising several elements, beginning from the physiologically based pharmacokinetic/pharmacodynamic (PBPK/PD) models, through 3D printed tablets with the model proposed dose, information range and flow, and the patient themselves.
View Article and Find Full Text PDFPhysiologically based pharmacokinetic and absorption modeling are being used by industry and regulatory bodies to address various scientifically challenging questions. While there is high confidence in the prediction of exposure for the BCS class I drugs administered as immediate-release formulations, in the case of prolonged-release formulations, special attention should be given to the input dissolution data. Our goal was to develop and verify a PBPK model for a BCS class I compound, ropinirole, and check the biopredictiveness of the dissolution data for the prolonged-release formulation administered by Parkinson's patients.
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