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At least 721 records · Page 40Linked to original sources
PubMedDate not supplied

Failure of prescription prenatal vitamin products to meet USP standards for folic acid dissolution.

OBJECTIVE: To determine whether prescription prenatal vitamins meet United States Pharmacopeial Convention (USP) standards for folic acid dissolution. METHODS: Dissolution was measured using USP Apparatus II and test conditions specified in the 23rd revision of the United States Pharmacopeia (USP 23). Folic acid was assayed by a chromatographic method modified from that specified in the official monographs, for oil- and water-soluble vitamins with minerals tablets, in USP 23. RESULTS: Only three out of nine multivitamin products met USP specifications for folic acid release. Most missed by a wide margin; folic acid dissolution from two products was less than 25%. CONCLUSIONS: Because a wide variety of brand-name and generic prescription prenatal multivitamin products were tested, these results are likely to be representative of the multivitamin products on the market. Given the significance of folic acid to public health, the authors believe that this subject should be studied further and that prompt action should be taken to ensure that folic-acid-containing products are of the highest quality possible.

Chemistry, Pharmaceutical↗
PubMedDate not supplied

[Stability and in vitro activity of voriconazole eyedrops at a concentration of 3 microg/mL].

OBJECTIVE: To assess the stability and activity of voriconazole 3 microg/mL eyedrops as prepared for use against amphotericin B- and fluconazole-resistant fungal endophthalmitis. METHOD: Stability (concentration using UV-spectrophotometry; pH, osmolarity, and particle formation) and sterility were analyzed under various preservation conditions--room temperature (22-24 degrees C) or refrigerated (2-8 degrees C). The preparation's in vitro efficacy was analyzed using the standard National Committee for Clinical Laboratory Standards method for 30 days. RESULTS: Voriconazole concentrations were found to be within limits allowed by the United Stated Pharmacopeia (90-115%). pH (room temperature: 6.96-7.60; refrigerated: 6.84-7.21) and osmolarity (room temperature: 265-284 mOsm/l; refrigerated: 270-285 mOsm/l) remained within eye physiological ranges throughout the study under the analyzed conditions. The preparation s antifungal activity remained stable during the first three weeks. CONCLUSIONS: The voriconazole 3 microg/mL eyewash preparation remained stable, sterile and with full antifungal activity for 21 days when stored both at room temperature and under refrigeration conditions.

Antifungal Agents↗
PubMedDate not supplied

Remote site production of sterile purified water from available surface water.

A water purification and sterilization device was tested for its functional capabilities. Challenge water consisting of potable water augmented with bacteria, endotoxin, virus, suspended solids, and dissociable ions (sodium chloride, lead or arsenic salts) was passed through the device. The product water quality attributes were analyzed. The device demonstrated reduction in bacteria of >7 logs, endotoxin was reduced by >4 logs, virus was reduced by >4 logs, and dissociable ions were reduced by >3 logs. The product water of the device met the limits for a range of chemical entities specified by the United States Pharmacopeia and Association for the Advancement of Medical Instrumentation. The product water met the quality attributes of Sterile Water for Injection, USP, Sterile Purified Water, USP, and the Water for Dialysis. The device provides a logistical advantage in reducing the weight of transport of packaged water by 83% and the cube by 67%. It operates manually by gravity and is disposable after a single use. The device provides an effective alternative to the transport and use of packaged sterile water in remote locations by production of sterile water at the point-of-need using available water. It also is capable of producing safe drinking water following the production of clinical waters. This device has been cleared by the US Food and Drug Administration for production of three liters Sterile Purified Water, USP from Environmental Protection Agency (EPA) grade drinking water.

Communicable Disease Control↗
PubMed2004

Decomposition of microcystin-LR, microcystin-RR, and microcystin-YR in water samples submitted to in vitro dissolution tests.

The presence of cyanobacterial toxins (microcystins) in waters and food increases the risk of toxicity to animal and human health. These toxins can degrade in the human gastrointestinal tract before they are absorbed. To evaluate this possible degradation, water samples spiked with known concentrations of microcystins MC-LR, MC-RR, and MC-YR, which are the toxins most commonly produced by such toxic cyanobacteria as Microcystis aeruginosa, Oscillatoria spp., and Nostoc spp., were submitted to a dissolution test that used gastric and intestinal fluids according to U.S. Pharmacopeia conditions. HPLC with UV detection was used to determine the toxins before and after treatments. This study revealed enzymatic alterations in gastric conditions for all the toxins assayed. MC-RR was the toxin most affected: its range of inactivation was 49-64%. The percentage of degradation for MC-YR and MC-LR was around 30%. However, none was degraded by intestinal digestion.

