The Pharmaceutical Sciences in 2020: Report of a Conference Organized by the Board of Pharmaceutical Sciences of the International Pharmaceutical Federation (FIP)

The Board of Pharmaceutical Sciences (BPS) of the International Pharmaceutical Federation (FIP) has developed a view on the future of pharmaceutical sciences in 2020. This followed an international conference with invited participants from various fields (academicians, scientists, regulators, industrialists, venture capitalists) who shared their views on the forces that might determine how the pharmaceutical sciences will look in 2020. The commentary here provides a summary of major research activities that will drive drug discovery and development, enabling technologies for pharmaceutical sciences, paradigm shifts in drug discovery, development and regulations, and changes in education to meet the demands of academia, industry and regulatory institutions for pharmaceutical sciences in 2020

A science based approach to topical drug classification system (TCS).

The Biopharmaceutics Classification System (BCS) for oral immediate release solid drug products has been very successful; its implementation in drug industry and regulatory approval has shown significant progress. This has been the case primarily because BCS was developed using sound scientific judgment. Following the success of BCS, we have considered the topical drug products for similar classification system based on sound scientific principles. In USA, most of the generic topical drug products have qualitatively (Q1) and quantitatively (Q2) same excipients as the reference listed drug (RLD). The applications of in vitro release (IVR) and in vitro characterization are considered for a range of dosage forms (suspensions, creams, ointments and gels) of differing strengths. We advance a Topical Drug Classification System (TCS) based on a consideration of Q1, Q2 as well as the arrangement of matter and microstructure of topical formulations (Q3). Four distinct classes are presented for the various scenarios that may arise and depending on whether biowaiver can be granted or not

LC determination of propylene glycol in human plasma after pre-column derivatization with benzoyl chloride

A simple high-performance liquid chromatographic method, using photodiode array detection was developed for the determination of propylene glycol in human plasma and in the fluid retreived after continuous veno-venous hemofiltration. The method entailed alkaline derivatization with benzoyl chloride and ethylene glycol as internal standard. The separation of the compounds, after extraction with pentane, was carried out on a Pursuit C8 column with UV-detection at 230 nm. Validation samples were analyzed with an accuracy between 95 and 105%, and intra- and inter-day coefficients of variation of less than 8%. The calibration curve was linear over a concentration range of 5-100 mg

Retroperitoneal haemorrhage in renal angiomyolipoma causing hepatic functional decompensation: a case report

Renal angiomyolipomata usually present as incidental findings on routine imaging, but rarely they may give rise to significant haemorrhage. If bleeding occurs, first-line treatment is currently angiography with selective embolisation. Prophylactic embolisation may be considered in some cases, depending on lesion size and patient co-morbidities

Metabolomics to unveil and understand phenotypic diversity between pathogen populations

Visceral leishmaniasis is caused by a parasite called Leishmania donovani, which every year infects about half a million people and claims several thousand lives. Existing treatments are now becoming less effective due to the emergence of drug resistance. Improving our understanding of the mechanisms used by the parasite to adapt to drugs and achieve resistance is crucial for developing future treatment strategies. Unfortunately, the biological mechanism whereby Leishmania acquires drug resistance is poorly understood. Recent years have brought new technologies with the potential to increase greatly our understanding of drug resistance mechanisms. The latest mass spectrometry techniques allow the metabolome of parasites to be studied rapidly and in great detail. We have applied this approach to determine the metabolome of drug-sensitive and drug-resistant parasites isolated from patients with leishmaniasis. The data show that there are wholesale differences between the isolates and that the membrane composition has been drastically modified in drug-resistant parasites compared with drug-sensitive parasites. Our findings demonstrate that untargeted metabolomics has great potential to identify major metabolic differences between closely related parasite strains and thus should find many applications in distinguishing parasite phenotypes of clinical relevance

A new method for chlorhexidine (CHX) determination: CHX release after application of differently concentrated CHX-containing preparations on artificial fissures

Aims of the study were (1) to establish a method for quantification of chlorhexidine (CHX) in small volumes and (2) to determine CHX release from differently concentrated CHX-containing preparations, varnishes, and a CHX gel applied on artificial fissures. CHX determination was conducted in a microplate reader using polystyrene wells. The reduced intensity of fluorescence of the microplates was used for CHX quantification. For verification of the technique, intra- and inter-assay coefficients of variation were calculated for graded series of CHX concentrations, and the lower limit of quantification (LLOQ) was determined. Additionally, artificial fissures were prepared in 50 bovine enamel samples, divided into five groups (A–E, n = 10) and stored in distilled water (7 days); A: CHX-varnish EC40; B: CHX-varnish Cervitec; C: CHX-gel Chlorhexamed; D: negative control, no CHX application; and E: CXH-diacetate standard (E1, n = 5) or CHX-digluconate (E2, n = 5) in the solution. The specimens were brushed daily, and CHX in the solution was measured. The method showed intra- and inter-assay coefficients of variation of <10 and <20%, respectively; LLOQ was 0.91–1.22 nmol/well. The cumulative CHX release (mean ± SD) during the 7 days was: EC40 (217.2 ± 41.8 nmol), CHX-gel (31.3 ± 8.5 nmol), Cervitec (18.6 ± 1.7 nmol). Groups A–C revealed a significantly higher CHX release than group D and a continuous CHX-release with the highest increase from day 0 to 7 for EC40 and the lowest for Chlorhexamed. The new method is a reliable tool to quantify CHX in small volumes. Both tested varnishes demonstrate prolonged and higher CHX release from artificial fissures than the CHX-gel tested