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PubMed1989

Stability-indicating high-performance liquid chromatographic assay for the determination of metoclopramide hydrochloride in pharmaceutical dosage forms.

A simple, reliable and selective high-performance liquid chromatographic method for the determination of metoclopramide hydrochloride in pharmaceutical dosage forms has been developed and evaluated. The drug and the internal standard (phenobarbitone) were eluted from a 5-micron C8 reversed-phase column at ambient temperature with a mobile phase consisting of phosphate buffer (10 mM)-methanol-acetonitrile (50 + 28 + 22) adjusted to pH 4.8 with orthophosphoric acid. The mobile phase was pumped at a flow-rate of 1.5 ml min-1 and the effluent was monitored spectrophotometrically at 214 nm. The retention times of the internal standard and metoclopramide hydrochloride were 3.0 and 7.5 min, respectively. Quantification was achieved by measuring the peak-height ratio of the drug to the internal standard. A linear relationship was found over the range 1-10 micrograms ml-1. Within-day coefficients of variation (CVs) ranged from 0.50 to 1.70% and between-day CVs from 0.68 to 4.07% at three different concentrations. The developed procedure was compared with the current BP method for the assay of metoclopramide hydrochloride in tablets. The proposed method was also used to study the stability of metoclopramide hydrochloride.

Chemical Phenomena↗
PubMed1996

Development of oral dosage form for elderly patients: use of agar as base of rapidly disintegrating oral tablets.

Rapidly disintegrating tablets as an oral dosage form for elderly patients with impaired swallowing were investigated using agar powders (AG) or treated agar powders (TAG). When the compression pressure was changed from 0.4 to 2.0 ton/cm2, the disintegration time of AG tablets increased from about 60 to about 160s, and the hardness significantly increased from 3 to 13 kgw. The disintegration time and hardness of the TAG tablets were scarcely affected by the compression pressure: the disintegration time was 5--6s, and the hardness was 2--3 kgw. The rapid disintegration of the TAG tablets seemed due to the rapid water penetration into the tablet resulting from the large pore size and large overall pore volume. It was found that rapidly disintegrating oral tablets with proper hardness can be prepared using TAG.

Absorption↗
PubMedDate not supplied

Sustained-release dosage form of nitrofurantoin. Part 2. In vivo urinary excretion in man.

The in vivo absorption of crystalline nitrofurantoin and the dosage forms of nitrofurantoin prepared with microcapsules were carried out in man by determination of urinary excretion of unchanged nitrofurantoin. The cumulative amount of drug excreted and the duration of the therapeutic urine levels were compared. The microcapsule administration showed that the peak reached during the excretion of nitrofurantoin in urine, decreased significantly when compared to the pure drug. This could be an explanation for the decrease in side-effects of nitrofurantoin such as nausea and vomiting. Experiments in male albino rats showed that the microcapsules did not produce gastric haemorrhage seen with the same doses of the pure drug.

Adult↗
PubMed2004

[Experimental basis for the use of new dosage forms of doxorubicin for correction of its hepatotoxic, prooxidant and immunosuppressory effects].

The study was aimed at design of new dosage forms of doxorubicin (films, erythrocyte vehicles) for correction of its hepatotoxic, prooxidant and immunosuppressory effects. The experiments were performed on Wistar rats with the use of doxorubicin of Lens-Pharm (Moscow) and auxiliary substances meeting the requirements of the standards. Technology for preparation of doxorubicin-entrapped films was developed and the optimal polymer for the vehicle was recommended, i.e. oxypropylmethylcellulose Methocel 65 Hg 50 providing preservation of the antimicrobial activity. Conditions for storage of the antibiotic-entrapped films were determined. The main qualitative indices of the antibiotic-entrapped films were shown to be stable during the storage for 12 months. Erythrocyte-vehicles with entrapped doxorubicin were prepared. Antibiotic-free erythrocyte vehicles were found to preserve their ability to entrap doxorubicin for 9 days and the doxorubicin-entrapped erythrocyte vehicles were stable for 48 hours. A procedure for spectrophotometric qualitative evaluation of doxorubicin entrapping into the films and erythrocyte vehicles was developed. It was observed that administration of doxorubicin immobilized in the films had a stabilizing effect on the immunity status, the level of lipid peroxidation, the potency of the antioxidant system, cytolysis and cholestasis. Administration of the doxorubicin entrapped in the erythrocyte vehicles stimulated the body immune response, normalized the indices of the lipid peroxidation--antioxidant system and the state of the hepatic cells in the laboratory animals infected by staphylococci.

Animals↗
PubMedDate not supplied

Selective delivery of high levels of mitomycin C to peritoneal carcinomatosis using a new dosage form.

