Two-centre experience in the treatment of thyroglossal duct remnants using the modified muscle-sparing Sistrunk technique.

The Sistrunk procedure has long been the method of choice for treating patients with thyroglossal duct remnants (TDRs). However, the extent of the surgical resection in the suprahyoid segment of the TDR remains controversial, as this anatomical site is the origin of both disease recurrence and surgical morbidity. The aim of this two-centre retrospective cohort study was to investigate the outcomes of a modified muscle-sparing Sistrunk procedure in primary TDRs. The primary predictor was the surgical approach, and the outcome variable was the recurrence rate. A total of 110 consecutive patients (62 (56.4%) male, 48 (43.6%) female) who underwent a modified muscle-sparing Sistrunk procedure were included in the study. Their mean age at presentation was 26.9 ± 18.9 years. A modified muscle-sparing Sistrunk procedure using cold instruments, electrocautery, and a harmonic scalpel was performed in all patients. Recurrence was recorded in six (5.5%) patients. The median hospital stay was 2 days (range 1-7 days), and the median follow-up duration was 7 years (range 2-13 years). There was no significant difference in recurrence rate between the conventional and modified muscle-sparing Sistrunk procedure in primary TDRs. The study findings showed that the modified muscle-sparing Sistrunk procedure had low recurrence and complication rates in the context of primary TDR.

Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation: Report of an FDA Public Workshop.

On May 19, 2016, the US Food and Drug Administration (FDA) hosted a public workshop, entitled "Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation." The topic of mechanistic oral absorption modeling, which is one of the major applications of physiologically based pharmacokinetic (PBPK) modeling and simulation, focuses on predicting oral absorption by mechanistically integrating gastrointestinal transit, dissolution, and permeation processes, incorporating systems, active pharmaceutical ingredient (API), and the drug product information, into a systemic mathematical whole-body framework.

Combination of decentralized waste drying and SSF techniques for household biowaste minimization and ethanol production.

The results of the demonstration of an innovative household biowaste management and treatment scheme established in two Greek Municipalities for the production of lignocellulosic ethanol using dehydrated household biowaste as a substrate, are presented within this research. This is the first time that biowaste drying was tested at a decentralized level for the production of ethanol using the Simultaneous Saccharification and Fermentation (SSF) process, at a pilot scale in Greece. The decentralized biowaste drying method proved that the household biowaste mass and volume reduction may reach 80% through the dehydration process used. The chemical characteristics related to lignocellulosic ethanol production have proved to differ substantially between seasons thus; special attention should be given to the process applied for ethanol production mainly regarding the enzyme quality and quantity used during the pretreatment stage. The maximum ethanol production achieved was 29.12g/L, approximately 60% of the maximum theoretical yield based on the substrate's sugar content. The use of the decentralized waste drying as an alternative approach for household biowaste minimization and the production of second generation ethanol is considered to be a promising approach for efficient biowaste management and treatment in the future.

Hydrogen storage properties of MgH2-diatomite composites obtained by high-energy ball milling.

To investigate the effects of specific porous microstructure of diatomite on the hydrogen storage properties of MgH(2), a two-step preparation was carried out. The first step was decrepitation of MgH(2) particle size during 10 h of milling. The second step was additional 1 h of milling with diatomite. The microstructure and phase composition of materials was characterized by X-ray diffraction, whereas the powder morphology and degree of additive dispersion were analyzed by scanning electron microscopy. The hydrogen desorption behaviour of nanocomposites was investigated by differential scanning calorimetry. The results show that addition of porous diatomite structure leads to decrease in desorption temperature, since there was no other effect that can have an influence on kinetics, such as formation of the metastable gamma-phase, reduction of oxides to the native metal and/or homogeneous dispersion of the catalyst. This indicates that the microstructure of added material plays the main role in the enhancement of desorption properties of composites.

An HPTLC method for the determination and the purity control of ciprofloxacin HCl in coated tablets.

A high-performance thin-layer chromatographic method (HPTLC) has been developed for the determination and the purity control of a synthetic fluoroquinolone antibiotic ciprofloxacin hydrochloride in coated tablets when desfluoro compound, ethylene diamine compound, by-compound A and fluoroquinolonic acid are considered as impurities. Silica gel F254 was used as a stationary phase and a mixture of acetonitrile, ammonia 25%, methanol and methylene chloride (1:2:4:4, v/v/v/v) as a mobile phase. The method was validated in terms of linearity (range), selectivity (placebo and related compounds), precision, accuracy (Recovery), system suitability (repeatability, peak symmetry, resolution) and impurities limit of detection (LOD). The analysis of variance (ANOVA) and t-test were applied to correlate the results of ciprofloxacin hydrochloride determination in coated tablets by means of the HPTLC method and the official British Pharmacopoeia (BP 1999) high-performance liquid chromatographic (HPLC) method.

Validation of a high-performance thin-layer chromatographic method for trace analysis for some generic drugs affecting gastrointestinal function.

To prevent cross-contamination between pharmaceutical products manufactured with the same equipment, cleanup procedures must be introduced before the manufacture of a new product begins. From an analytical point of view, it is crucial to select and validate a suitable analytical method to determine contaminants in the rinse water, swabs, and the placebo of the next product. High performance thin-layer chromatography (HPTLC) was chosen in our laboratory for this purpose and was optimized to meet the requirements of trace determination. The method was validated in terms of the limit of detection, limit of quantitation (LOQ), linearity close to the LOQ, sample preparation from the swab media and from the placebo of the next product made with the same equipment (recovery), precision, selectivity (interference from the swab and placebo matrixes), resolution (from related compounds), and robustness. The HPTLC method was applied to 2 different generic drugs affecting gastrointestinal function--the water-soluble H2-receptor antagonist ranitidine hydrochloride (RHCl) and the water-insoluble choleretic drug ursodeoxycholic acid (UDCA). Chromatography was performed on silica plates by using toluene-methanol-diethylamine (9 + 1 + 1, v/v/v) and n-heptane-ethyl acetate-glacial acetic acid (5 + 5 + 1, v/v/v) as the mobile phases for RHCl and UDCA, respectively. RHCl was measured in situ at 320 nm, whereas the detection of UDCA was performed at 502 nm after postchromatographic derivatization. The method was used for the determination of RHCl and UDCA in the swabs, the final rinse water, and the placebo batch after the cleanup process.

