Formulation and Design of Multiunit Particulate System (MUPS) Tablet of Pantoprazole by QbD: Effect of Compression Variables on the Finished Product.

The aim of the study was to optimize compression process variables of Pantoprazole oro-dispersible (Multiunit particulate system) MUPS tablet. Enteric coated Pantoprazole pellets were compressed to oro-dispersible tablet for geriatric and pediatric patients for easy administration. The risk related to compression process variables was identify, assessed and mitigated using Failure Mode and Effect Analysis (FMEA). A full factorial design was applied to develop design space and determine control strategy for compression process, which were developed, have promising chemical and physical results. The compression process variables studied were pre-compression force (X1), main compression force (X2) and turret speed (X3), versus affecting hardness (Y1), disintegration time (Y2), friability (Y3), weight variation (Y4), content uniformity (Y5), drug release in 0.1N HCl (Y6) and assay (Y7) as responses/Critical quality attributes (CQAs). Response surface graphs depicted that X2 had more impact on CQAs than X1. Design space plot revealed that tablet CQAs were within limit when X3 maximum 44 rpm and X2 in the range of 10 to 12.5 kN. Scale up performed on commercial scale compression machine of same make that of lab scale showed reproducible physical and chemical parameters. It could be concluded that a quality Pantoprazole oro-dispersible MUPS tablet was successfully designed using QbD approach to compression process variables.

Vitamin D Deficiency Among Women in Labor and Cord Blood of Newborns.

25-hydroxy Vitamin D levels of 106 maternal blood samples and cord blood levels of their newborns were studied. Maternal mean (SD) vitamin D level was 16.3(10.3) ng/mL, and mean (SD) cord blood level was 12.8 (8.5) ng/mL. Seventy-five (70.7%) mothers (70.7%) and 88 (83%) newborns had hypovitaminosis-D. Seventy (93.3%) newborns of mothers with hypovitaminosis-D had low vitamin D levels. There was a strong correlation between maternal and newborn Vitamin D levels (r=0.6; P<0.001). There is a high prevalence of hypovitaminosis D in women in labor and their newborns.

Flare up of choroiditis and choroidal neovasculazation associated with punctate inner choroidopathy during early pregnancy.

A 28-year-old, healthy female, who had a recent repeated history of miscarriage, presented with bilateral choroidal neovascular membranes (CNVM), for which she received photodynamic therapy with three doses of lucentis, at intervals of one month each, to which she responded. After five months, the patient again presented with complaints of diminution of vision since 15 days. She had a history of miscarriage two days before presenting to our clinic. CNVM was scarred at this time and the fundus picture showed multiple small punctate spots around the fovea at the level of the choroid, which showed early hyperfluroscence on fundus fluorescein angiography, suggestive of punctate inner choroidopathy. She was advised systemic steroids, to which she responded dramatically.

A comparative study of clinical and autopsy findings (clinical audit) in 100 cases died of trauma.

Clinical audit is the systematic analysis of quality of any aspect of patient care with the aim of identifying possible improvements. In the present study one aspect of clinical audit - a comparison of clinical findings and autopsy findings was done in 100 cases died of trauma and brought for autopsy to Medical College, Trivandrum. This Study was conducted to find out the frequency of discrepancy and the type of co-existing injuries along with the missed injury. The discrepancies were classified according to the classification by Battle et al and Andersen et al. No discrepancy was observed in 62%, class I discrepancy (Major) in 25%, class II (Major) in 3%, and class III & IV (Minor) in 5% each. The injuries very rarely over looked were head injuries (11.4%) and spinal injuries (16.7%). The most frequent missed ones were abdominal injuries (64.3%) and chest injuries (63.9%). In majority of missed injuries head injury was a common occurrence i.e. 88.8% of missed abdominal injury, 78.1% of missed chest injuries, and all cases of missed spinal injuries.

Effect of surgical stress on neutrophil function.