Selective delivery of a high level of Mitomycin C (MMC) in intraperitoneal disseminated lesions was studied using a new dosage form of MMC, called MMC-CH. Intracavitary MMC-CH delivered a much higher level of MMC selectively to intraperitoneal tissues, with a much lower level of MMC in the whole body, in comparison with MMC solution. The index [MMC level in the intraperitoneal organs]: [MMC level in blood] was much higher and increased with time in the MMC-CH group, but not in the MMC solution group.

Animals↗
PubMedDate not supplied

Liquid chromatographic method for perphenazine and its sulfoxide in pharmaceutical dosage forms for determination of stability.

A liquid chromatographic method is described for determination of perphenazine and perphenazine sulfoxide in representative dosage forms. Sulfoxide levels were nondetectable or less than 1% in tablets and in an injectable product. Sulfoxide levels increase with time in some syrup formulations and may be as high as 11% in syrup formulations before their expiration date.

Chromatography, Liquid↗
PubMed2005

Biowaiver monographs for immediate release solid oral dosage forms: ibuprofen.

Literature data are reviewed on the properties of ibuprofen related to the biopharmaceutics classification system (BCS). Ibuprofen was assessed to be a BCS class II drug. Differences in composition and/or manufacturing procedures were reported to have an effect on the rate, but not the extent of absorption; such differences are likely to be detectable by comparative in vitro dissolution tests. Also in view of its therapeutic use, its wide therapeutic index and uncomplicated pharmacokinetic properties, a biowaiver for immediate release (IR) ibuprofen solid oral drug products is scientifically justified, provided that the test product contains only those excipients reported in this paper in their usual amounts, the dosage form is rapidly dissolving (85% in 30 min or less) in buffer pH 6.8 and the test product also exhibits similar dissolution profiles to the reference product in buffer pH 1.2, 4.5, and 6.8.

Administration, Oral↗
PubMed2004

Voltammetric behaviour of rabeprazole at a glassy carbon electrode and its determination in tablet dosage form.

The oxidative behaviour of rabeprazole was studied at a glassy carbon electrode in Britton-Robinson (BR) buffer solutions using cyclic, linear sweep and differential-pulse voltammetry. The oxidation process was shown to be irreversible over the pH range (6.0-11.0) and was diffusion-adsorption controlled. An analytical method was developed for the determination of rabeprazole in BR buffer solution at pH 8.0 as supporting electrolyte. The anodic peak current varied linearly with rabeprazole concentration in the range 1.0 x 10(-6) to 2.0 x 10(-5) M of rabeprazole with a limit of detection of 4.0 x 10(-7) M. Validation parameters, such as sensitivity, accuracy, precision and recovery, were evaluated. The proposed method was applied to the determination of rabeprazole in the tablet dosage form. The results were compared with those obtained by a published high-performance liquid chromatographic method. No difference was found statistically.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMed1995

New evaluation method for in vitro/in vivo correlation of enteric-coated multiple unit dosage forms.

PURPOSE: To establish the evaluating method for drug dissolution profiles in the gastrointestinal (GI) tract based on in vitro data for the enteric-coated multiple unit. METHODS: Dissolution profile in the GI tract was calculated by the convolution procedure using an in vitro dissolution profile as a weighting function, and the gastric-emptying (GE) process as an input function (GE-convolution method). A computer program, GECONV, was developed for numerical execution of the convolution integral. RESULTS: The in vivo dissolution profile of enteric-coated aspirin granules estimated by GE-convolution was in good agreement with the in vivo cumulative absorption profile calculated by the Wagner-Nelson method using the plasma concentration data after oral administration to healthy subjects. The in vitro/in vivo correlation improved markedly by taking the GE process into consideration. CONCLUSIONS: These findings indicated that this convolution method is useful for estimating the in vivo dissolution profile of drugs, when they are administered in an enteric-coated multiple unit type dosage form, because the gastric emptying process is a determinant process for the in vivo drug dissolution.

Adult↗
PubMed2004

Microbiological assay for the determination of meropenem in pharmaceutical dosage form.

Meropenem is a highly active carbapenem antibiotic used in the treatment of a wide range of serious infections. The present work reports a microbiological assay, applying the cylinder-plate method, for the determination of meropenem in powder for injection. The validation method yielded good results and included linearity, precision, accuracy and specificity. The assay is based on the inhibitory effect of meropenem upon the strain of Micrococcus luteus ATCC 9341 used as the test microorganism. The results of assay were treated statistically by analysis of variance (ANOVA) and were found to be linear (r=0.9999) in the range of 1.5-6.0 microg ml(-1), precise (intra-assay: R.S.D.=0.29; inter-assay: R.S.D.=0.94) and accurate. A preliminary stability study of meropenem was performed to show that the microbiological assay is specific for the determination of meropenem in the presence of its degradation products. The degraded samples were also analysed by the HPLC method. The proposed method allows the quantitation of meropenem in pharmaceutical dosage form and can be used for the drug analysis in routine quality control.

