A novel approach to establishing the design space for the oral formulation manufacturing process.

A novel approach to establishing the design space for the oral formulation manufacturing process was investigated. A response surface method incorporating multivariate spline interpolation was applied to overcome the nonlinear problem, which is always problematic in pharmaceutical development studies, and a bootstrap resampling technique, polynomial approximation technique, and 95% confidence intervals based on a nonparametric approach were applied to estimate the reliability of the established design space derived from the nonlinear response surface model. The critical quality attributes (CQAs) of intermediate material rather than the critical process parameters (CPPs) were chosen as the causal factors for the response variables, which were CQAs of the final product to avoid scale-gap and equipment-gap.

Quantitative evaluation and visualization of lumbar foraminal nerve root entrapment by using diffusion tensor imaging: preliminary results.

Background And Purpose: DTI can provide valuable structural information that may become an innovative tool in evaluating lumbar foraminal nerve root entrapment. The purpose of this study was to visualize the lumbar nerve roots and to measure their FA in healthy volunteers and patients with lumbar foraminal stenosis by using DTI and tractography with 3T MR imaging.

Materials And Methods: Eight patients with lumbar foraminal stenosis and 8 healthy volunteers underwent 3T MR imaging.

[Thoracic aortic aneurysm due to giant cell arteritis without any specific symptom].

A 76-year-old female was admitted to our hospital for investigation and treatment of aortic regurgitation. She was found to have an ascending aortic aneurysm extending to the proximal arch. She had not suffered from any symptoms except chest discomfort.

[Gigantic coronary aneurysm arisen from coronary fistula between the left circumflex artery and the left ventricle].

A 71-year-old male was referred to our hospital due to abnormality detected by a chest roentgenogram. He had no symptoms except for slight chest oppression. He was found to have a giant coronary aneurysm.

Polymer-like polyphenols of black tea and their lipase and amylase inhibitory activities.

Lipase and amylase inhibitory activities of black tea were examined. After solvent partitioning of a black tea extract with the ethyl acetate and n-butanol, the two soluble fractions showed comparable inhibitory activities. Activity in the ethyl acetate fraction was mainly attributable to polyphenols with low-molecular weights, such as theaflavin gallates.

Direct refolding of recombinant human growth differentiation factor 5 for large-scale production process.

An efficient downstream process for the production of recombinant human growth differentiation factor 5 (rhGDF5) has been developed for industrial application utilizing a novel "direct refolding" method. In this method, the starting material is an inclusion body produced in Escherichia coli, and the critical step is the direct refolding step that follows directly after solubilization of the inclusion body. rhGDF5 can be refolded at a markedly high concentration of 2.

Pulmonary artery systolic pressure is elevated in the elderly: relationships between echocardiographic and pathological findings.

Objective: We investigated the relationship between the right cardiac system and increased pulmonary artery systolic pressure (PASP) in the elderly.

Patients And Methods: Echocardiography stable state data were available for 163 of 200 consecutive autopsied patients. Of these, PASP could be estimated by extrapolation from the maximum pressure gradient in tricuspid valve regurgitation from echocardiograms in 73 cases; however, 22 cases with secondary changes attributable to left cardiac insufficiency had to be excluded.

[A case of sepsis by Neisseria meningitidis beginning with pneumonia during a trip abroad].

A 62-year-male presented a high fever and a dry cough during a trip to Australia. He was admitted to a hospital as soon as be returned to Japan. The next day after returning to Japan, he was transferred to our hospital with septic shock and loss of consciousness.

[A case of fluorouracil-induced pneumonitis].

A 73-year-old man with colon cancer had been treated elsewhere for pneumonia on June 12, 1994. He was admitted to our hospital on June 21 with progressive dyspnea and bilateral diffuse infiltrates on chest X-ray. On admission, plain chest radiographs and chest CT scans revealed bilateral interstitial shadows predominantly in the outer zone, of the lower lobes.

[Random biopsy and recurrence risk in patients with bladder cancer].

Background: We studied the relationship between the recurrence rate of primary superficial bladder cancer and random biopsy.

Methods: We performed transurethral resection of primary superficial bladder cancer in 144 patients, and in 55 of those cases a random biopsy was also performed. The non-recurrence rate was examined in many recurrence facters.

Aetiology of maxillofacial fracture.

The aetiological factors associated with maxillofacial fractures, and the trends in these factors over a 13 year period are reported. The First Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Tokyo Medical and Dental University, managed 695 patients with maxillofacial fractures between 1977 and 1989. The male to female ratio was 3.

Sequence in DNA synthetic phase ratio of spontaneous hypertensive rat (SHR) myocardium--study on development of cardiomegaly.

We studied the relative synthetic phase (S-phase) ratio of cardiac myocytes of spontaneously hypertensive rats (SHR) utilizing monoclonal antibody to 5-bromo 2'-deoxyuridine (BrdU), a halogen derivative of thymidine. BrdU was administered intraperitoneally to SHR and Wistar Kyoto rats at 66.7 mg/kg/day for 3 consecutive days.

Multiple intrahepatic portosystemic venous shunts: treatment by portal vein embolization.

A rare case of symptomatic, multiple, intrahepatic, portosystemic venous shunts which was treated by portal vein embolization after surgical cannulation is reported. The patient, having suffered from hepatic encephalopathy, improved dramatically after embolization. This method might be the only choice of therapy for intrahepatic portosystemic shunts of this kind.

[Diagnosis and surgical treatment of accessory mitral valve with associated congenital heart disease].

Accessory mitral valve (AcMV) is a rare cardiac anomaly that may possibly cause left ventricular outflow tract (LVOT) obstruction. Five patients who underwent surgical resection of AcMV were reported. All these patients had associated cardiac anomalies, which include transposition of great arteries (TGA) in two cases, ventricular septal defect (VSD) in one, double outlet right ventricle (DORV) in one and membranous septal aneurysm (MSA) in one.

[Bacteriological, pharmacokinetic and clinical studies of cefpirome in the field of pediatrics].

Bacteriological, pharmacokinetic and clinical studies on cefpirome (CPR, HR 810), a new cephem antibiotic, were carried out in the field of pediatrics. The results obtained are summarized below. 1.

Sensitive photon detector based on selective laser ionization.

A selective laser ionization photodetector (SLIP) is proposed and demonstrated. The SLIP uses an atomic-gas target as a detection element, instead of the photoelectric surface in photomultiplier tubes. The atomic gas resonantly absorbs the signal radiation to be detected and then is selectively photoionized by an intense laser beam.

[Acute cerebellar ataxia and facial palsy after DPT immunization].

Since the initial report of Beyers & Moll (1948), numerous cases of seizures and encephalopathy after pertussis immunization or DPT immunization have been reported. However, acute cerebellar ataxia and/or facial palsy after DPT immunization is unusual, although there have been several reports from Japan. We report a 1-year-11-month-old girl with acute cerebellar ataxia and facial palsy after DPT immunization.

[Retrograde coronary sinus perfusion of cardioplegic solution in Jatene operation in neonates and infants].

The clinical benefits of retrograde coronary sinus perfusion of a cardioplegic solution were investigated in 7 neonates and 23 infants undergoing Jatene operation. After an initial infusion of albumin-containing crystalloid cardioplegic solution via the aortic root, 21 patients received additional solution delivered by retrograde coronary sinus perfusion (retrograde group) and 9 patients received by selective antegrade coronary perfusion (antegrade group) every 20 to 30 minutes. There were no differences in age, weight, and left ventricular preoperative pressure and morphology between the two groups.