Nomogram for computing the value of similarity factor.

The objective of present work was to construct nomogram for obtaining a value of similarity factor (f2) by employing the values of number of observations (n) and sum of squared difference of percentage drug dissolved between reference (R) and test (T) products . The steps for rearrangement of equation of similarity factor are presented. The values of f2 were selected in the range of 45 to 100 for 4 to 12 observations (n) for computing the values of Linear regression analysis was performed between number of observations and . Perfect correlation was observed in each case. Nomogram was constructed and later it was validated by using drug dissolution data from literature and our laboratory. The use of nomogram is recommended during research and development work to investigate effect of formulation or process variables. The nomogram can also be used during change in manufacturing site or change in equipment. It is concluded that the steps for calculation of f2 can be truncated in the middle (i.e. at the step of calculation of factor and a decision of similarity/dissimilarity can be taken employing the nomogram.

1-Year clinical outcomes of diabeticpatients treated with everolimus-elutingbioresorbable vascular scaffolds: a pooled analysis of the ABSORB and the SPIRIT trials

Objectives The aim of this study was to evaluate 1-year clinical outcomes of diabetic patients treatedwith the Absorb bioresorbable vascular scaffold (BVS).Background Clinical outcomes of diabetic patients after BVS implantation have been unreported.Methods This study included 101 patients in the ABSORB Cohort B trial and the first consecutive 450patients with 1 year of follow-up in the ABSORB EXTEND trial. A total of 136 diabetic patients werecompared with 415 nondiabetic patients. In addition, 882 diabetic patients treated with everolimuselutingmetal stents (EES) in pooled data from the SPIRIT trials (SPIRIT FIRST [Clinical Trial of the AbbottVascular XIENCE V Everolimus Eluting Coronary Stent System], SPIRIT II [A Clinical Evaluation of the XIENCEV Everolimus Eluting Coronary Stent System], SPIRIT III [Clinical Trial of the XIENCE V Everolimus ElutingCoronary Stent System (EECSS)], SPIRIT IV Clinical Trial [Clinical Evaluation of the XIENCE V EverolimusEluting Coronary Stent System]) were used for the comparison by applying propensity score matching.The primary endpoint was a device-oriented composite endpoint (DoCE), including cardiac death, targetvessel myocardial infarction, and target lesion revascularization at 1-year follow-up.Results The cumulative incidence of DoCE did not differ between diabetic and nondiabetic patientstreated with the BVS (3.7% vs. 5.1%, p » 0.64). Diabetic patients treated with the BVS had a similarincidence of the DoCE compared with diabetic patients treated with EES in the matched study group(3.9% for the BVS vs. 6.4% for EES, p » 0.38). There were no differences in the incidence of definite orprobable scaffold/stent thrombosis (0.7% for both diabetic and nondiabetic patients with the BVS; 1.0%for diabetic patients with the BVS vs. 1.7% for diabetic patients with EES in the matched study group).Conclusions In the present analyses, diabetic patients treated with the BVS showed...

Exploration of Novel Co-processed Multifunctional Diluent for the Development of Tablet Dosage Form.

The aim of this investigation was to develop a novel multifunctional co-processed diluent consisting of microcrystalline cellulose (Avicel PH 102), crospovidone (Polyplasdone XL) and polyethylene glycol 4000. Colloidal silicon dioxide and talc were also incorporated as minor components in the diluent to improve tableting properties. Melt granulation was adopted for preparation of co-processed diluent. Percentage of Avicel PH 102, Polyplasdone XL and polyethylene glycol 4000 were selected as independent variables and disintegration time was chosen as a dependent variable in simplex lattice design. The co-processed diluent was characterised for angle of repose, bulk density, tapped density, Carr's index, percentage of fines and dilution potential study. Acetaminophen and metformin were used as poorly compressible model drugs for preparation of tablets. The blend of granules of drug and extra-granular co-processed diluent exhibited better flow as compared to the blend of drug granules and physical mixture of diluents blend. The diluent exhibited satisfactory tableting properties. The tablets exhibited fairly rapid drug release. In conclusion, melt granulation is proposed as a method of preparing co-processed diluent. The concept can be used to bypass patents on excipient manufacturing.

Unsuccessful deflation of a bifoil balloon during percutaneous mitral valvuloplasty.

A middle-aged woman was subjected to balloon mitral valvuloplasty using a bifoil balloon catheter. After inflation the balloon failed to deflate in spite of negative suction, probably due to a kink. The balloon was perforated with a transseptal puncture needle in order to deflate it and save open heart surgery.

Tricuspid balloon valvuloplasty: a more simplified approach using inoue balloon.