Bacterial Toxins↗
PubMed2000

Prediction of drug absorption using multivariate statistics.

Literature data on compounds both well- and poorly-absorbed in humans were used to build a statistical pattern recognition model of passive intestinal absorption. Robust outlier detection was utilized to analyze the well-absorbed compounds, some of which were intermingled with the poorly-absorbed compounds in the model space. Outliers were identified as being actively transported. The descriptors chosen for inclusion in the model were PSA and AlogP98, based on consideration of the physical processes involved in membrane permeability and the interrelationships and redundancies between available descriptors. These descriptors are quite straightforward for a medicinal chemist to interpret, enhancing the utility of the model. Molecular weight, while often used in passive absorption models, was shown to be superfluous, as it is already a component of both PSA and AlogP98. Extensive validation of the model on hundreds of known orally delivered drugs, "drug-like" molecules, and Pharmacopeia, Inc. compounds, which had been assayed for Caco-2 cell permeability, demonstrated a good rate of successful predictions (74-92%, depending on the dataset and exact criterion used).

Biological Transport↗
PubMed2004

The discovery of orally active triaminotriazine aniline amides as inhibitors of p38 MAP kinase.

A new structural class of triaminotriazine aniline amides possessing potent p38 enzyme activity has been discovered. The initial hit (compound 1a) was identified through screening the Pharmacopeia ECLiPS compound collection. SAR modification led to the identification of a short acting triaminotriazine aniline methoxyamide (compound 1m) possessing in vitro and in vivo oral activity in animal models of acute and chronic inflammatory disease. An X-ray crystal structure of compound 1m in this class, cocrystallized with unactivated p38 alpha protein, indicates that these compounds bind to the ATP binding pocket and possess key H-bonding interactions within a deeper cleft. Hydrogen bonding between one of the triazine nitrogens and the backbone NH of the Met109 residue occurs through a water molecule. The methoxyamide NH and carbonyl oxygen are within H-bonding distance of Glu71 and Asp168.

Administration, Oral↗
PubMed2006

The development of USP botanical dietary supplement monographs, 1995-2005.

The development of USP botanical dietary supplement monographs by the Subcommittee on Natural Products (1995-2000) and the Dietary Supplements-Botanicals Committee of Experts (2000-2005) of the USP is described in this review. Featured details include the USP as an organization, focusing upon its history, mission, and publication of the United States Pharmacopeia-National Formulary (USP-NF); the formulation and composition of botanical dietary supplement monographs and related general chapters, as well as appropriate admission criteria; and a summary of the accomplishments of the Committees (1995-2005).

Dietary Supplements↗
PubMed2000

Analysis of libraries encoded with GC tags: compound elution, tag decode analysis, and statistical sampling analysis.

Libraries encoded with electrophoric tags present a unique challenge with respect to library quality control and characterization. Libraries are prepared on Tentagel resin in 200-fold redundancy wherein each resin particle contains one compound per one tag set. The amount of compound present on the bead is ca. 200-500 pmole while tag levels are estimated at 0.5-1 pmol/bead. Several quality control protocols have been developed in order to accurately estimate bead yield and purity for the entire library, ensure high tag fidelity, and to determine the overall performance of individual synthons. This review provides a unique, collective portrait of Pharmacopeia's approach in assessing the quality of libraries prepared using its molecular encoding technology.

Chromatography, Liquid↗
PubMed2001

Italian drug information centres: benchmark report.

