The use of the SeDeM diagram expert system for the formulation of Captopril SR matrix tablets by direct compression

The SeDeM Diagram Expert System has been used to study excipients, Captopril and designed formulations for their galenic characterization and to ascertain the critical points of the formula affecting product quality to obtain suitable formulations of Captopril Direct Compression SR Matrix Tablets. The application of the Sedem Diagram Expert System enables selecting excipients with in order to optimize the formula in the preformulation and formulation studies. The methodology is based on the implementation of ICH Q8, establishing the design space of the formula with the use of experiment design, using the parameters of the SeDeM Diagram Expert System as system responses

Učinak topljivosti na kinetiku oslobađanja vodotopljivih i vodonetopljivih lijekova iz matriksnog sustava na bazi HPMC

The purpose of the present research work was to observe the effects of drug solubility on the release kinetics of water soluble verapamil hydrochloride and insoluble aceclofenac from polymer based matrix formulations. Matrix formulations were prepared by the direct compression method. The formulations were evaluated for various physical parameters. Along with the dynamics of water uptake and erosion, SEM and in vitro drug release of tablets were studied. Applying an exponential equation, it was found that the kinetics of soluble drug release followed anomalous non-Fickian diffusion transport whereas insoluble drug showed zero-order release. SEM study showed pore formation on the tablet surface that differed depending on drug solubility. t-Test pointed to a significant difference in the amount of both drugs released due to their difference in solubility. Solubility of the drug affects the kinetics and the mechanism of drug release.Cilj rada bio je praćenje učinka topljivosti na kinetiku oslobađanja vodotopljivog verapamil hidroklorida i netopljivog lijeka aceklofenaka iz matriksnih sustava na bazi hidrofilnog polimera. Matriksni sustavi pripravljeni su izravnom metodom kompresije. Uz ispitivanje uobičajenih fizikalnih svojstava, ispitivana je i dinamika primanja vode, te erozija, SEM i in vitro oslobađanje ljekovite tvari iz tableta. Primjenom eksponencijalne jednadžbe utvrđeno je da mehanizam oslobađanja topljivih lijekova slijedi anomalni ne-Fickov difuzijski transport, dok netopljivi lijekovi slijede kinetiku nultog reda. SEM ispitivanja pokazala su pore na površini matriksa ovisne o topljivosti ljekovite tvari. T-test ukazuje da količina oslobođenog lijeka značajno ovisi o njegovoj topljivosti. Topljivost lijeka ima značajan učinak na kinetiku i mehanizam oslobađanja

Razvoj i vrednovanje dvoslojnih tableta propranolol hidroklorida

The objective of the present research was to develop a bilayer tablet of propranolol hydrochloride using superdisintegrant sodium starch glycolate for the fast release layer and water immiscible polymers such as ethyl cellulose, Eudragit RLPO and Eudragit RSPO for the sustaining layer. In vitro dissolution studies were carried out in a USP 24 apparatus I. The formulations gave an initial burst effect to provide the loading dose of the drug followed by sustained release for 12 hrs from the sustaining layer of matrix embedded tablets. In vitro dissolution kinetics followed the Higuchi model via a non-Fickian diffusion controlled release mechanism after the initial burst release. FT-IR studies revealed that there was no interaction between the drug and polymers used in the study. Statistical analysis (ANOVA) showed no significant difference in the cumulative amount of drug release after 15 min, but significant difference (p 0.005) in the amount of drug released after 12 h from optimized formulations was observed.U radu je opisan razvoj dvoslojnih tableta propranolol hidroklorida, koristeći superdezintegrator škrob glikolat natrij u sloju za brzo oslobađanje i polimere koji se ne miješaju s vodom (etil celuloza, Eudragit RLPO i Eudragit RSPO) u sloju za usporeno oslobađanje. In vitro oslobađanje praćeno je u USP aparatu I te je uočeno početno naglo oslobađanje ljekovite tvari iza kojeg slijedi polagano oslobađanje tijekom 12 sati. In vitro kinetika oslobađanja prati Higouchijev model, dok mehanizam kontroliranog oslobađanja ne slijedi Fickov zakon poslije početnog naglog oslobađanja. FT-IR studije ukazuju da nema interakcije između ljekovite tvari i polimera upotrebljenih u oblikovanju. Statistička analiza (ANOVA) nije pokazala značajne razlike u kumulativnoj količini oslobođenog lijeka iz optimiranih formulacija poslije 15 minuta i polije 12 h

HAM56 antibody: a tool in the differential diagnosis between colorectal and gynecological malignancy.

HAM56, a monoclonal antibody first used to identify macrophages and endothelial cells, also stains many carcinomas (except those arising in the digestive tract). This property is useful in the differentiation between primary ovarian and metastatic colonic carcinomas in the ovary, or between gynecological (ovarian and endometrial) and colonic implants and lymph node metastases. This distinction is important as the prognoses of colorectal and gynecological malignancies differ significantly. Sixteen primary ovarian carcinomas (10 with peritoneal implants and 3 with lymph node metastases), eight cases of primary colonic carcinomas (four metastatic to ovary, four with peritoneal implants, and four with lymph node metastases), and three primary endometrial carcinomas, all with metastases to the ovary, were immunostained with the HAM56 antibody using the ABC immunoperoxidase technique. Linear membranous immunostaining was considered positive, whereas staining of mucin and debris was regarded as negative. Using these parameters, 15/16 ovarian primaries, 9/10 ovarian implants, 3/3 ovarian lymph node metastases, and 3/3 endometrial primaries and their ovarian metastases were positive. Colonic primaries, their ovarian metastases, peritoneal implants, and lymph node metastases were all negative. It is concluded that the HAM56 antibody is a useful tool in the distinction between colorectal and ovarian malignancies in those cases where the routine histological appearance may be ambiguous