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At least 685 records · Page 38Linked to original sources
PubMed1991

Quantitation of insulin injection by high-performance liquid chromatography and high-performance capillary electrophoresis.

High-performance capillary electrophoresis (HPCE) was evaluated as a potential technique for the regulatory analysis of commercial dosage forms of insulin. A comparison was made to a liquid chromatographic analysis presently being proposed as an official monograph in the United States Pharmacopeia. The salient points of this comparison were accuracy, precision and ease of use. Both authentic (i.e. single blind, spiked) samples and commercial pharmaceutical formulations (injections) were examined. Chromatographic analyses of both commercial formulations and authentic samples were characterized by good precision, with accuracy being supported by results from authentic (spiked) samples. Conventional HPCE (by which is meant a non-micellar electrolyte used with an uncoated, unmodified fused-silica capillary) achieved reasonable accuracy, but less than impressive precision, when applied to authentic samples. When used for commercial formulations, this type of HPCE did not produce a level of accuracy suitable for regulatory purposes, even with the use of an internal standard.

Animals↗
PubMed2001

Development and validation of a simple capillary zone electrophoresis method for the analysis of kanamycin sulfate with UV detection after pre-capillary derivatization.

Capillary zone electrophoresis was successfully applied to separate eight related substances of kanamycin and several minor unknowns from the main component. Strategies to enhance derivatization and selectivity and to optimize separation parameters involved the application of experimental designs. This chemometrical approach considers main effects as well as interactions of the influential parameters, thus conducting a more thorough investigation of the method than the common step-by-step approach. Central composite face centered designs established optimal separation conditions: 30 mM borax buffer, pH 10.0 containing 16.0% (v/v) methanol and optimal composition of derivatization reagent: 27 mg/ml 1,2-phthalic dicarboxaldehyde and 25 microl/ml mercaptoacetic acid in borate buffer, pH 10.4. The standard curves were linear over the concentration range of 0.007-1.01 mg/ml for the main component and 0.003-0.1 mg/ml for the related substances. The limit of quantitation was 0.14% (m/m) for the related substances and impurities (S/N= 10). The assay method was used to determine the composition of several commercial samples. Quantitative analysis indicates potential usefulness of capillary electrophoresis as an alternative to the assay method prescribed in the European Pharmacopoeia and the United States Pharmacopeia.

Anti-Bacterial Agents↗
PubMed1985

Simple thin-layer chromatographic method for the investigation of six related compounds in flurazepam hydrochloride and its capsules.

A simple and rapid thin-layer chromatographic procedure is presented for the separation and tentative identification of flurazepam hydrochloride and its six related impurities in bulk samples and capsules. A methanolic sample solution is applied to a plate of silica gel containing a fluorescent indicator, which is developed once with a basic quaternary solvent system. Spots are visible under a short wavelength UV lamp, with a limit of detectability ranging from about 62.5 ng (related compound B) to 500 ng (related compound C). The proposed procedure shows several advantages over the related compounds test of the United States Pharmacopeia.

Capsules↗
PubMed2000

Separation of erythromycin and related substances on base-deactivated reversed-phase silica gel columns.

An official liquid chromatographic method for the analysis of erythromycin and related substances, which is based on a polymer reversed-phase, is described in the European Pharmacopoeia and in the United States Pharmacopeia. The pH of the mobile phase used in this system is 9.0. Recent advanced technology has led to the introduction of a new generation of silica-based reversed-phase column packings, which are claimed to be much more stable towards bases. They are useful for the analysis of basic compounds. Studies to verify the separation of erythromycin and related substances on Hypersil BDS C18, Luna C18(2), Inertsil ODS-2 and Supelcosil ABZ+ have been performed and the results are presented. It is shown that these base-deactivated phases give a better sensitivity and selectivity towards erythromycins than the polymer phase, provided that an adapted mobile phase is used. This is the first liquid chromatographic method described for the separation of erythromycin D from erythromycin A.

Chromatography, High Pressure Liquid↗
PubMed1992

Drug allergy.