OBJECTIVE: Pharmacist-operated Drug Information Centres (DICs) in Italy were surveyed to gather current information concerning the status, availability and scope of their services. METHODS: 40 DICs were identified and a questionnaire was mailed to them. Topics covered in the questionnaire included staffing, resources, activities and services. The results were compared with previous survey results to identify trends. RESULTS: Information from 36 DICs was analysed (response rate = 90%). Almost all regions of the country are represented. Pharmacists, part-time or full-time, are the most frequent employees working in the DICs. 91% of DICs participate in the P/T committee, 74% takes part in the technical scientific committee for clinical experimentation and/or to the Medical Ethics committee and 60% participate in the hospital infection committee. 90% of DICs produce newsletters and/or bulletins and are involved in research projects. Regarding the question-answer service, requests are mainly concerned with clinical comparative efficacy, therapeutic use, adverse effects. The most frequent users are physicians (67%) followed by pharmacists (16%) while other professionals use DICs to lesser extent. The most frequently used information sources, include "Goodman and Gilman's the pharmacological basis of therapeutics", Martindale: the Extra Pharmacopeia and Physician's Desk Reference; journals such as the Medical Letter, Adverse Drug Reactions Bulletin and Drug and Therapeutic Bulletin, Micromedex, Medline and IOWA databases. Data collected through the questionnaire and details about organisation and activity of Italian DICs are available in "Eupharma", the web-site of the Italian Society of Hospital Pharmacy (SIFO) at the URL http://www.sifo.it. CONCLUSION: The results parallel the European and American trends. In future communication and collaboration at European level could help to identify best practice models that would result in the standardisation of the activities and in the harmonisation of programs in common areas of interest.

Data Collection↗
PubMed1989

Quantitative Fourier transform-infrared/attenuated total reflectance (FT-IR/ATR) analysis of trimethoprim and sulfamethoxazole in a pharmaceutical formulation using partial least squares.

An alternative procedure for the simultaneous determination of trimethoprim and sulfamethoxazole in an intravenous pharmaceutical formulation is presented. Infrared spectra of 14 calibration and 6 validation samples were collected using Fourier transform-infrared/attenuated total reflectance (FT-IR/ATR). Partial least-squares (PLS) analysis of the spectral data yielded an average relative error of prediction of 0.69% for trimethoprim and 0.38% for sulfamethoxazole. Analysis of a commercial formulation gave concentration values for sulfamethoxazole and trimethoprim in close agreement with those obtained by a modification of the high-performance liquid chromatography (HPLC) assay listed in the United States Pharmacopeia (USP).

Chromatography, High Pressure Liquid↗
PubMed1997

Experimental analysis of tensile properties of some suturing materials.

The aim of the investigation is to quantitatively evaluate the failure load of several suture materials currently used in dentistry surgery. No chromic catgut, silk, Prolene, Ethilon, Ethibond, Vicryl and Vicryl Rapid, obtained from Ethicon s.p.a., in the sizes 3-0, 4-0, and 5-0 have been tested. The analysis has been carried out measuring the diameter of each suture with an optical microscope to determine the accuracy of manufacturers' data. Tensile testing has been performed to evaluate the failure load of each material. Finally, sutures of the same effective diameter class have been compared relative to failure load. Results show that monofilament sutures present a failure load remarkably superior to that of multifilament sutures. Using SEM analysis monofilament sutures present less surface irregularities than multifilament sutures. Only monofilaments Ethilon 4-0 and 5-0, Prolene 4-0, and multifilament no chromic catgut 4-0 and 5-0 meet the requirements of the Italian Pharmacopeia. In contrast, Prolene 5-0 and the other multifilaments, silk, Ethibond, Vicryl and Vicryl rapid, have a larger diameter than that declared on the label by the producer.

Journal Article↗
PubMed1993

Gelatin-acacia microcapsules for trapping micro oil droplets containing lipophilic drugs and ready disintegration in the gastrointestinal tract.

Nonhardened gelatin-acacia microcapsules were studied for encapsulation of microdroplets of oil solution containing a lipophilic drug as core material and ready disintegration with release of micro oil droplets in the gastrointestinal tract. Probucol and S-312-d, a Ca-channel blocker, were employed as model lipophilic drugs. Glyceryl tricaprylate and tricaprate mixture solutions containing these drugs were encapsulated according to the complex coacervation method and were recovered as free-flowing powders without any hardening (cross-linking) step. The microcapsules obtained were disintegrated, and the emulsion was reproduced within 3 min at 37 degrees C in the first or second test solution defined in the Japanese Pharmacopeia XII. When the microcapsules were stored as a powder at room temperature in a closed bottle, no significant change in their appearance or disintegration time upon rehydration was observed even after 1 year. Oral bioavailabilities of model drugs from the microcapsules were tested in rats and dogs and compared with those from other conventional formulations. Gastrointestinal absorption of both probucol and S-312-d from the microcapsules was remarkably more efficient than that from other formulations such as powders, granules, or oil solution. The proposed method for microencapsulation could be useful for powdering drug-containing oil solutions or O/W emulsions while maintaining excellent bioavailability.

