Dry granulation of vitamin D3 and iron in corn starch matrix: Powder flow and structural properties.

In this work, a twin-screw dry granulation (TSDG) was adopted to produce vitamin D3 (VD3) and iron blended dry granules using corn starch as an excipient. Response surface methodology was applied to determine the effect of the formulation compositions (VD3 and iron) on granule properties [tapped bulk density, oil holding capacity, and volumetric mean particle size (Dv50)]. Results indicated that the model fitted well, and responses, in particular flow properties, were significantly affected by the composition. The Dv50 was only influenced by the addition of VD3. The flow properties were characterized by the Carr index and Hausner ratio, which indicated very poor flow of the granules. Scanning electron microscopy with energy dispersive spectroscopy confirm the presence and distribution of Fe++ and VD3 in the granules. Overall, TSDG was proven to be a simple alternative method for the preparation of dry granules of VD3 and iron in a blend.

One-step continuous extrusion process for the manufacturing of solid dispersions.

The purpose of this study was to evaluate the performance of synthetic magnesium aluminometasilicate (MAS) as a novel inorganic carrier in hot melt extrusion (HME) processing of indomethacin (IND) for the development of solid dispersions. A continuous extrusion process at various IND/excipient blend ratios (20%, 30% and 40%) was performed using a twin-screw extruder. Physicochemical characterization carried out by SEM, DSC, and XRPD demonstrated the presence of IND in amorphous nature within the porous network of the inorganic material for all extruded formulations. Further, AFM and FTIR studies revealed a single-phase amorphous system and intermolecular H-bonding formation. The IND/MAS extrudates showed enhanced INM dissolution rates within 100% been released within 1h. Stability studies under accelerated conditions (40°C, RH 75%) showed that MAS retained the physical stability of the amorphous solid dispersions even at high drug loadings for 12 months.

Effects of nebulized budesonide as an adjunct to standard treatment of asthma exacerbations: a randomized, double-blind, placebo-controlled trial.

This study was done to determine the effects and outcome of inhaled budesonide in addition to standard management of asthma exacerbations in pediatric age groups. A randomized, double-blind, placebo controlled trial was done in a tertiary care urban hospital. Sixty six children aged 5 to 15 years with moderate to severe asthma exacerbations were eligible. All patients received a single dose of prednisolone 1mg/kg orally as first dose of systemic corticosteroids and then salbutamol (0.15mg/kg) and ipratropium bromide (500mcg) was nebulized every 20 minutes for 3 doses and then hourly for 2 hours as a part of standard treatment of asthma exacerbations. The intervention was 2mg (4mL) of budesonide or 4mL of normal saline which was nebulized immediately after the 1st dose of nebulized salbutamol and ipratropium bromide. The baseline characteristics of the budesonide group (n=33) and placebo group (n=33) were similar, but at 1 hour, 2 hour and 3 hour PEFR, respiratory rate, pulse rate, SaO2 and asthma score were significantly improved in the budesonide group compared to placebo group (p<0.01). The positive immediate effect of nebulized budesonide added to standard treatment of asthma exacerbations is an encouraging finding for further investigations of its routine use in the treatment of asthma exacerbations in children.

Sustained release solid lipid matrices processed by hot-melt extrusion (HME).

The aim of this work was to develop sustained release solid lipid matrices of diclofenac sodium (Df-Na) processed by hot melt extrusion (HME) and subsequent compression into tablets. Different extrusion processing approaches such as "cold", "hot" and pre-mixed formulations were used to develop the Compritol(®) 888 ATO lipid matrices by altering the extrusion temperatures, drug loading and formulation composition. The extrudates were characterized via a range of techniques such as differential scanning calorimetry (DSC), hot stage microscopy (HSM) and X-ray powder diffraction (XRPD) to identify the drug state within the lipid matrix. Df-Na was found to be either in crystalline or amorphous state depending on the processing conditions. Energy dispersive X-ray (EDX) microanalysis demonstrated excellent drug distribution of Df-Na on the surface of the compressed tablets. The lipid matrices developed by HME provided sustained release of pre-mixed formulations for 12h mainly controlled by diffusion.

Dissolution enhancement of poorly water-soluble APIs processed by hot-melt extrusion using hydrophilic polymers.

The aim of this study was to investigate the efficiency of hydrophilic polymers to enhance the dissolution rate of poorly water-soluble active pharmaceutical ingredients (APIs) processed by hot-melt extrusion (HME). Indomethacin (INM) and famotidine (FMT) were selected as model active substances while polyvinyl caprolactam graft copolymer, soluplus (SOL) and vinylpyrrolidone-vinyl acetate copolymer grades, Kollidon VA64 (VA64) and Plasdone S630 (S630) were used as hydrophilic polymeric carriers. For the purpose of the study, drug-polymer binary blends at various ratios were processed by a Randcastle single screw extruder. The physicochemical properties and the morphology of the extrudates were evaluated through X-ray diffraction (XRD), differential scanning calorimetry (DSC) and scanning electron microscopy (SEM). Increased drug loadings of up to 40% were achieved in the extruded formulations for both drugs. INM and FMT exhibited strong plasticization effects with increasing concentrations and were found to be molecularly dispersed within the polymer blends. The in vitro dissolution studies showed increased INM/FMT release rates for all formulations compared to that of pure APIs alone.

Kala azar in Pregnancy.

Kala azar (KA) is one of the most important tropical diseases. More so is the issue of KA in pregnancy. In this retrospective study we tried to find out the out come of pregnant patient treated with Sodium Antimony Gluconate (SAG) for KA in one of the most endemic area of Bangladesh, Fulbaria. SAG is the available and registered drug for treatment of KA patient with pregnancy in Bangladesh. A total of 16 pregnant women presented with KA during the study period of 2005 to 2009. Out of the 16 patients 11 had abortion and they were all with in the 16 to 22nd week of pregnancy. The abortion took place mostly on the 22nd to 24th day of treatment when the patient had become afebrile. Rest of the 5 patients was in their 30 to 34th week of pregnancy and had good obstetric outcome. All the 16 patients were clinically cured at the end of treatment. No follow up records were available and there was no data regarding the 5 children. It is of our opinion that the abortions were induced by SAG and therefore we recommend that SAG should not be used in early or mid pregnancy for treating KA.

Basal and maximal acid output in chronic duodenal ulcer patients needing surgery.

Basal acid output (BAO) and maximal acid output (MAO) were studied in a group of duodenal ulcer patients needing surgical treatment and in a group of healthy control subjects. The MAO levels in both the patients and the controls were lower than those reported from Europe, North America or Hongkong but were similar to those from India. The BAO levels were similar to those observed by workers in other countries. The MAO levels of the duodenal ulcer patients were much higher than those of the control subjects and there was hardly any overlap between the two groups. The ulcer patients had levels of greater than 15.0 mmol/hour. Whether duodenal ulcer patients from Bangladesh with MAO values of over 15.0 mmol/hour will always need surgery remains to be studied.