Drug Delivery Approaches in Addressing Clinical Pharmacology-Related Issues: Opportunities and Challenges

Abstract

Abstract. Various drug delivery approaches can be used to maximize therapeutic efficacy and minimize side effects, by impacting absorption, distribution, metabolism, and elimination (ADME) of a drug compound. For those drugs with poor water solubility or low permeability, techniques such as amorphous solid dispersion, liposomes, and complexations have been used to improve their oral bioavailability. Modified release (MR) formulations have been widely used to improve patient compliance, as well as to reduce side effects, especially for those drugs with short half-lives or narrow therapeutic windows. More than ten drugs using sterile long-acting release (LAR) formulations with clear clinical benefit have been successfully marketed. Furthermore, drug delivery systems have been used in delaying drug clearance processes. Additionally, modifying the in vivo drug distribution using targeted delivery systems has significantly improved oncology treatments. All the drug delivery approaches have their advantages and limitations. For both brand and generic drugs, the achievement of consistent quality and therapeutic performance using drug delivery systems can also pose serious challenges in developing a drug for the market, which requires close collaboration among industry, academia, and regulatory agencies. With the advent of personalized medicines, there will be great opportunities and challenges in utilizing drug delivery systems to provide better products and services for patients.

Regulatory Requirements of the European Medicines Agency for Evaluation of Bioequivalence of Modified-release Medicinal Products

“…Лекарственные препараты с немедленным высвобождением -это лекарственные препараты, действующее вещество которых высвобождается из формы дозирования в течение 45 мин не менее чем на 75 % от номинального количества (1 группа согласно ОФС 1.4.2.0014.15 «Растворение для твердых дозированных лекарственных форм» 3 ). Скорость и/или место высвобождения действующего вещества лекарственного препарата с модифицированным высвобождением отличаются от таковых для лекарственной формы с немедленным высвобождением, вводимой тем же путем.…”

“…Основной клинический замысел разработки препарата с модифицированным высвобождениемдостижение оптимальной фармакотерапии за счет изменения профиля поступления действующего вещества с целью повышения эффективности, безопасности и/или удобства приема препарата (например, прием одной таблетки в сутки вместо трех) [1][2][3].…”

Applications of Activity‐Based Protein Profiling (ABPP) and Bioimaging in Drug Discovery

“…Frequently,f ailure in clinicalt rials occurs due to undesirable side effects. [1] To minimize this kind of risk, it is highly desirable that preclinical experiments are carried out under natural environments so that the action mechanism can be comprehensively understood. [2] However, methods currently used for the study of drug-target engagement are mostlyi nv itro methods, [3] which may in certain cases provide limited insight into genuine drug-target interactions.…”

Nanoencapsulation Enhances Anticoagulant Activity of Adenosine and Dipeptide IleTrp

“…One of the main problems with the use of drugs is their degradation in the body, requiring an increase in the drug concentration to achieve a therapeutic effect; however, increasing the concentration can lead to a number of side effects [1][2][3]. Increasing stability is particularly important for peptide drugs.…”