Analysis of Variance↗
PubMed2005

Implication of biopharmaceutics and pharmacokinetics of rifampicin in variable bioavailability from solid oral dosage forms.

Rifampicin is one of the oldest and most effective chemotherapeutic agents available for the treatment of tuberculosis but exhibits variable bioavailability from separate and fixed dose combination formulations, which has been identified as a major bottleneck in the effective treatment of tuberculosis. In this investigation, physico-chemical characterization, single dose pharmacokinetic studies and the permeability of rifampicin under physiological conditions in the rat were studied to trace the possible reasons for its variable absorption. Rifampicin exhibits very high solubility in acidic and basic pH, corresponding to the pH of the stomach and distal intestine, respectively, whereas it is moderately soluble at the jejunal pH. From single-dose pharmacokinetic studies and permeability characterization, rifampicin is a highly permeable molecule and thus according to BCS, it is a borderline class II drug. This investigation has ruled out the possibility of intrinsic solubility, effective permeability, drug decomposition, presystemic metabolism and interaction with other antituberculosis drugs as direct factors responsible for the variable bioavailability of rifampicin. However, it was found that the rate of dissolution in association with pH and the concentration-dependent absorption of rifampicin affects the in vivo performance of the dosage forms. In addition, this is the first report of methodology for correcting inlet concentration for permeability calculations of a chemically unstable molecule.

Animals↗
PubMedDate not supplied

Comparative bioavailability of S-carboxymethylcysteine from two dosage forms: hard gelatin capsule and syrup.

Measurement of plasma concentrations after the oral administration of S-carboxymethylcysteine in two different dosage forms, as a hard gelatin capsule and as a syrup, shows its relative bioavailability from the two formulations to be similar. With the exception of the time required to reach peak concentration, which shows a slight variation attributable to the time taken for the drug to be released from the capsule and to dissolve, parameters such as peak concentration, biological half-life and area under the serum-concentration curve whether from t = 0 to t = 8 h or from t = 0 to t = infinity, are not statistically different. The areas under the plasma-concentration curves between t = 0 and t = 8 h and between t = 0 and t = infinity shows that for a confidence limit of 95 per cent, the mean for the capsular form does not differ by more than 3.3-10.3 per cent from the mean for the syrup.

Adult↗
PubMed1983

Quantitation of amikacin, kanamycin, neomycin, and tobramycin in pharmaceutical dosage forms using the Hantzsch reaction.

A spectrophotometric assay method for the quantitative determination of amikacin, kanamycin, neomycin, and tobramycin in pharmaceutical dosage forms has been developed. The method is based on the Hantzsch reaction, forming dihydrolutidine derivatives which can be measured spectrophotometrically. The excipients EDTA, phenol, sodium bisulfite, and sodium citrate do not interfere, while salts of ammonia do interfere. The relative standard deviations based on seven readings were 1.64, 1.88, 2.10, and 1.93% for amikacin, kanamycin, neomycin, and tobramycin, respectively. Assay results have been compared with microbiological assay results provided by the manufacturers. The assay method appears to be stability indicating.

Amikacin↗
PubMed1992

An implantable dosage form for the treatment of bone infections.

The object of this investigation was the development of an implantable sustained-release dosage form, for the treatment of bone infections. Cross-linked polydimethylsiloxane (PDMS) was used as the matrix material. The drug delivery system was prepared by incorporating tobramycin, as a free base (C18H37N5O9.H2O) or as a sulfate salt [(C18H37N5O9)2.5H2SO4], into the matrix and molding into spherical beads. Following in vitro studies, the cumulative amount of drug released when plotted as a function of the square root of time was linear for both the base and the salt. The addition of glycerol to the matrix substantially accelerated the rate of drug release and the plots of cumulative amount of drug released continued to be linear as a function of the square root of time. The glycerol-incorporated beads swelled in contact with the aqueous medium but a negligible amount of glycerol was released even after exposure to the medium for 20 days. 13C solid-state and high-resolution NMR studies indicated that a fraction of the added glycerol participated in the cross-linking reaction of the polymer. The effect of the initial molecular weight of PDMS and the effect of the concentration of the cross-linker on the kinetics of drug release were investigated.

Cross-Linking Reagents↗
PubMed1983

High pressure liquid chromatographic determination of sulfisoxazole in dosage forms: collaborative study.