Acacia↗
PubMed1994

Gamma sterilization of a semi-solid poly(ortho ester) designed for controlled drug delivery--validation and radiation effects.

Radiation sterilization is becoming increasingly popular for the sterilization of many pharmaceutical products. Although this technique is not limited to the sterilization of polymers, it is probably the most suitable method for such materials. This method however suffers several drawbacks. The sterilization of a product must lead to a safety level of 10(-6), i.e. one chance in a million to find a contaminated sample. In many cases, this assurance of sterility can be achieved by using a uniform treatment dose of 2.5 Mrad, recommended by the pharmacopeia. We investigated the possibility of using doses of radiation inferior to 2.5 Mrad to sterilize a semi-solid poly(ortho ester) (POE) developed for use as carrier in controlled drug delivery. After determination of the initial bioburden, the polymer was intentionally contaminated with the bioindicator Bacillus pumilus E 601. Following exposure to gamma irradiation, the D10 value of the radio resistant bioindicator was determined. Using the initial contamination value, the reduction factor D10 and the safety level, it is possible to calculate an optimal sterilizing dose for POE. All polymers are affected by ionizing radiation and the amount of radiation which produces a significant change in properties may vary from one polymer to the other. A molecular weight and dynamic viscosity decrease resulting from backbone cleavage was observed for this POE at a dose lower than 2.0 Mrad. Evaluation of the structure using 1H-NMR, 13C-NMR and IR analysis shows that for doses higher than 2.0 Mrad, another degredation process takes place.(ABSTRACT TRUNCATED AT 250 WORDS)

Chemical Phenomena↗
PubMed2004

Standardized pill imprint codes: a pharma fantasy.

To safely use medications, professionals and consumers need usable and reliable methods to identify tablets patients are prescribed and taking. Currently, each manufacturer assigns its own identifying codes and symbols. Standardization of the system for identifying solid dosage forms is a goal that has been widely advocated, yet stubbornly resistant to progress. Physicians, pharmacists, and consumers attempting to identify pills must use various methods which have shortcomings in ease of use, availability, and accuracy. Arguments have been advanced, particularly by pharmaceutical manufacturers, that evidence of unworkability of the current system is not compelling, and costs of retooling current manufacturing processes could be prohibitive. These issues are currently being explored by a task force led by the U.S. Pharmacopeia Safe Medication Use, and Pharmaceutical Forms Dosage Expert Committees. This paper presents a fictitious case study of an elderly patient succumbing to digoxin overdose illustrating the dilemmas posed in the tablet-imprint debate.

Drug Labeling↗
PubMed2000

A combination of poloxamers increases gene expression of plasmid DNA in skeletal muscle.

Intramuscular administration of plasmid DNA is a promising strategy to express therapeutic genes, however, it is limited by a relatively low level of gene expression. We report here that a non-ionic carrier, SP1017, composed of two amphiphilic block copolymers, pluronics L61 and F127, also known as poloxamers, significantly increases intramuscular expression of plasmid DNA. Two reporter genes, luciferase and beta-galactosidase, and one therapeutic gene, erythropoietin, were injected intramuscularly with and without SP1017 into C57Bl/6 and Balb/C mice and Sprague-Dawley rats. SP1017 increased gene expression by about 10-fold and maintained higher gene expression compared with naked DNA. Comparison of SP1017 with polyvinyl pyrrolidone (PVP) showed that SP1017 exhibited a significantly higher efficacy and its optimal dose was 500-fold lower. Experiments with beta-galactosidase using X-gal staining suggested that SP1017 considerably increased plasmid DNA diffusion through the tissue. SP1017 also improved expression of the erythropoietin gene leading to an increase in its systemic level and hematocrits. Previous toxicity studies have suggested that SP1017 has over a 1000-fold safety margin. Poloxamers used in SP1017 are listed in the US Pharmacopeia as inactive excipients and are widely used in a variety of clinical applications. We believe that the described system constitutes a simple and efficient gene transfer method to achieve local or systemic production of therapeutic proteins.