Although allergic drug reactions are just one type of adverse reaction to medications, they are clinically very important because of the morbidity and mortality they cause. An ever-expanding pharmacopeia increases the potential for allergic drug reactions. An understanding of the types of allergic drug reactions, their immunopathologic mechanisms, and the most likely medications involved; an approach to determine the drug responsible for the reaction; and ways to prevent future allergic drug reactions are important features in minimizing patient morbidity.

Desensitization, Immunologic↗
PubMed1999

History and regulatory issues of generic drugs.

In the November 1987 edition of the Journal of the Society of Clinical Pharmacology and Therapeutics, Dr Richard Weinshilboum of the Department of Pharmacology at the Mayo Clinic made the following observation: "The past half century has been a golden age for pharmacologic therapy. Fifty years ago there were no antibiotics: there were no antihypertensives; there were no antineoplastics; there were no antipsychotics; there were no antidepressants; and the list could go on and on. With the exception of a few effective drugs, the pharmacopeia of that time was filled with placebos. Our generation has witnessed the transformation of medicine. A transformation due in part to the development of drugs capable of controlling or curing diseases that have plagued mankind throughout human history." There is plenty of room for both the innovator and generic manufacturer in this market, but both sides need protection. The regulations adopted by the FDA for providing a safe and effective route to drug approvals will foster both sides while maintaining its primary purpose, assurance to the public that the products they consume have been adequately studied and appropriately applied.

Drug Approval↗
PubMed2003

Dynamics of infection in tick vectors and at the tick-host interface.

Tick-borne flaviviruses are common, widespread, and successfully adapted to their mode of transmission. Most tick vectors of flaviviruses are ixodid species. These ticks are characterized by a comparatively long life cycle, lasting several years, during which the infecting virus may be maintained from one developmental stage of the tick to the next. Hence ticks act as highly efficient reservoirs of flaviviruses. Many tick-borne flaviviruses are transmitted vertically, from adult to offspring, although the frequency is too low to maintain the viruses solely in the tick population. Instead, the survival of tick-borne flaviviruses is dependent on horizontal transmission, both from an infected tick to a susceptible vertebrate host and from an infected vertebrate to uninfected ticks feeding on the animal. The dynamics of transmission and infection have traditionally been considered in isolation: in the tick, following virus uptake in the infected blood meal, infection of the midgut, passage through the hemocoel to the salivary glands, and transmission via the saliva; and in the vertebrate host, virus delivery into the skin at the site of tick feeding, infection of the draining lymph nodes, and dissemination to target organs. However, there is now compelling evidence of a complex interaction between the tick vector and its vertebrate host that affects virus transmission profoundly. The feeding site in the skin is a battleground in which the hemostatic, inflammatory, and immune responses of the host are countered by antihemostatic, anti-inflammatory, and immunomodulatory molecules (mostly proteins and peptides) secreted in tick saliva. Here we speculate that exploitation of the tick pharmacopeia, rather than development of viremia, is the key step in successful tick-borne flavivirus transmission.

Animals↗
PubMed1998

Developing a uniform reporting system for preventable adverse drug events.

The United States Pharmacopeia (USP) Practitioners' Reporting Network utilized nearly three decades of experience to design and develop a nationwide, anonymous, Internet-accessible service for hospitals to report and benchmark medication errors (also known as "preventable adverse drug events"). As nationwide experiential reporting enters the 21st century, the features of MedMARx will provide facilities with the unprecedented ability to conduct daily continuous quality improvement that encompasses medication error risk analysis and prevention based on the experiences of other facilities. Data elements were developed based on review by expert panels and USP's experience with the Medication Errors Reporting Program. The success of this model could indicate its usefulness in other practice settings and for broader applications in health care.

Adverse Drug Reaction Reporting Systems↗
PubMed1999

Small molecule antagonists of the bradykinin B1 receptor.

