Validity of functional assessment for control of trunk in patients with subacute stroke: a multicenter, cross-sectional study.

[Purpose] The purpose of this study was to clarify the criterion validity, construct validity, and feasibility of the Functional Assessment for Control of Trunk (FACT). [Participants and Methods] This study was a multicenter, cross-sectional study of patients with subacute stroke at three Japanese rehabilitation hospitals. To clarify feasibility, we examined the differences in the measurement time between FACT and the Trunk Impairment Scale (TIS). For the criterion validity of FACT, correlations between FACT, TIS, and the trunk items of the Stroke Impairment Assessment Set (SIAS) were examined using Spearman's rank correlation coefficient. For the construct validity of FACT, we examined the correlations with the other assessments. [Results] Seventy-three patients participated in this study. The measurement time was significantly shorter for FACT (212.6 ± 79.2 s) than TIS (372.4 ± 199.6 s). For criterion validity, FACT correlated significantly with TIS (r=0.896) and two SIAS trunk items (r=0.453, 0.594). For construct validity, significant correlations were found for FACT and other tests (r=0.249-0.797). Areas under the curve for FACT and TIS were 0.809 and 0.812, respectively, and the cutoff values for walking independence were 9 and 13 points, respectively. [Conclusion] For inpatients with stroke, FACT offered feasibility, criterion validity, and construct validity.

Cognitive and physical functions related to the level of supervision and dependence in the toileting of stroke patients.

PURPOSE: This study aimed to clarify which cognitive and physical factors are associated with the need for toileting assistance in stroke patients and to calculate cut-off values for discriminating between independent supervision and dependent toileting ability. METHOD: This cross-sectional study included 163 first-stroke patients in nine convalescent rehabilitation wards. Based on their FIMⓇ instrument score for toileting, the patients were divided into an independent-supervision group and a dependent group. Multiple logistic regression analysis and receiver operating characteristic analysis were performed to identify factors related to toileting performance. The Minimental State Examination (MMSE); the Stroke Impairment Assessment Set (SIAS) score for the affected lower limb, speech, and visuospatial functions; and the Functional Assessment for Control of Trunk (FACT) were analyzed as independent variables. RESULT: The multiple logistic regression analysis showed that the FIMⓇ instrument score for toileting was associated with the SIAS score for the affected lower limb function, MMSE, and FACT. On receiver operating characteristic analysis, the SIAS score for the affected lower limb function cut-off value was 8/7 points, the MMSE cut-off value was 25/24 points, and the FACT cut-off value was 14/13 points. CONCLUSION: Affected lower limb function, cognitive function, and trunk function were related with the need for toileting assistance. These cut-off values may be useful for judging whether toileting assistance is needed in stroke patients.

Formulation design for orally disintegrating tablets containing enteric-coated particles.

The purpose of this study was to investigate the applicability of our newly developed technology (RACTAB® technology) for preparing orally disintegrating tablets (ODTs) containing enteric-coated particles. Tamsulosin hydrochloride (TAM) was used as a model drug contained in the enteric-coated particles. Enteric-coated particles containing TAM (ECP-T) were prepared by spray coating a mixture of TAM with controlled-release materials. ECP-T was then mixed with rapidly disintegrating granules (RDGs), which were prepared using the suspension spray-coating method, and was tableted to form ODTs (ODTRAC). ODTRAC was evaluated for its hardness, thickness, internal structure (X-ray-CT scanning), functional properties (controlled-release profile), and in vivo disintegration time. Since RDGs with micronized ethylcellulose (MEC) increased tablet hardness by increasing the contact frequency between granules, ODTRAC containing ECP-T exhibited high hardness (>50 N) and low friability (<0.5%) with a relatively low compression force. After tableting, the structure of ECP-T in ODTRAC remained intact and no damage was observed on the surface. ECP-T recovered from ODTRAC showed the same dissolution profile of TAM in Japanese Pharmacopoeia (JP) 1st and JP 2nd media as that of intact ECP-T, which indicated that the tableting process did not affect the acid-resistibility of the particle. In addition, ODTRAC rapidly disintegrated in vivo (< 30 s), even at a high compression force (at 9 kN). These findings clearly suggest that RACTAB® technology is a useful approach to prepare ODTs containing enteric-coated particles.

Further improvement of orally disintegrating tablets using micronized ethylcellulose.

The aim of this study is to design a new orally disintegrating tablet (ODT) containing micronized ethylcellulose (MEC). The new ODT was prepared by physical mixing of rapidly disintegrating granules (RDGs) with MEC. To obtain RDGs, mannitol was spray-coated with a suspension of corn starch and crospovidone (9:1, w/w ratio) using a fluidized-bed granulator (suspension spray-coating method). The new ODTs were evaluated for their hardness, friability, thickness, internal structure (X-ray-CT scanning), in vivo disintegration time, and water absorption rate. Since MEC increases tablet hardness by increasing the contact frequency between the granules, the new ODTs could obtain high hardness (>50 N) and low friability (<0.5 %) with relatively low compression force. In addition, fine capillary channels formed in ODTs facilitated the wicking action and enabled rapid disintegration in vivo (<30 s). On the other hand, since MEC has low hygroscopicity, the tablet hardness of ODTs containing MEC remained high for 1 month in high-humidity conditions. In conclusion, the new ODTs containing MEC developed in this study possessed superior properties for clinical use and are expected to be applied for a wide range of functionally released drugs for bitter taste masking, sustained release, and controlled release (pH-dependent film coating, matrix, and microcapsule).