Journal of Pharmaceutical Investigation 

About: Journal of Pharmaceutical Investigation is an academic journal. The journal publishes majorly in the area(s): Bioequivalence & Drug delivery. It has an ISSN identifier of 2093-5552. Over the lifetime, 1207 publications have been published receiving 7819 citations.

Nanomedicines: current status and future perspectives in aspect of drug delivery and pharmacokinetics

Abstract: Nanomedicines have evolved into various forms including dendrimers, nanocrystals, emulsions, liposomes, solid lipid nanoparticles, micelles, and polymeric nanoparticles since their first launch in the market. Widely highlighted benefits of nanomedicines over conventional medicines include superior efficacy, safety, physicochemical properties, and pharmacokinetic/pharmacodynamic profiles of pharmaceutical ingredients. Especially, various kinetic characteristics of nanomedicines in body are further influenced by their formulations. This review provides an updated understanding of nanomedicines with respect to delivery and pharmacokinetics. It describes the process and advantages of the nanomedicines approved by FDA and EMA. New FDA and EMA guidelines will also be discussed. Based on the analysis of recent guidelines and approved nanomedicines, key issues in the future development of nanomedicines will be addressed.

Biocompatibility, biodegradation and biomedical applications of poly(lactic acid)/poly(lactic-co-glycolic acid) micro and nanoparticles

Abstract: Poly(lactic acid) (PLA) and poly(lactic-co-glycolic acid) (PLGA) are among the well-documented FDA-approved polymers used for the preparation of safe and effective vaccine, drug and gene delivery systems using well-described reproducible methods of fabrication. Various nano and microparticulates are fabricated using these polymers. Their successful performance relies on PLA and PLGA biocompatibility and degradability characteristics. This review provides an overview of the biocompatibility and biodegradation of PLA, PLGA and their copolymers, with a special emphasis on tissue responses for these polymers as well as their degradation pathways and drug release models. Moreover, the potential of PLA and PLGA based nano and microparticulates in various advanced biomedical applications is highlighted. PLA and PLGA based delivery systems show promises of releasing different drugs, proteins and nucleic acids in a stable and controlled manner and greatly ameliorating their therapeutic efficacy. In addition, advancement in surface modification and targeting of nanoparticles has extended the scope of their utility.

Food-Effect Bioavailability and Fed Bioequivalence Studies

Abstract: A new medical system was started in Korea in 2000 and pharmaceutical affairs law was revised in 2001. According to the revised law, generic substitution is permitted only to the drug products which are proven to be bioequivalent to the reference listed drugs. To expand the list of bioequivalence-proven drug products and to ensure the credibility of the therapeutic equivalence of generic drug are the hot issues in Korea. Also, the KFDA has a plan to revise the pharmaceutical affairs law that bioequivalence reports of all the generic prescription drug products should be submitted to the KFDA for drug approval after July in 2004. Therefore, it is increasing the necessity to develop the bioequivalence-demonstrating methods for specific drug substances and preparations which require to conduct food-effect bioavailability or bioequivalence study. There are some differences between US and Japanese guidances of food-effect bioavailability and bioequivalence studies. In this paper, we examined the recently published US guidance about food-effect study and it will be a reference to make our own guidance about food-effect bioavailability and bioequivalence guidances in Korea.

Mechanisms of drug release from advanced drug formulations such as polymeric-based drug-delivery systems and lipid nanoparticles

Abstract: Drug release from a polymeric nanocarrier is affected by several factors including the sort of composition (drug, polymer, and excipient), the ratio of composition, physical or chemical interaction between components, and manufacturing methods. Depending on the mechanism of drug release from the vehicles, it can be divided into four categories (diffusion, solvent, chemical interaction, and stimulated release). Recently, lipids have attracted great interest as carriers for water-insoluble drug delivery. Lipid-based drug-delivery systems have received a lot of interest because of their ability to improve solubility and bioavailability of drugs that are poorly soluble in water. The lipid carrier, formulation strategy, and rational drug-delivery system should be selected appropriately for a lipid-based drug-delivery system to be successful. In this review, the general release characteristics and mechanisms of drug from nanocarriers will be discussed.

Brain-specific drug delivery

Abstract: The subject compounds, which are adapted for the site-specific/sustained delivery of centrally acting drug species to the brain, are: (a) compounds of the formula: ADD-DHC BD (I), wherein ADD BD is a centrally acting drug species, and ADDHC BD is the reduced, biooxidizable, blood-brain barrier penetrating lipoidal form of a dihydropyridine$(1,10)$pyridinium salt redox carrier, with the proviso that when ADDHC BD is$(10,)$wherein R is lower alkyl or benzyl and ADD BD is a drug species containing a single NH2 or OH functional group, the single OH group when present being a primary or secondary OH group, said drug species being linked directly through said NH2 or OH functional group to the carbonyl function of ADDHC BD, then ADD BD must be other than a sympathetic stimulant, steroid sex hormone, memory enhancer, long chain alkanol or anticancer or antitumor agent; and (b) non-toxic pharmaceutically acceptable salts of compounds of formula (I) wherein ADD BD is a centrally acting drug species and ADDHC BD is the reduced, biooxidizable, blood-brain barrier penetrating lipoidal form of a dihydropyridine$(1,10)$pyridinium salt redox carrier. The correspnding ionic pyridinium salt type drug/carrier entities ADD-QC BD+ are also disclosed, as are derivatives of testicularly acting drug species capable of penetrating the blood-testis barrier.