Screening Pharmacopeia's encoded combinatorial libraries has led to the identification of potent, selective, competitive antagonists at the bradykinin B1 receptor. Libraries were screened using a displacement assay of [3H]-des-Arglo-kallidin ([3H]-dAK) at IMR-90 cells expressing an endogenous human B1 receptor (Bmax = 20,000 receptors/cell, K(D) = 0.5+/-0.1 nM) or against membranes from 293E cells expressing a recombinant human B1 receptor (Bmax = 8,000 receptors/cell, K(D) = 0.5 +/- 0.3 nM). Compound PS020990, an optimized, representative member from the class of compounds, inhibits specific binding of 3H-dAK at IMR-90 cells with a KI of 6 +/- 1 nM. The compound inhibits dAK-induced phosphatidyl inositol turnover (K(Bapp) = 0.4 +/- 0.2 nM) and calcium mobilization (K(Bapp) = 17 +/- 2 nM) in IMR-90 cells. Compounds from the lead series are inactive at the B2 receptor and are > 1000-fold specific for B1 vs. a variety of other receptors, ion channels and enzymes. PS020990 and other related chemotypes therefore offer an excellent opportunity to explore further the role of B1 receptors in disease models and represent a potential therapeutic avenue.

Bradykinin↗
PubMed1986

Oral glucocorticoids and their complications. A review.

Glucocorticoid preparations form one of the cornerstones of the modern medical pharmacopeia. This class of medications has been especially useful to dermatologists, who are purported to be among its most prolific users. Oral glucocorticoids, available now for over 30 years, are prescribed to over 7% of hospitalized patients. Of this group, some 17% may experience adverse effects. It behooves any physician who uses these powerful agents to be aware of the potential complications and side effects. In this article we have undertaken to summarize and discuss selective examples of this rapidly growing segment of the literature.

Administration, Oral↗
PubMed1988

DERM/INFONET: a concept becomes a reality.

The DERMatology INFOrmation NETwork (DERM/INFONET) of the American Academy of Dermatology has become a reality. DERM/INFONET consists of a number of data bases providing information and educational programs for the dermatologist. Currently the components are: DERM/MLS (Medical Literature Search), DERM/RX (dermatologic therapy), DERM/USP (United States Pharmacopeia data base), DERM/ALLERGENS (Food and Drug Administration and Environmental Protection Agency Listings of allergens); Melanoma Prognosis Model; Electronic Mail; Bulletin Board; Meetings Calendar; ICD/CPT (International Classification of Diseases/Current Procedural Terminology) codes; AAD Membership/Committee Directories; and Dermatology Quiz. Additional data bases are planned. As audiovisual and alphanumeric communication systems evolve, newer opportunities for enhancing the DERM/INFONET Biomedical Communication Network will undoubtedly provide even greater opportunities for aiding the dermatologist in delivering state-of-the art management for their patients.

Computer Communication Networks↗
PubMed1985

Hemodynamic effects of lysine-vasopressin in orthostatic hypotension.

Previous investigations have demonstrated that the postural stimulation of arginine vasopressin (AVP) release is reduced in patients with Shy-Drager syndrome. We studied the effects of lypressin nasal spray on hemodynamic parameters in ten patients with chronic orthostatic hypotension. Heart rate, blood pressure, and stroke volume were measured at 0 degrees, 45 degrees and 70 degrees tilt before and one-half hour after two nasal sprays (four United States Pharmacopeia posterior pituitary pressor units, 7.4 micrograms) of lypressin. Lypressin did not significantly alter the effect of tilt on heart rate, stroke volume, and cardiac output but increased the blood pressure and total peripheral resistance. AVP analogues should be tested for treating chronic postural hypotension.

Administration, Intranasal↗
PubMed1998

Influence of pH on in vitro disintegration of phosphate binders.