Determination of free bile acids in pharmaceuticals by thin layer chromatography and high performance liquid chromatography.

High-performance liquid chromatography with evaporative light scattering detection (HPLC-ELSD) and thin layer chromatography with flame ionization detection (TLC-FID) have been applied to the separation of five main free bile acids present in humans: cholic (CA), chenodeoxycholic (CDCA), deoxycholic (DCA), lithocholic (LCA) and ursodeoxycholic (UDCA) acid. HPLC separation was performed on Biospher Si 100 column using a mixture of n-heptane, isopropanol, ethylacetate, methanol and glacial acetic acid as a mobile phase. All the compounds were separated in less than 12 minutes by using a gradient elution mode. TLC-FID separation was performed on S-II Chromarods with a mixture of isooctane, ethylacetate and glacial acetic acid as a mobile phase. HPLC-ELSD method was applied to the determination of CDCA and UDCA in pharmaceuticals and their purity control when LCA, DCA and CA were considered as impurities.

Quantitative structure-chromatographic retention relationship study of six underivatized equine estrogens.

Underivatized estrone (ES), equilin (EQ), equilenin (EQN) and their corresponding 17 alpha-diols 17 alpha-estradiol (ESD), 17 alpha-dihydroequilin (DHEQ) and 17 alpha-dihydroequilenin (DHEQN) were separated by TLC, RP-HPLC and capillary GC. Their dipole moments (mu) and Randic's connectivity indices ((1)chi) were determined as parameters of importance for the separation. The number of H atoms was taken as an additive structural parameter of importance for the quantitative structure-chromatographic retention relationship study (QSRR). Principal component analysis (PCA) was applied in order to find similarities and dissimilarities between 9 TLC and 10 RP-HPLC systems. PCA indicated that proton donor-proton acceptor interactions play the most important role for the TLC and RP-HPLC separation. The two-dimensional non-linear map of PC variables showed that the keto-estrogens (ES, EQ and EQN) and the corresponding diols (ESD, DHEQ and DHEQN) form two separate clusters. The relationship between GC retention of equine estrogens characterized by Kováts indices (KI), their (1)chi and mu was expressed by the equation KI/100 = al(1)chi+ b/mu(2) + c. The biological activity of the estrogens was related to log 1/mu(2).

Densitometric determination of conjugated oestrogens in the raw material and in pharmaceutical preparations.

A densitometric method for determination of complex mixtures of conjugated oestrogens in raw material and tablets was developed. The proposed procedure comprised hydrolysis of sodium sulphate esters of oestrone, equilin, 17 alpha-oestradiol, equilenin, 17 alpha-dihydroequilin and 17 alpha-dihydroequilenin, the chloroform extraction of free oestrogens and methyltestosterone (internal standard) and separation on TLC plates using chloroform-cyclohexane-dioxane-triethylamine (4.5:4.1:0.6, v/v) as the solvent for development. Quantitative assay was achieved by direct scanning of the oestrogen spots at 280 nm. The proposed method is simple, rapid, reproducible and adequate to control the content of conjugated oestrogens in the raw material and in pharmaceutical preparations.

Spectrophotometric determination of procaine hydrochloride by means of iron (3+)-4-aminobenzohydroxamic acid complex.

A rapid, simple and reproducible method is presented, for the determination of procaine hydrochloride in bulk and in pharmaceutical preparations containing also corbadrine or caffeine. The method is based on the conversion of procaine into the corresponding hydroxamic acid which reacts with iron (III) forming a complex of violet colour stable at pH 2.0, with a maximum absorption at a wavelength of 540 nm, and with molar absorptivity (epsilon = 0.43 X 10(3) l mol-1 cm-1). The minimum detectable amount was 1.47 X 10(-4) M/l, and Lambert-Beer law is obeyed in the range 2.93 X 10(-4) - 4.106 X 10(-3) M/l. By the application of Bent-French method it has been established that the stoichiometric ratio of 4-aminobenzohydroxamic acid and iron (3+) in the complex is 3:1. No interference with degradation product of procaine (4-aminobenzoic acid) was observed.

Fluorodensitometric determination of conjugated estrogens in raw material and in pharmaceutical preparations.

A simple, rapid and reproducible fluorodensitometric method for the determination of conjugated estrogens has been developed. The proposed procedure includes the following steps: extraction, hydrolysis of sodium sulphate esters of estrone, equilin, equilenin and their 17-alpha-hydroxy derivatives, separation of the liberated 3-phenolic steroids and in situ measurement of fluorescence. The fluorescence emission was measured after spraying the spots of estrone and estradiol with 2,4-dinitrophenyl-hydrazine in sulphuric acid-ethanol medium and equilin and 17-alpha-dihydroequilin with phosphoric acid and sodium hydroxide solution, respectively. Equilenin and 17-alpha-dihydroequilenin were determined by measuring the native fluorescence. The method applied to the determination of raw material and tablets provided results which agreed well with the stated content and the requirements of USP XXI for conjugated estrogens.