We report a more simplified technique of the balloon tricuspid valvuloplasty using inoue balloon set in a patient suffering from severe rheumatic tricuspid stenosis. We believe that this technique may be useful in a difficult case of tricuspid valvuloplasty.

Percutaneous transvenous mitral commissurotomy using Inoue balloon catheter: a left femoral vein approach.

Percutaneous transvenous mitral commissurotomy by the Inoue technique is usually recommended from right femoral vein approach only. We report an unusual patient in whom the left femoral vein approach was used successfully. We believe that the left femoral vein approach can be reserved as a last resort in certain cases.

Difficult mitral valvuloplasty: an "over the wire" modification of Inoue technique.

Failure to cross the mitral valve remains an important cause of the technical failure in performing mitral valvuloplasty with the Inoue technique, especially during initial experience of the operator. We report two such cases where conventional methods failed and an "over the wire" modification of the Inoue technique had to be utilized. This particular modification can be beneficial in the rare cases where negotiating the Inoue balloon across the mitral valve is particularly difficult.

Spectrophotometric determination of ampicillin and its dosage forms.

A new spectrophotometric procedure is described for the determination of ampicillin. The method is based on the reaction of ampicillin with acetylacetone-formaldehyde reagent to give a yellow coloured product having lambda max at 400 nm. A variety of pharmaceutical dosage forms containing ampicillin are successfully analysed by the proposed procedure.

Left ventricular mass and function in children with severe protein energy malnutrition.

We studied 25 children, aged 1-5 years (mean 2.65 +/- 0.8 years) with severe protein energy malnutrition, and compared their left ventricular mass and function to those of 26 healthy, age- and sex-matched normal children. The mean left ventricular mass in the patients was lower than that in the controls (25.75 +/- 8.09 g vs. 32.44 +/- 11.64 g; P less than 0.05, C.I. 2.08 to 11.30). However, left ventricular mass (g)/kg body weight was significantly increased in the patients (4.44 +/- 1.45 vs. 2.42 +/- 0.87; P less than 0.001, C.I. 1.28 to 2.76) suggesting relative cardiac "sparing". The systolic function indices like ejection fraction, percentage fractional shortening, and velocity of circumferential fiber shortening were not significantly different in the patients and in the normal children. The left ventricular end-diastolic volume, stroke volume and cardiac output were reduced in proportion to decrease in body size in the patients, so that the cardiac index was not reduced but slightly increased in the patients. (5.95 +/- 1.9 l/min/m2 in patients, 4.97 +/- 1.4 l/min/m2 in controls; P less than 0.05, C.I. 0.04 to 1.92). There was no significant difference in any of these parameters of left ventricular function or mass in patients with marasmus, as compared to those of patients with marasmic kwashiorkor. Amongst the 25 patients, however, 5 patients (20%) had an ejection fraction of less than 50%. Compared to the other 20 patients, these 5 patients had lower left ventricular mass (18.4 +/- 4.3 g vs. 27.5 +/- 7.8 g, P less than 0.05 C.I. 1.63 to 16.75), lower left ventricular mass (g)/kg body weight and a worse prognosis.(ABSTRACT TRUNCATED AT 250 WORDS)

Noninvasive assessment of left ventricular function in asymptomatic diabetics and its relation to metabolic control and microangiopathy.

Fifty otherwise healthy patients with diabetes mellitus (37 males, 13 females; mean age: 53 +/- 10 years) of more than five year duration were compared with twenty six healthy age and sex matched controls. Detailed echocardiographic evaluation was done in all and systolic time intervals (STI) were measured. In diabetics, metabolic control and presence of microangiopathy were evaluated. PEP Index (patients: 146.23 +/- 17.04; controls: 121.99 +/- 5.15; p less than 0.001), PEP/LVET ratio (patients: 0.38 +/- 0.07; controls: 0.32 +/- 0.02; p less than 0.001), LVEF% (patients: 54.1 +/- 10.56; controls: 64.71 +/- 6.33; p less than 0.001), all were significantly altered in diabetics suggesting left ventricular dysfunction. The left ventricular posterior wall thickness (patients: 0.96 +/- 0.23 cm; controls: 0.85 +/- 0.12 cm; p less than 0.01) and interventricular septal thickness (patients: 1.2 +/- 0.24 cm; controls: 0.87 +/- 0.25 cm; p less than 0.001) in diastole were increased in diabetics. The PEPI correlated with day-to-day control but not with chronic glycemic control of diabetes mellitus. The PEP/LVET was significantly increased in patients with severe, as compared to those with none or mild microangiopathy (p less than 0.05). Thus, significant left ventricular dysfunction is evident in asymptomatic, otherwise healthy diabetics. Both metabolic control and microangiopathy may be responsible for the abnormalities.