Hyperphosphatemia, a common complication in patients with end-stage renal disease, is treated with oral phosphate-binding medications that restrict phosphorus absorption from the gastrointestinal (GI) tract. Impaired product performance, such as failure to disintegrate and/or dissolve in the GI tract, could limit the efficacy of the phosphate binder. Disintegration may be as important as dissolution for predicting in vitro product performance for medications that act locally on the GI tract, such as phosphate binders. Furthermore, patients with end-stage renal disease have a wide range in GI pH, and pH can influence a product's performance. The purpose of this study was to determine the effect of pH on in vitro disintegration of phosphate binders. Fifteen different commercially available phosphate binders (seven calcium carbonate tablet formulations, two calcium acetate tablet formulations, three aluminum hydroxide capsule formulations, and three aluminum hydroxide tablet formulations) were studied using the United States Pharmacopeia (USP) standard disintegration apparatus. Phosphate binders were tested in simulated gastric fluid (pH 1.5), distilled water (pH 5.1), and simulated intestinal fluid (pH 7.5). Product failure was defined as two or more individual tablets or capsules failing to disintegrate completely within 30 minutes. Results indicate that 9 of the 15 phosphate binders tested showed statistically significant differences in disintegration time (DT) based on pH. The percentage of binders that passed the disintegration study test in distilled water, gastric fluid, and intestinal fluid were 80%, 80%, and 73%, respectively. The findings of this study show that the disintegration of commercially available phosphate binders is highly variable. The pH significantly affected in vitro disintegration in the majority of phosphate binders tested; how significantly this affects in vivo performance has yet to be studied.

Absorption↗
PubMed1998

The pharmacology of native N-methyl-D-aspartate receptor subtypes: different receptors control the release of different striatal and spinal transmitters.

1. N-methyl-D-aspartate (NMDA) increases the release of radiolabelled dopamine, GABA, acetylcholine and spermidine from rat striatal slices and of noradrenaline from the dorsal cervical spinal cord. 2. These five responses show differing sensitivities to NMDA and also to a variety of competitive antagonists, NMDA channel blockers, glycine antagonists and polyamine site antagonists. 3. Inhibitory activity profiles for 20 different antagonists are presented. All compounds tested showed some degree of selectivity with regard to the different responses and each response showed particular characteristics that suggested mediation by a particular native NMDA receptor subtype. 4. Receptors controlling dopamine, GABA and noradrenaline release were generally more sensitive to most antagonists compared to those controlling acetylcholine and spermidine release. 5. Receptors controlling spermidine release were furthermore insensitive to magnesium, argiotoxin, ifenprodil and eliprodil and displayed low sensitivity to memantine, dextrorphan and dextromethorphan. 6. Receptors controlling noradrenaline release could be further discriminated from those controlling dopamine and GABA release by very high sensitivity to magnesium and MK-801 and to the glycine antagonist L-689,560 but not to other glycine antagonists (CNQX, DNQX, 7-Chlorokynurenate, HA-966). 7. Many other individual drug or receptor differences were noted. The different profiles observed suggest a wide diversity of native NMDA receptors with different properties and an unexpectedly rich pharmacopeia of subtype selective antagonists of native NMDA receptors. 8. Matching subtype selectivity to particular behavioural effects may be possible and the design of subtype selective NMDA antagonists for particular clinical applications while avoiding side effect generation seems to be feasible.

Animals↗
PubMed1982

[Separation of albumin and IgG by direct chromatographic fractionation of human plasma on DEAE and CM-trisacryl M].

We described a continuous chromatographic process using gel-filtration on Ultrogel AcA 202 and ion exchange chromatography on DEAE and CM-Trisacryl M. The human plasma cryosupernatant is firstly desalted on Ultrogel AcA 202 equilibrated in 0.025 M Tris-HCl buffer pH 8.8. containing 0.035 M NaCl and, then, applied to a column of DEAE-Trisacryl M. By these steps, we have obtained following results: - the IgG are not adsorbed and obtained directly with a minimal purity of 99.5%; - a fraction containing alpha2 and beta2 globulin (such as transferrin is removed by elution with 0.025 M Tris-HCl, buffer pH 8.5 containing 0.075 M Na Cl; - crude albumin (purity of 70%) is eluted with 0.025 M Tris-HCl, buffer pH 7.5 containing 0.15 M NaCl. The prepurified albumin is equilibrated on Ultrogel AcA 202 (0.04 M acetate buffer, pH 4.2) and, then, applied to a CM-Trisacryl M column: - the non adsorbed fraction contains alpha and beta-globulins; - a 98% pure albumin is removed by elution with 0.1 M acetate buffer pH 5; - the more adsorbed protein fraction are removed by elution with 0.1 M acetate buffer, pH 4.2. All the chromatographic steps can be completed within 7 h. The purity of the final products fulfills the Pharmacopeia requirements. The characteristics of this plasma protein fractionation process are discussed related to the properties of the new ion exchangers Trisacryl.