The present study was undertaken to find out the effect of surgical stress on nonspecific immune response. Twenty patients posted for various elective surgeries participated in the study (male : 17, female : 3, age : 43.4±2 yrs). The blood samples were taken preoperatively (4 to 6 days prior to surgery) and the following parameters were assessed: phagocytic index of neutrophils, avidity index of neutrophils and percentage of neutrophils in differential count. These were compared with the respective parameters assessed in the blood samples taken 24 hours after surgery. There was a significant (P=0.0001) decrease in the phagocytic index of neutrophil and a significant (P=0.003) increase in the percentage of neutrophils in differential count in the postoperative blood samples. However, the avidity index did not show a significant change. It could be tentatively concluded that surgical stress causes depression of nonspecific immunity in the early postoperative period.

Neuropharmacological actions of panchagavya formulation containing Emblica officinalis Gaerth and Glycyrrhiza glabra Linn in mice.

A panchagavya Ayurvedic formulation containing E. officinalis, G. glabra, and cow's ghee was evaluated for its effect on pentobarbital-induced sleeping time, pentylenetetrazol-induced seizures, maximal electroshock-induced seizures, spontaneous motor activity, rota-rod performance (motor coordination) and antagonism to amphetamine in mice. The formulation (300, 500 mg/kg, po) produced a significant prolongation of pentobarbital-induced sleeping time and reduced spontaneous locomotor activity. The formulation also significantly antagonised the amphetamine induced hyper-locomotor activity (500, 750 mg/kg, po) and protected mice against tonic convulsions induced by maximal electroshock (500, 750 mg/kg, po). The formulation slightly prolonged the phases of seizure activity but did not protect mice against lethality induced by pentylenetetrazole. The formulation did not show neurotoxicity. The results suggest that the panchagavya formulation is sedative in nature.

Density-dependent growth and metamorphosis in the larval bronze frog Rana temporalis is influenced by genetic relatedness of the cohort.

Effects of density and kinship on growth and metamorphosis in tadpoles of Rana temporalis were studied in a 2 4 factorial experiment. Fifteen egg masses were collected from streams in the Western Ghat region of south India. The tadpoles were raised as siblings or in groups of non-siblings at increasing density levels, viz. 15, 30, 60 and 120/5 l water. With an increase in density level from 15 to 120 tadpoles/5 l water, duration of the larval stage increased and fewer individuals metamorphosed irrespective of whether they belonged to sibling or non-sibling groups by day 100 when the experiments were terminated. The size of individuals at metamorphosis declined significantly with increase in the density of rearing. However, at higher densities (60 and 120 tadpoles/5 l water) sibling group tadpoles performed better compared to mixed groups and took significantly less time to metamorphose. Also, more individuals of sibling groups metamorphosed compared to non-sibling groups at a given density. Mixed rearing retarded growth rates, prolonged larval duration resulting in a wider spectrum of size classes, and lowered the number of individuals recruited to terrestrial life. The study shows that interference competition occurred more strongly in cohorts of mixed relatedness than in sibling groups.

The ontogeny of kin recognition in tadpoles of the toad Bufo melanostictus (Anura; bufonidae).

The ontogeny of kin recognition and influence of social environment on the development of kin recognition behaviour was experimentally investigated in tadpoles of Bufo melanostictus that lived in aggregations and showed low larval dispersion. Embryos and tadpoles of the toad were reared as (i) kin only, (ii) with kin and non-kin (separated by a mesh screen), and (iii) in isolation. They were tested for the ability to discriminate between (i) familiar siblings and unfamiliar non-siblings, (ii) familiar siblings and familiar non-siblings and, (iii) unfamiliar siblings and unfamiliar non-siblings. All tadpoles were fed on boiled spinach before conducting trials. Preference of test tadpoles to associate near the end compartments whether empty or containing members of specific stimulus groups was assessed using a rectangular choice tank. When tested in tanks with empty end compartments, the test tadpoles showed random distribution and thus no bias for the apparatus or the procedure. In the presence of kin/non-kin in the end compartments a significantly greater number of test tadpoles spent the majority of the time near familiar or unfamiliar kin rather than near familiar or unfamiliar non-kin. Kin discrimination ability persisted throughout larval development. Familiarity with siblings is not required for discriminating kin from non-kin, and kin discrimination ability is not modified following exposure to non-kin. Also, involvement of dietary cues is unlikely to be the prime mechanism of kin recognition in B. melanostictus unlike in some other anurans.