Animals↗
PubMed2004

Emerging experimental therapeutics for bipolar disorder: clues from the molecular pathophysiology.

Bipolar affective disorder (manic-depressive illness) is a common, severe, chronic, and often life-threatening illness, associated with significant comorbidity. The recognition of the significant morbidity and mortality of patients with bipolar disorder, as well as the growing appreciation that a high percentage of patients respond poorly to existing treatments, has made the task of discovering new therapeutic agents, that are both efficacious and have few side effects increasingly more important. Most recent agents introduced into the pharmacopeia for the treatment of bipolar disorder have been anticonvulsants and atypical antipsychotics. We propose that novel treatments developed specifically for bipolar disorder will arise from (1) understanding more precisely the molecular mechanisms of treatments that are clearly efficacious or (2) developing medications based on the knowledge obtained of the underlying pathophysiology of bipolar disorder. Knowledge with regard to the underlying pathophysiology of bipolar disorder is increasing at a rapid pace, including alterations in intracellular signaling cascades as well as impairments of cellular plasticity and resilience in critical neuronal circuits. We propose that therapeutics designed to enhance cellular plasticity and resilience and that counter maladaptive stress-responsive systems may have considerable utility for the treatment of bipolar disorder. Therapeutic strategies designed to address cellular resilience and plasticity include the regulation of neurotrophic pathways, glucocorticoid signaling, phosphodiesterase activity, and glutamatergic throughput and mitochondrial function. While the task of developing novel medications for bipolar disorder is truly daunting, these and similar approaches will ultimately lead to better medications for the millions who suffer from this devastating illness.

Antimanic Agents↗
PubMed1994

Spectrofluorimetry at zero angle: determination of salicylic acid in an acetylsalicylic acid pharmaceutical formulation.

In this work, a solid-state spectrofluorimetric method for drug assays was developed. In particular, we report the determination of salicylic acid (SA), as a hydrolysis product, in solid pharmaceutical formulations containing acetylsalicylic acid (ASA). Recently, we described a sensitive and accurate fluorescence method that provided, through a mathematical application, the simultaneous determination of ASA and SA. By means of the spectrofluorimetric method reported herein it was possible to carry out the SA determination, without any mathematical calculation and with a sensitivity 100 times that of our previous method. The intra- and inter-day reproducibility of the spectrofluorimetric method, expressed as the relative standard deviation, ranged from 0.1 to 0.3%. The present method requires a fluorescence apparatus with the excitation and detection systems in-line (zero angle). The detection system was not sensitive to the excitation wavelength, but was highly sensitive to emission wavelengths from 350 to 800 nm. The results obtained were compared with those of our previous spectrofluorimetric method, together with those of a high-performance liquid chromatography method and a US Pharmacopeia method. The sensitivity of the method was of the order of 10(-8) g.

Aspirin↗
PubMed2000

Meeting the International Conference on Harmonisation's Guidelines on Validation of Analytical Procedures: quantification as exemplified by a near-infrared reflectance assay of paracetamol in intact tablets.

This Perspective explains how the International Conference on Harmonisation's Guidelines on Validation of Analytical Procedures for quantitative methods can be met by near-infrared (NIR) assays of intact pharmaceutical products. Each of the validation characteristics (accuracy, precision, specificity, detection limit, quantification limit, linearity, range, robustness and system suitability testing) is defined, examined for their relevance to quantitative methods and examples given on how they may be used to demonstrate that near-infrared assays are fit for purpose. Methods for preparing samples for calibration are given in detail. The intention is to provide information so that a pharmaceutical manufacturer could validate a method suitable for an application for a variation of a marketing authorisation for an existing product and use a NIR assay instead of the previous method. The perspective is illustrated in detail using a NIR reflectance assay of paracetamol in intact tablets. This proven assay gives results comparable to the British Pharmacopeia ultraviolet assay for paracetamol, the standard errors of calibration and prediction for the NIR method being 0.48% w/w and 0.71% w/w respectively. The method is also precise, the standard deviation and coefficient of variation for six NIR assays on the same day being 0.14% w/w and 0.16% w/w respectively, while measurements over six consecutive days gave 0.31% w/w and 0.36% w/w respectively.

Acetaminophen↗