Requirements for generic anti-epileptic medicines: a regulatory perspective

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Patient preference and acceptability of calcium plus vitamin D3 supplementation: a randomised, open, cross-over trial

Preference for a drug formulation is important in adherence to long-term medication for chronic illnesses such as osteoporosis. We investigated the preference for and acceptability of chewable tablet containing calcium and vitamin D (Calci Chew D3, Nycomed) compared to that of a sachet containing calcium and vitamin D3 (Cad, Will-Pharma). This open, randomised, cross-over trial was set up to compare the preference and acceptability of two calcium plus vitamin D3 formulations (both with 500 mg calcium and 400/440 IU vitamin D3), given twice a day in patients with osteoporosis. Preference and acceptability were assessed by means of questionnaires. Preference was determined by asking the question, which treatment the patient preferred, and acceptability was measured by scoring five variables, using rating scales. Of the 102 patients indicating a preference for a trial medication, 67% preferred the chewable tablet, 19% the sachet with calcium and vitamin D3, and 15% stated no preference. The significant preference for Calci Chew D3 (p < 0.0001) was associated with higher scores for all five acceptability variables. The two formulations were tolerated equally well. A significant greater number of patients considered the chewable tablet as preferable and acceptable to the sachet, containing calcium and vitamin D3. Trial registration: Current Controlled Trials ISRCTN18822358

HIV-1 Infection of DC: Evidence for the Acquisition of Virus Particles from Infected T Cells by Antigen Uptake Mechanism

Dendritic cells (DC) play a pivotal role in transmission and dissemination of HIV-1. Earlier studies reported that DC present at the site of infection trap virus particles via DC-SIGN and transfer the virus to the interacting naïve T cells. This prompted us to ask the question whether DC could acquire virus from infected T cells during DC-T cell interaction. To address this, we investigated the likely transfer of virus from HIV-1 infected T cells to DC and the underlying mechanisms involved. Results indicate that DC acquire virus from infected T cells via antigen uptake mechanism and this results in infection of DC with expression of proteins directed by viral DNA. Further studies with HIV-1 lacking the Env protein also resulted in infection of DC. The use of antibodies against DC-SIGN and DC-SIGN-R ruled out a role for receptor in the infection of DC. Additional data show that DC infection is directly correlated with the ability of DC to take up antigen from infected T cells. Overall, these studies provide evidence to suggest that HIV-1, besides infecting immune cells, also utilizes immunological mechanism(s) to acquire and disseminate virus

Murid Herpesvirus-4 Exploits Dendritic Cells to Infect B Cells

Dendritic cells (DCs) play a central role in initiating immune responses. Some persistent viruses infect DCs and can disrupt their functions in vitro. However, these viruses remain strongly immunogenic in vivo. Thus what role DC infection plays in the pathogenesis of persistent infections is unclear. Here we show that a persistent, B cell-tropic gamma-herpesvirus, Murid Herpesvirus-4 (MuHV-4), infects DCs early after host entry, before it establishes a substantial infection of B cells. DC-specific virus marking by cre-lox recombination revealed that a significant fraction of the virus latent in B cells had passed through a DC, and a virus attenuated for replication in DCs was impaired in B cell colonization. In vitro MuHV-4 dramatically altered the DC cytoskeleton, suggesting that it manipulates DC migration and shape in order to spread. MuHV-4 therefore uses DCs to colonize B cells

Harvesting of marine microalgae using cationic cellulose nanocrystals

Flocculation of marine microalgae is challenging because of the high ionic strength of the culture medium. We investigated cationic cellulose nanocrystals (CNCs) as biobased flocculants for the marine microalgae Nannochloropsis oculata, and compared its performance to chitosan. Cationic CNCs induced flocculation at a low dose of 11 mg L-1, while chitosan required a dose of 35 mg L-1. Our cationic CNCs possess a permanent positive charge, allowing flocculation over a wide pH-range (4 to 10). The CNC maximum flocculation efficiency was 90 %, while chitosan achieved > 95 %, attributed to small flocs remaining in suspension for CNCs. However, centrifugation for 1 min at 180 g or gravity filtration using a 30 μm nylon filter after CNC flocculation resulted in the removal of these small, stable flocs (∼150 μm diam) and > 95% harvesting efficiency. Cationic CNCs can thus serve as a sustainable alternative natural flocculant for harvesting both freshwater and marine microalgae.status: publishe