A reverse phase high pressure liquid chromatographic method for the determination of sulfisoxazole in tablets, solution, and ointment dosage forms was collaboratively studied by 7 laboratories. The method uses a C18 column, an acetonitrile-acetic acid-water mobile phase, sulfadimethoxime as the internal standard, and photometric detection at 254 nm. Collaborators were supplied samples of 2 commercial tablets, 1 synthetic tablet powder, 1 commercial and 1 synthetic ophthalmic solution, and 1 commercial ophthalmic ointment. Mean recoveries of sulfisoxazole from the synthetic tablet powder and ophthalmic solution were 99.9 and 100.0%, respectively. Mean coefficients of variation for all samples analyzed were less than 2%. The method was adopted interim official first action.

Chromatography, High Pressure Liquid↗
PubMed1997

[Clinical efficacy of GG032X tablets, a new dosage form of ondansetron (fast dispersing tablet), on cisplatin-induced nausea and emesis].

The inhibitory effects of GG032X tablets, a new dosage form (fast dispersing tablet) of ondansetron, 5-HT2 receptor antagonist, on nausea and emesis induced by cisplatin (CDDP), were investigated along with safety and usefulness. Subjects were chemotherapy patients starting CDDP administration for the first time, who were receiving a high single dose of CDDP (50 mg/m2 or more and intravenous drip infusion of less than 4 hours), or lower multiple doses of CDDP (a single dose of 10 mg/m2 or more, administered intravenously for 3-5 consecutive days). GG032X tablets were administered orally 1-2 hours before CDDP administration. In lower multiple doses of CDDP, GG032X tablets and CDDP were administered, as much as possible, at the same respective time when they were administered on the first day. Efficacy of GG032X tablets was evaluated in terms of inhibitory effect on nausea and emesis 24 hours after administration of a high single dose of CDDP, and of the inhibitory effect on nausea and emesis during the study period (3-5 days) in lower multiple doses of CDDP. Efficacy, safety and usefulness were evaluated in accordance with the evaluation criteria used in the clinical study of already-approved ondanstron tablets. In a high single dose of CDDP, the cases judged "effective" or better in the investigation of the inhibitory effect of the drug on nausea and emesis, accounted for 52.9% (63/119 cases). As for the overall safety rating, the cases judged as "safe" accounted for 87.0% (107/123 cases), and as a "minor safety problem" accounted for 13.0% (16/123 cases). As for the usefulness rating, the cases judged "useful" or better accounted for 52.1% (62/119 cases). Major adverse effects included headache, fever, atrial fibrillation and increases in total bilirubin, GOT and GPT values. None of these was serious, and the patients recovered without any treatment or by nosotropic therapy. Meanwhile, in lower multiple doses of CDDP, the inhibitory effect judged "effective" or better accounted for 70.6% (12/17 cases). As for the overall safety rating, all cases were judged "safe". In terms of usefulness, those cases judged "useful" or better accounted for 70.6% (12/17 cases). No adverse effect was observed. Study results of these two groups were almost the same as those for already-approved ondansetron tablets. According to the results of questionnaires for the patients who participated in the study and took GG032X tablets, the drug was found to be easy to take and had favorable results. Based on the above results, GG032X tablets were evaluated as having the same inhibitory effect as the already-approved ondansetron tablets against CDDP-induced nausea and emesis, and were considered safe and clinically useful.

Administration, Oral↗
PubMed2005

Application of HPLC and HPTLC for the simultaneous determination of tizanidine and rofecoxib in pharmaceutical dosage form.

Two methods are described for the simultaneous determination of tizanidine and rofecoxib in binary mixture. The first method was based on HPTLC separation of the two drugs followed by densitometric measurements of their spots at 311 nm. The separation was carried out on Merck HPTLC aluminium sheets of silica gel 60 F254 using toluene:methanol:acetone (7.5:2.5:1.0, v/v/v) as mobile phase. The linear regression analysis data was used for the regression line in the range of 10-100 and 100-1500 ng/spot for tizanidine and rofecoxib, respectively. The second method was based on HPLC separation of the two drugs on the reversed phase kromasil column [C18 (5 microm, 25 cm x 4.6 mm, i.d.)] at ambient temperature using a mobile phase consisting of phosphate buffer pH 5.5 and methanol (45:55, v/v). Flow rate was 1.0 ml/min with an average operating pressure of 180 kg/cm2. Quantitation was achieved with UV detection at 235 nm based on peak area with linear calibration curves at concentration ranges 10-200 and 100-2000 microg/ml for tizanidine and rofecoxib, respectively. Both methods have been successively applied to pharmaceutical formulation. No chromatographic interference from the tablet excipients was found. Both methods were validated in terms of precision, robustness, recovery and limits of detection and quantitation. The analysis of variance (ANOVA) and Student's t-test were applied to correlate the results of tizanidine and rofecoxib determination in dosage form by means of HPTLC and HPLC method.

Chromatography, High Pressure Liquid↗