Acrylic Resins↗
PubMed2001

Physicochemical assessments of parenteral lipid emulsions: light obscuration versus laser diffraction.

The United States Pharmacopeia (USP) has proposed a new Chapter <729> entitled 'Globule Size Distribution in Intravenous Emulsions' that is intended to identify methods for analyzing the stability of lipid emulsions. We studied the differences between particle-sizing instruments when analyzing the physicochemical stability of a parenteral nutrition mixture compounded with intravenous lipid emulsion, known as an all-in-one mixture. As the growth of lipid droplets, i.e. coalescence, signals an irreversible change in emulsion stability, we focused our investigation on the large diameter tail (>5 microm) of the globule size distribution. Of the four proposed methods, droplet size was studied over a range of mixture stabilities using a low osmolality parenteral nutrition formula employing both light scattering and light obscuration techniques. In addition, the same mixtures were also freshly prepared, and then spiked with a known amount of 5 microm latex spheres. The response obtained from the light obscuration technique was linear and detected both unstable and latex-spiked mixtures in every case for droplets or particles >5 microm. The results of the laser diffraction method were non-linear and overestimated, was less sensitive or missed entirely, globules or particles in the large diameter tail of the dispersion. The results demonstrate that light obscuration is superior to laser diffraction in identifying unstable intravenous fat emulsions.

Chemical Phenomena↗
PubMed2002

Identification of critical process variables for coating actives onto tablets via statistically designed experiments.

The objective of this work was to identify, using a statistical experimental design, the critical processing variables that affect content uniformity and loading of active agent coated on tablets in a 24" Accela-Cota. United States Pharmacopeia (USP) specifies that the % relative standard deviation (RSD) of drug content within a batch should be less than 6%. A Plackett-Burman experimental design was used to identify the process variables that influence the content uniformity and loading efficiency of the drug in the aqueous-based film coat of the tablets. The process variables investigated were inlet airflow, pan speed, inlet air temperature, coating time, atomization pressure, and fan pressure. Atomization pressure was identified as a major variable with respect to content uniformity (P<0.01). Pan speed and coating duration were also identified as variables significantly affecting content uniformity (P<0.05). Fan pressure was identified as a critical variable affecting recovery (P<<0.01). Temperature also significantly affected recovery (P<0.05). A good correlation was obtained between observed and predicted values for content uniformity (r(2)=0.85) and recovery (r(2)=0.95). It was possible to achieve % RSD less than 6% while maintaining the recovery at 80% or higher.

Models, Statistical↗
PubMed2003

Polymorphic properties of micronized carbamazepine produced by RESS.

Carbamazepine microparticles were produced by the rapid expansion of supercritical carbon dioxide solutions (RESS) method. The characteristics of the resulting particles were studied by X-ray powder diffraction (XRPD), differential scanning calorimetry (DSC), scanning electron microscopy (SEM) and image analysis. X-ray diffractograms and SEM photomicrographs revealed that the crystalline nature of the produced carbamazepine microparticles depended on operating pressure and temperature conditions. Different polymorphs were obtained under various operating conditions. Under certain temperature (below 40 degrees C) and pressure (below 240 bar) conditions, it was possible to form primarily the carbamazepine polymorph stipulated by US Pharmacopeia. A significant reduction was observed in the particle size and size distribution range of carbamazepine produced by RESS. The processed particles had a mean diameter smaller than 3 microm and a size distribution range between 0.5 and 2.5 microm compared to unprocessed starting material with a mean diameter of approximately 85 microm and a size distribution range between 15 and 336 microm. Thus, this study demonstrates that the polymorphic characteristics of carbamazepine microparticles produced by the RESS method can be controlled by varying operating pressure and temperature parameters.

Calorimetry, Differential Scanning↗